The State, Rutte and officials reply — no conspiracy, no case

PELS RIJCKEN

District Court of the Northern Netherlands, Leeuwarden location

Hearing of 10 January 2024

Case number/docket number C/17/190788 / HA ZA 2023-172

Statement of defence

in the matter of

1. The State of the Netherlands, having its seat in The Hague

2. Everhardus Ite Hofstra

3. Jaap Tamino van Dissel

4. Maria Petronella Gerarda Koopmans

5. Mark Rutte

6. Sigrid Agnes Maria Kaag

7. Hugo Mattheüs de Jonge

8. Ernst Johan Kuipers

9. Diederik Antonius Maria Paulus Johannes Gommers

10. Wopke Bastiaan Hoekstra

11. Cornelia van Nieuwenhuizen

12. Feike Sijbesma

all electing domicile in The Hague

lawyers: Mr R.W. Veldhuis and Ms M.E.A. Möhring

and

13. Albert Bourla

lawyer: Mr D. Roessingh

14. Giselle Jacqueline Marie-Thérèse Van Cann

15. Paul Edwin Jansen

lawyer: Mr L. Broers

16. William Henry Bill Gates III

lawyer: Mr W.H. Heemskerk

Pels Rijcken & Droogleever Fortuijn N.V. | P.O. Box 11756 | 2502 AT The Hague | +31 70 515 3000 | pelsrijcken.nl

17. Agnes Catharina van der Voort-Kant

lawyer: Mr A.H. Ekker

defendants

versus

1. [redacted]

2. [redacted]

3. [redacted]

4. [redacted]

5. [redacted]

6. [redacted]

7. [redacted]

claimants

lawyers: Mr P.W.J. Stassen and Mr A.G.W. van Kessel

1. Introduction

1.1 The Covid-19 pandemic was a turbulent period in which various, sometimes far-reaching, measures were necessary to protect public health and society. These included, for example, a curfew, compulsory closures of various sectors and of schools, the advice to stay at home as much as possible, the obligation to keep a distance of 1.5 metres from others, and lockdowns. Normal social life was thereby suddenly – and for a prolonged period – turned completely upside down.

1.2 The State's policy was at all times based on three pillars: (i) an acceptable load on the healthcare system – hospitals must be able to provide good-quality care both to Covid-19 patients and to patients in regular care; (ii) protecting vulnerable people in society; and (iii) keeping sight of, and having insight into, the spread of the virus, at a time when little was yet known about the virus.

1.3 The State realises that for people this led to a period of uncertainty, and that in such a situation people rightly ask questions about the approach to the pandemic and the measures taken in that connection. There is every room for such questions.

Against that background, the Dutch Safety Board (Onderzoeksraad voor Veiligheid, OVV) also carried out an extensive investigation into the government's approach to the coronavirus crisis. Its aim was to reconstruct, understand and, where possible, explain the events and actions during the coronavirus crisis. This resulted in three extensive sub-reports.[fn 1]

1.4 The core contention of the claimants in these proceedings is that there was intentional and unlawful deception, in that the defendants allegedly called on the Dutch population (and therefore also the claimants) to be vaccinated against Covid-19, while the defendants allegedly knew that the vaccine was neither safe nor effective. The claimants also seek a declaratory judgment to that effect.

This contention of the claimants is incorrect and lacks any factual basis. That contention and claim are based entirely on the claimants' theory that there is a worldwide conspiracy of which the defendants are allegedly part. That conspiracy is allegedly aimed, among other things, at carrying out the 'Great Reset'. According to the claimants, the 'Great Reset' means that after Covid-19 "a great many things in the world will have to change forever",[fn 2] because Covid-19 has exposed structural flaws and would lead to a "new normal".[fn 3] All "factors determining a human life" would thereby be made the "object of forced change".[fn 4] What this actually

[fn 1] Available at: https://www.onderzoeksraad.nl/nl/page/20666/aanpak-coronacrisis.

[fn 2] Summons, para. 117.

[fn 3] Summons, para. 122.

[fn 4] Summons, para. 186.

means in concrete terms (and why this should lead to the claims being granted) cannot be inferred from the summons. The summons does, however, take the position that, in order to bring about the 'Great Reset', it is pretended that there are major crises, while those crises apparently did not in reality occur.[fn 5] Part of the 'Great Reset' would thus also be the 'Covid-19 project', involving a "pretended Sars-Cov-2 virus".[fn 6] Covid-19 thus allegedly does not actually exist, and the "Covid-19 injections" allegedly lead to (serious) injury and death.[fn 7] According to the claimants, the vaccinations against Covid-19 are "crucial" for carrying out the 'Covid-19 project'.[fn 8] According to the claimants, this therefore amounts to (mental) abuse of the population,[fn 9] a medical experiment on the population,[fn 10] a wish to overthrow the State[fn 11] and even genocide.[fn 12] Why all this would be happening, incidentally, remains unclear after reading the summons.

1.5 According to the claimants, this conspiracy was set in motion by NGOs (in particular the WEF[fn 13]) and is financed by the World Bank.[fn 14] According to the claimants, the State – and various other defendants – are under the direction of the WEF and are implementing the 'Great Reset' and the 'Covid-19 project'.

1.6 The concrete trigger for these theories of the claimants is apparently the book "The Great Reset", which sets out what, according to its authors, the world might look like after Covid-19. This book was written by, among others, Mr Schwab, the chairman of the WEF.[fn 15] Under the heading 'The Great Reset', the WEF initiates the sharing of insights and information on a global approach to the social and economic crisis following the pandemic.[fn 16]

See on this Jean Dohmen, 'Hoe de Great Reset werd gekaapt' [How the Great Reset was hijacked], FD 22 January 2022, pp. 17-18 (exhibit 1) and Nieuwsuur, 'The Great Reset: de steeds terugkerende verzinsels' [The Great Reset: the ever-recurring fabrications], 14 July 2022.[fn 17]

1.7 The claimants' theory is apparently that this book, or the WEF initiative based on it, is a plan which the State (and the other defendants) are implementing on the instructions of the WEF. That theory has no factual basis whatsoever.

[fn 5] Summons, para. 186.

[fn 6] Summons, paras. 41, 109.

[fn 7] Summons, para. 109.

[fn 8] Summons, para. 48.

[fn 9] Summons, para. 277.

[fn 10] Summons, para. 273.

[fn 11] Summons, para. 275.

[fn 12] Summons, para. 281.

[fn 13] GAVI is also mentioned, and, in passing, the UN as well.

[fn 14] Summons, para. 114.

[fn 15] Klaus Schwab & Thierry Malleret, Covid 19. The great reset, Zürich: ISBN Agentur Schweiz 2020.

[fn 16] Appendix to the Proceedings of the House of Representatives (Aanhangsel Handelingen II) 2021/22, 2541, answer to question 4.

[fn 17] NOS, The Great Reset: de steeds terugkerende verzinsels, https://nos.nl/nieuwsuur/collectie/13903/video/2436700-the-great-reset-de-steeds-terugkerende-verzinsels-

1.8 The WEF is nothing more than an organisation aimed at bringing about international cooperation. The WEF aims to be an independent and impartial international consultative body and to offer a platform for public-private cooperation. The WEF, as a private-law foundation under Swiss law, does not have the power to give instructions to the State or its ministers and state secretaries, and that does not happen either. The policy of the State is not determined by the WEF but by the Cabinet – which is scrutinised by the States General (Parliament).

1.9 Nor is the State in any way committed to the objectives of the WEF (or of its chairman), or to the ideas of 'The Great Reset'.

See also, to the same effect, the answers to various parliamentary questions put by MP Van Houwelingen on this subject:

"The WEF objectives as such are not objectives of the Cabinet. The Cabinet is not committed to Mr Klaus Schwab."[fn 18]

"(...) The Dutch government has no affiliation with the Great Reset Initiative and, apart from publicly accessible information on it from the WEF, holds no documents on it. (...)"[fn 19]

1.10 The claimants then go on to unfold theories about the 'Covid-19 project' – which is allegedly part of the 'Great Reset'. Those theories are, quite simply, objectionable. Without any factual basis, or even the beginning of substantiation, it is asserted that Covid-19 (a disease that has cost many people their lives, has led to major damage to health and has also caused much other suffering) does not exist, but was invented in order then – intentionally and wilfully – to be able to administer vaccinations to the population that would lead to (serious) injury and death. Those accusations are not only serious, but also incorrect and unfounded. There is no conspiracy and no 'Covid-19 project': the coronavirus Covid-19 most certainly exists, and the vaccines have been found to be safe and effective.[fn 20] The claimants' contentions run counter to the worldwide scientific consensus and are a patchwork of unfounded suggestions and speculation. These contentions also defy the laws of logic in other respects, since it is impossible to see (and the claimants do not explain) why vaccinations would be given to the population that would lead to (serious) injury and death.

1.11 The summons therefore amounts to nothing more than (conspiracy) theories without any factual basis, with those theories then being used to make far-reaching, objectionable and entirely unfounded accusations. The summons is built on quicksand. There is no conspiracy aimed at a 'Great

[fn 18] Appendix to the Proceedings of the House of Representatives 2021/22, 1164, p. 5.

[fn 19] Appendix to the Proceedings of the House of Representatives 2021/22, 2541, p. 11, answer to question 53.

[fn 20] See below in section 5.

Reset' or a 'Covid-19 project', and the claimants have not provided even the beginning of proof of one. The claims of the claimants are thereby deprived of any basis.

1.12 The State considers it important to emphasise that the consequences of the theories formulated in the summons are not harmless. The narrative used in those theories, of a malevolent elite turning against the population, can ultimately undermine the democratic constitutional state. Already now it provides a group of people with a justification for online hate messages, (death) threats and worse.

1.13 In keeping with this last point, the summons in this case is directed not only against the State but also against various natural persons who, as ministers or state secretaries, as OMT members or otherwise, worked tirelessly to combat the pandemic. These people – many of whom already have to contend with hate messages and (death) threats, and some of whom also require security protection – have been summoned in their private capacity, and at their home addresses, only then to read far-reaching accusations against them personally in the summons. In addition, banners about these proceedings have been hung along the (motor)ways by the foundation that is apparently behind this summons[fn 21] (and offered for sale on its website), on which these persons are named in full (exhibit 2). Both the summons and photos of the banners have been widely shared with the media[fn 22] and on the internet,[fn 23] with accompanying texts such as "Share this, people, the responsible scum is finally coming before the court!!" and "There must be retribution!" (exhibit 3). On the first hearing date of these proceedings, various persons with such banners also gathered in front of the court, and in addition a lorry was parked right in front of the court bearing photos of some individual defendants, with the text "Wanted" above them and, around them, texts including "coronavaccin = vergif" [coronavirus vaccine = poison], "375.000 prikdoden in EU" [375,000 jab deaths in the EU] and "Vaccinazi macht vrij!!" [Vaccinazi sets you free!!] (exhibit 4).

1.14 And all this while there is no legally cognisable interest whatsoever in involving these persons in these proceedings in their private capacity. After all, the accusations made against these persons in the summons concern their work for the State. It is settled case law that this conduct of these persons must therefore be attributed to the State.[fn 24] That means – as (the lawyers of) the claimants know very well – that the accusations have wrongly been directed at these persons in their private capacity and should be directed at the State. To the extent that the claims of the claimants are

[fn 21] See: https://rechtoprecht.online/. For the avoidance of doubt: this does not mean that these proceedings are (or can be) a collective action. That is not the case, if only because the requirements of art. 3:305a DCC have not been met. To the extent that the claimants state in the summons that these proceedings also serve "the interest of fellow human beings" (para. 19 of the summons) or take positions on the vaccination of minors (para. 34 of the summons), it therefore also holds that they cannot stand up for those interests in these proceedings.

[fn 22] See on this also: https://chrisklomp.nl/een-kansloze-corona-aanklacht/. See further the video at https://rechtoprecht.online/rechtszaak.

[fn 23] https://rechtoprecht.online/index

[fn 24] ECLI:NL:HR:1991:ZC0360, NJ 1993/165, para. 3.3. See also Court of Appeal of The Hague 18 July 2017, ECLI:NL:GHDHA:2017:2033, para. 10.

directed against these individual persons, the claims of the claimants must therefore already be dismissed on this ground.

The State also expressly requests your court to rule on this defence. The reason for this is that the State is increasingly confronted with summonses that, without any legally cognisable interest, are directed against individual ministers and state secretaries in their private capacity and other persons connected with the State. The State wishes to put a stop to this, in order to protect the interests of these persons.

1.15 That the claims of the claimants cannot succeed is already established by the foregoing. It is therefore merely for the sake of completeness that the State will elaborate its defence further below. The defence in this statement of defence is in each case conducted not only by the State but also by the other defendants on whose behalf this statement is filed (defendants 1 to 10 and 14 [sic – see translator's note]).

2. The Covid-19 pandemic

2.1 The discovery of the virus

2.1.1 In early January 2020, a new type of coronavirus was identified in Wuhan (China), which had caused a cluster of severe cases of pneumonia.[fn 25] The newly discovered virus was named 'SARS-Coronavirus-2', and the respiratory disease resulting from the virus 'Covid-19'.[fn 26]

2.1.2 An infection with the Covid-19 virus can lead to (very) serious symptoms, such as high fever, shortness of breath, pneumonia and septic shock. A considerable proportion of the people who develop pneumonia as a result of Covid-19 need ventilation and must for that reason be admitted to the ICU. The virus has also proved fatal to a large number of people.[fn 27]

It is now also known that the virus can lead to long-term damage to health, such as so-called 'post-covid'.[fn 28]

2.1.3 On 22 January 2020, the Minister for Medical Care informed the House of Representatives about the new virus.[fn 29] At that time the virus had not yet reached the Netherlands. The minister wrote, among other things, that the RIVM would organise an Outbreak Management Team (OMT):

[fn 25] Advice following OMT 2019-nCoV (Wuhan), 27 January 2020. The OMT advices can be consulted here: https://www.rivm.nl/corona/covid-19/adviezen.

[fn 26] Dutch Safety Board, Aanpak coronacrisis. Deel 1: tot september 2020 [Approach to the coronavirus crisis. Part 1: up to September 2020], The Hague: Onderzoeksraad 2022, p. 40, available at: https://www.rijksoverheid.nl/documenten/rapporten/2022/02/16/aanpak-coronacrisis-deel-1-tot-september-2020.

[fn 27] RIVM, 'Covid-19 Richtlijn' [Covid-19 Guideline], https://lci.rivm.nl/richtlijnen/covid-19.

[fn 28] Rijksoverheid, Post-Covid (langdurige klachten na corona) [Post-Covid (long-term symptoms after corona)], https://www.rijksoverheid.nl/onderwerpen/coronavirus-covid-19/luchtwegvirussen-zoals-griep-en-corona/post-covid.

[fn 29] Parliamentary Papers II (Kamerstukken II) 2019/20, 25295, no. 75.

a team of experts that would advise on the virus and on any further measures to be taken. At that time there was still much uncertainty about the virus:[fn 30]

"It is established that human-to-human transmission has been described, but essential data on how easily that transmission occurs are lacking. The incubation period is probably a minimum of 3 to a maximum of 14 days. The degree of human-to-human contagiousness and the circumstances under which transmission takes place are not yet fully known. Current data point to transmission via droplets released when coughing and sneezing. Transmission by virus in droplets can take place over a range of 1.5 to 2 metres. When a person carrying the virus becomes contagious, and how long the contagiousness persists during illness, is still unknown."

2.1.4 The European Centre for Disease Prevention and Control (ECDC) at that time still assessed the risk of introduction of the virus into Europe as moderate and the risk of further spread within Europe as low.[fn 31] The RIVM stated at the time that the virus did not appear to be very contagious,[fn 32] and that the chance of the virus coming to the Netherlands was considered small.[fn 33]

2.1.5 These assessments were soon overtaken by events.

2.2 The worldwide spread of the virus

2.2.1 On 30 January 2020, the World Health Organization (WHO) – part of the United Nations – found that the virus had spread to various countries on various continents. The WHO accordingly declared that there was "a public health emergency of international concern over the global outbreak of a novel coronavirus".[fn 34]

2.2.2 The worldwide spread of the virus then proceeded rapidly. The number of infections rose quickly, not only in the Netherlands (where the first person tested positive on 27 February 2020) but also worldwide.[fn 35] Worldwide, by the end of February 2020, almost 100,000 people had already (as far as known) been infected with the virus.[fn 36]

[fn 30] Advice following OMT 2019-nCoV (Wuhan), 27 January 2020.

[fn 31] Advice following OMT 2019-nCoV (Wuhan), 27 January 2020.

[fn 32] RIVM, 24 January 2020, https://twitter.com/rivm/status/1220717815340158978.

[fn 33] RIVM, 'Patiënten met longontsteking van onbekende oorzaak in China' [Patients with pneumonia of unknown cause in China], 10 January 2020, https://www.rivm.nl/nieuws/nieuwe-longziekte-in-china.

[fn 34] WHO, 'WHO Director-General's statement on IHR Emergency Committee on Novel Coronavirus (2019-nCoV)', 30 January 2020, https://www.who.int/director-general/speeches/detail/who-director-general-s-statement-on-ihr-emergency-committee-on-novel-coronavirus-(2019-ncov).

[fn 35] Dutch Safety Board, Aanpak coronacrisis. Deel 1, p. 43.

[fn 36] Advice following the 58th OMT Covid-19, 8 March 2020.

2.2.3 On 11 March 2020, the WHO formally determined that there was a pandemic.[fn 37] At that time there were (as far as known) 118,000 infections worldwide in 114 countries, and 4,291 people had died as a result of the virus. The WHO expected the number of infections, the number of affected countries and the number of deaths to rise in the following days and weeks. The decision to classify the Covid-19 outbreak as a pandemic had not been taken lightly, the WHO emphasised:[fn 38]

"Pandemic is not a word to use lightly or carelessly. It is a word that, if misused, can cause unreasonable fear, or unjustified acceptance that the fight is over, leading to unnecessary suffering and death.

Describing the situation as a pandemic does not change WHO's assessment of the threat posed by this virus. It doesn't change what WHO is doing, and it doesn't change what countries should do.

We have never before seen a pandemic sparked by a coronavirus. This is the first pandemic caused by a coronavirus.

And we have never before seen a pandemic that can be controlled, at the same time."

2.2.4 Against this background, on 12 March 2020 the WHO sent an open letter about the seriousness of the pandemic. In that letter all countries are called on to protect public health, with due regard for economic and social stability and with respect for human rights.[fn 39]

2.3 The first wave in the Netherlands

2.3.1 From February 2020 the virus also spread in the Netherlands. As the graph below shows, the virus spread rapidly within a short time and the number of infectious people rose sharply:[fn 40]

[fn 37] WHO, 'WHO Director-General's opening remarks at the media briefing on COVID-19', 11 March 2020, https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.

[fn 38] WHO, 'WHO Director-General's opening remarks at the media briefing on COVID-19', 11 March 2020.

[fn 39] In this letter – contrary to what the claimants assert (summons, para. 11) – nothing is yet said about (the need for) vaccination.

[fn 40] Rijksoverheid, 'Coronadashboard: besmettelijke mensen' [Coronavirus dashboard: infectious people], https://coronadashboard.rijksoverheid.nl/landelijk/besmettelijke-mensen

[Graph: "Number of infectious people over time" – "This graph shows the estimated number of infectious people over time."]

2.3.2 It was therefore soon no longer possible for the RIVM and the GGD (municipal health services) to trace the source of infection for every person infected with the virus. The pressure on healthcare increased (regionally), and concerns also began to arise about the available ICU capacity.[fn 41] Overall, the situation in the Netherlands was therefore one of uncertainty.[fn 42]

2.3.3 With effect from 12 March 2020, the State accordingly took the first far-reaching measures: everyone with symptoms had to stay at home, gatherings of more than a hundred people were cancelled, and everyone had to stay at home as much as possible. From 15 March 2020 the Netherlands was in lockdown:[fn 43] in addition to the measures taken earlier, restaurants and bars, schools and childcare closed, and everyone in the Netherlands was asked to keep a distance of 1.5 metres. Practising close-contact professions was not permitted. On 19 March 2020 nursing homes were closed to visitors. Further, on 26 March 2020 the gathering of groups in the street was no longer permitted. The aim was thereby to slow down the spread of the virus and thus also to keep the burden on healthcare and the ICU manageable.[fn 44]

Testing was of great importance in this respect. On 16 March 2020 the WHO called on all countries to test persons with symptoms of Covid-19.[fn 45] The Netherlands, like many other countries, however, faced a shortage of test materials.[fn 46] The House of Representatives also expressly asked the minister to classify the acquisition of the necessary protective and test materials and ventilation equipment even more as a top priority, as the minister also wrote in his letter.[fn 47] It was necessary to

[fn 41] Dutch Safety Board, Aanpak coronacrisis. Deel 1, p. 46.

[fn 42] Advice following the 59th OMT, 12 March 2020.

[fn 43] Dutch Safety Board, Aanpak coronacrisis. Deel 1, pp. 50, 59.

[fn 44] Dutch Safety Board, Aanpak coronacrisis. Deel 1, p. 50.

[fn 45] WHO, 'WHO Director-General's opening remarks at the media briefing on COVID-19', 16 March 2020, https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19-16-march-2020.

[fn 46] Parliamentary Papers II 2019/20, 25295, no. 179.

[fn 47] Parliamentary Papers II 2019/20, 25295, no. 179.

prioritise. Therefore, at first only patients in hospitals and certain healthcare providers were tested.

In the meantime, various measures were taken to resolve the shortage of test materials. One of these was setting up the National Coordination Structure for Testing Capacity (Landelijke Coördinatiestructuur Testcapaciteit, LCT) and establishing the Diagnostics Taskforce to increase the available testing capacity.[fn 48]

To the extent that the claimants assert that there was no shortage of testing capacity,[fn 49] that is incorrect. There most certainly was a shortage of tests, and not only in the Netherlands. In support of their contention to the contrary, the claimants refer to the World Integrated Trade Solutions (WITS) database of the World Bank. According to the claimants, this shows that Covid-19 tests were already being traded in 2017. That, however, does not follow from the exhibits submitted by the claimants. The relevant WITS web page states (underlining added): "The data here track previously existing medical devices that are now classified by the Wold Customs Organization as critical to tackling Covid-19."[fn 50]

2.3.4 The State's policy was at all times based on three pillars: (i) an acceptable load on the healthcare system – hospitals must be able to provide good-quality care both to Covid-19 patients and to patients in regular care; (ii) protecting vulnerable people in society; and (iii) keeping sight of, and having insight into, the spread of the virus. In addition to these three pillars, the socio-societal perspective was also an important starting point in the trade-offs to be made by the State. That starting point was aimed at limiting social and economic damage in the short term, paying attention to structural social and economic damage, and preventing burdens from falling disproportionately on certain groups.

