Pfizer CEO Bourla — vaccine safe, claims are conspiracy theory

DE BRAUW BLACKSTONE WESTBROEK

District Court of the Northern Netherlands, Leeuwarden location

Case and docket number: C/17/190788 / HA ZA 23/172

Hearing: 21 February 2024

STATEMENT OF DEFENCE

in the matter of:

Albert BOURLA, residing in Greenwich, United States of America, defendant sub 11, lawyers: Ms D.C. Roessingh and Ms M. Bredenoord-Spoek

versus:

1. [claimant 1], residing in [redacted]

2. [claimant 2], residing in [redacted]

3. [claimant 3], residing in [redacted]

4. [claimant 4], residing in [redacted]

5. [claimant 5], residing in [redacted]

6. [claimant 6], last residing in [redacted] [fn 1]

7. [claimant 7], residing in [redacted]

(together “[redacted] et al.” and individually referred to by their surnames), claimants,

[fn 1] Proceedings suspended due to death. See the deed of deliberation on suspension under Article 225(2) DCCP (...) of 22 November 2023 and the deed after deliberation on suspension under Article 225(2) DCCP of 10 January 2024.

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

TABLE OF CONTENTS

1 INTRODUCTION — 5

2 PROCEDURAL OBSERVATIONS — 8

2.1 Bourla will not contest the jurisdiction of the court, but cannot be deemed to accept the jurisdictional requirements — 8

2.2 Claims must be dismissed for lack of substantiation — 9

3 THE CLAIMS HAVE NO FACTUAL BASIS — 9

3.1 General authorisation process for vaccines in the EU — 10

3.1.1 Obtaining a marketing authorisation — 10

3.1.2 Pharmacovigilance after authorisation — 12

3.2 Development, approval and pharmacovigilance of Comirnaty and other COVID-19 vaccines — 13

3.2.1 Clinical trials (before approval) — 13

3.2.2 Approval — 14

3.2.3 Additional pharmacovigilance for COVID-19 vaccines — 16

3.2.4 Interim conclusion — 17

3.3 The argument of [redacted] et al. is a collection of conspiracy theories and falsehoods already established as such, dressed up as facts — 18

3.3.1 Misrepresentation of the development process of Comirnaty — 18

3.3.2 The purpose and effects of Comirnaty have been communicated to the public consistently and transparently — 23

3.3.3 The chemical composition of Comirnaty has long been known — 28

3.3.4 [redacted] et al. fundamentally misinterpret Pfizer’s report of 30 April 2021 — 32

3.3.5 The vague remarks of [redacted] et al. about allegedly differing qualities of vaccine batches are irrelevant and incorrect — 35

3.3.6 Incorrect statements about the relationship with the European Commission — 39

3.3.7 Comirnaty is not gene therapy — 39

4 [REDACTED] ET AL. HAVE NOT ESTABLISHED A SINGLE ELEMENT OF AN UNLAWFUL ACT — 40

4.1 No unlawful conduct — 41

4.1.1 No torture or cruel, inhuman or degrading treatment or punishment under Article 7 ICCPR — 41

4.1.2 No breach of a statutory duty — 42

4.1.3 No conduct contrary to what is proper in society according to unwritten law — 43

4.2 No damage — 44

4.2.1 Graphene oxide is not a component of the COVID-19 vaccines — 44

4.2.2 [redacted] et al. do not meet their burden of allegation; moreover, the majority of them admit that they have not suffered material damage — 45

4.2.3 Allegedly suffered non-material damage is not eligible for compensation — 47

4.3 No causal link — 49

4.4 No group liability (Article 6:166 DCC) — 50

5 BURDEN OF ADDUCING EVIDENCE AND OFFER OF PROOF — 50

Dr Albert Bourla (“Bourla”) submits his statement of defence as follows.

1 INTRODUCTION

1. The SARS-CoV-2 virus (the “Coronavirus”) really exists. Just as real is COVID-19, the highly contagious and potentially life-threatening respiratory disease caused by the Coronavirus.

2. Shortly after it emerged, on 11 March 2020, the infection had spread to 114 countries worldwide and the World Health Organization (the “WHO”) declared the Coronavirus outbreak a global pandemic. [fn 2] As a result of this pandemic, approximately 700 million people worldwide have been infected with COVID-19 and almost seven million people have died. [fn 3] In the Netherlands alone, more than eight million confirmed COVID-19 infections have been recorded, resulting in more than 22,000 deaths. [fn 4]

3. Naturally, when the COVID-19 pandemic emerged in early 2020, it almost immediately became the greatest concern of governments, businesses and civil-society organisations around the world. Governments from all over the world called on pharmaceutical companies to develop a vaccine. Pfizer and BioNTech were among the first to take on this responsibility, together with other pharmaceutical companies such as Moderna, Janssen and AstraZeneca. [fn 5] As early as 2020, Pfizer conducted clinical studies, and in that same year it succeeded in obtaining a conditional marketing authorisation from regulatory authorities, including in the EU. These approvals were granted on the basis of extensive data obtained during the clinical studies, which showed that the Pfizer/BioNTech vaccine

[fn 2] WHO, WHO Director-General's opening remarks at the media briefing on COVID-19, 11 March 2020 (Bourla-1), available at www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-COVID-19---11-march-2020

[fn 3] data.who.int/dashboards/covid19/cases?n=c

[fn 4] covid19.who.int/region/euro/country/nl

[fn 5] For a complete list of COVID-19 vaccines approved by the EMA, see EMA, COVID-19 medicines (Bourla-2), available at www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines

(“Comirnaty”) [fn 6] met the statutory standards for safety, efficacy and manufacturing quality.

4. The devastation and loss of human life caused by the pandemic were limited and ultimately largely overcome through a joint effort of governments, citizens, businesses and the scientific community. Vaccines in particular, including Comirnaty, contributed greatly to slowing the pandemic. On 5 May 2023, the WHO declared that the COVID-19 pandemic was officially over. [fn 7] Scientific analyses show that, in the first two years of the pandemic alone, the COVID-19 vaccines prevented approximately 14 to 19 million deaths worldwide. [fn 8]

5. Nevertheless, a (fortunately small) part of the population embraced various conspiracy theories, including that the Coronavirus itself is a hoax, that the vaccines against it are toxic, or that the COVID-19 pandemic is a conspiracy by “the global elite” to achieve some illegal and/or immoral aim.

6. [redacted] et al. can unfortunately be counted among this part of the population – as, incidentally, can general practitioner Van Walraven, who has apparently been willing to issue ‘medical statements’ for the purposes of these proceedings. [redacted] et al. claim that COVID-19 is not a disease, but that this phenomenon was invented as part of a project called The Great Reset, which was planned and aimed at forcing a total reordering of the world. According to [redacted] et al., this project was initiated by NGOs, in particular the World Economic Forum (“WEF”), financed by the World Bank and carried out in the Netherlands by the defendants in these proceedings. Vaccinating the entire population with a COVID-19 vaccine was supposedly part of this project. [fn 9] The concrete trigger for these theories of [redacted] et al. is apparently the book ‘The Great

[fn 6] The Pfizer/BioNTech COVID-19 vaccine is also known as BNT162b2. These names may be used interchangeably.