2.3.5 In forming its policy, the State further at all times took advice from the OMT. The OMT gives medical-epidemiological advice and consists of experts and representatives of various professional organisations who advise from their own areas of expertise. The OMT therefore has specific expertise to give the best possible epidemiological advice.[fn 51] In addition, the State also relied on advice from the RIVM, the WHO and the ECDC. Furthermore, advice on the social effects of the crisis and possible measures was given by the Netherlands Institute for Social Research (Sociaal en Cultureel Planbureau, SCP), and the Ministries of Economic Affairs and Climate Policy, Social Affairs and Employment, and Finance (the 'Troika') advised on the economic, social and financial effects. Finally,

[fn 48] Dutch Safety Board, Aanpak coronacrisis. Deel 3: Januari 2020 - september 2022 [Part 3: January 2020 – September 2022], The Hague: Onderzoeksraad 2023, p. 56, available at: https://www.rijksoverheid.nl/documenten/rapporten/2023/10/25/aanpak-coronacrisis.

[fn 49] Summons, § 188.

[fn 50] WITS website, 'Medical Diagnostic Test instruments and apparatus (902780) exports by country in 2017', https://wits.worldbank.org/trade/comtrade/en/country/ALL/year/2017/tradeflow/Exports/partner/WLD/nomen/h5/product/902780

[fn 51] See, among others, Court of Appeal of The Hague 26 February 2021, ECLI:NL:GHDHA:2021:285, para. 6.8; District Court of The Hague 3 April 2020, ECLI:NL:RBDHA:2020:3013, para. 4.8; Parliamentary Papers II 2000/01, 25295, no. 3 (letter from the Minister of Health, Welfare and Sport of 22 June 2001).

implementation tests were carried out by, among others, the RIVM behavioural unit, the National Police, the safety regions and the Association of Netherlands Municipalities.

2.3.6 Despite the measures taken, the number of infections rose rapidly and sharply. Great pressure on healthcare arose, as a result of which other forms of care had to be scaled down (including for life-threatening diseases such as cancer and heart conditions).[fn 52] The armed forces (Defence) were called in to support healthcare. Occupancy increased rapidly not only in respect of hospital beds; ICU occupancy also increased rapidly. In that period everything was done to scale up ICU capacity and to make maximum use of existing capacity.[fn 53] However, hospital ICU departments became so full that patients had to be transferred to ICU departments of other hospitals, and ultimately even to Germany.[fn 54] For an overview of ICU occupancy, see:[fn 55]

[Graph: "The total number of patients present in the ICU with suspected or proven COVID-19 per day, 2020 – 2022" – legend: "Total number of ICU patients present with suspected or proven COVID-19 status"; "Currently still being supplemented by the ICUs"; vertical axis 0–1250; horizontal axis "Date", 01-Apr 2020 to 01-Oct 2022.]

2.3.7 On 21 April 2020 the figures for hospitals and ICUs were encouraging, but the pressure on healthcare was still enormously high (regular care, for example, was still scaled down to a large extent). The situation in nursing homes was still very worrying. There were many uncertainties. Because the spread of the virus decreased as a result of the measures and the pressure on healthcare was falling,

[fn 52] RIVM, Impact van de eerste COVID-19 golf op de reguliere zorg en gezondheid [Impact of the first COVID-19 wave on regular care and health], 2020, https://www.rivm.nl/bibliotheek/rapporten/2020-0183.pdf.

[fn 53] Parliamentary Papers II 2020/21, 25295, no. 1063.

[fn 54] Dutch Safety Board, Aanpak coronacrisis. Deel 1, p. 58. ICU occupancy peaked on 7 April 2020. At that time there were 1,424 coronavirus patients in the ICU, 46 of them in Germany. The claimants' contention that there was never a shortage of ICU beds (para. 94 of the summons) is therefore incorrect.

[fn 55] National Intensive Care Evaluation (NICE), 'COVID-19 infecties op de IC's 2020 - 2022' [COVID-19 infections in the ICUs 2020 – 2022], https://www.stichting-nice.nl/covid-19-op-de-ic-history.jsp.

some relaxations could, however, be announced. For example, primary schools reopened from 11 May 2020, and more was also possible in the field of sport. The explanation of this decision-making showed how far-reaching the pandemic was, and how much the Cabinet struggled to find a balance between imposing restrictive measures and keeping society open.[fn 56]

2.3.8 At the press conference of 6 May 2020 it was emphasised that the Netherlands had to learn to live with the virus for as long as there was no vaccine.[fn 57] In order to be able to continue daily life as normally as possible until then, testing was of the utmost importance. From 1 June 2020, everyone in the Netherlands with symptoms could therefore be tested. Because everyone could be tested, and had to stay at home after a positive test, there was from that moment some room for relaxing the measures.

2.4 The second wave in the Netherlands

2.4.1 In the summer of 2020 the reproduction number (the average number of people infected by someone with the coronavirus) rose again. It became clear that a second wave was heading for the Netherlands.[fn 58] This led to more measures being taken again in September 2020.[fn 59]

2.4.2 Nevertheless, infections continued to rise. The chairman of the Federation of Medical Specialists described this second wave as a 'tsunami'.[fn 60] The number of infections is shown in the graph below:[fn 61]

[fn 56] Rijksoverheid, 'Letterlijke tekst persconferentie minister-president Mark Rutte en directeur Jaap van Dissel (Centrum Infectieziektebestrijding) na afloop van crisisberaad kabinet' [Verbatim text of the press conference of Prime Minister Mark Rutte and director Jaap van Dissel (Centre for Infectious Disease Control) after the Cabinet crisis consultation], 21 April 2020, https://www.rijksoverheid.nl/documenten/mediateksten/2020/04/21/letterlijke-tekst-persconferentie-minister-president-mark-rutte-en-directeur-jaap-van-dissel-centrum-infectieziektebestrijding-na-afloop-[illegible]

[fn 57] Rijksoverheid, 'Letterlijke tekst persconferentie minister-president Rutte en minister De Jonge na afloop van crisisberaad kabinet' [Verbatim text of the press conference of Prime Minister Rutte and Minister De Jonge after the Cabinet crisis consultation], 6 May 2020, https://www.rijksoverheid.nl/documenten/mediateksten/2020/05/19/letterlijke-tekst-persconferentie-minister-president-rutte-en-minister-de-jonge-na-afloop-van-crisisberaad-kabinet.

[fn 58] Parliamentary Papers II 2020/21, 25295, no. 613.

[fn 59] See also: Dutch Safety Board, Aanpak coronacrisis. Deel 1, p. 80; Rijksoverheid, 'Aangescherpte maatregelen om de verspreiding van het virus terug te dringen' [Tightened measures to reduce the spread of the virus], 28 September 2020, https://www.rijksoverheid.nl/actueel/nieuws/2020/09/28/aangescherpte-maatregelen-om-de-verspreiding-van-het-virus-terug-te-dringen.

[fn 60] Peter Paul van Benthem, 'Blog: Tsunami genaamd COVID-19' [Blog: A tsunami called COVID-19], 12 October 2020, https://demedischspecialist.nl/nieuwsoverzicht/nieuws/blog-tsunami-genaamd-covid-19.

[fn 61] NOS, 'De coronaweek in grafieken: verpleeghuis steeds vaker bron van besmetting' [The coronavirus week in graphs: nursing home increasingly the source of infection], 13 October 2020, https://nos.nl/artikel/2352186-de-coronaweek-in-grafieken-verpleeghuis-steeds-vaker-bron-van-[illegible]

[Graph: "Number of infections doubled in two weeks" – "Positive coronavirus tests in the period 1 June – 13 October"; vertical axis 0 to 8,000.]

2.4.3 Within two weeks the occupancy of hospital beds had doubled. The number of ICU admissions also showed a persistently rising trend, and all this while the pressure on healthcare was already high. The OMT expected that occupancy in hospitals and ICUs would turn out twice as high as in March 2020 if no measures were taken and the earlier measures proved ineffective. Against that background the OMT advised taking new, additional measures.[fn 62]

On 13 October 2020 the Cabinet decided on a partial lockdown.[fn 63]

2.4.4 In early November 2020 a stabilisation could be seen in the number of hospital and ICU admissions. However, there were many signals that the burden on healthcare was too high. The reproduction number was also high in certain places. To make sure that a downward trend would set in, the OMT advised a brief tightening of the measures.[fn 64] The Cabinet followed this advice and – on top of the partial lockdown – introduced additional measures for a period of two weeks.[fn 65] After that, there was a return to the partial lockdown.

2.4.5 The partial lockdown, however, could not sufficiently prevent further spread of the virus. In mid-December there were almost 200 new hospital admissions and more than 25 new ICU admissions every day, and that number was rising slightly. The pressure on healthcare was further increased, and the accumulation of regular care and increasing Covid-19 care would no longer be sustainable if there were a further rise. The country was heading for an increase in the number of infections higher than in March 2020.[fn 66]

[fn 62] Advice following the 80th OMT, 13 October 2020.

[fn 63] Rijksoverheid, 'Gedeeltelijke lockdown om besmettingen terug te dringen' [Partial lockdown to reduce infections], 13 October 2020, https://www.rijksoverheid.nl/actueel/nieuws/2020/10/13/gedeeltelijke-lockdown-om-besmettingen-terug-[illegible]

[fn 64] Advice following the 83rd and 84th OMT, 3 November 2020.

[fn 65] Rijksoverheid, 'Tijdelijke verzwaring van gedeeltelijke lockdown' [Temporary tightening of the partial lockdown], 3 November 2020, https://www.rijksoverheid.nl/onderwerpen/coronavirus-tijdlijn/nieuws/2020/11/03/tijdelijke-verzwaring-van-de-gedeeltelijke-lockdown.

[fn 66] Advice following the 91st OMT, 14 December 2020.

2.4.6 For that reason the Netherlands went into lockdown again from 16 December 2020, which was explained as follows:[fn 67]

"The point is: as human beings we have to be alert all day long, tens or hundreds of times, to keep the virus at a distance. The virus only has to be lucky once to jump across, and we have to be lucky with every contact.

That is an unequal struggle. And it is exactly what we are looking at now. Because the virus is jumping across – and far too often. Every day an average of 60 people die of corona. Every day we record an average of some 9,000 new infections. That is a full Kuip [Rotterdam football stadium] in less than 6 days. The figures are also rising in the hospitals and nursing homes. In the 2nd wave more people end up in hospital than in the first wave.

I know: numbers are abstract. And they certainly do not tell the whole story either. But the reality is that by now more than a million regular hospital treatments have been postponed. Imagine that happening to you when you are waiting for treatment.

The reality is that the people in the hospitals and nursing homes have once again been running on empty for three months. There is really nothing left to give.

By now some 30,000 people with corona have been in hospital, 6,000 of them in intensive care. Of those 6,000, the group under 50 years of age was 2.5 times larger than the group over 80.

The hard truth is that almost all of these 6,000 people would have died if they had not been treated in intensive care. And that, almost without exception, long after their discharge from hospital they still suffer from shortness of breath, extreme fatigue and other symptoms.

That is what corona does. That is why it is so important that healthcare remains accessible. That there is a bed for you if you need one.

So much, briefly, for the background to the lockdown. We have no choice: the number of contacts between people must come down. Everything must now be focused on that."

2.5 Start of the vaccination campaign and the third wave in the Netherlands

2.5.1 This was the situation the Netherlands was in when the first Covid-19 vaccination was administered on 6 January 2021.[fn 68]

[fn 67] Rijksoverheid, 'Tv-toespraak van minister-president Mark Rutte over de lockdown' [TV address by Prime Minister Mark Rutte on the lockdown], 14 December 2020, https://www.rijksoverheid.nl/documenten/toespraken/2020/12/14/tv-toespraak-van-minister-president-[illegible]

[fn 68] Dutch Safety Board, Aanpak coronacrisis. Deel 2: september 2020 tot juli 2021 [Part 2: September 2020 to July 2021], The Hague: Onderzoeksraad 2022, p. 165. Available at: https://www.rijksoverheid.nl/documenten/rapporten/2022/10/12/aanpak-coronacrisis.

2.5.2 The scarcity of vaccines at that time made it necessary to set priorities in offering vaccines. The aim was to reduce serious illness and death from Covid-19 as much as possible.[fn 69] For that reason the most vulnerable people were vaccinated first: people aged sixty or over (from oldest to youngest), and people with underlying health problems.[fn 70] In addition, medical staff with direct patient contact, such as nurses in nursing homes, were also vaccinated with priority,[fn 71] so that staff absence in the overburdened healthcare system could be prevented as much as possible. The vaccine would then be offered by age group (from oldest to youngest).[fn 72] In this way everyone in the Netherlands was offered the opportunity to be vaccinated, with the State informing the population as well and as fully as possible.

2.5.3 By the end of February 2021, almost 800,000 people had received a first Covid-19 vaccination. Slightly more than 200,000 people had also received a second dose of the vaccine.[fn 73] These were (some of) the most vulnerable people (over-80s, residents of care institutions) and healthcare workers.

2.5.4 At the end of March 2021 a third wave began to become visible in the number of infections.[fn 74] The third wave was expected to peak around mid-April 2021.[fn 75] The lockdown therefore remained in force.

2.5.5 On 13 April 2021 the Cabinet announced that certain restrictions (such as the curfew) could be lifted from the end of April 2021, partly because of the increased vaccination rate – in particular among the elderly and the vulnerable:[fn 76]

"With all the vaccinations we are administering, we will – as far as we can now foresee – reach a point in the second half of May that we are all incredibly looking forward to. By then all people over sixty and people with a high medical risk will have had a first vaccine. Once they are protected, far fewer people will become seriously ill from a coronavirus infection. And together with the people who have already been ill and have built up protection that way, this ensures that the virus can take up much less room. And we are already seeing that now. That is why we will soon dare to release measures in a number of steps."

[fn 69] Dutch Safety Board, Aanpak coronacrisis. Deel 2, p. 147.

[fn 70] Health Council of the Netherlands (Gezondheidsraad), Strategieën voor COVID-19-vaccinatie [Strategies for COVID-19 vaccination] No. 2020/23, The Hague: 19 November 2020. Available at: https://www.gezondheidsraad.nl/documenten/adviezen/2020/11/19/strategieen-voor-[illegible]

[fn 71] Dutch Safety Board, Aanpak coronacrisis. Deel 2, p. 147.

[fn 72] Parliamentary Papers II 2020/21, 25 295, no. 745, p. 8.

[fn 73] RIVM, 'Eerste cijfers vaccinatiegraad in beeld' [First vaccination rate figures], 23 February 2021, https://www.rivm.nl/nieuws/eerste-cijfers-vaccinatiegraad-in-beeld.

[fn 74] Rijksoverheid, 'Letterlijke tekst persconferentie minister-president Rutte en minister de Jonge' [Verbatim text of the press conference of Prime Minister Rutte and Minister De Jonge], 23 March 2021, https://www.rijksoverheid.nl/documenten/mediateksten/2021/03/23/letterlijke-tekst-persconferentie-minister-president-rutte-en-minister-de-jonge-23-maart-2021.

[fn 75] Dutch Safety Board, Aanpak coronacrisis. Deel 2, p. 67.

[fn 76] Rijksoverheid, 'Letterlijke tekst persconferentie minister-president Rutte en minister de Jonge', 13 April 2021, https://www.rijksoverheid.nl/documenten/mediateksten/2021/04/13/letterlijke-tekst-persconferentie-minister-president-rutte-en-minister-de-jonge-13-april-2021.

2.5.6 The effects of the start of the vaccination campaign were accordingly clearly visible during the third wave. In the third wave the RIVM noted that the number of hospital admissions of people under sixty (who had generally not yet been vaccinated) rose sharply, whereas the number of hospital admissions of people over eighty (a large proportion of whom had been vaccinated) fell – probably as a result of the vaccinations.[fn 77]

2.5.7 By mid-May 2021, more than 6 million people in the Netherlands had been vaccinated with a first dose of the Covid-19 vaccine. Almost 2.5 million people had been vaccinated against the virus with two doses.[fn 78]

[Table: "Total participation in COVID-19 vaccination" – "Table 1: Number of persons who have received a first and/or second dose of COVID-19 vaccine, week 1 to week 20, 2021, by type of provider". Columns: target group and/or provider; start date; vaccine; first dose; second dose; total number of vaccinations. Rows: age groups (including healthcare workers) vaccinated by GGD (from over-90s, start 25-01-2021, through 85-89, 80-84, 75-79, 70-74 and younger age groups down to under-20s and "age unknown"); vaccinated by general practitioners (estimated), start 15-02-2021, AZ; vaccinated by other providers (estimated), start 06-01-2021, COM/MOD/AZ/JANSS. Totals: first dose 7.153.355; second dose 2.304.562; total vaccinations 8.457.917. The individual row figures are not reliably legible in the scan: [illegible].]

2.5.8 As of 19 May 2021, and then again as of 28 May 2021, (accordingly) further relaxations were announced. In principle all sectors, including secondary education, could reopen subject to conditions. Here too vaccination played a major role: "And it will take a little while yet, but the end of this crisis comes closer with every jab."[fn 79]

[fn 77] RIVM, 'In derde golf sterke stijging ziekenhuisopnamen jongere leeftijdsgroepen' [In third wave sharp rise in hospital admissions of younger age groups], 4 May 2021, https://www.rivm.nl/nieuws/in-derde-golf-sterke-stijging-ziekenhuisopnames-jongere-leeftijdsgroepen.

[fn 78] RIVM, 'Deelname COVID-19-vaccinatie in Nederland' [Participation in COVID-19 vaccination in the Netherlands], 25 May 2021, https://www.rivm.nl/sites/default/files/2021-05/Wekelijkse%20rapportage%20COVID-19%20Vaccinatiegraad_25_05_2021.pdf.

[fn 79] Rijksoverheid, 'Letterlijke tekst persconferentie minister-president Rutte en minister de Jonge', 28 May 2021, https://www.rijksoverheid.nl/documenten/mediateksten/2021/05/28/letterlijke-tekst-persconferentie-minister-president-rutte-en-minister-de-jonge-28-mei-2021.

2.5.9 At the end of June 2021 society reopened (subject to the 1.5-metre measure).[fn 80] At that point 9.9 million people in the Netherlands had been vaccinated with their first dose of the vaccine against Covid-19, and 5.3 million people had also already received their second dose:[fn 81]

[Graph: "Participation in COVID-19 vaccination (percentage)", 0%–100%, by age group (week 25): 90+ (75%); 85-89 (83%); 80-84 (87%); 75-79 (88%); 70-74 (85%); 65-69 (76%); [illegible]; 55-59 (44%); 50-54 (35%); 45-49 (15%); 40-44 (17%); 35-39 (10%); 30-34 (9%); 25-29 (9%); 20-24 (11%); 17-19 (8%); horizontal axis: week number. "Figure 2: Cumulative vaccination rate for full COVID-19 vaccination by age group and week, week 1 to week 25, 2021."]

2.6 A high vaccination rate and the lifting of the last measures

2.6.1 In the summer of 2021 the epidemiological picture was stable. The vaccination rate among adults now stood at 85.6%. Already 81.7% of adults were fully vaccinated and thereby protected to a high degree.[fn 82] As a result, the 1.5-metre measure could also be lifted in September 2021.[fn 83]

2.6.2 When the number of infections rose again in the autumn of 2021, it once more became clear how effective the vaccine was. The OMT wrote about this:[fn 84]

"The inflow and occupancy in nursing wards and ICU in hospital is increasing slightly. The average daily number of admissions to nursing wards in the past week was on average 42 compared with 34 the week before, and 10 versus 7 in the ICU (source: LCPS). The

[fn 80] Rijksoverheid, 'Letterlijke tekst persconferentie minister-president Rutte en minister de Jonge' [Verbatim text of the press conference of Prime Minister Rutte and Minister De Jonge], 18 June 2021, https://www.rijksoverheid.nl/documenten/mediateksten/2021/06/18/letterlijke-tekst-persconferentie-minister-president-rutte-en-minister-de-jonge-18-juni-2021.

[fn 81] RIVM, 'Deelname vaccinatie in Nederland' [Participation in vaccination in the Netherlands], 29 June 2021, https://www.rivm.nl/sites/default/files/2021-06/COVID-19_Vaccinatie_Schattingen_WebSite_rapport_20210629_1059_aangepast.pdf.

[fn 82] Parliamentary Papers II 2020/21, 25295, no. 1422.

[fn 83] Letter to Parliament 'Stand van zaken COVID-19' [State of affairs COVID-19] dated 14 September 2021, Parliamentary Papers II 2020/21, 25295, no. 1422.

[fn 84] Advice following the 127th OMT, 11 October 2021.

incidence of hospital admission is much higher in the unvaccinated population than in the vaccinated population. In September this incidence was, in all age groups, at least 10 times as high in the unvaccinated population compared with the fully vaccinated population. The previously found very high vaccine effectiveness against both hospital admission and ICU admission in the Netherlands persists in the most recent data (95% and 98%)."

2.6.3 As a result of the increased vaccination rate, the peak in the number of infections was lower. Nevertheless, the peak was higher than the Cabinet considered responsible, partly in view of the pressure that had arisen on healthcare.[fn 85] This led to the reintroduction of various restrictive measures. In addition, the booster vaccination campaign for people aged over 60 also started.[fn 86] At that time booster vaccines were proving very effective in other countries against further infections.[fn 87]

2.6.4 In December 2021 the more contagious Omicron variant advanced. The severity of the course of illness with this variant was not yet known at the time. For that reason, a hard lockdown was decided on at the end of that month.[fn 88] In addition, the booster campaign was further expanded.[fn 89]

2.6.5 Despite the high number of infections, the Cabinet, after advice from the OMT, considered it responsible on 25 January 2022 to relax measures.[fn 90] An important reason for this was the high vaccination rate. The vaccines protected well against hospital admissions, thereby relieving the burden on healthcare. The group of unvaccinated people was clearly over-represented in the number of hospital admissions:[fn 91]

[fn 85] Parliamentary Papers II 2020/21, 25295, no. 1468.

[fn 86] Rijksoverheid, 'Letterlijke tekst persconferentie coronavirus minister president Rutte en minister de Jonge' [Verbatim text of the coronavirus press conference of Prime Minister Rutte and Minister De Jonge], 12 November 2021, https://www.rijksoverheid.nl/documenten/mediateksten/2021/11/12/letterlijke-tekst-persconferentie-coronavirus-minister-president-rutte-en-minister-de-jonge-12-november-2021.

[fn 87] Health Council of the Netherlands, Advies Boostervaccinatie tegen COVID-19 bij personen van 18 tot 60 jaar [Advice on booster vaccination against COVID-19 in persons aged 18 to 60], 25 November 2021. Available at: https://www.gezondheidsraad.nl/documenten/adviezen/2021/11/25/boostervaccinatie-tegen-covid-19-bij-personen-van-18-tot-60-jaar.

[fn 88] Parliamentary Papers II 2020/21, 25295, no. 1672.

[fn 89] Health Council of the Netherlands, Advies Boostervaccinatie tegen COVID-19 bij personen van 18 tot 60 jaar, 25 November 2021. Available at: https://www.gezondheidsraad.nl/documenten/adviezen/2021/11/25/boostervaccinatie-tegen-covid-19-bij-personen-van-18-tot-60-jaar

[fn 90] Advice following the 139th OMT, 24 January 2022.

[fn 91] Rijksoverheid, 'Letterlijke tekst persconferentie coronavirus minister-president Rutte en minister Kuipers' [Verbatim text of the coronavirus press conference of Prime Minister Rutte and Minister Kuipers], 25 January 2022, https://www.rijksoverheid.nl/documenten/mediateksten/2022/01/25/letterlijke-tekst-persconferentie-coronavirus-minister-president-rutte-en-minister-kuipers.

[Graphic: "Vaccines still offer high protection" – "Hardly any people in hospital with booster vaccination" – Netherlands – Hospital – legend: vaccination + booster; basic vaccination; [illegible]. Source: RIVM, 19 January [2022]. The figures in the graphic are not legible in the scan.]

2.6.6 On 15 February 2022 the press conference opened with the words "the country is opening up again". The number of virus infections was higher than ever, but the number of hospital admissions remained stable and low. Thanks in part to the vaccines, the Netherlands was more resilient to the virus:[fn 92]

"Fortunately we are now in a different phase. You can see here that a very large number of people are infected at the moment, more than ever. You can also see that after the last two press conferences on 14 January and 25 January, at which we announced relaxations, the number of infections rose further. We now seem to be at or just past the peak. And if you now look at how hospital occupancy is going, the picture is totally different from the past two years. Hospital occupancy always rose along with infections. But now you see that it remains practically stable, despite those high infection figures. So what we already hoped and suspected turns out to be true: we are more resilient to the virus. Thanks to vaccines and booster jabs. And thanks to the immunity that people have built up because they have been infected. And moreover, that Omicron variant makes people less ill."

2.6.7 In March 2022 practically all coronavirus measures were lifted. The obligation to wear a face mask at airports did still apply. That measure lapsed on 21 May 2022.[fn 93]

[fn 92] Rijksoverheid, 'Letterlijke tekst persconferentie coronavirus minister-president Rutte en minister Kuipers', 25 January 2022, https://www.rijksoverheid.nl/documenten/mediateksten/2022/01/25/letterlijke-tekst-persconferentie-coronavirus-minister-president-rutte-en-minister-kuipers.

[fn 93] Rijksoverheid, 'Mondkapjes en vliegen: Nederlandse regels veranderen vanaf 21 mei 2022' [Face masks and flying: Dutch rules change from 21 May 2022], 13 May 2022, https://www.rijksoverheid.nl/actueel/nieuws/2022/05/13/mondkapjes-en-vliegen-nederlandse-regels-veranderen-vanaf-21-mei-2022.

2.7 The consequences of the Covid-19 pandemic: excess mortality and illness

2.7.1 Up to and including 2022, more than 48,000 people in the Netherlands died of Covid-19.[fn 94] In the years 2020, 2021 and 2022 – during the Covid-19 pandemic – there was also clear (and substantial) excess mortality in the Netherlands. This is shown by the figures of Statistics Netherlands (CBS):[fn 95]

[Graph: "Excess mortality", x 1000, vertical axis -5 to 20, years 2015 to 2022; "*provisional figures".]

It is therefore incorrect that, as the claimants assert, there was no excess mortality during the pandemic.[fn 96]

In support of that position the claimants submitted a table as exhibit 4 which, according to the claimants, originates from CBS. That table, however, cannot be found on the CBS website. Moreover, the data that can be found on the CBS website show that the figures included in the table submitted as exhibit 4 are not correct. For example, exhibit 4 states that the number of deaths in 2020 was 162,348, whereas according to CBS there were 168,678.[fn 97] Further, exhibit 4 states that the number of inhabitants of the Netherlands in 2020 was 17.47 million people, whereas according to CBS there were (rounded) 17.41 [million].[fn 98] The percentages included in exhibit 4 are therefore also incorrect. In any event: the position of

[fn 94] CBS, Gezondheid in coronatijd [Health in the time of corona], 1 September 2023, https://www.cbs.nl/nl-nl/visualisaties/welvaart-in-coronatijd/gezondheid-in-coronatijd.

[fn 95] CBS, '2022 derde jaar op rij met oversterfte' [2022 third year in a row with excess mortality], 25 January 2023, https://www.cbs.nl/nl-nl/nieuws/2023/04/2022-derde-jaar-op-rij-met-oversterfte.

[fn 96] Summons, para. 29.

[fn 97] Statline, 'Bevolkingsontwikkeling; maand en jaar' [Population development; month and year] (exhibit 5). See also: https://www.cbs.nl/nl-nl/visualisaties/dashboard-bevolking/bevolkingsgroei/overlijden.

[fn 98] CBS, 'Bevolkingsteller' [Population counter] (via "toon tabel" [show table]), https://www.cbs.nl/nl-nl/visualisaties/dashboard-[illegible]

the claimants that according to CBS there was no excess mortality in 2020 conflicts with what CBS itself concludes on the matter: "In 2020 and 2021 a total of 340 thousand people died. That is 30 thousand (10 percent) more people than expected if there had been no COVID-19 epidemic. Total mortality from COVID-19 based on the cause-of-death statistics in those years was 40 thousand. The three waves of excess mortality that were visible in 2020 and 2021 coincide with the periods in which many people died of COVID-19. In particular, the rise, the peaks and then the fall in excess mortality and COVID-19 mortality occur at about the same time in each wave."[fn 99]

2.7.2 That there was excess mortality during the coronavirus pandemic can also be seen clearly in the graph below:[fn 100]

[Graph: "2.2.1 Deaths per week*" – light blue area: 95% interval; vertical axis 0 to 6000; 2020 and 2021; labels: 1st wave, heatwave, 2nd wave, 3rd wave; lines: "Deaths" and "Deaths, expected"; "*Provisional figures".]

[fn 99] CBS, 'Sterfte, oversterfte en COVID-19-sterfte in 2020 en 2021' [Mortality, excess mortality and COVID-19 mortality in 2020 and 2021], 23 June 2022, https://www.cbs.nl/nl-nl/longread/statistische-trends/2022/sterfte-oversterfte-en-covid-19-sterfte-in-2020-en-2021

[fn 100] CBS, 'Sterfte, oversterfte en COVID-19-sterfte in 2020 en 2021', 23 June 2022.

2.7.3 Against that background, CBS concludes that the excess mortality in the period 2020–2022 – and in particular in 2020 and 2021 – is connected with mortality from Covid-19. Whereas excess mortality in that period was 45,800, more than 48,000 people died of Covid-19 in that same period. CBS also reports – with reference to a study by the RIVM[fn 101] – that vaccination against Covid-19 is associated with a reduced chance of dying of Covid-19.[fn 102]

2.7.4 Infection with the coronavirus can also, apart from the risk of death, have serious and long-lasting physical consequences. For example, a large number of people have been admitted to hospital or the ICU.[fn 103] Research shows that nine out of ten patients admitted to hospital still have symptoms a year later.[fn 104] But even without hospital admission Covid-19 can have consequences in the form of long-lasting symptoms after an infection (post-covid). Frequently described long-lasting symptoms are fatigue, shortness of breath, headache, forgetfulness and difficulty concentrating, loss of smell, palpitations, muscle pain, and anxiety and mood complaints.[fn 105] In the first five months of 2022, more than 700 people with long-lasting Covid symptoms reported to the UWV (Employee Insurance Agency). In 62% of cases the Covid symptoms were so serious and so long-lasting that the persons concerned were declared fully unfit for work.[fn 106]

2.7.5 The social consequences of the coronavirus crisis are also great. During the coronavirus years there was a great deal of postponed care, which has consequences for the number of healthy life years people have. In that connection it is also relevant that waiting times in healthcare are still long. That applies not only to physical care but also to mental healthcare – where an increase in the number of referrals has been observed since the coronavirus crisis (in particular among young people). Furthermore, young people have fallen behind in their education. The economic effects of the coronavirus crisis have also been considerable, despite the dampening effect on those effects of the support granted by the government to businesses.[fn 107]

[fn 101] RIVM, 'Vaccinatie verlaagt kans op COVID-19 sterfte en verhoogt kans op sterfte door andere oorzaken niet' [Vaccination reduces the chance of COVID-19 death and does not increase the chance of death from other causes], 23 June 2022. Available at: https://www.rivm.nl/nieuws/vaccinatie-verlaagt-kans-op-covid-19-sterfte-en-verhoogt-kans-op-sterfte-door-andere-oorzaken-niet

[fn 102] CBS, 'Oversterfte en doodsoorzaken in 2020 tot en met 2022' [Excess mortality and causes of death in 2020 to 2022], 11 December 2023. Available at: https://www.cbs.nl/nl-nl/longread/rapportages/2023/oversterfte-en-doodsoorzaken-in-2020-tot-en-met-[illegible]

[fn 103] Health Council of the Netherlands, Langdurige klachten na Covid-19. Contouren van het post-Covid-syndroom [Long-lasting symptoms after Covid-19. Contours of the post-Covid syndrome], no. 2022/04, The Hague: 2022. Available at: https://www.gezondheidsraad.nl/onderwerpen/zorg/alle-adviezen-over-zorg/langdurige-klachten-na-covid-19.

[fn 104] Erasmus MC, 9 op de 10 patiënten houden langdurige klachten na ziekenhuisopname voor covid-19 [9 out of 10 patients have long-lasting symptoms after hospital admission for covid-19], https://amazingerasmusmc.nl/infectie/9-op-de-10-patienten-houden-langdurige-klachten-na-ziekenhuisopname-voor-covid-19/.

[fn 105] Health Council of the Netherlands, Langdurige klachten na Covid-19. Contouren van het post-Covid-syndroom, no. 2022/04.

[fn 106] UWV, 'UWV: meeste cliënten met langdurige coronaklachten volledig arbeidsongeschikt' [UWV: most clients with long-lasting coronavirus symptoms fully unfit for work], 28 June 2022, https://www.uwv.nl/nl/persberichten/uwv-meeste-clienten-met-langdurige-coronaklachten-volledig-arbeidsongeschikt

[fn 107] See also Maatschappelijk Impact Team [Social Impact Team], 'Maatschappelijke impact van de coronacrisis, Presentatie voor de Technische Briefing in de Tweede Kamer' [Social impact of the coronavirus crisis, presentation for the technical briefing in the House of Representatives], 13 December 2022, https://www.rijksoverheid.nl/binaries/rijksoverheid/documenten/publicaties/2022/12/23/presentatie-voorzitter-mit-technische-briefing-13-12-2022/Presentatie+voorzitter+MIT+technische+briefing+13+december+2022.pdf.

2.7.6 The consequences of Covid-19 are therefore serious. The theories of the claimants – which amount to saying that Covid-19 does not exist – do no justice to the people who died as a result of Covid-19 and their loved ones, to the people who are (or have been) ill for a long time as a result of Covid-19, and to the people who have otherwise suffered harm as a result of Covid-19.

3. The claims of the claimants

3.1 In these proceedings the claimants seek a declaratory judgment that the defendants (as a group and each individually) acted unlawfully towards the claimants "by intentionally misleading them in an unlawful manner and thereby inducing them to have Covid-19 injections administered, of which the defendants knew, or at least ought to have known, that these injections were not safe and effective". In addition, the claimants seek an order that the defendants pay damages, to be assessed in separate follow-up proceedings (schadestaatprocedure).

3.2 These proceedings therefore concern a far-reaching claim, by which serious accusations are made against the defendants. The State notes here at the outset that the claimants' accusation that the defendants, each individually or as a group, intentionally misled the claimants and thereby induced them to take a Covid-19 vaccination has been explained entirely insufficiently. The claimants have not even explained – nor made plausible – 1) that they had themselves vaccinated, 2) which vaccine was involved, 3) at what time or times this took place, and 4) what information from which defendant was decisive for each of them in doing so. Since this explanation and substantiation are lacking, the State disputes that the claimants had themselves vaccinated as a result of information provided by the defendants.

3.3 But in any event: there is no question of intentionally and unlawfully misleading the claimants in order to induce them to take a Covid-19 vaccine while the defendants knew or ought to have known that those vaccines were not safe and effective, as set out in the declaratory judgment sought. The State will explain this in more detail below. The State's starting point is that the claimants have not met their burden of assertion (stelplicht), and that the claims must already be dismissed for that reason.

4. Protecting public health

4.1 The State has a positive obligation to protect public health. That follows from art. 22 of the Constitution, which provides that the State shall take measures to promote public health, and also from art. 2 and art. 8 ECHR. This also means that the State is obliged to prevent epidemic, endemic and other diseases as far as possible and to combat outbreaks of them.[fn 108]

[fn 108] See also Court of Appeal of The Hague 14 December 2021, ECLI:NL:GHDHA:2021:2453, para. 6.10 and Court of Appeal of The Hague 14 December 2021, ECLI:NL:GHDHA:2021:2452, para. 6.15. See further Bunschoten, in: T&C Grondwet en Statuut, commentary on art. 22 of the Constitution.

4.2 In view of the seriousness of the Covid-19 pandemic and the (possible) consequences of that pandemic for the health of the Dutch population,[fn 109] the State was therefore unquestionably obliged to take measures to combat the Covid-19 pandemic.

4.3 The State gave effect to this positive obligation by taking various, sometimes far-reaching, measures – after carefully weighing all the interests involved. Furthermore – once vaccines became available – the State made vaccines against Covid-19 available (free of charge and on an informed basis) to everyone in the Netherlands who wanted them, and recommended that the population make use of this opportunity.

4.4 As will be explained in more detail below, these vaccines were admitted to the European market after assessment by the European Medicines Agency (EMA), and the Health Council gave positive advice on including these vaccines in the National Immunisation Programme (Rijksvaccinatieprogramma). In the authorisation procedure there was no departure from the regular substantive requirements imposed for the authorisation of new medicines. The State could therefore unquestionably decide to include these vaccines in the National Immunisation Programme and to call on the population to have themselves vaccinated. In doing so the State did not act unlawfully, but on the contrary gave effect to its positive obligation to protect public health.

5. The development and authorisation of the vaccines against Covid-19

5.1 Obtaining a marketing authorisation (EMA)

5.1.1 A medicinal product, such as a vaccine, may only be placed on the market in the Netherlands if a marketing authorisation has been granted for it by the national or European medicines authority.[fn 110] The national medicines authority is the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG).[fn 111] The European medicines authority is the EMA.[fn 112]

5.1.2 For medicinal products that protect against viral diseases, such as Covid-19, it is compulsory, in order to obtain a marketing authorisation, to follow the centralised procedure[fn 113]

[fn 109] See section 2 above.

[fn 110] Art. 40(1) Medicines Act (Geneesmiddelenwet).

[fn 111] Art. 2 and art. 9, opening words and under f, Medicines Act.

[fn 112] Art. 1 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

[fn 113] CBG, 'Centrale procedure' [Centralised procedure], https://www.cbg-meb.nl/onderwerpen/hv-centrale-procedure.

at the EMA.[fn 114] If the marketing authorisation is then granted by the EMA (and thus: under the responsibility of the European Commission), that authorisation is valid in one go for the entire European Union – and therefore also for the Netherlands.[fn 115]

5.1.3 In essence, that centralised procedure at the EMA involves the following.

Within the EMA there is a special committee that focuses on medicinal products for human use[fn 116] – the Committee for Medicinal Products for Human Use (CHMP). The CHMP coordinates the scientific evaluation of the quality, safety and efficacy of medicinal products for human use.[fn 117] Each member state appoints a member and an alternate who sit on the CHMP[fn 118] and in principle represent the competent national authorities. The Dutch representatives on the CHMP both work at the CBG. In this way the national medicines authorities have a say in the decision-making of the CHMP and the EMA.

5.1.4 Every application for an authorisation for a medicinal product for human use must be accompanied by the particulars and documents referred to in art. 6 of Regulation (EC) 726/2004 (the medicinal product dossier). The medicinal product dossier consists of five parts (administrative data, data on the production process and quality, characteristics of the medicinal product, results of laboratory tests, and results of tests on human subjects).[fn 119]

5.1.5 The starting point is that these data must have been submitted at the time the application is made. However, there is also the possibility of an accelerated procedure, a so-called 'rolling review'.[fn 120] In that case information is already shared with (and assessed by) the EMA while the clinical trials are still in full swing. In that way the assessment can start earlier. This yields a considerable saving of time, without any concessions being made in the assessment of the quality, safety and efficacy of the vaccine.[fn 121]

[fn 114] Regulation (EC) No 726/2004, Annex 1, art. 3 (as amended on 20 May 2008, see recital 8).

[fn 115] Art. 13(1) Regulation (EC) No 726/2004.

[fn 116] Art. 5(1) and art. 56(1) Regulation (EC) No 726/2004.

[fn 117] Art. 57(1)(b) of Regulation (EC) No 726/2004.

[fn 118] Art. 61 of Regulation (EC) No 726/2004.

[fn 119] CBG, 'CBG jaarverslag 2020: procedures om een geneesmiddel op de markt te brengen' [CBG annual report 2020: procedures for placing a medicinal product on the market], https://www.cbgjaarverslag.nl/cbg-jaarverslag/2020/01/procedures-om-een-geneesmiddel-of-vaccin-op-[illegible]

[fn 120] CBG, CBG Jaarverslag 2020: procedures om een geneesmiddel op de markt te brengen, 2020; see also: EMA, 'COVID-19 guidance: evaluation and marketing authorisation', https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/guidance-developers-companies/covid-19-guidance-evaluation-marketing-authorisation.

[fn 121] EMA, 'Start of rolling review for adapted Comirnaty COVID-19 vaccine', 15 June 2022, https://www.ema.europa.eu/en/news/start-rolling-review-adapted-comirnaty-covid-19-vaccine.

5.1.7 The CHMP assesses whether the conditions for granting a marketing authorisation have been met. To that end the CHMP appoints one of its members (from one of the member states) as rapporteur.[fn 122] This rapporteur is responsible for coordinating the assessment. The committee concerned may appoint a second member (from another member state) as co-rapporteur. It is the task of the co-rapporteur to critique the rapporteur's report or to draw up a second report independently.[fn 123]

5.1.8 The rapporteurs each draw up a scientific report in which they summarise the data from the authorisation application, give their assessment of the efficacy of the medicinal product and give their view on possible uncertainties in the data. The CHMP then meets in plenary session to discuss the reports and adopt a final opinion.[fn 124] In this plenary session all member states and national medicines authorities are represented by their experts who sit on the CHMP. The final opinion is sent to the European Commission within 15 days.[fn 125] The European Commission ultimately decides, on the basis of the CHMP's opinion, whether a marketing authorisation is actually granted.[fn 126]

5.1.9 On the basis of art. 14-a(1) of Regulation (EC) No 726/2004, a conditional authorisation may be granted – prior to the submission of complete clinical data – if the benefit of the immediate availability of the medicinal product on the market outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation may only be granted on this basis if the benefit-risk balance of the medicinal product is positive and it is likely that the applicant will be able to provide comprehensive data (art. 14-a(3)). Specific obligations may be attached to a marketing authorisation in that case (art. 14-a(4)). In any event, the marketing authorisation holder is required to complete ongoing studies or to conduct new studies with a view to confirming that the benefit-risk balance is positive (art. 14-a(5)). The period of validity of a marketing authorisation granted on the basis of this article is one year (and it can then be renewed).

5.1.10 Regulation (EC) No 507/2006 lays down further rules for obtaining a conditional marketing authorisation for medicinal products for human use.[fn 127] Art. 4 of that Regulation provides as follows:

[fn 122] Art. 62 Regulation (EC) 726/2004.

[fn 123] Art. 6 Rules of procedure of the Committee for Medicinal Products for Human Use. See: EMA, 'Rules of procedure', https://www.ema.europa.eu/en/documents/other/chmp-rules-procedure_en.pdf.

[fn 124] EMA, 'From laboratory to patient: the journey of a medicine assessed by EMA', https://www.ema.europa.eu/en/documents/other/laboratory-patient-journey-centrally-authorised-medicine_en.pdf.

[fn 125] Art. 5(2) in conjunction with art. 9(3) Regulation (EC) 726/2004.

[fn 126] Art. 10(2) Regulation (EC) 726/2004.

[fn 127] Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council.

"A conditional marketing authorisation may be granted where the Committee finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:

a) the benefit-risk balance of the medicinal product, as defined in Article 1(28a) of Directive 2001/83/EC, is positive;

b) it is likely that the applicant will be in a position to provide the comprehensive clinical data;

c) unmet medical needs will be fulfilled;

d) the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required."