[fn 7] WHO, Statement on the fifteenth meeting of the IHR (2005), 5 May 2023 (Bourla-3), available at www.who.int/news/item/05-05-2023-statement-on-the-fifteenth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic

[fn 8] The Lancet, Global impact of the first year of COVID-19, 23 June 2022 (Bourla-4), available at www.thelancet.com/action/showPdf?pii=S1473-3099%2822%2900320-6

[fn 9] See, among others, the summons, nos. 2, 61-65, 117-125, 186 and 198.

Reset’, which sets out what, according to its authors, the world might look like after COVID-19. [fn 10] Nothing more and nothing less. The conspiracy theory of [redacted] et al. therefore has no factual basis whatsoever.

7. In these proceedings, [redacted] et al. specifically claim that (i) Bourla and the other defendants intentionally and unlawfully misled them by calling on the Dutch population (including [redacted] et al.) to be vaccinated against COVID-19, while they knew or should have known that the vaccine was not safe and not effective, and (ii) they have suffered damage as a result.

8. These accusations are incorrect. Bourla did not mislead [redacted] et al., nor did he otherwise act unlawfully towards them. In reality, Bourla, in his role as CEO of Pfizer, contributed to the development of a vaccine against COVID-19 that is effective and has a favourable safety profile. That makes it all the more bitter that Bourla is now being personally summoned and confronted with the aforementioned accusations. The claims formulated by [redacted] et al. suffer from fundamental procedural and substantive defects. Procedurally, it is striking that the claims against the various defendants are barely – or in many cases not at all – connected with one another, so that a claim against Bourla, who resides in the United States, cannot in principle be brought before the Dutch courts under Dutch procedural law. [fn 11] In addition, [redacted] et al. do not meet their burden of allegation. On the merits, too, the claims have no prospect of success. [redacted] et al. present the court with a hotchpotch, in places incomprehensible, of unsubstantiated and incorrect assertions that are unrelated (to one another and to the claim). The claims of [redacted] et al. should therefore be dismissed.

9. In this statement of defence, Bourla will rebut the assertions of [redacted] et al., insofar as they are comprehensible and relate

[fn 10] This book was written by, among others, Mr Schwab, the chairman of the WEF. The WEF is an organisation aimed at bringing about international cooperation and, under the heading The Great Reset, initiates the sharing of insights and information about a global approach to the social and economic crisis following the pandemic (Appendix to the Proceedings of the House of Representatives (Aanhangsel Handelingen II) 2021/22, 2541, answer to question 4).

[fn 11] See further section 2.1 on jurisdiction.

to him, to Pfizer and/or to the qualities of Comirnaty. The following structure is used:

in chapter 2, Bourla will highlight some of the most conspicuous procedural defects in the claims of [redacted] et al.;

in chapter 3, Bourla will rebut the factual assertions of [redacted] et al.; and

in chapter 4, it will be explained why the claims have no legal basis.

2 PROCEDURAL OBSERVATIONS

2.1 Bourla will not contest the jurisdiction of the court, but cannot be deemed to accept the jurisdictional requirements

10. The District Court of the Northern Netherlands, Leeuwarden location, lacks jurisdiction to hear the claims against Bourla. In paragraphs 296-297 of the summons, [redacted] et al. merely refer to Article 107 DCCP, which concerns internal or relative competence. [redacted] et al. have not explained – let alone substantiated – why and on what basis the court would have international jurisdiction over the claims against Bourla. Had they considered Article 7(1) DCCP (which provides the correct framework), they would not have succeeded. They have not come anywhere near asserting such a connection between their claims against the intended anchor defendant, Mr Hofstra, and their claims against Bourla. The District Court of the Northern Netherlands, Leeuwarden location, could therefore – after its own motion assessment – simply declare that it lacks jurisdiction with respect to the claims against Bourla. That said, the claims of [redacted] et al. are so evidently unfounded that Bourla will not raise a jurisdictional defence, in favour of having the claims dealt with on the merits once and for all. [fn 12]

[fn 12] Bourla cannot hereby be deemed to agree with any of the requirements for jurisdiction of the Dutch courts, such as that there is such a connection, within the meaning of Article 7 DCCP, between the claims against Bourla and those against the other defendants.

2.2 Claims must be dismissed for lack of substantiation

11. [redacted] et al. should have asserted the necessary facts and, if these were disputed, proved them, in order to be able to invoke the legal consequences they seek. Relying on Article 6:162 DCC, they claim that (i) they were misled; (ii) without that deception they would not have taken a COVID-19 vaccine; and (iii) they suffered damage as a result of the vaccine.

12. These assertions apparently imply that [redacted] et al. took a COVID-19 vaccine. In that case, they could at least have been expected to state (i) which vaccine they allegedly took and when [fn 13], and (ii) that they took these vaccines as a result of the alleged deception. [redacted] et al. have not even asserted these elementary points. For that reason alone, their claims cannot be granted. In addition, proper assertions and proper substantiation are lacking as to (i) the nature of the alleged deception and (iii) their alleged damage.

13. Notwithstanding the foregoing, Bourla believes that the court can indeed rule on the assertions that [redacted] et al. do put forward. Although the 65-page summons is riddled with fabricated assertions that sometimes make no sense whatsoever and whose relevance is not always clear, it is clear to Bourla what [redacted] et al. are trying to achieve. Bourla disputes everything that [redacted] et al. have asserted in the initial summons, except insofar as this statement of defence shows that Bourla acknowledges the correctness of any assertion of [redacted] et al. Bourla responds as best he can to the suggestions of [redacted] et al.

[fn 13] Only for [redacted] does exhibit 91 show which vaccine she allegedly took and when.

3 THE CLAIMS HAVE NO FACTUAL BASIS

14. This chapter will discuss the general authorisation process for vaccines in the EU (section 3.1) and the specific development of Comirnaty

(section 3.2). The specific assertions of [redacted] et al. will then be rebutted (section 3.3).

3.1 General authorisation process for vaccines in the EU

3.1.1 Obtaining a marketing authorisation

15. All Pfizer vaccines are initially developed and tested in a laboratory. If the initial tests are favourable, they are followed by clinical studies of increasing size, including randomised controlled studies comparing the new vaccine with an existing vaccine or a placebo. [fn 14]

16. The results of the development programme are submitted to the appropriate competent authority, together with extensive pharmaceutical data relating to the manufacture of the vaccine, as part of the application for a marketing authorisation.

17. At European level, the European Commission decides on the grant of a marketing authorisation, following regulatory and scientific assessment by the European Medicines Agency (the “EMA”) and its advisory committee, the Committee for Medicinal Products for Human Use (the “CHMP”). [fn 15]

18. If, after thorough examination, the EMA concludes that the balance of the benefits and risks associated with the use of the vaccine is positive, the EMA may decide to grant a marketing authorisation for the product. The vaccine and the approved product information for healthcare professionals and vaccine recipients then become available on the market.

19. That marketing authorisation may also be granted conditionally, for example in emergency situations relating to a threat to public health identified by the World Health Organization

[fn 14] In this case, the candidate vaccine Comirnaty was compared with a placebo, because there were no existing COVID-19 vaccines.

[fn 15] The legal framework for the authorisation, manufacture and distribution of medicinal products in the EU is laid down mainly in Directive 2001/83/EC on the Community code relating to medicinal products for human use and Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

or by the EU in the context of Decision No 2119/98/EC. [fn 16] Article 4(1) of Regulation (EC) No 507/2006 provides as follows in this regard:

“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 risk-benefit 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.”