5.2 The authorisation of the Covid-19 vaccines on the European market

5.2.1 For a number of Covid-19 vaccines, use was made of the rolling review procedure referred to above. In a rolling review, as stated, the same documents must be submitted and the same steps are taken as in the normal procedure, but the process is accelerated by dovetailing parts of it. In a rolling review the vaccine is also assessed according to the usual standards of quality, safety and efficacy.[fn 128] In short, coronavirus vaccines have been tested against the same (very) strict criteria as vaccines against other infectious diseases. Thanks to the rolling review, the assessment can merely take place earlier (and thus faster):[fn 129]

[fn 128] EMA, 'EMA starts second rolling review of a COVID-19 vaccine', 6 October 2020, https://www.ema.europa.eu/en/news/ema-starts-second-rolling-review-covid-19-vaccine

[fn 129] EMA, 'COVID-19 vaccines: development, evaluation, approval and monitoring', https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-vaccines-development-evaluation-approval-and-monitoring.

[Figure (in English in the original): "Figure 5: Standard evaluation process compared with rolling review of COVID-19 vaccines" – STANDARD: Research & development → Developer applies for marketing authorisation → Standard EMA evaluation → EMA opinion; COVID-19: Research & development with rolling review cycles → EMA evaluation with rolling review → EMA opinion.]

5.2.2 On the basis of a rolling review and on the basis of the procedure of art. 14-a of Regulation No 726/2004, the EMA gave a positive opinion on the four vaccines against Covid-19 used in the Netherlands, and a (conditional) marketing authorisation was granted for these vaccines by the European Commission:

i. The BioNTech/Pfizer vaccine (Comirnaty) was conditionally authorised on 21 December 2020.[fn 130]

ii. The Moderna vaccine (Spikevax) was conditionally authorised on 6 January 2021.[fn 131]

iii. The AstraZeneca vaccine (Vaxzevria) was conditionally authorised on 29 January 2021.[fn 132]

iv. The Janssen vaccine (Jcovden) was conditionally authorised on 11 March 2021.[fn 133]

5.2.3 The said vaccines were therefore admitted to the European market subject to conditions. Those conditions mean that the manufacturers are obliged, during the following two years, to supply additional information as soon as those additional data become available. For example, further research must still be carried out into (among other things) the duration of

[fn 130] EMA, 'Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)): An overview of Comirnaty, including its adapted vaccines, and why it is authorised in the EU' (exhibit 6). For the full assessment report see: https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-[illegible]

[fn 131] EMA, 'Spikevax (COVID-19 mRNA Vaccine (nucleoside modified)): An overview of Spikevax, including its adapted vaccines, and why it is authorised in the EU' (exhibit 7). For the full assessment report see: https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf.

[fn 132] EMA, 'Vaxzevria (COVID-19 Vaccine (ChAdOx1-S [recombinant])): An overview of Vaxzevria and why it is authorised in the EU' (exhibit 8). For the full assessment report see: https://www.ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf.

[fn 133] EMA, 'Jcovden (COVID-19 vaccine (Ad26.COV2-S [recombinant])): An overview of Jcovden and why it is authorised in the EU' (exhibit 9). For the full assessment report see: https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar-public-assessment-report_en.pdf.

protection of the vaccines, how well the vaccines prevent severe COVID-19, how well the vaccine protects people with a less well-functioning immune system, children and pregnant women, and whether the vaccine also prevents coronavirus symptoms. A conditional authorisation is only granted if (among other things) the benefit of the immediate availability of the medicinal product on the market outweighs the risk inherent in the fact that additional data are still required (see above in paras. 5.1.9–5.1.10).

5.3 The advice of the Health Council

5.3.1 After the (conditional) approval of the vaccines by the European Commission for admission to the European market, the vaccines may be offered in the Netherlands. The Health Council then advises the Cabinet on the deployment of the vaccines by the State.[fn 134] The Health Council assesses whether there is a significant burden of disease and whether vaccination is effective, safe, acceptable and efficient. In doing so the Health Council relies on peer-reviewed and published scientific articles on the safety and effectiveness of the vaccines examined, and on the data of the EMA and the FDA. The Health Council also advises on whether a vaccination should be given a place in a public vaccination programme, and on whether vaccination can be designated as essential care or as individual care.[fn 135]

The recent report of the Dutch Safety Board shows that the Health Council "[has] followed its statutory task conscientiously in its advice. In its advice, the advisory body has been guided primarily by the state of science".[fn 136]

5.3.2 On 24 December 2020 the Health Council concluded that vaccination with the Pfizer vaccine is effective, sufficiently safe and acceptable, and advised deploying the vaccine in public vaccination programmes against Covid-19 (exhibit 10).[fn 137]

5.3.3 The Health Council noted in that connection that, although the vaccine does have side effects, these are predominantly mild, of short duration and transient, and that the health gain from vaccination therefore outweighs the side effects.

[fn 134] Dutch Safety Board, Aanpak coronacrisis. Deel 2, p. 147, p. 131.

[fn 135] Health Council, Het individuele, collectieve en publieke belang van vaccinatie [The individual, collective and public importance of vaccination] (no. 2013/21), The Hague, 2013, https://www.gezondheidsraad.nl/documenten/adviezen/2013/10/03/het-individuele-collectieve-en-publieke-belang-van-vaccinatie.

[fn 136] Dutch Safety Board, Aanpak coronacrisis. Deel 2, p. 136.

[fn 137] The exhibit is the Health Council's summary. The full report of the Health Council is available at: https://www.gezondheidsraad.nl/binaries/gezondheidsraad/documenten/adviezen/2020/12/24/covid-19-vaccinatie-biontech-pfizer/Advies-COVID-19-vaccinatie-BioNTech-Pfizer.pdf.

5.3.4 The Health Council reached similar conclusions with regard to the use of the Moderna vaccine (advice of 11 January 2021, exhibit 11),[fn 138] the AstraZeneca vaccine (advice of 4 February 2021, exhibit 12)[fn 139] and the Janssen vaccine (advice of 17 March 2021, exhibit 13).[fn 140]

5.3.5 The Health Council therefore gave positive advice on the deployment of the BioNTech/Pfizer, Moderna, AstraZeneca and Janssen vaccines in the Netherlands.

For the sake of completeness, the State also points out the following.

Between 14 March and 22 March 2021 the Netherlands, as a precaution, stopped vaccinating with the AstraZeneca vaccine. Norway and Denmark had reported side effects: in six persons under the age of fifty, thrombosis had occurred together with a reduced number of blood platelets. On 18 March 2021, however, the EMA concluded that the benefits of the vaccine outweighed the risk of rare side effects.[fn 141]

In early April 2021 the Netherlands Pharmacovigilance Centre Lareb reported that a Dutch woman had died after vaccination with AstraZeneca as a result of thrombosis together with a reduced number of blood platelets. Five further reports had also been received about women between 25 and 65 years of age who experienced these side effects after vaccination with AstraZeneca.[fn 142] These reports resembled reports in other European countries.[fn 143] As a precaution, the Netherlands then decided – partly in response to advice from the Health Council of 2 June 2021 – no longer to administer the AstraZeneca vaccine in the Netherlands to persons under the age of sixty.[fn 144]

5.3.6 All in all, therefore, only vaccines were used in the Netherlands that – after review by the competent authorities – have been admitted (subject to conditions) to the European market. That means that the EMA considers the vaccines safe and effective. The Health Council also gave positive advice on offering the vaccines in the Netherlands. Only after that were the vaccines offered by the State to the Dutch population. The State

[fn 138] The exhibit is the Health Council's summary. The full report of the Health Council is available at: https://www.gezondheidsraad.nl/binaries/gezondheidsraad/documenten/adviezen/2021/01/11/covid-19-vaccinatie-moderna-vaccin-en-de-vaccinatiestrategie/Advies-COVID-19-vaccinatie-Moderna-vaccin-en-de-vaccinatiestrategie.pdf.

[fn 139] The exhibit is the Health Council's summary. The full report of the Health Council is available at: https://www.gezondheidsraad.nl/binaries/gezondheidsraad/documenten/adviezen/2021/02/04/covid-19-vaccinatie-astrazeneca-vaccin/Advies-COVID-19-vaccinatie-AstraZeneca-vaccin.pdf.

[fn 140] The exhibit is the Health Council's summary. The full report of the Health Council is available at: https://www.gezondheidsraad.nl/binaries/gezondheidsraad/documenten/adviezen/2021/03/17/covid-19-vaccinatie-janssen-vaccin/Advies-COVID-19-vaccinatie-Janssen-vaccin.pdf.

[fn 141] EMA, 'COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets', https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots.

[fn 142] Dutch Safety Board, Aanpak coronacrisis. Deel 2, p. 67.

[fn 143] Lareb, 'Update meldingen van trombose met een laag aantal bloedplaatjes na coronavaccinatie' [Update on reports of thrombosis with a low platelet count after coronavirus vaccination], 2 May 2022, https://www.lareb.nl/news/update-meldingen-van-trombose-met-een-laag-aantal-bloedplaatjes-na-[illegible]

[fn 144] Dutch Safety Board, Aanpak coronacrisis. Deel 2, p. 67; Health Council, Inzet vaccins in huidige fase COVID-19-vaccinatieprogramma [Deployment of vaccines in the current phase of the COVID-19 vaccination programme] (no. 2021/28), The Hague: 2021.

was entitled in doing so to rely on the review by the EMA, which is independent of the State, and on the advice of the Health Council, which is independent of the State.

6. No unlawful conduct

6.1 Introduction

6.1.1 Despite the foregoing, the claimants take the position that the vaccines are not safe or not effective. With this contention the claimants go against the scientific consensus that the vaccines are in fact safe and effective. In the Netherlands only vaccines have been used that have been tested and assessed by the competent authorities and found by those authorities to be safe and effective.

These vaccines have also been used in the rest of the European Union (and beyond). Globally, too, the approach of the various countries as regards vaccination policy is largely comparable to the Dutch approach.

6.1.2 In the summons the claimants – notwithstanding the scientific consensus – take the far-reaching and unfounded position that the State and various other defendants moreover knew that the vaccines were not safe and not effective, and nevertheless called on the population to be vaccinated. This accusation again lacks any factual basis. As explained above, the vaccines are in fact safe and effective, and the State was also entitled to assume so. Moreover: the claimants do assert a thing or two about what certain persons allegedly knew at certain moments, but then fail to substantiate those contentions. Where the claimants do take more concrete positions on the safety and effectiveness of the vaccines, these are contentions based on incorrect information or contentions that are not legally conclusive.

6.1.3 The State explains this below.

6.2 "You do it for someone else"

6.2.1 According to the claimants, the vaccines against Covid-19 do not prevent transmission. The motto 'you do it for someone else' is therefore incorrect, according to the claimants.

6.2.2 The State's starting point is that this contention of the claimants cannot in any event result in the claims of the claimants being granted. Even if it were the case that the motto 'you do it for someone else' were incorrect (which it is not), that would after all not yet mean that there was unlawful conduct. At most it would mean that the claimants took a vaccine that helps only themselves (and not others as well). Why that would be unlawful is impossible to see – let alone that it could support the declaratory judgment sought, which speaks of "intentionally misleading [the claimants] in an

unlawful manner" by inducing them to take vaccines against Covid-19 "of which the defendants knew, or at least ought to have known, that these injections were not safe and effective".

6.2.3 In any event: it is correct that taking a vaccine against Covid-19 helps not only yourself but also others.

6.2.4 Taking a vaccine contributes to increasing the vaccination rate. Increasing the vaccination rate has the effect that the virus has less chance to spread. After all, after vaccination a person develops antibodies against Covid-19 and is as such protected against the virus. The chance that someone who has been vaccinated against Covid-19 nevertheless becomes infected with the virus is smaller than for someone who has not been vaccinated, and the chance that someone who has been vaccinated infects another person is also smaller than for someone who has not been vaccinated. In that way the spread of the virus is also dampened.

6.2.5 The more people have been vaccinated against Covid-19, the less chance the virus therefore has to spread. In this way taking a vaccine contributes to protecting others, including vulnerable people and people who cannot be vaccinated (for example for medical reasons) or do not want to be. Increasing the vaccination rate and thereby dampening the spread of the virus also helps to reduce the pressure on healthcare. In addition, persons who become infected with Covid-19 despite vaccination generally become less seriously ill and need to be admitted to hospital less often. As a result, more healthcare capacity is available for persons who do (urgently) need it. Further, increasing the vaccination rate and thereby dampening the spread of the virus helps to ensure that restrictive and far-reaching measures to combat the virus (with all the consequences they entail) are not – or at any rate less – necessary. That is in the interest of the functioning of society as a whole.

6.2.6 Vaccination against Covid-19 is therefore – irrespective of whether the vaccine counteracts transmission – for various reasons not only in your own interest, but also in the interest of others.

6.2.7 Moreover, the WHO, the ECDC, the OMT, the RIVM and the Health Council – experts who base their reports and advice on scientific research – all endorse, to a greater or lesser extent, that Covid-19 vaccinations do in fact help to counteract the transmission of the coronavirus. In that connection the State refers to the following sources:

- The ECDC report of 29 March 2021 ('Risk of SARS-CoV-2 transmission from newly-infected individuals with documented previous infection or vaccination'), which states: "There is evidence that

vaccination significantly reduces viral load and symptomatic/asymptomatic infections in vaccinated individuals, which could translate into reduced transmission, although the vaccine efficacy varies by vaccine product and target group. In light of this fact, the total number of infections is expected to decrease significantly as vaccination coverage increases, provided that there is a match between the vaccine strains and the circulating virus strains. This will lead to decreased transmission overall."[fn 145]

- The ECDC report 'Interim guidance on benefits of full vaccination against COVID-19 for transmission and implications for non-pharmaceutical interventions' of 21 April 2021, which reads: "In summary, based on the limited evidence available, the likelihood of an infected vaccinated person transmitting the disease is currently assessed to be very low to low."[fn 146]

- The Health Council's advice 'Transmissie na vaccinatie' [Transmission after vaccination] of 20 May 2021, in which the Health Council concluded that vaccination protects the vaccinated person against (severe) illness and death and contributes to a greater or lesser extent to preventing infections in others.[fn 147]

- The OMT's advice of 24 May 2021,[fn 148] in which the OMT endorses the Health Council's advice and expects that the actual effect of vaccination on preventing transmission has itself been underestimated. The OMT further emphasised – both in the advice of 11 August 2021[fn 149] and in the advice of 13 September 2021[fn 150] – that the chance that a vaccinated person carries infectious virus is low. In the advice of 1 November 2021 the OMT further writes that the prevalence of infections is higher among the unvaccinated and that the chance of transmission in the event of an infection after vaccination is smaller.[fn 151] Finally, it also follows from the OMT's advice of 11 November 2021 that, according to the OMT, the residual risk of transmission and infection after vaccination is considerably reduced and is even smaller than after a negative test.[fn 152]

[fn 145] See: ECDC, Risk of SARS-CoV-2 transmission from newly-infected individuals with documented previous infection or vaccination, https://www.ecdc.europa.eu/en/publications-data/sars-cov-2-transmission-newly-infected-individuals-previous-infection.

[fn 146] See ECDC, 'Interim guidance on the benefits of full vaccination against COVID-19 for transmission and implications for non-pharmaceutical interventions', 21 April 2021, p. 9, available at: https://www.ecdc.europa.eu/sites/default/files/documents/Interim-guidance-benefits-of-full-vaccination-against-COVID-19-for-transmission-and-implications-for-non-pharmaceutical-interventions.pdf.

[fn 147] Health Council, 'Advies transmissie na vaccinatie' [Advice on transmission after vaccination], 20 May 2021, available at: https://www.gezondheidsraad.nl/documenten/adviezen/2021/05/20/transmissie-na-vaccinatie

[fn 148] Advice following the 114th OMT (part 2), 24 May 2021.

[fn 149] Advice following the 123rd and 124th OMT, 13 August 2021, p. 5.

[fn 150] Advice following the 126th OMT, 13 September 20201 [sic], pp. 6-7.

[fn 151] Advice following the 128th OMT, 1 November 2021, p. 7.

[fn 152] Advice following the 130th OMT, 11 November 2021, p. 7.

- Research by the RIVM also shows that vaccines against Covid-19 counteract transmission of the Alpha variant of the virus.[fn 153] That research shows (i) that transmission from vaccinated to vaccinated persons is 40% lower than transmission from unvaccinated to vaccinated persons and (ii) that transmission from vaccinated to unvaccinated persons is 63% lower than transmission from unvaccinated to unvaccinated persons.[fn 154]

- The ECDC report of 1 September 2021 ('Interim public health considerations for the provision of additional COVID-19 vaccine doses') points to another study that supports the RIVM's findings.[fn 155]

- Research by the RIVM into 'transmission pairs' in the period July and August 2021 shows that in those months it was mainly unvaccinated people in the Netherlands who caused further infections – and that they mainly infected other unvaccinated people.[fn 156]

- Since May 2021 the RIVM has also been conducting a large-scale study into the long-term effects of vaccination against Covid-19.[fn 157] That study, which includes surveys up to 14 March 2023, shows that the Vaccine Effectiveness against Transmission (VET) for both the Delta and the Omicron variant is 64%.[fn 158]

- In a news item of 1 December 2023 the EMA confirmed, on the basis of a large number of scientific studies, that vaccines counteract transmission.[fn 159] The RIVM also refers to an overview of international research into the effect of vaccination on transmission, which shows that vaccination reduces the chance of further infection.[fn 160]

6.2.8 The State is entitled to base its policy on the advice of these experts. That is settled case law.

[fn 153] De Gier et al., 'Vaccine effectiveness against SARS-CoV-2 transmission and infections among household and other close contacts of confirmed cases, the Netherlands, February to May 2021', Eurosurveillance 31 2021.

[fn 154] Other research also concludes that vaccination counteracts transmission, see: D.W. Eyre et al., The Impact of SARS-CoV-2 vaccination on Alpha & Delta variant transmission, available at: https://www.nejm.org/doi/full/10.1056/nejmoa2116597.

[fn 155] ECDC, 'Interim public health considerations for the provision of additional COVID-19 vaccine doses', p. 14, available at: https://www.ecdc.europa.eu/en/publications-data/covid-19-public-health-considerations-additional-vaccine-doses. See also: ECDC, 'Interim guidance on the benefits of full vaccination against COVID-19 for transmission and implications for non-pharmaceutical interventions', 21 [April 2021].

[fn 156] https://www.tweedekamer.nl/debat_en_vergadering/commissievergaderingen/details?id=2021A05298

[fn 157] RIVM, 'The national immunization programme in the Netherlands: surveillance and developments in 2022-2023 (RIVM report 2023-0330)', Bilthoven: RIVM 2023, pp. 293-294. Available at: https://www.rivm.nl/bibliotheek/rapporten/2023-0330.pdf.

[fn 158] RIVM, The national immunization programme in the Netherlands: surveillance and developments in 2022-2023 (RIVM report 2023-0330), Bilthoven: RIVM 2023, pp. 273-274.

[fn 159] EMA, 'COVID-19 vaccines key facts', updated 1 December 2023, https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-[illegible]

[fn 160] RIVM, The national immunization programme in the Netherlands: surveillance and developments in 2021-2022 (RIVM report 2022-0342), Bilthoven: RIVM 2022, p. 281: "In all studies where vaccination status was included it was observed that vaccination of the index reduced the SAR [secondary attack rate].", with further references there. Available at: https://www.rivm.nl/bibliotheek/rapporten/2022-0042.pdf.

See, for example:

- Court of Appeal of The Hague 14 December 2021, ECLI:NL:GHDHA:2021:2452, para. 6.17;

- Court of Appeal of The Hague 26 February 2021, ECLI:NL:GHDHA:2021:285, para. 6.9;

- District Court of The Hague 3 April 2020, ECLI:NL:RBDHA:2020:3013, para. 4.8;

- District Court of The Hague 24 July 2020, ECLI:NL:RBDHA:2020:6856, para. 4.12.

6.2.9 The conclusion is therefore that the State could unquestionably and reasonably call on citizens to be vaccinated, and to do so not only for themselves but also for someone else.

6.3 Graphene oxide

6.3.1 The claimants further assert that the vaccines are harmful to health because the mRNA vaccines of Pfizer and Moderna allegedly contain graphene oxide,[fn 161] which, according to the claimants, is highly toxic.[fn 162]

6.3.2 The CBG's Medicines Information Bank shows which substances are present in the vaccines of Pfizer[fn 163] and Moderna.[fn 164] It shows that no graphene oxide is present in these vaccines. Nor have the claimants in any way made plausible that graphene oxide is present in the Moderna and Pfizer vaccines.

See on this also the fact check carried out by Reuters: Fact Check - No evidence graphene oxide is present in available COVID-19 vaccines via lipid nanoparticles.[fn 165] It also addresses the video by Karen Kingston cited by the claimants and the (unrelated) patent with number CN 11220919A cited by the claimants.

6.4 Pfizer report

6.4.1 The claimants further argue that the Pfizer vaccine is dangerous.[fn 166] They base that contention on a report. According to the claimants, that report is an account of a clinical trial conducted by Pfizer in which the trial subjects were vaccinated with the vaccine. According to the claimants, 29,914 women, 9,182 men and 2,990 children took part in this trial. During this trial, the claimants assert, 1,223 trial subjects died and 11,361 trial subjects suffered serious permanent physical injury.

[fn 161] Summons, paras. 151, 265.

[fn 162] Summons, para. 154.

[fn 163] CBG, 'Geneesmiddeleninformatiebank Comirnaty' [Medicines Information Bank: Comirnaty], https://www.geneesmiddeleninformatiebank.nl/nl/co127747.

[fn 164] CBG, 'Geneesmiddeleninformatiebank Spikevax' [Medicines Information Bank: Spikevax], https://www.geneesmiddeleninformatiebank.nl/nl/cp127630

[fn 165] Reuters, 'No evidence graphene oxide is present in available COVID-19 vaccines via lipid nanoparticles', https://www.reuters.com/article/factcheck-graphene-lipidvaccines/fact-check-no-evidence-graphene-oxide-is-present-in-available-covid-19-vaccines-via-lipid-nanoparticles-idUSL1N2P12XHL.

[fn 166] See the report (exhibit 40 to the summons) and summons, paras. 143 - 144.

6.4.2 A reading of this report submitted by the claimants, however, shows something different.

6.4.3 The report is not a clinical trial, but an analysis of the side effects of the vaccine reported to Pfizer by various bodies from various countries.[fn 167] In total 42,086 side effects were reported.[fn 168]

6.4.4 The numbers of reports cited by the claimants – 1,223 deaths and 11,361 persons with serious permanent injury – should not be set against the total number of side effects (42,086), as the claimants do, but against the total number of doses shipped worldwide. Yet it is precisely the total number of doses shipped worldwide that has been blacked out in the report submitted by the claimants as an exhibit. The number of doses shipped worldwide is of great importance for interpreting the report and the stated number of deaths and persons with serious permanent injury.

In that connection the State also points to an EMA report showing that in the period 21 December 2020 to 29 April 2021 more than 97 million doses of the Pfizer vaccine were shipped.[fn 169] Although this period is longer than the period covered by the report cited by the claimants, it shows that the number of reported deaths and the number of reported persons with serious permanent physical injury – set against the total number of doses – is very limited, and also significantly smaller than the claimants make out.

6.4.5 It must moreover be borne in mind that these are reports to Pfizer of deaths and of persons with serious permanent physical injury after vaccination. That does not yet mean that the death of these persons, or the serious permanent physical injury suffered by these persons, was actually caused by vaccination. That applies all the more since in the initial period of vaccination – which this report covers – it was mainly the elderly and the vulnerable who were vaccinated.

6.4.6 It therefore cannot be inferred from the report submitted by the claimants that the Pfizer vaccine is dangerous.[fn 170] Moreover, the Pfizer vaccine was approved by the EMA, and the deployment of the vaccine in the Netherlands was assessed by the Health Council. The State was entitled to rely on this.

Finally: it has been neither asserted nor shown that the claimants took a Pfizer vaccine. Without further explanation it is therefore impossible to see what interest they have in these contentions and how that could lead to the declaratory judgment sought being granted.

[fn 167] Summons, exhibit 40, p. 5.

[fn 168] Of which 25,379 were medically confirmed and 16,707 non-medically confirmed. Summons, exhibit [40, p. 6].

[fn 169] EMA, 'Assessment report on the annual renewal of the conditional marketing authorisation', p. 16, https://www.ema.europa.eu/en/documents/variation-report/comirnaty-h-c-5735-r-0046-epar-assessment-[illegible]

[fn 170] See to the same effect also: NOS, 'Bronnen bij #ophef over de Pfizer-papers' [Sources for the #furore over the Pfizer papers], 31 July 2022, https://nos.nl/nieuwsuur/collectie/13903/artikel/2438923-bronnen-bij-ophef-over-de-pfizer-papers.

6.5 Aarhus Convention

6.5.1 The claimants further assert that the Aarhus Convention was violated by the 'Temporary regulation on the deviating handling of licence applications for gene therapy in connection with combating COVID-19' ('Tijdelijke regeling afwijkende behandeling vergunningaanvragen gentherapie in verband met bestrijding COVID-19')[fn 171].[fn 172]

6.5.2 The Temporary Regulation provided that, for an application for a licence for clinical trials with genetically modified organisms aimed at combating Covid-19, the uniform public preparatory procedure of the General Administrative Law Act (Awb) was not followed, but the regular preparatory procedure. Whatever else may be said of the claimants' contentions, it is in any event impossible to see that the claimants would not have had themselves vaccinated if the uniform public preparatory procedure had been followed, let alone that not following the uniform public preparatory procedure could justify the conclusion that the claimants were "intentionally and unlawfully misled by the defendants in order thereby to induce them to have Covid-19 vaccinations administered, of which the defendants knew (....) that these were not safe and effective." The claimants' argument about the Aarhus Convention therefore lacks relevance in these proceedings.

6.5.3 Incidentally, there is no violation of the Aarhus Convention either.

6.5.4 The legal basis for the Temporary Regulation[fn 173] is the Environmental Management Act (Wet milieubeheer). Art. 9.2.2.1 of the Environmental Management Act provides that rules shall be laid down by order in council concerning, in short, genetically modified organisms where a reasonable suspicion has arisen that acts involving them will give rise to undesirable effects for human health or the environment. If the expected or established effects for human health or the environment, in the minister's opinion, make it urgently necessary for a regulation to be adopted and the adoption of an order in council cannot be awaited, the minister may adopt a regulation (art. 9.2.2.6 Environmental Management Act).

6.5.5 Use was made of that latter possibility with the Temporary Regulation. Because of the pandemic, the minister considered it necessary to introduce a ministerial regulation and thereby to accelerate the licensing procedure. It was after all of great importance that a vaccine could be developed as quickly as possible to combat the pandemic. This was also in line with the wish of the House of Representatives, which

[fn 171] [illegible in this scan; the other transcriptions read 'Stcrt. 2020, 18941' (Government Gazette)]

[fn 172] Summons, para. 132.

[fn 173] This ministerial regulation was in force between 31 March 2020 and 29 October 2020. On 29 October 2020 the regulation was withdrawn, because from that moment the subject of the regulation was governed by EU Regulation 2020/1043. That regulation was implemented by introducing a new regulation, again on the basis of art. 9.2.2.6 Environmental Management Act (Stcrt. 2020, 18941 and Stcrt. 2020, 54619). See also the Decree of 20 October 2022 amending the Genetically Modified Organisms (Environmental Management) Decree 2013 (implementation of Regulation (EU) 2019, 1381 and (EU) 2020, 1043), Stb. 2022, 407). The claimants make no mention of this new regulation in the summons.

had asked the minister to accelerate the licensing procedure so that new treatments and technologies, such as the vaccine against the new coronavirus, could be developed and tested more quickly.[fn 174] That acceleration was achieved by following, with regard to the licence, not the uniform preparatory procedure but the regular preparatory procedure. The regulation did not detract from safety.[fn 175] After all, the requirement to carry out an environmental risk assessment for licensing remained in force, contrary to what the claimants assert.

Moreover, this does not concern an authorisation to place Covid-19 vaccines on the market,[fn 176] as the claimants seem to think, but a licence to conduct clinical trials with Covid-19 vaccines under development.

6.5.6 The ministerial regulation does not conflict with the Aarhus Convention, which concerns access to information, public participation in decision-making and access to justice in environmental matters. The purpose of the Aarhus Convention is to contribute to the protection of the right of every person to live in an environment adequate to his or her health and well-being (art. 1). Although the Aarhus Convention does, among other things, provide for arrangements for public participation in decisions on the release of genetically modified organisms into the environment, the Aarhus Convention provides in that respect that the contracting states shall apply those arrangements for public participation, within the framework of national law, to the extent feasible and appropriate (art. 6(11)).

6.5.7 The ministerial regulation considerably shortened the licensing process for conducting clinical trials. This falls within the possibilities offered by art. 6(11) of the Aarhus Convention.

The Court of Appeal of The Hague also previously held that the State has complied with the information obligations arising from the Aarhus Convention (ECLI:NL:GHDHA:2021:1094, para. 5.9).

6.5.8 On the basis of the ministerial regulation – within the applicable statutory frameworks – four licences were issued to conduct clinical trials with the Janssen vaccine.[fn 177] The grant of the licences was published in the Government Gazette (Staatscourant), and objection and appeal were available against it.[fn 178] The claimants did not make use of that possibility.

6.5.9 The Janssen vaccine was subsequently (that is: after completion of the clinical trials), following assessment by the EMA, admitted to the European market and approved by the Health Council (see para. 5.2 above). The assessment of the safety and

[fn 174] Parliamentary Papers II 2020/21, 25295, no. 180.

[fn 175] See also the explanatory notes to this decree, Stcrt. 2021, 38878.

[fn 176] That, after all, is what the EMA was concerned with, as explained above.

[fn 177] Stcrt. 2020, 38421.

[fn 178] Stcrt. 2020, 38421.

effectiveness of this vaccine by these bodies took place after completion of the clinical trials for which a licence had been granted. There is therefore no question of the claimants having taken part in a clinical trial by taking a vaccine against Covid-19, as they assert.[fn 179]

6.5.10 The State notes in this connection that it has been neither asserted nor shown that the claimants took a Janssen vaccine. It is therefore impossible to see what interest the claimants have in their position on this point.

To the extent that the claimants' contentions also concern the Pfizer vaccine, they likewise lack relevance. The ministerial regulation does not apply to the Pfizer vaccine, because of the absence of genetically modified organisms in that vaccine. Here too, incidentally, it has been neither asserted nor shown that the claimants took a Pfizer vaccine.

6.6 The three "excesses" alleged by the claimants

6.6.1 In the summons the claimants also mention three somewhat bizarre "examples of excesses" to which "the extremely reprehensible and objectionable acts and omissions of the State" allegedly led.

6.6.2 As the first example, the claimants assert that Mr Gates made an investment in Heineken, and that Heineken broadcast an advertisement in which the slogan "the night belongs to the vaccinated" can be heard. The State should have counteracted this in order to protect its citizens, the claimants argue.[fn 180] Why that is the case, and why the absence of such action amounts to unlawful conduct by the State, the claimants do not, however, make clear. The State is not responsible for Mr Gates's investments or for statements by Heineken.

6.6.3 The second example the claimants mention is that there were allegedly crimes that civil servants should have reported.[fn 181] However, as explained above, there is no crime whatsoever, so this contention of the claimants fails.

To the extent that the claimants in that connection also point to communications made to the municipality of Haaksbergen, the State notes for the sake of completeness that the municipality of Haaksbergen is not part of the public-law legal entity the State of the Netherlands.

6.6.4 Then, as a third example, the claimants accuse the State of having "threatened its citizens with death" via national television. To that end the State allegedly made two "gruesome video messages" and broadcast them via Postbus 51.[fn 182] The videos referred to by the claimants do not originate from the State, and were

[fn 179] Summons, para. 133.

[fn 180] Summons, para. 258.

[fn 181] Summons, para. 259.

[fn 182] Summons, para. 262.

not broadcast via Postbus 51 either (which, incidentally, has not existed for a few years now). The first video was broadcast by the programme 'De Sociëteit' and is a reference to the Netflix series 'Squid Game'.[fn 183] The second video was broadcast by the programme 'Plakshot'[fn 184] and is a variation on a drill rap.

See on these videos also the answer to the parliamentary questions of Van Houwelingen, Appendix to the Proceedings of the House of Representatives 2021/22, 823.

6.6.5 In view of the foregoing, there is therefore no unlawful conduct whatsoever on the part of the State.

6.7 The individual accusations

6.7.1 It likewise follows from the foregoing that there is no unlawful conduct on the part of the various natural persons (wrongly) involved in these proceedings, who, as ministers or state secretaries, as OMT members or otherwise, in fact worked tirelessly to combat the pandemic. The – far-reaching – accusations made against these persons are objectionable and unfounded.

6.7.2 For the sake of completeness, the following is noted per person about the individual accusations made. The order of the summons is followed.

6.7.3 Hofstra. Where the claimants speak of "the advice of Hofstra" (which apparently is something different from the advice of the OMT),[fn 185] it is not clear what they are referring to. The claimants then assert that Hofstra knew that "healthcare capacity was not under threat".[fn 186] It is not clear on what the claimants base this contention. The claimants do assert that healthcare capacity has been scaled down since 1972, but that is – whatever may be said of it – not relevant to the question of what healthcare capacity actually was during the coronavirus pandemic (and whether it was under threat). It has already been explained at length above that occupancy in hospitals and ICUs was repeatedly under (very) severe pressure during the pandemic, and that overall the pressure on healthcare was high.[fn 187] Because of the exponential manner in which the number of infections increases, ICU capacity would, incidentally, also come under threat within the foreseeable future without measures, even with a higher capacity. What the (bare) contention of the claimants about the PCR test has to do with healthcare capacity is impossible to see. The claimants further point to pandemic exercises that Hofstra supervised and to the call on people to be vaccinated (among other things by means of an open letter and the vaccination campaign).[fn 188] That is not unlawful

[fn 183] NPO, 'De Sociëteit', https://npo.nl/start/serie/de-societeit/seizoen-2021/de-societeit_35/afspelen, from [illegible].

[fn 184] Summons, exhibit 90; from second 00:05 - 00:10 #plakshot appears on screen.

[fn 185] Summons, para. 29.

[fn 186] Summons, para. 30.

[fn 187] See section 2.

[fn 188] Summons, paras. 31-32, 34.

– on the contrary. The claimants' follow-up contention that Hofstra knew in April 2021 that (batches of) the vaccines were life-threatening and offered no protection whatsoever against the virus[fn 189] is unsubstantiated and lacks any factual basis. It has not even been explained which batches are supposedly involved, nor that the claimants were vaccinated with those batches. Hofstra is not a "participant" in "the Covid-19 project".[fn 190] The claimants then also assert that Hofstra should have opposed, in short, the use by the GGD of the 'vaccination bus' at schools.[fn 191] These buses were used to offer an accessible way of vaccinating, among other places in areas with a low vaccination rate.[fn 192] The contention taken by the claimants (without any explanation or substantiation) that these buses were used with the intention of persuading young people aged 12 and over to be vaccinated without parental consent is incorrect. Moreover, this contention lacks relevance in these proceedings, since the claimants are adults.

6.7.4 Van Dissel. The claimants assert that the OMT's advice was "evidently unlawful" and "wrong and harmful", but (again) do not substantiate this at all. Moreover, this concerns advice of the OMT, for which Van Dissel is not personally liable. It is unfounded and objectionable for the claimants to assert that Van Dissel intentionally defended the OMT's advice in "the knowledge that this advice was wrong and harmful".[fn 193] Equally unfounded is the claimants' contention that Van Dissel is "connected to the bigger picture".[fn 194] That Van Dissel spoke out in favour of the vaccination policy and called on people to be vaccinated[fn 195] is not unlawful – on the contrary – as has already been explained at length above.

6.7.5 Koopmans. The claimants suggest that Koopmans's appointment to a WHO research team was terminated because she sat on the CDC in Guangdong in China.[fn 196] The answers to parliamentary questions previously asked about this[fn 197] show that the termination of Koopmans's appointment does not mean that there were questions about Koopmans's integrity. Illustrative of this is that Koopmans simply remained a member of other WHO committees and that she was a member of the OMT throughout the Covid-19 pandemic. It is incorrect (that Koopmans knew) "that Moderna had already started its Covid-19 vaccine trials in 2017" or that Covid-19 "was a project and not a disease", as the claimants assert – without any form of substantiation whatsoever.[fn 198] The claimants further assert – again without any substantiation – that Koopmans had the aforementioned report of

[fn 189] Summons, para. 33.

[fn 190] Summons, para. 31.

[fn 191] Summons, para. 34.

[fn 192] RIVM, 'Invloed van prikbussen op vaccinatiegraad' [Influence of vaccination buses on the vaccination rate], 12 September 2022, https://www.rivm.nl/gedragsonderzoek/invloed-van-prikbussen-op-vaccinatiegraad.

[fn 193] Summons, para. 36.

[fn 194] Summons, para. 36.

[fn 195] Summons, para. 38.

[fn 196] Summons, para. 40.

[fn 197] Appendix to the Proceedings of the House of Representatives 2020/21, no. 1372.

[fn 198] Summons, para. 41.

Pfizer,[fn 199] but do not substantiate that at all either, quite apart from the fact that that report does not show what the claimants read into it (see para. 6.4 above). Further unfounded is the contention that the defendants concealed important information from the public or spread incorrect information. Nor is there any question of Koopmans having "concealed" her role in the Disinformation Think Tank, as the claimants assert[fn 200] – quite apart from the question of why that would be unlawful. It is moreover factually incorrect that the vaccines were harmful. It is also factually incorrect that Koopmans had information showing that the vaccines were harmful, as the claimants – objectionably enough – assert.[fn 201]

6.7.6 Rutte. Rutte is not a "prominent member" of the WEF.[fn 202] He is listed as an author on the WEF website (claimants' exhibit 11) because he once wrote an article that was published on the WEF website.[fn 203] What exactly the claimants wish to suggest with the two photos of Rutte and Mr Schwab (also exhibit 11) remains unclear, as does why those photos would show "the relationship between Rutte" and Schwab. It is incorrect that Mr Schwab is Rutte's "superior", as the claimants assert[fn 204] – but substantiate only by reference to a letter (claimants' exhibit 12) which, according to the claimants, shows that the chairman of the WEF "instructs" Rutte to ensure that the Netherlands leads the reforms in Europe to be implemented in the context of the 'Great Reset'. That is not what that letter says. Nor is there any assignment from the WEF on Covid-19 accepted by Rutte which Rutte carries out on behalf of the WEF. It has further been explained at length above that – and why – calling on the population to be vaccinated against Covid-19 is not unlawful, but on the contrary fulfilled the State's positive obligation to protect public health. That applies without qualification to the statements of Rutte cited by the claimants – and, incidentally, also to the statements of all the other defendants.[fn 205] It is harmful – and factually incorrect – for the claimants to assert that Rutte knew that "the narrative surrounding the so-called Covid-19 pandemic was not true and that the Covid-19 injections – in particular certain batches – cause serious physical injury". This contention is also not substantiated at all, just like the subsequent contention that Rutte misled the population.[fn 206] The other accusations made against Rutte (such as propagating that taking a vaccine also helps someone else) have already been dealt with at length above.

[fn 199] Summons, para. 42.

[fn 200] Summons, para. 45.

[fn 201] Summons, para. 45.

[fn 202] Summons, para. 47.

[fn 203] https://www.weforum.org/agenda/2017/01/water-shaped-my-countrys-past-it-will-shape-the-future-for-all-of-us/.

[fn 204] Summons, para. 48.

[fn 205] Summons, paras. 49-54.

[fn 206] Summons, para. 55.

6.7.7 Kaag. Kaag is not a "prominent member" of the WEF,[fn 207] did not "go to work for the WEF", was not part of a WEF think tank in which "plans [were] devised for implementing a total reshuffling of, among other things, Dutch society",[fn 208] does not work on (devising or implementing) "the Great Reset" or "the Covid-19 project" and does not champion their implementation.[fn 209] None of these contentions of the claimants is substantiated in any way. The video the claimants cite in that connection (claimants' exhibit 16) is of unclear origin and appears to have been taken out of context (it also appears to have been edited). In any event: Kaag is not committed to the "Build Back Better assignment of the WEF and the UN" – quite apart from the fact that it is not explained what that would entail and why that would be unlawful. The letter the claimants submit in that connection (claimants' exhibit 17) is addressed to the WHO and is a letter in which Kaag states that she is no longer available for the WHO's Global Preparedness Monitoring Board. It therefore cannot substantiate the claimants' contentions. It is factually incorrect that (Kaag knew that) "many people died in Pfizer trials and thousands of people suffered serious physical injury", as the claimants assert – again: without any substantiation.[fn 210] Where the claimants also speak of the "exchange of information" between the Ministry of Finance and the WEF,[fn 211] this in fact concerns the sending of invitations by the WEF and the answering of those invitations, as is evident, of all things, from exhibit 20 submitted by the claimants themselves. That – and why – this would be unlawful is impossible to see. Finally, it is also incorrect that Kaag "knows that there is a false narrative".[fn 212]

6.7.8 De Jonge. De Jonge is not a "prominent member" of the WEF. Nor can this be inferred from the (mere) circumstance that De Jonge is listed on the WEF website, as the claimants seem to think.[fn 213] Nor is there any question of De Jonge carrying out a "task assigned" by the WHO or the WEF.[fn 214] The claimants' contention that "military psychological behavioural influencing tactics" were used, aimed at arousing great fear and with the purpose of misleading the population, lacks any factual basis. Nothing of the kind follows from the quotations cited by the claimants either, which moreover have nothing to do with vaccination.[fn 215] Nor does it follow from claimants' exhibit 22, a document which incidentally does not originate from De Jonge (but is part of the Catshuis briefing of 1 November 2020 and was made public as an annex to the letter to Parliament of 8 December 2020[fn 216]). That calling on the population to be vaccinated is not unlawful has already been explained at length

[fn 207] She was, however, among other things a member of the Global Action Group and a member of the Middle East and Africa stewardship board. See on this Appendix to the Proceedings of the House of Representatives 2021/22, 2541 (answer to questions 20 and 68, and also the answer to question 14).

[fn 208] Summons, para. 61.

[fn 209] Summons, paras. 61-64.

[fn 210] Summons, para. 66.

[fn 211] Summons, paras. 67-69.

[fn 212] Summons, para. 69.

[fn 213] Summons, para. 73.

[fn 214] Summons, paras. 73-74.

[fn 215] Summons, paras. 74-76.

[fn 216] Status letter COVID-19 of 8 December 2020, reference 1792353-215138-PDC19.

above. The claimants' contention that De Jonge intentionally misled many people and intentionally endangered their lives and health[fn 217] is objectionable, all the more so since any form of substantiation for this contention is lacking. Furthermore, the Netherlands, Italy, France and Germany (the Inclusive Vaccine Alliance) already made agreements in June 2020 with vaccine developers on the supply of vaccines to Europe, should the development of a vaccine proceed well.[fn 218] The European Commission later took this over and, on behalf of all member states of the European Union, concluded so-called 'advance payment agreements' with suppliers of promising candidate vaccines against Covid-19.[fn 219] To the extent that the claimants assert that De Jonge wrongly stated that money had been invested (by the Netherlands) in the development of vaccines,[fn 220] that is therefore incorrect. Finally, the claimants' accusation that the comparison De Jonge made with frikandellen [a Dutch deep-fried meat snack] (to illustrate that people do not know exactly what is in them but eat them anyway) "[is] unworthy of a minister and in flagrant conflict with the fundamental-rights provision of article 7 ICCPR"[fn 221] (the prohibition of torture) is characteristic of the line of reasoning in the summons, and speaks for itself.

6.7.9 Kuipers. It has already been explained above that there most certainly was a shortage of ICU beds, and that healthcare came under great pressure. The accusations the claimants make against Kuipers in this connection (and by which they deny this) are therefore unfounded.[fn 222] It is further factually incorrect that Kuipers pushed for people to be vaccinated with a vaccine that had not been authorised.[fn 223] That does not follow at all from what the claimants assert on this, nor from claimants' exhibit 27. At the time of the statements complained of (30 December 2021), the Pfizer vaccine had already been authorised by the EMA, and the Health Council had also already given positive advice on that vaccine (see section 5 above). It is moreover objectionable that the claimants assert that "Under Kuipers's responsibility these injections [are] to this day administered to mostly defenceless people without any form of informed consent, and the harmful effects of the Covid-19 injections are concealed by Kuipers".[fn 224] It has already been explained above that this is incorrect, quite apart from the fact that any form of substantiation for this contention is lacking.