20. The EMA confirms that the conditional marketing authorisation is a pragmatic tool for approving a medicinal product that fulfils an unmet medical need. [fn 17] Earlier approval through a conditional marketing authorisation does not detract from the guarantees that the medicinal product meets the strict EU standards for safety, efficacy and quality and that comprehensive data continue to be generated after approval. Additional information may, however, be supplied, for example on protection in specific groups such as children and pregnant women. A conditional marketing authorisation is valid for one year and can then be renewed annually. Once comprehensive clinical data have been submitted, the CHMP may recommend converting the conditional marketing authorisation into a standard marketing authorisation.

[fn 16] Commission Regulation (EC) No 507/2006 provides for the grant of a “conditional marketing authorisation” for certain medicinal products falling within the scope of Regulation (EC) No 726/2004.

[fn 17] EMA, Conditional marketing authorisation (Bourla-5), available at www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation

3.1.2 Pharmacovigilance after authorisation

21. The safety profile of a medicinal product cannot be fully established during development before authorisation. In particular, it is possible that very rare side effects are not identified even in large clinical trials. In order to identify new safety information as quickly as possible, advanced pharmacovigilance procedures are therefore implemented for all medicinal products after they have been placed on the market. [fn 18]

22. With every application for a marketing authorisation in the EU, a draft risk management plan (an “RMP”) is submitted. After approval, the RMP forms part of the marketing authorisation. An RMP may also contain additional pharmacovigilance activities that constitute conditions of the marketing authorisation. [fn 19]

23. Routine pharmacovigilance activities mean that the marketing authorisation holder must record side effects of which it becomes aware and report them to the competent regulatory authorities. [fn 20] Where reports of suspected side effects result in a confirmed safety signal, this leads to appropriate action, including updating the product information, as approved by the regulatory authorities.

[fn 18] The principal EU legislation concerning the pharmacovigilance obligations of authorisation holders is Directive 2001/83/EC, Regulation (EC) No 726/2004 and Commission Implementing Regulation (EU) No 520/2012. The EU legislation is supplemented by detailed guidelines issued by the EMA together with the heads of the medicines agencies on good pharmacovigilance practices for both regulators and industry. See EMA, Good pharmacovigilance practices (Bourla-6), available at ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices

[fn 19] See EMA, Comirnaty risk management plan, October 2023 (selection) (Bourla-7) for the current version of the Comirnaty RMP. Available, as updated from time to time, at ema.europa.eu/en/documents/rmp-summary/comirnaty-epar-risk-management-plan_en.pdf.

[fn 20] For more information, see EMA, Periodic safety update reports (PSURs) (Bourla-8), available at ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs#:~:text=PSURs%20are%20pharmacovigilance%20documents%20intended,time%20points%20after%20its%20authorisation.

3.2 Development, approval and pharmacovigilance of Comirnaty and other COVID-19 vaccines

24. The procedure outlined above was followed in the development, approval and pharmacovigilance of Comirnaty. As far as Bourla knows on the basis of publicly available information, the same applies to COVID-19 vaccines produced by other manufacturers. [fn 21]

3.2.1 Clinical trials (before approval)

25. On 13 March 2020, Pfizer issued a statement calling on the biopharmaceutical industry to work together in the fight against COVID-19. In that statement, Pfizer already referred to its contact with BioNTech in connection with the development of a potential mRNA vaccine against the Coronavirus. [fn 22] An actual letter of intent between these two parties was announced on 17 March 2020. [fn 23] On 9 April 2020, they provided further details of their collaboration, including the intention to begin clinical studies of candidate vaccines by the end of April 2020, subject to approval by the regulatory authorities. [fn 24]

26. On 23 April 2020, a study was started to select candidate vaccines on the basis of dosage. This resulted in the selection of one of the four candidate vaccines, BNT162b2 (Comirnaty), administered in a two-dose schedule of 30 micrograms. [fn 25]

27. The efficacy and safety of BNT162b2 were then examined in a large clinical study conducted in the

[fn 21] EMA, COVID-19 vaccines development, evaluation, approval and monitoring (Bourla-9), available at www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-COVID-19/treatments-vaccines/vaccines-COVID-19/COVID-19-vaccines-development-evaluation-approval-monitoring

[fn 22] Pfizer, Pfizer Outlines Five-Point Plan to Battle COVID-19, 13 March 2020 (Bourla-10), available at www.pfizer.com/news/press-release/press-release-detail/pfizer-outlines-five-point-plan-battle-COVID-19

[fn 23] Pfizer, Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine, 17 March 2020 (Bourla-11), available at investors.pfizer.com/Investors/News/news-details/2020/Pfizer-and-BioNTech-to-Co-Develop-Potential-COVID-19-Vaccine-03-17-2020/default.aspx

[fn 24] Pfizer, Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate, 9 April 2020 (Bourla-12), available at www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-further-details-collaboration

[fn 25] ClinicalTrials.gov, A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults, 13 January 2022 (Bourla-13), available at clinicaltrials.gov/ct2/show/study/NCT04380701

United States, Germany, South Africa, Turkey, Argentina and Brazil. [fn 26] Almost 44,000 people took part, of whom approximately 50% received Comirnaty and approximately 50% a placebo. [fn 27] The results showed that the efficacy of the vaccine against laboratory-confirmed symptomatic COVID-19 infection – occurring at least seven days after the second dose, and without evidence of prior COVID-19 infection – was 95% in persons aged 16 or older (with eight COVID-19 cases in the vaccination group compared with 162 COVID-19 cases in the placebo group). [fn 28]

28. Of the almost 44,000 enrolled subjects included in the safety database at the data cut-off date (14 November 2020), the percentage withdrawn because of side effects was very small (0.2% in the vaccine group and 0.1% in the placebo group). [fn 29] There were no reported deaths among study participants that were considered to be related to the vaccine. [fn 30]

3.2.2 Approval

29. During the COVID-19 pandemic, use was made of various mechanisms available to the EMA to accelerate the statutory assessment of medicinal products in the context of public health crises. These included:

the procedure under Regulation (EC) No 726/2004, which provides for a regulatory assessment with a time limit of 150 days for issuing an opinion after receipt of an application for a marketing authorisation, instead of the 210 days the EMA usually has;

a “rolling review”, in which the EMA can assess clinical trial data as they become available and before a formal application for a marketing authorisation has been submitted; and

the establishment of a task force by the EMA to ensure a rapid and coordinated response to the pandemic. [fn 31]

[fn 26] Study C4591001; see ClinicalTrials.gov, Study to Describe the Safety, Tolerability, Immunogenicity [...], 28 February 2023 (Bourla-14), available at clinicaltrials.gov/ct2/show/NCT04368728

[fn 27] EMA, Comirnaty Assessment report, 19 February 2021 (Bourla-15), available at ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf, pp. 75-76.

[fn 28] EMA, Comirnaty Assessment report, 19 February 2021 (Bourla-15), available at ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf, p. 131.

[fn 29] EMA, Comirnaty Assessment report, 19 February 2021 (Bourla-15), available at ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf, p. 94 et seq.

[fn 30] EMA, Comirnaty Assessment report, 19 February 2021 (Bourla-15), available at ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf, p. 109.

30. These accelerated procedures do not change the substantive product requirements or the established assessment principles, but are intended to organise the product assessment very efficiently, within timetables suited to the specific situation.

31. The first data on Comirnaty were submitted to the EMA by BioNTech on 5 October 2020 as part of the rolling review process, followed by the formal application for a marketing authorisation on 30 November 2020. [fn 32]

32. The CHMP carried out a rigorous evaluation of the pharmaceutical, preclinical and clinical data on Comirnaty and concluded that the available data on the quality, safety and efficacy of Comirnaty showed that the balance of benefits and risks was favourable. [fn 33]

33. Following the CHMP’s positive opinion, the European Commission granted a conditional marketing authorisation for Comirnaty on 21 December 2020. [fn 34] The conditional authorisation was renewed by the European Commission on 3 November 2021 and converted into a standard marketing authorisation on 10 October 2022, on the basis of the finding that all

[fn 31] EMA, Comirnaty Assessment report, 19 February 2021 (Bourla-15), available at ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf

[fn 32] EMA, EMA starts second rolling review of a COVID-19 vaccine, 6 October 2020 (Bourla-16), available at ema.europa.eu/en/news/ema-starts-second-rolling-review-covid-19-vaccine

[fn 33] EMA, Comirnaty Assessment report, 19 February 2021 (Bourla-15), available at ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf, p. 138.

[fn 34] OJEU, 24 December 2020 (Bourla-17), available at eur-lex.europa.eu/legal-content/NL/TXT/PDF/?uri=OJ:C:2020:447I:FULL

specific obligations imposed on the original grant of the conditional authorisation had been fulfilled or had been reclassified, and that there were no longer any grounds for keeping the authorisation conditional. [fn 35]

3.2.3 Additional pharmacovigilance for COVID-19 vaccines

34. In view of the special circumstances of the COVID-19 pandemic, the EMA, together with the national competent authorities in the Member States – including the Health and Youth Care Inspectorate of the Dutch Ministry of Health, Welfare and Sport – drew up a specific pharmacovigilance plan for COVID-19 vaccines (the “EMA pharmacovigilance plan”). [fn 36] The EMA pharmacovigilance plan comprised active collection of data on rare potential risks, rapid assessment of new safety information, rapid evaluation of safety issues that could affect the balance of benefits and risks, active monitoring of vulnerable groups of people and rapid communication of new safety information. In addition to applying existing procedures, the EMA pharmacovigilance plan required marketing authorisation holders to submit monthly summary safety reports and periodic safety reports, containing information on reported side effects, adverse events of special interest and sales data. The EU Member States were tasked with collecting data on exposure to the vaccines, which were to be used for the interpretation of the safety data. [fn 37]

35. The suspected side effects have been recorded, investigated and reported to the relevant regulatory authorities, including the EMA and the Dutch Ministry of Health, Welfare and

[fn 35] OJEU, 24 December 2020 (Bourla-17), available at eur-lex.europa.eu/legal-content/NL/TXT/PDF/?uri=OJ:C:2022:457:FULL, p. 3.

[fn 36] See EMA, Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines (Bourla-18), available at ema.europa.eu/en/documents/other/pharmacovigilance-plan-eu-regulatory-network-covid-19-vaccines_en.pdf

[fn 37] See EMA, Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines (Bourla-18), available at ema.europa.eu/en/documents/other/pharmacovigilance-plan-eu-regulatory-network-covid-19-vaccines_en.pdf, p. 3, point 5.3.

Sport, in accordance with the applicable pharmacovigilance requirements. Such data have been analysed independently by regulatory authorities and by Pfizer/BioNTech in order to identify any new safety signals (that is: information on a new or known adverse event that is potentially caused by a medicinal product and requires further investigation). After investigation, appropriate measures are taken, including, if approved by the regulatory authorities, an amendment of the product information. Pfizer and BioNTech have at all times cooperated with the competent authorities and complied with their pharmacovigilance obligations with respect to Comirnaty. [fn 38]

3.2.4 Interim conclusion

36. Comirnaty was subjected to rigorous testing and regulatory assessments before it was introduced in the EU. The result of this assessment was clear: Comirnaty proved to be highly effective (95%) in preventing symptomatic COVID-19 infections. Scientific research suggests that COVID vaccines, including Comirnaty, have prevented almost 20 million deaths from COVID-19 worldwide, which would proportionally translate into approximately 44,500 lives saved in the Netherlands alone. [fn 39]

37. Since its market introduction, the efficacy, safety and manufacturing quality of Comirnaty have been closely monitored by both Pfizer and the competent regulatory authorities. These ongoing assessments continue to confirm that Comirnaty, as since updated to take account of the mutations of the Coronavirus, meets all statutory requirements, including with respect to safety: Comirnaty was found to cause few side effects, which are generally mild and short-lived. [fn 40] The

[fn 38] See also section 3.3.4.

[fn 39] Watson O. et al., Global impact of the first year of COVID-19 vaccination: a mathematical modelling study, 23 June 2022 (Bourla-19), available at https://www.thelancet.com/action/showPdf?pii=1473-3099%2822%2900320-6

[fn 40] See www.ema.europa.eu/en/medicines/human/EPAR/comirnaty: under What are the risks associated with Comirnaty: “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.”

health benefit of vaccination therefore outweighed the side effects. [fn 41]

3.3 The argument of [redacted] et al. is a collection of conspiracy theories and falsehoods already established as such, dressed up as facts

38. [redacted] et al. ignore the fact that new infectious diseases emerge from time to time and that measures may need to be taken to save lives. Instead, [redacted] et al. claim that the phenomenon that dominated almost everyone’s life for at least two years – the Coronavirus – was not real.

39. In an attempt to explain these measures, [redacted] et al. come up with vague and far-fetched conspiracy theories allegedly involving NGOs, governments, media, international organisations and companies. In this section, Bourla will address the factual assertions of [redacted] et al. Bourla repeats that assertions that are described as incomprehensible or are otherwise not directly addressed must be regarded as disputed.

3.3.1 Misrepresentation of the development process of Comirnaty

40. In essence, [redacted] et al. appear to claim that Pfizer started testing a vaccine against the Coronavirus too quickly. In particular, they emphasise that Pfizer began testing a few days after the Chinese authorities released the genetic code of the Coronavirus on 10 January 2020. [fn 42] [redacted] et al. do not substantiate this assertion. In this context they refer to exhibit 47. However, this exhibit contains only bare assertions that do not appear to originate from any external source, and in any event no information about the development process of a COVID-19 vaccine. [redacted] et al.

[fn 41] See also Health Council of the Netherlands (Gezondheidsraad), Advies – COVID-19 vaccinatie BioNTech-Pfizer, 24 December 2020 (Bourla-20), available at www.gezondheidsraad.nl/binaries/gezondheidsraad/documenten/adviezen/2020/12/24/covid-19-vaccinatie-biontech-pfizer/Advies-COVID-19-vaccinatie-BioNTech-Pfizer.pdf, p. 4.

[fn 42] See summons, nos. 41, 148, 163, 165 and 200. In no. 41, the date of release of the genetic code is incorrectly stated as 8 January 2020.

moreover have not explained – and Bourla has not understood – why the aforementioned assertion would be relevant to the claims brought.