6.7.10 Gommers. The contentions the claimants take regarding Gommers largely amount to a repetition of moves with respect to the – unsubstantiated – contentions already refuted above. Reference is made to that earlier refutation. What is new is that the claimants assert that Gommers began to adjust "his tactics of behavioural influencing" and pretended to have a critical attitude in order to

[fn 217] Summons, paras. 78 and 85.

[fn 218] Rijksoverheid, 'Mogelijk coronavaccin voor Europa gecontracteerd' [Possible coronavirus vaccine contracted for Europe], 13 June 2020, https://www.rijksoverheid.nl/onderwerpen/coronavirus-tijdlijn/nieuws/2020/06/13/mogelijk-coronavaccin-voor-europa-gecontracteerd.

[fn 219] Parliamentary Papers II 2020/21, 25295, no. 565.

[fn 220] Summons, para. 83.

[fn 221] Summons, para. 84.

[fn 222] Summons, para. 94.

[fn 223] Summons, paras. 95-97.

[fn 224] Summons, para. 99.

influence people.[fn 225] This is nothing more than a theory of the claimants' own, which has no substantiation whatsoever. It is incorrect (that Gommers knew) "that what he was doing" would lead "to enormous harm to the Dutch population".[fn 226] The same applies to the serious suggestion that Gommers had the intention that people working in healthcare would suffer injury, so that healthcare capacity would decrease further.[fn 227] Those – objectionable – contentions are also not substantiated at all.

6.7.11 Hoekstra. With regard to Hoekstra, too, it is incorrect that he is a "prominent member" of the WEF, as the claimants assert.[fn 228] Nor does that follow from the image of the WEF website submitted as exhibit 31. Nor is Hoekstra a champion of "the Covid-19 project: The Great Reset". This contention is also not substantiated, other than by reference to a letter. That Hoekstra was invited to a WEF meeting[fn 229] is self-evidently not unlawful. Nor was this correspondence conducted "in secret". The inferences the claimants draw from this letter about the mutual hierarchical relationships are based on nothing more than the circumstance that Mr Schwab, in another letter, addresses Hoekstra as 'Dear Minister', whereas conversely Hoekstra addresses Mr Schwab as 'Your Excellency',[fn 230] and are therefore far-fetched. The far-reaching inferences the claimants attach to this letter are incorrect and find no support in the text of that letter. There is no unconditional undertaking by Hoekstra to cooperate in "the Covid-19 project: The Great Reset".[fn 231] Why the coronavirus support package the claimants also mention[fn 232] would be unlawful is impossible to see. It is further incorrect that (Hoekstra knew that) the vaccines were not safe or effective, and any form of substantiation for that contention is also lacking. The contention that Hoekstra abused his office as Minister of Finance is incorrect and objectionable.

6.7.12 Van Nieuwenhuizen. The claimants' accusation against Van Nieuwenhuizen in fact concerns only the alleged violation of the Aarhus Convention. There is no such violation, just as there is no participation in a clinical trial by taking a Covid-19 vaccine, as has already been explained above (para. 6.5). In any event, that sole accusation cannot support the declaratory judgment sought against her – in short: that there was intentional deception, with knowledge that the vaccines were not safe.

6.7.13 Sijbesma. Sijbesma was asked by the Cabinet to lend a helping hand as special envoy for corona, and started his work on 26 March 2020.

[fn 225] Summons, para. 106.

[fn 226] Summons, paras. 108 and 109.

[fn 227] Summons, para. 109.

[fn 228] Summons, para. 112.

[fn 229] Summons, para. 115.

[fn 230] Summons, para. 113.

[fn 231] Summons, para. 124.

[fn 232] Summons, para. 125.

As special envoy for corona, Sijbesma (i) focused on investigating the options for increasing testing capacity; and (ii) mapped the developments surrounding possible coronavirus vaccines (so that the Netherlands would have an option on any vaccines available).[fn 233] Sijbesma fulfilled the role of special envoy for corona in a personal capacity, voluntarily, unpaid and without reimbursement of expenses. Sijbesma acted as adviser, scout and connecting link between the State and the (international) business community. He had no power on behalf of the State to determine or implement testing or vaccination policy, or to conclude contracts on behalf of the State, as is also evident from the news item about Sijbesma's role on rijksoverheid.nl that the claimants themselves submit (as exhibit 56). Nor did Sijbesma have any role whatsoever with regard to vaccine safety. Sijbesma was special envoy up to and including September 2020. Accordingly, when the Netherlands started vaccinating (in January 2021) and the claimants were faced with the choice of whether or not they wanted to be vaccinated, Sijbesma had already not been an envoy for quite some time. The role of special envoy for corona had, contrary to what the claimants suggest,[fn 234] no direct connection with Sijbesma's capacity at that time as (former) director of various companies and person involved in various international organisations. As stated, he fulfilled that role in a personal capacity. Nor was Sijbesma appointed as special envoy for corona in the capacity of representative of a "non-governmental organisation such as (NGO, WEF)" (or of the WBG), as the claimants apparently believe. It is incorrect that Sijbesma is an outspoken advocate of a "total reshuffling", as the claimants assert.[fn 235] This contention is also not substantiated by the claimants. The claimants' position that, in the appointment of Sijbesma as special envoy, the ties of Sijbesma (and the other defendants) with the WEF were intentionally disregarded[fn 236] lacks a factual basis.[fn 237] Nor is Sijbesma carrying out a "worldwide plan". To the extent that the claimants assert that there was no shortage of tests (and reproach Sijbesma in that connection),[fn 238] the incorrectness of that contention (or those contentions), including contentions about the WITS database – with which Sijbesma, incidentally, had nothing to do and to which he had no access – is already apparent from the foregoing (see para. 2.3.3). Sijbesma therefore did not, in the Buitenhof broadcast of 12 April 2020, take part in a "lie", as the claimants call it, or give a presentation of the facts that was "demonstrably false". This is quite apart from the fact that those contentions of the claimants about testing are not relevant to the claims of the claimants, which after all concern vaccination. The connection between the Rothschild patent mentioned by the claimants, the linking of "everything, and above all also people's bodies, via 5G and 6G internet technology",[fn 239] and this case also remains unclear after reading the summons. These contentions, or rather theories,

[fn 233] See also https://www.rijksoverheid.nl/documenten/publicaties/2020/08/13/toelichting-rol-feike-sijbesma-als-[illegible]

[fn 234] Summons, para. 185.

[fn 235] Summons, para. 186.

[fn 236] Summons, para. 187.

[fn 237] Nor is there any question of this having been concealed. The WEF website states which persons are involved with the WEF and in what way, and that Sijbesma has been a member of the Board of Trustees since 2019.

[fn 238] Summons, paras. 187-194.

[fn 239] Summons, para. 196.

are (likewise) unfounded and unsubstantiated. Sijbesma has (had) no involvement in this. It is also incorrect (that Sijbesma knows) that Covid-19 is a project and not a disease, and that he "is fully familiar with and involved in the Covid-19 project that is to lead to the Great Reset", and that this is the real reason why he was made corona envoy.[fn 240] Again, any factual substantiation for these contentions is lacking. The claimants' suggestion that Sijbesma received instructions, directions or anything else from the WEF is incorrect and lacks any factual basis, and there is no question of Sijbesma carrying out 'The Great Reset'. The same applies to the claimants' contention that Sijbesma acted unlawfully by making statements, or by failing to do so, in the said Buitenhof broadcast. The claimants' contentions that Sijbesma put on a "charade", widely propagated in the media,[fn 241] are therefore incorrect and lack any factual substantiation, let alone that there was any deception by Sijbesma.

6.8 Conclusion

6.8.1 The conclusion from the above is that there is no question of the claimants having been intentionally and unlawfully misled in order thereby to induce them to have Covid-19 injections administered of which the defendants knew, or at least ought to have known, that these injections were not safe and effective. The declaratory judgment sought therefore cannot be granted. There is no unlawful conduct whatsoever – let alone any form of group liability under art. 6:166 DCC.

6.8.2 It also follows from the above that there is no violation of art. 97a of the Criminal Code (Sr) (quite apart from the fact that the question of whether that is the case is not one for the civil court). None of the defendants has in any way entered into contact with a person or body established abroad with the intention (i) of inducing such a person or body to provide support for preparing, promoting or bringing about a revolution, or of strengthening such a person or body in an intention formed to that end, promising assistance therein or providing that assistance, or with the intention (ii) of preparing, promoting or bringing about such a revolution.

6.8.3 The relevant evidence available to the State to refute the claimants' contentions has been attached as exhibits to this statement. The State offers – to the extent that the burden of proof should rest on it under article 150 DCCP, and in the context of any rebuttal evidence – to prove all its contentions by all means permitted by law.

[fn 240] Summons, para. 199.

[fn 241] Summons, paras. 188 and 194.

7. The causal link and the alleged damage

7.1 Superfluously, the State further notes the following about the causal link and the damage alleged by the claimants.

7.2 The claimants assert that they have suffered (personal injury) damage. In support, the claimants refer to "diagnoses" by "medical specialists".[fn 242] However, these turn out to be seven documents signed by one and the same doctor. These documents read more like an indictment of Dutch vaccination policy than like a medical statement. For example, several of the statements contain the following – identical – passage:[fn 243]

"In view of the concealment of the side effects and the administration of vaccines that have not yet been fully tested and researched, under the pretext that there was an emergency, confidence in the government regarding the vaccines and the message the government conveyed has completely disappeared. In view of the IFR figure there was never a medical emergency and the mortality rate of Corona was in line with flu. This figure in itself does not justify any measure taken by the government and does not justify the necessity of administering vaccines. This has been completely ignored. In retrospect there was no medical necessity and there was therefore no crisis situation and thus no pandemic that posed a danger to humanity worse than the annual flu."

7.3 Such a passage does not belong in a medical statement. The doctor who signed the statements evidently adheres to the same theories as the claimants.[fn 244] That alone detracts from the neutrality, objectivity and reliability of the statements. For that reason alone, these statements cannot be given the weight the claimants attribute to them.

It is moreover even questionable whether these are statements of a doctor at all, rather than statements of the claimants themselves. After all, the opening sentence of these statements reads: "Herewith follows a medical statement by the above patient about his health and his situation (.)" (underlining added). For this reason too, no medical or special authority whatsoever can be attributed to these statements.

7.4 The claimants assert that they have suffered physical injury as a result of the graphene oxide that is allegedly part of the Covid vaccines.[fn 245]

7.5 According to the claimants' contentions, there is graphene oxide in the mRNA vaccines (the vaccines of Pfizer and Moderna). That the claimants were vaccinated with such a vaccine

[fn 242] Summons, para. 265.

[fn 243] Summons, exhibit 91, pp. 1, 3, 5, 9 & 13.

[fn 244] See also the 'Manifest van Alexander van Walraven aan alle artsen van Nederland' [Manifesto of Alexander van Walraven to all doctors of the Netherlands], available at https://www.youtube.com/watch?v=sOpfl70aqmu.

[fn 245] Summons, para. 265.

(and if so, with which one) has not been explained or substantiated. That alone defeats the argument. The State has already set out above that the vaccines do not contain graphene oxide (para. 6.3). Graphene oxide from the vaccines therefore cannot be the cause of the damage alleged by the claimants. But even apart from that, the alleged damage has not been made sufficiently plausible.

- Claimants 1 to 3 and 5 acknowledge that there are currently no external physical signs of serious physical injury. There are, however, allegedly less far-reaching complaints, they assert. This contention is not specified or substantiated in any way. Even the statement does not mention any concrete physical complaint. On the contrary, that statement says that these claimants have no complaints ("He himself has no complaints yet"). According to the statements they themselves submitted in the proceedings, these claimants therefore have no damage.

- Claimants 4, 6 and 7 assert that they have suffered serious physical injury as a result of the Covid vaccines.[fn 246] The statements submitted – whatever else may be said of them, see above in paras. 7.2–7.3 – do not, however, show that the alleged physical injury is the result of the Covid vaccines. The claimants assert that it is, but any form of (medical) substantiation for that contention is lacking – in fact these are merely bare assertions of the claimants themselves.

Claimants 4 and 6 allegedly developed Parkinson's disease as a result of the vaccine. The State points out in this connection that the determinants of Parkinson's disease are largely unknown. The statement gives no substantiation whatsoever for the contention that the vaccine is the cause of Parkinson's disease. It is incorrect that Parkinson's disease is on the list of side effects of the mRNA vaccines.[fn 247] Nor does that follow from Lareb's list of side effects.[fn 248]

With regard to claimant 7, the statement identifies the vaccine as the cause of a TIA. It is asserted in that connection that 'the vaccines' cause clotting problems. That does not follow from the list of side effects in the package leaflets of the mRNA vaccines.[fn 249] The remark in the statement that a TIA is a side effect of the vaccine

[fn 246] Summons, para. 265.

[fn 247] EMA, 'Bijlage 1: samenvatting van de productkenmerken Comirnaty' [Annex 1: summary of product characteristics, Comirnaty], https://www.ema.europa.eu/nl/documents/product-information/comirnaty-epar-product-information_nl.pdf. EMA, 'Bijlage 1: samenvatting van de productkenmerken Spikevax' [Annex 1: summary of product characteristics, Spikevax], https://www.ema.europa.eu/nl/documents/product-information/spikevax-previously-covid-19-vaccine-moderna-epar-product-information_nl.pdf.

[fn 248] Lareb, 'Bijwerkingen coronavaccins' [Side effects of coronavirus vaccines], https://www.lareb.nl/bijwerkingen-coronavaccins#pfizer.

[fn 249] EMA, 'Bijlage 1: samenvatting van de productkenmerken Comirnaty'. EMA, 'Bijlage 1: samenvatting van de productkenmerken Spikevax'.

"until the contrary is proven" does not hold up either scientifically or legally.

7.6 The claimants further assert that they have suffered non-material damage (apparently: mental injury within the meaning of art. 6:106 DCC[fn 250]). Although all seven claimants assert that they have suffered mental injury, this is mentioned in only five of the statements. For the other two claimants even that form of substantiation is lacking. But even where the statements do mention mental harm, that is insufficient. These statements are not very concrete, and are completely (or almost completely) identical. These statements therefore do not constitute sufficient substantiation for even the plausibility of the alleged non-material damage.

7.7 All in all, the claimants have not sufficiently made plausible that they have suffered damage as a result of the vaccine. The State recalls that the claimants have not even made plausible (i) that they had themselves vaccinated, (ii) which vaccine was involved, (iii) at what time or times this took place, and (iv) what information from which defendant was decisive for each of them in doing so. On that ground alone they have also not made plausible that they were induced to take a Covid-19 vaccination by "intentional deception" on the part of the defendants.

7.8 Finally, the State points out in that connection that everyone in the Netherlands has at all times been free to make their own assessment as to whether or not to take a vaccine, to form their own opinion on the usefulness and necessity of vaccination, and to choose not to be vaccinated. Some twenty percent of the adult population did in fact choose not to be vaccinated. The claimants also had that choice.

8. Conclusion

The State et al. move that the court:

i) dismiss the claims;

ii) order the claimants jointly and severally to pay the costs of the proceedings, with the provision that statutory interest shall be due on that order for costs with effect from the fifteenth day after the date of the judgment to be delivered in this case;

iii) order the claimants jointly and severally to pay the subsequent costs, assessed in accordance with the liquidation tariff at € 173 or, in the event of service, € 271;

[fn 250] [illegible – footnote text not legible in the scan]

iv) declare these orders for costs provisionally enforceable (uitvoerbaar bij voorraad).

handled by: R.W. Veldhuis and M.E.A. Möhring

correspondence: P.O. Box 11756, 2502 AT The Hague

telephone: +31 70 515 3793

e-mail: reimer.veldhuis@pelsrijcken.nl

case no.: 11020625

State et al. C/17/190788 / HA ZA 2023-172

List of exhibits to the statement of defence

1. Jean Dohmen, 'Hoe de Great Reset werd gekaapt' [How the Great Reset was hijacked], FD 22 January 2022

2. Images of the banners that were hung up

3. Various screenshots of posts on X (formerly Twitter)

4. a. Jan Westera, 'Vergeefs naar rechtbank voor zaak tegen Bill Gates' [Going to court in vain for case against Bill Gates], Leeuwarder Courant 23 November 2023; b. Image of the lorry from the aforementioned article; c. Screenshot of a post on X (formerly Twitter)

5. Screenshot of the StatLine website 'Bevolkingsontwikkeling; maand en jaar' [Population development; month and year]

6. EMA, 'Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)): An overview of Comirnaty, including its adapted vaccines, and why it is authorised in the EU'

7. EMA, 'Spikevax (COVID-19 mRNA Vaccine (nucleoside modified)): An overview of Spikevax, including its adapted vaccines, and why it is authorised in the EU'

8. EMA, 'Vaxzevria (COVID-19 Vaccine (ChAdOx1-S [recombinant])): An overview of Vaxzevria and why it is authorised in the EU'

9. EMA, 'Jcovden (COVID-19 vaccine (Ad26.COV2-S [recombinant])): An overview of Jcovden and why it is authorised in the EU'

10. Health Council, summary BioNTech/Pfizer, 24 December 2020

11. Health Council, summary Moderna vaccine and the vaccination strategy, 11 January 2021

12. Health Council, summary AstraZeneca vaccine, 4 February 2021

13. Health Council, summary Janssen vaccine, 17 March 2021

[Blank page or page without legible text.]

[Exhibit 1 – newspaper page (image). Legible text:]

BESTUUR [MANAGEMENT]

How the Great Reset was hijacked

Conspiracy theorists hijacked World Economic Forum boss Klaus Schwab's idea of a Great Reset. Fact-checkers have been typing their fingers to the bone for a year and a half to debunk all the conspiracy stories. 'That term worked like a red rag to a bull.'

Continued on page 18

page 17, 22-01-2022 – © Het Financieele Dagblad

[Newspaper page (image), apparently exhibit 1 continued. Legible text:]

Conspiracies: planned pandemic, [illegible]

Inzicht [Insight]

[remainder illegible]

[Image page; no legible text: [illegible]]

[Exhibit 2 – photograph of a banner. Legible text:]

FEIKE SIJBESMA (WEF) – In Friesland gedagvaard [Summoned in Friesland] – RechtOprecht.online

SIGRID KAAG (WEF) — Summoned in Friesland — RechtOprecht.online

MARION KOOPMANS (Virologist / OMT) — Summoned in Friesland — RechtOprecht.online

DIEDERIK GOMMERS (OMT) — Summoned in Friesland — RechtOprecht.online

NO ENTRY [traffic sign]

HUGO de JONGE (WEF) — Summoned in Friesland — RechtOprecht.online

RUTTE (WEF) — Summoned in Friesland — RechtOprecht.online

This is a [illegible] [illegible] before the court (Art. 121 Constitution)

[blank page]

Share this, people, the responsible scum is finally coming before the court!!!

Translate post

[Quoted post] Samen Voor Nederland … 32 m. — The first media banners have been put up. And these cannot be censored or ignored by the media. For more info see www.RechtOprecht.online

[Banner images:] RUTTE (WEF) — Summoned in Friesland — RechtOprecht.online; MARION KOOPMANS (Virologist / OMT) — Summoned in Friesland [rest illegible]

12:31 PM • Aug 8, 2023 • 11.5K Views — 36 · 317 · 510 · 3

Lawyers of the foundation 'Recht op Recht' have SUMMONED, among others, Rutte, Kaag & Marion Koopmans on behalf of victims of vaccine injury! There must be retribution!

Translate post

Do a [illegible] & RT if you can't wait until they are PUNISHED!

[Banner images:] MARK RUTTE (WEF) — Summoned in Friesland — RechtOprecht.online; MARION KOOPMANS (Virologist / OMT) — Summoned in Friesland — RechtOprecht.online

7:48 PM • Aug 8, 2023 • 57K Views — 216 · 801 · 2.3K · 5

4a

Leeuwarder Courant, 23 November 2023, page 22.

In vain to court for case against Bill Gates

JAN WESTERA

[Interest of Justice editorial note: the full text of this newspaper article (exhibit 4a) is a third-party copyrighted work and is not reproduced or translated in full here; the Dutch original is in the court file. Summary of its content: the article reports that the Recht Oprecht case drew a handful of supporters to the Zaailand square in front of the Leeuwarden court building on Wednesday, election day, when the proceedings brought on behalf of seven people who say they suffered Covid-19 vaccine injury were to start. It reports the foundation's two lawyers, Peter Stassen and Arno van Kessel, as saying in their own news broadcast that one of the seven had died in October, without giving a cause of death. It names, among the seventeen defendants, Bill Gates, Rutte and Everhard Hofstra (a member of the Outbreak Management Team). It quotes court spokesman Anno Rijpkema of the District Court of the Northern Netherlands as explaining that this was only a docket hearing on procedure, not on substance, that the defendants had been given six more weeks to respond to the summons served on 14 July, and that the judge (possibly a three-judge panel) would only be assigned after that. It reports Van Kessel as saying that the State Attorney acts for twelve defendants and that Gates had not yet retained counsel. Finally, it reports the foundation's move from a farm in Wergea to business premises in Leeuwarden and changes in its board according to Chamber of Commerce records (names of individual board members omitted here). The text on this page breaks off mid-sentence.]

[Banner in photo:] JAAP v DISSEL (RIVM/OMT) — summoned in Friesland — RechtOprecht.online; SIGRID K[illegible]

[Photo caption:] Supporters of Recht Oprecht gathered on Wednesday on the square in front of the court in Leeuwarden. PHOTO: LC

[Standfirst:] Lawsuit on behalf of seventeen people over damage from Covid vaccinations

4b

Corona vaccine = poison

Media = fake news

We are being conned

375,000 jab deaths in EU

24 million serious side effects in EU

It doesn't add up

Media = guilty

GGDs [municipal health services] are complicit

Children are our future and not guinea pigs

Vaccinazi makes you free!!!

4c

Ready for tomorrow. Square 't Zaailand opposite the court building!