41. Nevertheless, Bourla will briefly explain (i) how Pfizer and its commercial partner BioNTech, alongside other pharmaceutical companies, were able to start testing a Coronavirus vaccine shortly after they had received the genetic code of the Coronavirus, and (ii) how it became possible to start the vaccination campaign within approximately one year of the start of the pandemic. [fn 43]

Re (i): Rapid start of initial tests

42. Simply put, Comirnaty did not have to be developed from scratch. In developing Comirnaty, Pfizer and its commercial partner BioNTech were able to draw on a number of solutions for the use of mRNA technology and for achieving effective delivery of the vaccine that had been researched and tested for decades. [fn 44] These include, among other things, (a) the use of mRNA technology, and (b) the system for delivering the active substance into the cells (lipid nanoparticles).

(a) mRNA

43. Messenger ribonucleic acid (“mRNA”) is a nucleic acid present in all living cells. It contains instructions for the production of specific proteins. Human cells make many thousands of proteins that are needed for the body to function. Each of these proteins is associated with a unique mRNA sequence.

[fn 43] Incidentally, there are many publicly accessible publications about the development process of Comirnaty. See for example Lewis, L.M. et al., The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective, 18 September 2022 (Bourla-21), available at www.ncbi.nlm.nih.gov/pmc/articles/PMC9482796

[fn 44] Incidentally, [redacted] et al. themselves also appear to acknowledge that a considerable amount of work had already been done in this field before 2020. This is apparent from their assertion that Pfizer “had been working on the development of mRNA vaccines for the beta coronavirus since mid-2011”, and from their reference to a series of patent applications by Moderna for the period 2015-2020 (summons, no. 215, referring to exhibit 72). Although these patents have nothing to do with Pfizer and do not fit the assertion of [redacted] et al. in terms of timing, it does at least show that earlier scientific research, in this case into other coronaviruses, can be useful for later research, in this case for the development of a vaccine against COVID-19. See also https://www.pfizer.com/science/innovation/mrna-technology

44. mRNA was first discovered in 1961 at the Institut Pasteur in France. [fn 45] Since that time, many researchers have investigated its therapeutic potential, including possible use in vaccines. In particular, the founders of BioNTech and other researchers have been researching the therapeutic potential of mRNA for more than 30 years. [fn 46] [fn 47]

45. Comirnaty contains a form of mRNA that was prepared in a laboratory to code for the spike protein of SARS-CoV-2. After Comirnaty is administered, cells use the mRNA to produce this viral spike protein. This in turn is recognised by the immune system as a foreign protein, causing antibodies to be produced. Once the body has made antibodies against the viral spike protein, these remain in the body and the immune system can respond quickly to protect the vaccine recipient against infection if he or she is exposed to SARS-CoV-2. [fn 48] For the sake of completeness: persons to whom Comirnaty or another mRNA vaccine is administered are exposed only to the target antigen or protein encoded by the mRNA. Administration of the vaccine does not lead to infection with the virus itself.

46. The above means that, at the start of the pandemic, it was already technologically possible to make mRNA coding for the spike protein of SARS-CoV-2.

47. Pfizer/BioNTech were able to make various candidate vaccines shortly after the Chinese authorities had released the genetic code of SARS-CoV-2. Pfizer/BioNTech were then able to carry out the first laboratory tests and – subject to obtaining the required statutory approvals – the first

[fn 45] Institut Pasteur, Discovery of messenger RNA in 1961, 15 February 2021 (Bourla-22), available at www.pasteur.fr/en/home/research-journal/news/discovery-messenger-rna-1961#:~:text=We%20can%20be%20sure%20that,protect%20them%20against%20COVID%2D19

[fn 46] BioNTech, The History of BioNTech – The Road to a New Era of Immunotherapy (Bourla-23), available at www.biontech.com/int/en/home/about/who-we-are/history.html

[fn 47] The 2023 Nobel Prize in Physiology or Medicine, for example, was awarded to researchers on whose work Pfizer built when modifying the mRNA of the Coronavirus for Comirnaty; see Press release The Nobel Prize in Physiology or Medicine 2023, 2 October 2023 (Bourla-24), available at www.nobelprize.org/prizes/medicine/2023/press-release/

[fn 48] Bettini, E., SARS-CoV-2 mRNA Vaccines: Immunological Mechanism and Beyond, 2021 (Bourla-26), available at www.ncbi.nlm.nih.gov/pmc/articles/PMC7918810

clinical tests to identify the most promising candidate.

(b) Lipid nanoparticles

48. The use of mRNA technology in vaccines was initially limited by the fact that mRNA is susceptible to enzymatic degradation before it enters the cells. A great deal of research was therefore done into improving the stability of the RNA and overcoming the delivery problems through a range of possible approaches, [fn 49] including the use of lipids and lipid nanoparticles. A lipid nanoparticle (an “LNP”) is in fact a delivery system that ensures that the active substance – in the case of Comirnaty, mRNA coding for the SARS-CoV-2 spike protein – remains intact until it enters the cell. [fn 50] LNP technology had already been known for more than ten years and was already widely used for the effective delivery of a number of medicinal products. [fn 51] Pfizer/BioNTech therefore did not have to reinvent the wheel in this respect.

49. Pfizer/BioNTech were therefore able to begin developing vaccine candidates shortly after they had learned the genetic code of SARS-CoV-2 in January 2020.

Re (ii): Accelerated progress through the vaccine development stages

50. The candidate vaccine that would eventually become known by the name Comirnaty went through all the regular development and testing phases. [fn 52] The development process was not accelerated by skipping these stages – which are intended to guarantee the safety and effectiveness of the vaccine – but by eliminating bottlenecks and running tracks in parallel. Without wishing to be exhaustive,

[fn 49] Wadhwa et al., Opportunities and Challenges in the Delivery of mRNA-Based Vaccines, January 2020 (Bourla-27).

[fn 50] See also section 3.3.3.

[fn 51] See Science News, How COVID-19 vaccines were made so quickly without cutting corners, 29 June 2021 (Bourla-25), available at www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed

[fn 52] See section 3.2.

Bourla will mention some of the most important factors that contributed to a shorter development time for Comirnaty.

(a) Rapid results thanks to a large number of volunteers and the rapid spread of the Coronavirus

51. Pfizer was able to recruit almost 44,000 volunteers within a period of less than four months for the final phases of the clinical study. This compares favourably with earlier experience of recruiting volunteers; for example, it took more than two years to recruit just 101 volunteers for the clinical trials of the rabies vaccine in 2013. This alone saved approximately two years of development time. [fn 53]

52. In addition, the rapid spread of the Coronavirus meant that the number of cases of illness needed to draw a statistically sound conclusion on the efficacy of Comirnaty was reached much faster than usual. [fn 54] The infection rate needed to assess the efficacy of Comirnaty was reached approximately 1.5 years faster than had been the case in the past with some other viruses. [fn 55]

(b) Prioritisation by the competent government authorities

53. It is common knowledge that the regulatory authorities in the US, the EU and elsewhere gave heavy priority to the development of vaccines against the Coronavirus from early 2020. [fn 56] Simply put, candidate vaccines against the Coronavirus were at the front of the queue. Among other things, this meant that priority was given to assessing

[fn 53] See Science News, How COVID-19 vaccines were made so quickly without cutting corners, 29 June 2021 (Bourla-25), available at www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed

[fn 54] The effectiveness of a vaccine is measured by comparing the number of (severe) cases of COVID-19 within a certain period after vaccination between the vaccine and placebo groups. Sufficient participants in clinical trials must therefore fall ill before a statistically sound conclusion on the efficacy of the vaccine can be drawn.

[fn 55] See Science News, How COVID-19 vaccines were made so quickly without cutting corners, 29 June 2021 (Bourla-25), available at www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed

[fn 56] See Science News, How COVID-19 vaccines were made so quickly without cutting corners, 29 June 2021 (Bourla-25), available at www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed; see also EMA, COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines, 4 May 2020 (Bourla-28), available at https://www.ema.europa.eu/en/news/covid-19-how-ema-fast-tracks-development-support-and-approval-medicines-and-vaccines

the results of the future trials with Coronavirus vaccines. Since assessments by regulatory authorities usually form a major bottleneck in the vaccine development process, this prioritisation is estimated to have saved approximately four years of development time. [fn 57]

(c) Ramping up production pending approval by the regulatory authorities

54. Furthermore, Pfizer began large-scale production of Comirnaty before (conditional) marketing authorisations had been obtained, in order to ensure that a large number of doses would be available immediately after the authorisation was obtained. [fn 58] Pfizer was prepared to take this risk for the sake of global public health.

55. In summary, the success of BioNTech and Pfizer in offering an approved vaccine to millions of patients within one year can therefore only be described as an unprecedented achievement, made possible by the joint efforts of the scientific community, companies and regulatory authorities around the world.

3.3.2 The purpose and effects of Comirnaty have been communicated to the public consistently and transparently

56. In essence, [redacted] et al. claim that (i) they were told that one should get vaccinated not only for one’s own safety but also for that of others, (ii) that this was misleading and (iii) that they would not have had themselves vaccinated had they been properly informed of the fact that Comirnaty does not prevent transmission of the Coronavirus. [fn 59] Bourla will now address these incorrect allegations.

[fn 57] See Science News, How COVID-19 vaccines were made so quickly without cutting corners, 29 June 2021 (Bourla-25), available at www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed

[fn 58] See Science News, How COVID-19 vaccines were made so quickly without cutting corners, 29 June 2021 (Bourla-25), available at www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed

[fn 59] Summons, nos. 145 et seq. At the same time, none of the female claimants has asserted that she suffered damage because Comirnaty failed to prevent transmission of the Coronavirus from or to one of the female claimants.

The primary purpose of Comirnaty

57. The purpose of Comirnaty was to prevent vaccinated people from becoming seriously (symptomatically) ill and to minimise the number of deaths from COVID-19. This was made clear from the outset by the regulatory authorities that issued the call in early 2020 to develop a COVID-19 vaccine as quickly as possible.

58. A presentation by the EMA on the development of COVID-19 vaccines, for example, states that the “main measure of benefit” of a COVID-19 vaccine is the “prevention of symptomatic disease”. In that same presentation, the EMA indicates that it is not possible to establish, by the time a vaccine is approved, whether it will have the effects of “prevention of infection” and “prevention of virus transmission”. [fn 60]

[Image of EMA presentation slide, in English:] Clinical studies – efficacy and safety. MEASURING COVID-19 VACCINES' BENEFIT. Prevention of symptomatic disease as main measure of benefit: • Less disease with symptoms in people given vaccine compared to placebo. Other benefits likely uncertain at approval and only clearer after the vaccine is used: Long term protection; Prevention of infection (asymptomatic cases); Prevention of virus transmission in the community – needs specific studies post-approval. Efficacy levels: Studies designed to show efficacy of 50% or more; 50% efficacy means the vaccine prevents half of the cases of symptomatic COVID-19 compared with placebo; 90% efficacy means the vaccine prevents nine out of 10 cases of symptomatic COVID-19 compared with placebo. [Slide footer partly illegible: “… published by the European Medicines Agency”]

59. Numerous academic contributions published in the run-up to the authorisation of Comirnaty likewise explained

[fn 60] EMA, How are COVID-19 vaccines developed (Bourla-29), available at ema.europa.eu/en/documents/presentation/presentation-how-are-covid-19-vaccines-developed-marco-cavaleri_en.pdf, p. 8.

that the primary endpoint [fn 61] of the clinical studies is the ability of the vaccine to prevent severe cases of COVID-19:

“The primary endpoint for all the phase 3 vaccine trials is amelioration of COVID-19 disease.” [fn 62]

60. Preventing transmission was not a characteristic of the COVID-19 vaccines (including Comirnaty) that had to be tested and demonstrated before the vaccine could be placed on the market.

61. It was therefore clear from the outset that the primary purpose of Comirnaty was to reduce the risk of severe COVID-19 disease, and not to prevent transmission of the Coronavirus. As explained in section 3.2, the data at the time indicated that Comirnaty was 95% effective in preventing symptomatic COVID-19 disease, which can without doubt be regarded as achieving that purpose.

Public communications about the purpose and effect of Comirnaty

62. As stated, [redacted] et al. claim, among other things, to have been misled by Bourla in that they believed that Comirnaty had been developed to prevent vaccinated people from contracting the Coronavirus and subsequently transmitting it.

63. However, Bourla did not mislead [redacted] et al. Even before Comirnaty received a conditional marketing authorisation on 21 December 2020, Bourla was transparent about the fact that its transmission-preventing effect had not been tested during the clinical studies and was not known. [fn 63]

[fn 61] Simply put, endpoints are targeted outcomes of a clinical study that are analysed statistically to help determine the efficacy and safety of the therapy under investigation.

[fn 62] See for example Nature, Whither COVID-19 vaccines, 28 September 2020 (Bourla-30), available at www.nature.com/articles/s41587-020-0697-7

[fn 63] Incidentally, in a press release of 13 March 2020 Bourla said the following: “Many companies, including Pfizer, are working to develop antiviral therapies to help infected patients fight this emerging virus as well as new vaccines to prevent infection and halt the further spread of this disease.” However, the press release also contains a detailed disclaimer stating that all of this is highly uncertain and therefore that no rights can be derived from it: “This release contains forward-looking information about Pfizer's efforts to battle COVID-19 that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development (. . .). A further description [continued on page 26]

64. In an interview with NBC News published on 3 December 2020, for example, Bourla says that it is unknown whether people who have been vaccinated can still carry the Coronavirus and transmit it to others:

“I think this is something that needs to be examined. We are not certain about that right now.” [fn 64]

65. In an interview with The Journal published on 13 January 2021, Bourla again stated that, although there were “encouraging” initial data on Comirnaty’s ability to prevent transmission of the Coronavirus, these data were “not conclusive”. Bourla further cautioned that Pfizer had not yet proven the existence of a transmission-preventing effect:

“This is not conclusive yet. We know that in animals, [there is] significant protection from transferring the virus.... We haven't [proven that in] humans yet.” [fn 65]

66. Regulatory authorities have been equally clear about the fact that no tests had been carried out, and that no empirical data had yet been collected, on the question of whether Comirnaty has a transmission-preventing effect.