Translate post

[Banner images:] HOFSTRA (GGD doctor / OMT) — Summoned in Friesland — RechtOprecht.online; THE STATE OF THE NETHERLANDS [partly illegible] — [Fri]esland summoned [partly illegible] — RechtOprecht.online; [illegible]

9:40 PM - Nov 21, 2023 • 3,830 Views — 5 · 40 · 112 · 4

[blank page]

[Exhibit 5: screenshot of the CBS StatLine website ('Population trends; month and year'). The OCR of this screenshot is almost entirely illegible. Legible fragments: 'Recent', 'GE2022', 'For what actually happens' ('Voor wat er feitelijk gebeurt'), 'English', 'CBS, 2023'. Remaining text: [illegible].]

[blank page]

[Exhibit 6]

EMA/392045/2023 — EMEA/H/C/005735

Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified))

An overview of Comirnaty, including its adapted vaccines, and why it is authorised in the EU

What is Comirnaty and what is it used for?

Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.

The originally authorised Comirnaty contains tozinameran, a messenger RNA (mRNA) molecule with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.

Comirnaty is also available as three adapted vaccines:

Comirnaty Original/Omicron BA.1 contains tozinameran and riltozinameran, an mRNA molecule with instructions for producing a protein from the Omicron BA.1 subvariant of SARS-CoV-2;

Comirnaty Original/Omicron BA.4-5 contains tozinameran and famtozinameran, an mRNA molecule with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2;

Comirnaty Omicron XBB.1.5 contains raxtozinameran, an mRNA molecule with instructions for producing a protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2.

Comirnaty does not contain the virus itself and cannot cause COVID-19.

How is Comirnaty used?

Adults and children from 5 years of age should receive a single dose injected into the muscle of the upper arm, irrespective of their previous vaccination history.

Children from 6 months to 4 years of age who have completed a primary vaccination course or have had COVID-19 before should also receive a single dose, which can be injected into the muscle of the upper arm or thigh.

In children from 6 months to 4 years of age who have not completed a primary vaccination course and have not had COVID-19, the vaccine is given as three doses; the first two doses are given three weeks

apart, followed by a third dose given at least 8 weeks after the second dose. The injections can be given in the muscles of the upper arm or thigh.

An additional dose may be given to people with a severely weakened immune system.

The vaccines should be used according to official recommendations issued at national level by public health bodies.

For more information about using Comirnaty, including information about the adapted vaccines, doses for different age groups, see the package leaflet or consult a healthcare professional.

How does Comirnaty work?

Comirnaty works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body's cells and can differ between variants of the virus.

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person's immune system will then recognise the protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2, their immune system will recognise it and be ready to defend the body against it.

The mRNA from the vaccine is broken down after vaccination and removed from the body.

Adapted vaccines are expected to maintain protection against the virus as they contain mRNA more closely matching circulating variants of the virus.

What benefits of Comirnaty have been shown in studies?

A very large clinical trial showed that Comirnaty, given as a two-dose regimen, was effective at preventing COVID-19 in people from 12 years of age.

This main trial involved around 44,000 people aged 16 and above in total. Half received the vaccine and half were given a dummy injection. People did not know whether they received the vaccine or the dummy injection.

Efficacy in people aged 16 and above was calculated in over 36,000 participants (including people over 75 years of age) who had no sign of previous infection. The study showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (8 cases out of 18,198 got COVID-19 symptoms) compared with people who received a dummy injection (162 cases out of 18,325 got COVID-19 symptoms). This means that the vaccine demonstrated a 95% efficacy in the trial.

The trial in people aged 16 years and older also showed around 95% efficacy in the participants at risk of severe COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or obesity.

The trial was extended to include 2,260 children aged 12 to 15 who had no sign of previous infection. It showed that the immune response to Comirnaty in this group was comparable to the immune response in the 16 to 25 age group (as measured by the level of antibodies against SARS-CoV-2). Around 2,000 children received either the vaccine or a placebo (a dummy injection), without knowing which one they were given. Of the 1,005 children receiving the vaccine, none developed COVID-19 compared with 16 children out of the 978 who received placebo. This means that, in this study, the

vaccine was 100% effective at preventing COVID-19 (although the true rate could be between 75% and 100%).

Another study showed that an additional dose of Comirnaty increased the ability to produce antibodies against SARS-CoV-2 in organ transplant adult patients with severely weakened immune systems. A study in children aged 5 to 11 showed that the immune response to Comirnaty given at a lower dose (10 micrograms) was comparable to that seen with the higher dose (30 micrograms) in 16-to 25-year-olds (as measured by the level of antibodies against SARS-CoV-2). Of the 1,305 children receiving the vaccine, three developed COVID-19 compared with 16 out of the 663 children who received placebo. This means that, in this study, the vaccine was 90.7% effective at preventing symptomatic COVID-19 (although the true rate could be between 67.7% and 98.3%).

A main study in children from 6 months to 4 years of age evaluated the immune response triggered by the vaccine (given as 3 injections) by measuring the level of antibodies against SARS-CoV-2. The study showed that the immune response to the lower dose of Comirnaty (3 micrograms) was comparable to that seen with the higher dose (30 micrograms) in 16- to 25-year-olds.

Additional data showed that subsequent doses, including boosters, lead to a rise in levels antibodies against SARs-CoV-2. Available data also indicate that vaccines adapted specifically to target circulating strains of the virus are expected to elicit a strong immune response against these strains.

Can children be vaccinated with Comirnaty?

The originally authorised Comirnaty, Comirnaty Original/Omicron BA.4-5 and Comirnaty Omicron XBB.1.5 are authorised for adults and children from 6 months of age.

Comirnaty Original/Omicron BA.1 is authorised for adults and children from 12 years of age.

Can immunocompromised people be vaccinated with Comirnaty?

Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.

Severely immunocompromised people may be given an additional dose of Comirnaty as part of their primary vaccination.

Can pregnant or breast-feeding women be vaccinated with Comirnaty?

Comirnaty can be used during pregnancy. A large amount of data from pregnant women vaccinated with Comirnaty during the second or third trimester of their pregnancy has been analysed and showed no increase in pregnancy complications. Although data in the first trimester of pregnancy are more limited, no increased risk of miscarriage was seen.

Comirnaty can also be used during breast-feeding. Data from women who were breast-feeding after vaccination have not shown a risk of adverse effects in breast-fed babies.

No data are currently available regarding the use of the adapted vaccines in pregnant or breastfeeding women. However, based on similarity with the vaccine targeting the original strain, including a comparable safety profile, Comirnaty Original/Omicron BA.1 can be used during pregnancy and breast-feeding. In addition, based on the data available for the originally authorised Comirnaty and Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4-5 and Comirnaty Omicron XBB.1.5 can also be used during pregnancy and breast-feeding.

Can people with allergies be vaccinated with Comirnaty?

People who already know they have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.

Allergic reactions (hypersensitivity) have been seen in people receiving the vaccine. A very small number of cases of anaphylaxis (severe allergic reaction) have occurred. Therefore, as for all vaccines, Comirnaty, including its adapted vaccines, should be given under close medical supervision, with the appropriate medical treatment available. People who have a severe allergic reaction when they are given a dose of Comirnaty or its adapted vaccines should not receive subsequent doses.

How well does Comirnaty work for people of different ethnicities and genders?

The main Comirnaty trial included people of different ethnicities and genders. Efficacy of around 95% in the main trial was maintained across genders and ethnic groups.

What are the risks associated with Comirnaty?

For the full list of side effects and restrictions with Comirnaty, see the package leaflet.

The most common side effects with Comirnaty are usually mild or moderate and get better within a few days after vaccination. These include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills, fever and diarrhoea. They may affect more than 1 in 10 people. In children aged 6 to 23 months, the most common side effects also include irritability, sleepiness, loss of appetite, tenderness or redness at the injection site and fever. The most common side effects in children 2 to 4 years of age include pain or redness at the injection site, tiredness and fever. Redness at the injection site, enlarged lymph nodes, nausea and vomiting may occur in up to 1 in 10 people. Itching at the injection site, pain in the arm where the vaccine was injected, enlarged lymph nodes, difficulty sleeping, feeling unwell, decreased appetite, lethargy (lack of energy), hyperhidrosis (excessive sweating), night sweats, asthenia (weakness), and allergic reactions (such as rash, itching, itchy rash, and rapid swelling under the skin) are uncommon side effects (affecting less than 1 in 100 people). Weakness in muscles on one side of the face (acute peripheral facial paralysis or palsy) occurs in less than 1 in 1,000 people.

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) may occur in up to 1 in 10,000 people.

Very few cases of extensive swelling of the vaccinated arm, swelling of the face in people with a history of injections with dermal fillers (soft, gel-like substances injected under the skin), erythema multiforme (red patches on the skin with a dark red centre and paler red rings) paraesthesia (unusual feeling in the skin, such as tingling or a crawling feeling) and hypoesthesia (decreased feeling or sensitivity in the skin) have occurred. Allergic reactions have also occurred with Comirnaty, including a very small number of cases of severe allergic reactions (anaphylaxis).

The safety of the adapted vaccines is similar to that of the originally authorised Comirnaty vaccine.

Why is Comirnaty authorised in the EU?

Data show that Comirnaty causes the production of antibodies against SARS-CoV-2 that can protect against COVID-19. The main trials of Comirnaty showed that the vaccine has a high efficacy in all age groups. Most side effects are mild to moderate in severity and are gone within a few days.

The Agency therefore decided that the benefits of Comirnaty, including its adapted vaccines, are greater than its risks and that it can be authorised for use in the EU.

Comirnaty was originally given 'conditional authorisation' because there was more evidence to come about the vaccine. The company has provided comprehensive information, including data regarding its safety, efficacy, and how well Comirnaty prevents severe disease. In addition, the company has completed all requested studies on the pharmaceutical quality of the vaccine. As a result, the conditional authorisation has been switched to a standard one.

What measures are being taken to ensure the safe and effective use of Comirnaty?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Comirnaty have been included in the summary of product characteristics and the package leaflet.

A risk management plan (RMP) is also in place and contains important information about the vaccines' safety, how to collect further information and how to minimise any potential risks.

Safety measures for Comirnaty are implemented in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets Comirnaty will provide regular safety reports.

As for all medicines, data on the use of Comirnaty are continuously monitored. Suspected side effects are carefully evaluated and any necessary action taken to protect patients.

Other information about Comirnaty

Comirnaty received a conditional marketing authorisation valid throughout the EU on 21 December 2020. This was switched to a standard marketing authorisation on 10 October 2022.

More information about the COVID-19 vaccines is available on the COVID-19 vaccines key facts page. Further information on Comirnaty, including its adapted vaccines, can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/comirnaty

This overview was last updated in 08-2023.

[Exhibit 7]

EMA/404588/2023 — EMEA/H/C/005791

Spikevax¹ (COVID-19 mRNA Vaccine (nucleoside modified))

An overview of Spikevax, including its adapted vaccines, and why it is authorised in the EU

What is Spikevax and what is it used for?

Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.

The originally authorised Spikevax contains elasomeran, a molecule called messenger RNA (mRNA) with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.

Spikevax is also available as three adapted vaccines:

Spikevax bivalent Original/Omicron BA.1 contains elasomeran and an additional mRNA molecule, imelasomeran, with instructions for producing a protein from the Omicron BA.1 subvariant of SARS-CoV-2;

Spikevax bivalent Original/Omicron BA.4-5 contains elasomeran and an additional mRNA molecule, davesomeran, with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2;

Spikevax XBB.1.5 contains andusomeran, an mRNA molecule with instructions for producing a protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2.

Spikevax and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.

How is Spikevax used?

The originally authorised Spikevax is given in people from the age of 6 months as two injections, usually into the muscle of the upper arm, or the thigh in infants and young children, 28 days apart. A booster dose may be given to adults and children from the age of 6 years, at least 3 months after primary vaccination with Spikevax, or another mRNA vaccine or an adenoviral vector vaccine.

[fn 1] Previously known as COVID-19 Vaccine Moderna

Spikevax bivalent Original/Omicron BA.1 may be given as a single injection to adults and children from the age of 6 years, at least 3 months after primary vaccination or a booster dose with a COVID-19 vaccine.

Both Spikevax bivalent Original/Omicron BA.4-5 and Spikevax XBB.1.5 are given as a single injection to adults and children aged 5 years and older, irrespective of their previous COVID-19 vaccination history. In children from 6 months to 4 years of age, they are given as a single injection in those who have completed a primary vaccination course or have had COVID-19 before, or as two injections 28 days apart in those who have not previously been vaccinated against COVID-19 or had COVID-19. An additional dose of Spikevax, Spikevax bivalent Original/Omicron BA.4-5 or Spikevax XBB.1.5 may be given to adults and children aged 6 months and older with a severely weakened immune system. The vaccines should be used according to official recommendations, issued at national level, by public health bodies.

For more information about using Spikevax, including information about the adapted vaccines and doses for different age groups, see the package leaflet or consult a healthcare professional.

How does Spikevax work?

Spikevax works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body's cells and which can differ between variants of the virus.

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person's immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2, their immune system will recognise it and be ready to defend the body against it.

After vaccination, the mRNA from the vaccine is broken down and removed from the body.

Adapted vaccines work in the same way as the original vaccine and are expected to maintain protection against the virus as they contain mRNA more closely matching circulating variants of the virus.

What benefits of Spikevax have been shown in studies?

A very large clinical trial showed that Spikevax, given as a two-dose regimen, was effective at preventing COVID-19 in people from 18 years of age. The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.

Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection. The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1% efficacy in the trial. The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.

Another study showed that an additional dose of Spikevax increased the ability to produce antibodies against SARS-CoV-2 in organ transplant patients with severely weakened immune systems.

The effects of Spikevax were also investigated in a study involving over 3,000 children aged 12 to 17 years. The study showed that Spikevax produced a comparable immune response in 12- to 17-year-olds to that seen in young adults (aged 18 to 25 years), as measured by the level of antibodies against SARS-CoV-2. In addition, none of the 2,163 children who received the vaccine developed COVID-19, compared with four of 1,073 children given a dummy injection. These results allowed to conclude that the efficacy of Spikevax in children 12 to 17 years old is similar to that in adults.

An additional study involving three groups of children aged 6 months to under 2 years, 2 to 5 years and 6 to 11 years showed that Spikevax produced a comparable immune response in these age groups to that seen in young adults (aged 18 to 25 years), as measured by the level of antibodies against SARS-CoV-2. These results indicate that the efficacy of Spikevax in children 6 months to 11 years old is similar to that in adults.

Additional data showed that subsequent doses, including boosters, lead to a rise in levels of antibodies against SARS-CoV-2.

Based on available data, vaccines adapted specifically to target circulating strains of the virus are expected to elicit a strong immune response against these strains.

Can children be vaccinated with Spikevax?

Originally authorised Spikevax, Spikevax bivalent Original/Omicron BA.4-5 and Spikevax XBB.1.5 are authorised for adults and children from 6 months of age.

Spikevax bivalent Original/Omicron BA.1 is authorised for adults and children from 6 years of age.

Can immunocompromised people be vaccinated with Spikevax?

Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.

Severely immunocompromised people may be given an additional dose of Spikevax as part of their primary vaccination.

Can pregnant or breast-feeding women be vaccinated with Spikevax?

Spikevax can be used during pregnancy.

A large amount of data from pregnant women vaccinated with Spikevax during the second or third trimester of their pregnancy has been analysed and showed no increase in pregnancy complications. Although data in women in the first trimester of pregnancy are more limited, no increased risk of miscarriage was seen.

Spikevax can be used during breast-feeding. Data from women who were breast-feeding after vaccination have not shown a risk of adverse effects in breast-fed babies.

No data are currently available regarding the use of the adapted vaccines in pregnant or breast-feeding women. However, based on the similarity with the originally authorised Spikevax, including a comparable safety profile, the adapted vaccines can be used during pregnancy and breast-feeding.

Can people with allergies be vaccinated with Spikevax?

People who already know they have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.

Allergic reactions (hypersensitivity) have been seen in people receiving the vaccine. A very small number of cases of anaphylaxis (severe allergic reaction) have occurred. Therefore, as for all vaccines, Spikevax, including the adapted vaccines, should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions. People who have a severe allergic reaction when they are given a dose of Spikevax or its adapted vaccines should not receive subsequent doses.

How well does Spikevax work for people of different ethnicities and genders?

The main clinical trials for Spikevax included people of different ethnicities and genders. The high efficacy was maintained across genders and ethnic groups.

What are the risks associated with Spikevax?

For the full list of side effects and restrictions with Spikevax, see the package leaflet.

The most common side effects with Spikevax are usually mild or moderate and get better within a few days after vaccination. These include redness, pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea (feeling sick) and vomiting. They may affect more than 1 in 10 people. In infants under 3 years of age, irritability, crying, sleepiness and loss of appetite are also very common side effects (affecting more than 1 in 10 infants).

Hives and rash at the injection site, sometimes occurring more than a week after injection, rash affecting areas other than the injection site and diarrhoea may affect less than 1 in 10 people. Itching at the injection site, dizziness and abdominal pain may affect less than 1 in 100 people. Swelling of the face, which may affect people who had facial cosmetic injections in the past, weakness in muscles on one side of the face (acute peripheral facial paralysis or palsy), paraesthesia (unusual feeling in the skin, such as tingling or a crawling feeling) and hypoaesthesia (reduced sensation to touch, pain and temperature) may affect less than 1 in 1,000 people.

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) may occur in up to 1 in 10,000 people.

A very small number of cases of erythema multiforme (red patches on the skin with a dark red centre and paler red rings) have occurred. Allergic reactions have also occurred in people receiving the vaccine, including a very small number of cases of severe allergic reactions (anaphylaxis).

The safety of the adapted vaccines is comparable to that of the originally authorised Spikevax vaccine.

Why is Spikevax authorised in the EU?

Data have shown that originally authorised Spikevax and its adapted vaccines cause the production of antibodies against SARS-CoV-2 that can protect against COVID-19. The main trials showed that the originally authorised vaccine has a high efficacy in all age groups. Most side effects are mild to moderate in severity and are gone within a few days.

The European Medicines Agency therefore decided that the benefits of Spikevax, including its adapted vaccines, are greater than its risks, and it can be authorised for use in the EU.

Spikevax was originally given 'conditional authorisation' because there was more evidence to come about the vaccine. The company has provided comprehensive information, including data regarding its safety, efficacy, and how well Spikevax prevents severe disease. In addition, the company has completed all requested studies on the pharmaceutical quality of the vaccine. As a result, the conditional authorisation has been switched to a standard one.

What measures are being taken to ensure the safe and effective use of Spikevax?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Spikevax and its adapted vaccines have been included in the summary of product characteristics and the package leaflet.

A risk management plan (RMP) is also in place and contains important information about the vaccine's safety, how to collect further information and how to minimise any potential risks.

Safety measures for Spikevax and its adapted vaccines are implemented in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets Spikevax will provide regular safety reports.

As for all medicines, data on the use of Spikevax and its adapted vaccines are continuously monitored. Suspected side effects are carefully evaluated and any necessary action taken to protect patients.

Other information about Spikevax

COVID-19 Vaccine Moderna received a conditional marketing authorisation valid throughout the EU on 6 January 2021. This was switched to a standard marketing authorisation on 3 October 2022.

The name of the vaccine was changed to Spikevax on 22 June 2021.

More information about the COVID-19 vaccines is available on the COVID-19 vaccines key facts page.

Further information on Spikevax and its adapted vaccines can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/spikevax.

This overview was last updated in 09-2023.

[Exhibit 8]

EMA/863593/2022 — EMEA/H/C/005675

Vaxzevria¹ (COVID-19 Vaccine (ChAdOx1-S [recombinant]))

An overview of Vaxzevria and why it is authorised in the EU

What is Vaxzevria and what is it used for?

Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older.

Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19.

Vaxzevria does not contain the virus itself and cannot cause COVID-19.

How is Vaxzevria used?

Vaxzevria is given as two injections, usually into the muscle of the upper arm. The second dose should be given between 4 and 12 weeks after the first dose.

A booster dose may be given at least 3 months after the second dose. A booster dose of Vaxzevria can also be given to adults who have had two doses of an authorised mRNA COVID-19 vaccine. The vaccines should be used according to official recommendations issued at national level by public health bodies.

For more information about using Vaxzevria, see the package leaflet or consult a healthcare professional.

How does Vaxzevria work?

Vaxzevria works by preparing the body to defend itself against COVID-19. It is made up of another virus (adenovirus) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body's cells.

[fn 1] Previously known as COVID-19 Vaccine AstraZeneca

Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person's immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it. If, later on, the person comes into contact with SARS-CoV-2, their immune system will recognise it and be ready to defend the body against it.

The adenovirus in the vaccine cannot reproduce and does not cause disease.

What benefits of Vaxzevria have been shown in studies?

Combined results from 4 clinical trials in the United Kingdom, Brazil and South Africa showed that Vaxzevria was safe and effective at preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine and half were given a control injection, either a dummy injection or another non-COVID vaccine. People did not know if they had been given the test vaccine or the control injection.

The Agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases occurring in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine was to be given as two standard doses, and the second dose should be given between 4 and 12 weeks after the first, the Agency concentrated on results involving people who received this standard regimen.

These showed a 59.5% reduction in the number of symptomatic COVID-19 cases in people given the vaccine (64 of 5,258 got COVID-19 with symptoms) compared with people given control injections (154 of 5,210 got COVID-19 with symptoms). This means that the vaccine demonstrated around a 60% efficacy in these clinical trials.

Another study conducted in the United States, Peru and Chile involved around 26,000 people, of whom 21% were above 65 years of age. The participants received the second dose 4 weeks after the first one. The study showed a 74% reduction in the number of symptomatic COVID-19 cases in people given the vaccine (73 of 17,662 got COVID-19 with symptoms) compared with people given control injections (130 of 8,550 got COVID-19 with symptoms). The study also showed that the vaccine efficacy of Vaxzevria in older people is comparable to that seen in younger people.

Further data showed a rise in antibody levels when a booster dose was given after the second dose of Vaxzevria or after two doses of an mRNA vaccine in adults aged 30 years and above with a normal immune system.

Can children be vaccinated with Vaxzevria?

Vaxzevria is not currently authorised for use in children. EMA has agreed with the company on a plan to conduct trials involving children at a later stage.

Can immunocompromised people be vaccinated with Vaxzevria?

There are limited data on immunocompromised people (people with weakened immune systems).

Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.

Can pregnant or breast-feeding women be vaccinated with Vaxzevria?