67. For example, on 21 December 2020 the EMA published a document accompanying its recommendation to grant Comirnaty a conditional marketing authorisation. In it, the EMA explained that Comirnaty was 95% effective in preventing symptomatic COVID-19 disease, thereby meeting its purpose. At the same time, the EMA cautioned:

[fn 63, continued] of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.” See Pfizer, Pfizer Outlines Five-Point Plan to Battle COVID-19, 13 March 2020 (Bourla-10), available at www.pfizer.com/news/press-release/press-release-detail/pfizer-outlines-five-point-plan-battle-covid-19

[fn 64] NBC News, 3 vaccine executives say that after approval, distribution will be the main challenge, 3 December 2020 (Bourla-31), available at www.nbcnews.com/news/us-news/3-vaccine-executives-say-after-approval-distribution-will-be-main-n1249928

[fn 65] The Journal, Pfizer CEO says there is 'encouraging' data on whether its vaccine stops Covid transmission, 13 January 2021 (Bourla-32), available at www.thejournal.ie/pfizer-ceo-5323949-Jan2021/

“The impact of vaccination with Comirnaty on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus.” [fn 66]

68. The US Food and Drug Administration (“FDA”) likewise stated in a press release on 11 December 2020 that “at this time, [...] nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.” [fn 67]

69. The same applies to the WHO, which warned on 8 January 2021 that there was “not yet any evidence of the effect of the vaccine on virus transmission”. It then flagged this issue as a recommended area for further research. [fn 68]

70. The foregoing makes clear that it was not at all “revealed” during a hearing in the European Parliament on 10 October 2022 that the transmission-preventing effects of Comirnaty had not been tested during clinical trials, as [redacted] et al. suggest. [fn 69] At that point this had already been an established and transparently published fact for almost two years.

Actual transmission-preventing effect of Comirnaty

71. At the same time, Comirnaty did in fact contribute to reducing transmission of at least the earlier variants of the Coronavirus that occurred during the first phases of the COVID-19 pandemic. [fn 70]

[fn 66] EMA, Comirnaty, COVID-19 mRNA vaccine (nucleoside modified), 21 December 2020 (Bourla-33), available at ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-comirnaty_en.pdf

[fn 67] FDA, FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine, 11 December 2020 (Bourla-34), available at www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

[fn 68] WHO, Interim recommendations for use of the Pfizer-BioNTech COVID-19 vaccine, 8 January 2021 (Bourla-35), available at iris.who.int/bitstream/handle/10665/338484/WHO-2019-nCoV-vaccines-SAGE_recommendation-BNT162b2-2021.1-eng.pdf?isAllowed=y&sequence=1#page=5, p. 5.

[fn 69] Summons, no. 147.

[fn 70] See for example Reuters, Fact Check: Preventing transmission never required for COVID vaccines' initial approval (Bourla-36), available at www.reuters.com/article/factcheck-pfizer-vaccine-transmission/fact-check-preventing-transmission-never-required-for-covid-vaccines-initial-approval-pfizer-vax-did-reduce-transmission-of-early-variants-idUSL1N31F20E/

72. It is clear that the vaccine contributed to slowing the spread of the virus by reducing the viral load and (symptomatic) infections in vaccinated persons, which in turn leads to reduced transmission. [fn 71]

73. In addition, by preventing severe COVID-19 symptoms, COVID-19 vaccines, including Comirnaty, contributed to keeping the burden on national healthcare systems, including that in the Netherlands, under control.

74. In short, COVID-19 vaccines had tangible positive effects on public health that went beyond individual protection. The repeated assertions of [redacted] et al. that they were misled about the purpose of Comirnaty are unfounded. [fn 72]

3.3.3 The chemical composition of Comirnaty has long been known

75. [redacted] et al. claim that Comirnaty contains “graphene oxide”. [fn 73] This is incorrect.

76. In reality, the chemical composition of Comirnaty has been public ever since the conditional marketing authorisation was granted in the EU, including the Netherlands. The complete list of ingredients in Comirnaty, for example, has at all times been stated in the product information (the summary of product characteristics aimed at healthcare professionals and the package leaflet for patients receiving a vaccine) approved by the EMA and made available from the date on which the conditional marketing authorisation was granted, 21 December 2020. [fn 74] This list of ingredients has also been published in numerous other media and in government and academic sources, for example by the FDA in its Emergency Use Authorisation review memorandum of 11 December

[fn 71] See for example ECDC, Risk of SARS-CoV-2 transmission from newly-infected individuals with documented previous infection or vaccination, 29 March 2021 (Bourla-37), available at ecdc.europa.eu/en/publications-data/sars-cov-2-transmission-newly-infected-individuals-previous-infection

[fn 72] See also the statement of defence of the State et al. of 10 January 2024, no. 6.2.

[fn 73] Summons, nos. 150 et seq.

[fn 74] EMA, Comirnaty product information (selection) (Bourla-38), available at ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf, p. 345.

2020. [fn 75] Information about the chemical composition of Comirnaty had therefore been made public, and was directly available to [redacted] et al., before their alleged vaccinations.

77. For the sake of completeness, a brief description now follows of each of the ingredients in Comirnaty and their role in ensuring the safety, effectiveness and manufacturing quality of the vaccine.

The active substance

78. The active substance of Comirnaty is called Tozinameran. Simply put, Tozinameran consists of mRNA coding for the viral spike protein of SARS-CoV-2. It causes cells to produce the “spike” protein, a protein present on the surface of the SARS-CoV-2 virus. The protein itself is not infectious or otherwise harmful. The body does, however, respond to it as a “foreign” protein. In this way the cells are ‘trained’ to produce antibodies when they encounter the spike protein of the Coronavirus, so that the vaccine recipient is protected against infection when he or she is exposed to the virus. [fn 76]

The lipids (protective spheres)

79. Comirnaty contains four lipids. These form small fatty spheres that envelop the mRNA to protect it from destruction before it enters the cells. These protective spheres are known as lipid nanoparticles or LNPs.

80. The first lipid is usually referred to by the code name ALC-0315. [fn 77] Because ALC-0315 can be ionised during the manufacturing process, that is, acquire a positive charge, it can “stick” to the mRNA, which has a negative charge. This allows ALC-0315 to encapsulate and thus protect the mRNA. The fatty spheres

[fn 75] FDA, Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum, 20 November 2020 (Bourla-39), available at www.fda.gov/media/144416/download, p. 11.

[fn 76] See also paragraph 45 above.

[fn 77] The full scientific name of the compound ALC-0315 is ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate).

then carry the active substance, the mRNA, through the cell wall into the cytoplasm of the cell. [fn 78]

81. The second lipid is usually referred to by the code name ALC-0159. [fn 79] The main function of ALC-0159 is to form a protective layer around the LNP. This increases the stability of the mRNA and thus the shelf life of Comirnaty. [fn 80]

82. The third and fourth lipids in Comirnaty are cholesterol and DSPC. [fn 81] These are conventional lipids used in numerous authorised medicinal products and serve to further increase the stability of the LNP. [fn 82]

Other ingredients

83. Finally, Comirnaty contains several other ingredients, all of which are very common. First, Comirnaty contains sucrose, an ordinary sugar. Its function is to ensure that LNPs do not stick together when they are frozen. [fn 83] Second, Comirnaty contains a mixture of salts (including sodium chloride, or table salt) commonly known as phosphate-buffered saline, or trometamol, a widely used buffer for better stability. [fn 84] The purpose of these salts is to ensure that the acidity of the vaccine is comparable to that of the human

[fn 78] See Gov.UK, Summary of the Public Assessment Report COVID-19 Vaccine, December 2020 (Bourla-40), available for example at www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

[fn 79] The full scientific name of the compound ALC-0159 is 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide.