Preliminary animal studies do not show any harmful effects in pregnancy, however data on the use of Vaxzevria during pregnancy are very limited. Although there are no studies on breast-feeding, no risk during breast-feeding is expected.

The decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.

Can people with allergies be vaccinated with Vaxzevria?

People who already know they have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.

Allergic reactions (hypersensitivity) have been seen in people receiving the vaccine. Cases of anaphylaxis (severe allergic reaction) have also occurred. As for all vaccines, Vaxzevria should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions. People who have a severe allergic reaction when they are given the first dose of Vaxzevria should not receive the second dose.

How well does Vaxzevria work for people of different ethnicities and genders?

The clinical trial included people of different ethnicities and genders. The efficacy was maintained across genders and ethnic groups.

What are the risks associated with Vaxzevria?

The most common side effects with Vaxzevria are usually mild or moderate and get better within a few days after vaccination. When compared with the first dose, side effects reported after the second dose are milder and reported less frequently. People receiving Vaxzevria may experience more than one side effect at the same time.

The most common side effects are tenderness, pain and bruising at the injection site, headache, tiredness, muscle pain, general feeling of being unwell, chills, fever, joint pain and nausea (feeling sick). They may affect more than 1 in 10 people.

Thrombocytopenia (low levels of blood platelets), vomiting, diarrhoea, pain in legs or arms, swelling and redness at the injection site, flu-like illness and asthenia (weakness) may affect up to 1 in 10 people. Lymphadenopathy (enlarged lymph nodes), decreased appetite, dizziness, sleepiness, lethargy (lack of energy), hyperhidrosis (excessive sweating), abdominal (belly) pain, muscle spasms, itching, rash and urticaria (itchy rash) may affect up to 1 in 100 people.

Weakness in muscles on one side of the face (facial paralysis or palsy) may affect up to 1 in 1,000 people.

Thrombosis (formation of blood clots in the blood vessels) in combination with thrombocytopenia (thrombosis with thrombocytopenia syndrome, TTS) and Guillain-Barré syndrome (a neurological disorder in which the body's immune system damages nerve cells) may affect up to 1 in 10,000 people.

A very small number of cases of angioedema (rapid swelling under the skin), capillary leak syndrome (fluid leakage from small blood vessels causing tissue swelling and a drop in blood pressure) and transverse myelitis (a neurological condition characterised by an inflammation in the spinal cord) have

occurred with Vaxzevria. A very small number of cases of immune thrombocytopenia (a condition in which the immune system mistakenly targets blood platelets, reducing their levels and affecting normal blood clotting) and cerebrovascular venous and sinus thrombosis (formation of blood clots in the vessels draining blood from the brain) have also occurred.

Allergic reactions have occurred in people receiving the vaccine, including some cases of severe allergic reactions (anaphylaxis). As for all vaccines, Vaxzevria should be given under close supervision with appropriate medical treatment available.

Vaxzevria must not be given to people who have had thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine. Vaxzevria must also not be given to people who have previously had capillary leak syndrome.

Why is Vaxzevria authorised in the EU?

Vaxzevria offers a good level of protection against COVID-19 which is a critical need in the current pandemic. The main trials showed that the vaccine had around 60% efficacy against the main strain of SARS-CoV-2 in circulation at the time. Most side effects are mild to moderate in severity and are gone within a few days.

The European Medicines Agency decided that Vaxzevria's benefits are greater than its risks and it can be authorised for use in the EU.

Vaxzevria was originally given 'conditional authorisation' because there was more evidence to come about the vaccine. The company has provided comprehensive information, including data regarding its safety and efficacy, confirming the findings from earlier studies previously submitted. In addition, the company has completed all requested studies on the pharmaceutical quality of the vaccine. As a result, the conditional authorisation has been switched to a standard one.

What measures are being taken to ensure the safe and effective use of Vaxzevria?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vaxzevria have been included in the summary of product characteristics and the package leaflet.

A risk management plan for Vaxzevria is also in place and contains important information about the vaccine's safety, how to collect further information and how to minimise any potential risks. A summary of the RMP is available.

Safety measures for Vaxzevria are implemented in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets Vaxzevria will provide regular safety reports.

As for all medicines, data on the use of Vaxzevria are continuously monitored. Suspected side effects reported with Vaxzevria are carefully evaluated and any necessary action taken to protect patients.

Other information about Vaxzevria

COVID-19 Vaccine AstraZeneca received a conditional marketing authorisation valid throughout the EU on 29 January 2021. The name of the vaccine was changed to Vaxzevria on 25 March 2021. The conditional marketing authorisation was switched to a standard marketing authorisation on 31 October 2022.

More information about the COVID-19 vaccines, such as the use of adapted vaccines and boosters, is available on the COVID-19 vaccines key facts page.

Further information on Vaxzevria can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vaxzevria.

This overview was last updated in 11-2022.

[Exhibit 9]

EMA/234937/2023 — EMEA/H/C/005737

Jcovden¹ (COVID-19 vaccine (Ad26.COV2-S [recombinant]))

An overview of Jcovden and why it is authorised in the EU

What is Jcovden and what is it used for?

Jcovden is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus.

Jcovden is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein found on SARS-CoV-2.

Jcovden does not contain SARS-CoV-2 itself and cannot cause COVID-19.

How is Jcovden used?

Jcovden is given as an injection, usually into the muscle of the upper arm.

A booster dose may be given at least 2 months after the first dose of Jcovden in people aged 18 years and older. A booster dose may also be given after a primary vaccination course with an mRNA or adenoviral vector vaccine. The timing of a Jcovden booster dose depends on when a booster would normally be given for such vaccines.

The vaccine should be used according to official recommendations issued at national level by public health bodies. For more information about using Jcovden, see the package leaflet or consult a healthcare professional.

How does Jcovden work?

Jcovden works by preparing the body to defend itself against COVID-19. It is made up of another virus (an adenovirus) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body's cells.

[fn 1] Previously known as COVID-19 Vaccine Janssen

The adenovirus passes the SARS-CoV-2 gene into the vaccinated person's cells. The cells can then use the gene to produce the spike protein. The person's immune system will recognise the spike protein as foreign and produce antibodies and activate T cells (white blood cells) to target it.

Later, if the person comes into contact with the SARS-CoV-2 virus, the person's immune system will recognise the spike protein on the virus and be ready to defend the body against it.

The adenovirus in the vaccine cannot reproduce and does not cause the disease.

What benefits of Jcovden have been shown in studies?

Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that Jcovden was effective at preventing COVID-19 in people from 18 years of age. This study involved over 44,000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given Jcovden or placebo.

The trial found a 67% reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received Jcovden (116 cases out of 19,630 people) compared with people given placebo (348 of 19,691 people). This means that the vaccine had a 67% efficacy.

Further data showed a rise in antibody levels when a booster dose was given after completion of a primary course with Jcovden, an mRNA vaccine, or another adenoviral vector vaccine in people from 18 years of age.

Can children be vaccinated with Jcovden?

Jcovden is not currently authorised for use in children.

Can immunocompromised people be vaccinated with Jcovden?

There are no data on immunocompromised people (people with weakened immune systems). Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.

Can pregnant or breast-feeding women be vaccinated with Jcovden?

Animal studies do not show any harmful effects of Jcovden in pregnancy. However, data on the use of Jcovden during pregnancy are very limited. There are no studies of Jcovden on breast-feeding but no risk from breast-feeding is expected.

The decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.

Can people with allergies be vaccinated with Jcovden?

People who have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.

Allergic reactions (hypersensitivity) have occurred in people receiving the vaccine, including rare cases of anaphylaxis (severe allergic reaction). As for all vaccines, Jcovden should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions.

How well does Jcovden work for people of different ethnicities and genders?

The clinical trials included people of different ethnicities and genders. The vaccine worked across genders and ethnic groups.

What are the risks associated with Jcovden?

For the full list of side effects and restrictions with Jcovden, see the package leaflet.

The most common side effects with Jcovden are usually mild or moderate and get better within 1 or 2 days after vaccination.

The most common side effects are pain at the injection site, tiredness, headache, muscle pain and nausea. They may affect more than 1 in 10 people.

Fever, chills, as well as redness and swelling at injection site may affect up to 1 in 10 people. Dizziness, shaking, coughing, mouth and throat pain, sneezing, diarrhoea, vomiting, rash, joint pain, muscle weakness, backache, pain in the arms and legs, weakness and feeling generally unwell may affect up to 1 in 100 people. Rare side effects (which may affect up to 1 in 1,000 people) are lymphadenopathy (enlarged lymph nodes), itchy rash, hypersensitivity (allergy), paraesthesia (unusual sensations like numbness, tingling or pins and needles), hypoesthesia (reduced sensation to touch, pain and temperature), facial paralysis, tinnitus (ringing or buzzing in the ears), venous thromboembolism (formation of blood clots in veins) and sweating.

For booster vaccinations, the number and severity of reactions tend to be higher when people have previously been vaccinated with a vaccine other than Jcovden compared to people who have completed a primary course with Jcovden.

Thrombosis (formation of blood clots in the blood vessels) in combination with thrombocytopenia (low levels of blood platelets), known as TTS (thrombosis with thrombocytopenia syndrome), and Guillain-Barré syndrome (a neurological disorder in which the body's immune system damages nerve cells) may affect up to 1 in 10,000 people.

Allergic reactions, including anaphylaxis (severe allergic reaction), have occurred in people receiving the vaccine. As for all vaccines, Jcovden should be given under close supervision with appropriate medical treatment available.

A very small number of cases of immune thrombocytopenia (a condition in which the immune system mistakenly targets blood platelets, reducing their levels and affecting normal blood clotting), capillary leak syndrome (fluid leakage from small blood vessels causing tissue swelling and a drop in blood pressure), cutaneous small vessel vasculitis (inflammation of blood vessels in the skin), transverse myelitis (a neurological condition characterised by an inflammation in the spinal cord), myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) have occurred with Jcovden.

Jcovden must not be given to people who have previously had capillary leak syndrome; it must also not be given to people who have had TTS following vaccination with any COVID-19 vaccine.

Why is Jcovden authorised in the EU?

Jcovden offers a good level of protection against COVID-19 which is critical during the current pandemic. The main trial showed that the vaccine has around 67% efficacy. Most side effects are mild to moderate in severity and last only a few days.

The European Medicines Agency therefore decided that Jcovden's benefits are greater than its risks and it can be authorised for use in the EU.

Jcovden was originally given 'conditional authorisation' because there was more evidence to come about the vaccine. The company has provided comprehensive information, including data regarding its safety and efficacy, confirming the findings from earlier studies previously submitted. In addition, the company has completed all requested studies on the pharmaceutical quality of the vaccine. As a result, the conditional authorisation has been switched to a standard one.

What measures are being taken to ensure the safe and effective use of Jcovden?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jcovden have been included in the summary of product characteristics and the package leaflet.

A risk management plan (RMP) for Jcovden is also in place and contains important information about the vaccine's safety, how to collect further information and how to minimise any potential risks. A summary of the RMP is available.

Safety measures for Jcovden are implemented in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets Jcovden will provide regular safety reports.

As for all medicines, data on the use of Jcovden are continuously monitored. Suspected side effects reported with Jcovden are carefully evaluated and any necessary action taken to protect patients.

Other information about Jcovden

COVID-19 Vaccine Janssen received a conditional marketing authorisation valid throughout the EU on 11 March 2021. The name of the vaccine was changed to Jcovden on 28 April 2022. The conditional marketing authorisation was switched to a standard marketing authorisation on 9 January 2023.

More information about the COVID-19 vaccines is available on the COVID-19 vaccines key facts page.

Further information on Jcovden can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jcovden

This overview was last updated in 06-2023.

10

COVID-19 vaccination: BioNTech/Pfizer

No. 2020/29, The Hague, 24 December 2020

Summary

Health Council of the Netherlands

[Interest of Justice editorial note: this Health Council summary is marked 'Auteursrecht voorbehouden' (copyright reserved). Its text is therefore not reproduced or translated in full here; the Dutch original is in the court file and on www.gezondheidsraad.nl. The content is summarised below.]

[Summary of exhibit 10, pages 100–101:] At the request of the Minister of Health, Welfare and Sport, the Health Council's Committee on Medical Aspects of COVID-19 assessed the BNT162b2 vaccine of BioNTech and Pfizer (brand name Comirnaty), which had been assessed by the EMA and approved by the European Commission, against the Council's standard criteria for vaccination advice. (1) Disease burden: large; up to mid-December the GGD had confirmed 628,577 cases and 10,168 deaths from COVID-19; the risk of severe illness rises with age and chronic illness; the average age of patients was 67 on the nursing ward and 64 in the ICU, and most deaths were among older people, many living in nursing homes. (2) Efficacy: the vaccine is given in two doses about three weeks apart; in a trial of over 36,000 people (half vaccine, half placebo) efficacy was well above 90% in all groups, including older people and medical risk groups; how long protection lasts and whether vaccination prevents transmission was still unknown. (3) Safety: sufficiently safe and well tolerated; most people had side effects after both doses, mostly mild to moderate injection-site pain, tiredness, headache and muscle pain, more often in younger people and after the second dose, and mostly gone within a few days. (4) Acceptability: benefits outweigh the drawbacks; cost-effectiveness could not yet be assessed for lack of data.

[Summary, continued:] Advice: use the vaccine in public COVID-19 vaccination programmes, primarily for people aged 60 and over, starting with the oldest, in line with vaccination strategy 1 of the Council's earlier advice, to achieve the greatest health gain and reduce the inflow of patients to hospitals. Limited use for long-term care staff for as long as the medical risk groups they care for cannot themselves be vaccinated, and very selective use in curative care where staff absence causes acute health damage. According to the committee, the AstraZeneca vaccine, expected early 2021 in a large quantity of 4.5 million doses, could serve to vaccinate all healthcare workers.

[Standard colophon of the Health Council, summarised: the Health Council of the Netherlands, established in 1902, is an advisory body that informs the government and parliament on the state of science in public health and health (care) research (Article 22 of the Health Act); its advisory reports are public and are as a rule drawn up by multidisciplinary committees of experts appointed in a personal capacity; the document can be downloaded from www.gezondheidsraad.nl.]

This publication may be cited as follows: Health Council of the Netherlands. COVID-19 vaccination: BioNTech/Pfizer. The Hague: Health Council of the Netherlands, 2020; publication no. 2020/29.

11

COVID-19 vaccination: Moderna vaccine and the vaccination strategy

No. 2021/01, The Hague, 11 January 2021

Summary

Health Council of the Netherlands

[Interest of Justice editorial note: this Health Council summary is marked 'Auteursrecht voorbehouden' (copyright reserved). Its text is therefore not reproduced or translated in full here; the Dutch original is in the court file and on www.gezondheidsraad.nl. The content is summarised below.]

[Summary of exhibit 11, pages 105–106:] At the Minister's request, the Committee on Medical Aspects of COVID-19 assessed the mRNA-1273 vaccine developed by Moderna (brand name COVID-19 Vaccine Moderna), positively assessed by the EMA and registered by the European Commission, against the standard criteria. (1) Disease burden: large; up to early January the GGD had confirmed 834,064 cases and 11,826 deaths; risk of severe illness increases with age and chronic illness; average age 67 on the ward and 64 in the ICU; most deaths among older people, many in nursing homes. (2) Efficacy: two doses 28 days apart; in a trial of over 28,000 people (half vaccine, half placebo) the vaccine protected adults, older people and medical risk groups well over a follow-up of about two months, with efficacy well above 80% in all groups; duration of protection and effect on transmission still unknown. (3) Safety: sufficiently safe and well tolerated; side effects after both doses in most people, mostly mild to moderate injection-site pain, tiredness, headache and muscle pain, more often in younger people and after the second dose, mostly gone within a few days. (4) Acceptability: benefits outweigh drawbacks; cost-effectiveness not yet assessable.

[Summary, continued:] Advice: use the vaccine in public COVID-19 programmes. Because of its very high efficacy in older people, the greatest disease burden in that group and the relatively small quantity available, use it primarily for people aged 60 and over, oldest first, whether or not they belong to a medical risk group. Vaccinating older people, both those living independently and those in long-term care institutions, will lower the disease burden in that group and the pressure on healthcare; the vaccines now available should therefore be used for older people and the programme organised so that the chosen strategy can continue to be followed. (In the scan, the two text columns on these pages are out of order; the summary follows the logical order.)

[Standard colophon of the Health Council, summarised: the Health Council of the Netherlands, established in 1902, is an advisory body that informs the government and parliament on the state of science in public health and health (care) research (Article 22 of the Health Act); its advisory reports are public and are as a rule drawn up by multidisciplinary committees of experts appointed in a personal capacity; the document can be downloaded from www.gezondheidsraad.nl.]

This publication may be cited as follows: Health Council of the Netherlands. COVID-19 vaccination: Moderna vaccine and the vaccination strategy. The Hague: Health Council of the Netherlands, 2021; publication no. 2021/01.

Copyright reserved

12

COVID-19 vaccination: AstraZeneca vaccine

No. 2021/04, The Hague, 4 February 2021

Summary

Health Council of the Netherlands

[Interest of Justice editorial note: this Health Council summary is marked 'Auteursrecht voorbehouden' (copyright reserved). Its text is therefore not reproduced or translated in full here; the Dutch original is in the court file and on www.gezondheidsraad.nl. The content is summarised below.]

[Summary of exhibit 12, pages 110–111:] At the Minister's request, the Committee on Medical Aspects of COVID-19 assessed the ChAdOx1-S nCoV-19 vaccine developed by the University of Oxford and AstraZeneca (brand name Covid-19 vaccine AstraZeneca), positively assessed by the EMA and registered by the European Commission. (1) Disease burden: large; up to the end of January the GGD had confirmed 956,867 cases and 13,665 deaths; risk of severe illness increases with age and [illegible] chronic illness. (2) Efficacy: two doses 4 to 12 weeks apart; in a trial of over 10,000 people (half vaccine, half a control vaccine) efficacy over about two months of follow-up was about 60% in adults and medical risk groups; for people aged 56 and over there were too few data to calculate efficacy, but because the vaccine produces a comparable immune response in that group, the committee assumes it will be effective; duration of protection and effect on transmission still unknown. (3) Safety: sufficiently safe and well tolerated; most people had side effects, milder and less frequent after the second dose, mainly tenderness and pain at the injection site, tiredness and headache, mostly mild to moderate and gone within a few days. (4) Acceptability: benefits outweigh drawbacks; cost-effectiveness not yet assessable.

[Summary, continued:] Advice: use the vaccine in public COVID-19 programmes, first for people aged 60 to 64. Efficacy cannot yet be calculated for people aged 56 and over because few older people took part in the phase 3 trial, but an immune response in older people has been shown, so the committee assumes sufficient efficacy; because the immune system weakens with age (immunosenescence), it is uncertain whether the vaccine is sufficiently effective from age 65, so the committee considers it usable in adults up to 65. To prevent as much serious illness and death as possible, the first available doses should go to people aged 60 to 64, oldest first; modelling shows this yields a lower disease burden than vaccinating that group later with an mRNA vaccine after all over-65s, as currently planned. Specific medical risk groups at extra high risk should also be vaccinated, partly with this vaccine; patients with a severely compromised immune system preferably receive an mRNA vaccine. Once all older people are vaccinated, the committee advises moving on to medical risk groups under 60 and people aged 50 to 60, in both cases oldest first.

[Standard colophon of the Health Council, summarised: the Health Council of the Netherlands, established in 1902, is an advisory body that informs the government and parliament on the state of science in public health and health (care) research (Article 22 of the Health Act); its advisory reports are public and are as a rule drawn up by multidisciplinary committees of experts appointed in a personal capacity; the document can be downloaded from www.gezondheidsraad.nl.]

This publication may be cited as follows: Health Council of the Netherlands. COVID-19 vaccination: AstraZeneca vaccine. The Hague: Health Council of the Netherlands, 2021; publication no. 2021/04.

Copyright reserved

13

COVID-19 vaccination: Janssen vaccine

No. 2021/13, The Hague, 17 March 2021

Summary

Health Council of the Netherlands

[Interest of Justice editorial note: this Health Council summary is marked 'Auteursrecht voorbehouden' (copyright reserved). Its text is therefore not reproduced or translated in full here; the Dutch original is in the court file and on www.gezondheidsraad.nl. The content is summarised below.]

[Summary of exhibit 13, pages 115–116:] At the Minister's request, the Committee on Medical Aspects of COVID-19 assessed the Ad26.COV2.S vaccine developed by Janssen Pharmaceutica (brand name Covid-19 vaccine Janssen), positively assessed by the EMA and registered by the European Commission. (1) Disease burden: large; up to early March 2021 the GGD had confirmed 1,128,202 cases and 15,917 deaths; risk of severe illness increases with age and is higher in people with a chronic illness. (2) Efficacy: a single dose; in a trial of over 39,000 people (half vaccine, half placebo), from 28 days after vaccination efficacy was 66% against disease (positive PCR test with symptoms) and 85% [the remainder of this sentence is illegible in the scan]; duration of protection, effect on transmission and the added value of a second dose were still being studied. (3) Safety: sufficiently safe and well tolerated; most people had side effects, most commonly injection-site pain, tiredness, headache and muscle pain, more often in younger [illegible], in most cases gone within two days.

[Summary, continued:] (4) Acceptability: benefits outweigh drawbacks (side effects generally short-lived); cost-effectiveness not yet assessable. Advice: use the vaccine in public COVID-19 programmes, as it is effective, sufficiently safe and acceptable for adults, older people and medical risk groups; provisionally use it for people aged 60 and over, vaccinating from oldest to youngest until everyone in this group has had the opportunity to be vaccinated, so as to prevent as much serious illness and death from COVID-19 as possible.

[Standard colophon of the Health Council, summarised: the Health Council of the Netherlands, established in 1902, is an advisory body that informs the government and parliament on the state of science in public health and health (care) research (Article 22 of the Health Act); its advisory reports are public and are as a rule drawn up by multidisciplinary committees of experts appointed in a personal capacity; the document can be downloaded from www.gezondheidsraad.nl.]

This publication may be cited as follows: Health Council of the Netherlands. COVID-19 vaccination: Janssen vaccine. The Hague: Health Council of the Netherlands, 2021; publication no. 2021/13.

Copyright reserved