[fn 80] See for example Gov.UK, Summary of the Public Assessment Report COVID-19 Vaccine, December 2020 (Bourla-40), available at www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

[fn 81] The full scientific name of DSPC is 1,2-Distearoyl-sn-glycero-3-phosphocholine.

[fn 82] See for example Gov.UK, Summary of the Public Assessment Report COVID-19 Vaccine, December 2020 (Bourla-40), available at www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

[fn 83] MIT Technology Review, What are the ingredients of Pfizer's covid-19 vaccine, 9 December 2020 (Bourla-41), available at www.technologyreview.com/2020/12/09/1013538/what-are-the-ingredients-of-pfizers-covid-19-vaccine/

[fn 84] Specifically, these salts are: potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate. See FDA, Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum, 20 November 2020 (Bourla-39), available at www.fda.gov/media/144416/download, p. 11.

body. Third, Comirnaty contains water, because the vaccine is an aqueous solution.

84. The list of ingredients described in the preceding paragraphs is exhaustive: Comirnaty contains no other components, including “graphene oxide”. This has been confirmed time and again by the EMA and other authorities. [fn 85] Graphene oxide is not used in the manufacturing process of Comirnaty and cannot have been accidentally present in a dose of Comirnaty. This was also confirmed by the European Commissioner for Health and Food Safety, who stated on 8 March 2022 that “graphene oxide is not used in the manufacture or formulation of any of the COVID-19 vaccines or other medicines”. [fn 86]

85. In the summons, [redacted] et al. acknowledge that a number of independent third parties have investigated the assertion that graphene oxide is present in Comirnaty. [redacted] et al. are also right that the outcome of these fact-checks was always the same: Comirnaty does not contain graphene oxide. [fn 87] [redacted] et al. nevertheless dismiss these reports as “false”, without offering any substantiation whatsoever. [fn 88] [redacted] et al. then refer to “videos and scientific reports by highly renowned persons” in which they allegedly declare, “on the basis of evidence and with great precision”, “that graphene oxide is present in all mRNA injections as the main component”. [fn 89] The only thing [redacted] et al. refer to in this context is a video clip from an episode of an American online programme called “The Stew Peters Show”. [fn 90] In this clip, a guest – Ms Karen Kingston – suggests that all mRNA vaccines, including Comirnaty, contain graphene oxide. She attempts

[fn 85] See for example EU Parliament, Answer given by Ms Kyriakides on behalf of the European Commission, 26 October 2021 (Bourla-42), available at www.europarl.europa.eu/doceo/document/P-9-2021-003980-ASW_EN.html#ref1_87.

[fn 86] EU Parliament, Answer given by Ms Kyriakides on behalf of the European Commission, 8 March 2022 (Bourla-43), available at www.europarl.europa.eu/doceo/document/P-9-2022-000303-ASW_EN.pdf

[fn 87] Summons, no. 152. Some examples of such fact-checking: Reuters, COVID-19 vaccines do not contain graphene oxide, 23 July 2021 (Bourla-44), available at www.reuters.com/article/factcheck-grapheneoxide-vaccine-idUSL1N20Z14F/ and AP, Pfizer vaccine does not contain graphene oxide, 8 July 2021 (Bourla-45), available at apnews.com/article/fact-checking-430816913228

[fn 88] Summons, no. 152.

[fn 89] Summons, no. 153.

[fn 90] Summons, Exhibit 44.

to support this conclusion by referring in a misleading manner to a number of patents, none of which belongs to Pfizer or any of its group companies, and whose connection with Comirnaty is not understood and is in any event disputed.

86. There is no indication whatsoever that Ms Kingston has expert knowledge of the chemical composition, the development process, the effects or any other aspect of Comirnaty, let alone that she is a “highly renowned person”. Ms Kingston is a former employee of Pfizer. However, she was not involved in the research, development or manufacture of Comirnaty. In any event, Comirnaty simply does not contain graphene oxide.

87. The assertion of [redacted] et al. that graphene oxide is present in Comirnaty – even “as the main component” – is incorrect. [fn 91] The same therefore applies to the assertion that Bourla “intentionally [allowed this] misrepresentation to persist”. [fn 92]

3.3.4 [redacted] et al. fundamentally misinterpret Pfizer’s report of 30 April 2021

88. In the summons, [redacted] et al. refer no fewer than eight times to Pfizer report no. FDA-CBER-2021-5683-0000054 of 30 April 2021 (the “Pfizer report”). They present the Pfizer report as a “smoking gun” proving that Comirnaty is dangerous. Specifically, [redacted] et al. claim that 42,086 people took part in a Comirnaty trial (“trial”) that ran from November 2020 to February 2021, and that of these, 1,223 people died and 11,361 people suffered serious and permanent injury.

89. The Pfizer report proves nothing of the kind.

90. First, the Pfizer report does not relate to a clinical trial. Instead, it is an integrated analysis of post-authorisation safety data for Comirnaty, as the report itself describes. [fn 93] Simply put, the Pfizer report records

[fn 91] Summons, no. 153.

[fn 92] Summons, no. 152.

[fn 93] Exhibit 40, p. 5.

suspected side effects that were reported, usually through national authorities, before the cut-off date of 28 February 2021. The Pfizer report is an American report. The equivalent in EU medicines regulation is the Periodic Safety Update Report (“PSUR”). That is a report prepared by the holder of the marketing authorisation for a medicinal product, describing the worldwide safety experience with it at a defined time after authorisation. [fn 94]

91. Second, [redacted] et al. distort the figures presented in the Pfizer report. During the relevant period, 42,086 recipients of Comirnaty reported side effects. [fn 95] In order to assess the safety of Comirnaty in any meaningful way at all, this number must be set against the total number of people to whom Comirnaty was administered. This confirms the strong safety profile of Comirnaty: according to the EMA, more than 330 million doses of Comirnaty had been administered worldwide by 29 April 2021, [fn 96] which indicates that only a very limited proportion of vaccinations resulted in a report of an alleged side effect. [fn 97]

92. Third, [redacted] et al. misrepresent the significance of the reported side effects analysed in the Pfizer report. The report does not suggest that these side effects were caused by Comirnaty. The Pfizer report merely states that such side effects allegedly occurred at a certain

[fn 94] The English original reads as follows: “A report prepared by the marketing-authorisation holder describing the worldwide safety experience with a medicine at a defined time after its authorisation.” See EMA, Periodic safety update report (Bourla-46), available at www.ema.europa.eu/en/glossary/periodic-safety-update-report#:~:text=A%20report%20prepared%20by%20the,reports%3A%20questions%20and%20answers%27. See for example EMA, Comirnaty periodic safety update report assessment 19 June 2022 to 18 December 2022 (selection) (Bourla-47), available at www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/comirnaty-periodic-safety-update-report-assessment-19-june-2022-18-december-2022_en.pdf

[fn 95] Exhibit 40, p. 8.

[fn 96] EMA, Assessment report on the annual renewal of the conditional marketing authorisation (Comirnaty), 2021 (Bourla-48), available at www.ema.europa.eu/en/documents/variation-report/comirnaty-h-c-5735-r-0046-epar-assessment-report-renewal_en.pdf, p. 16.

[fn 97] Although the period in the EMA report is longer than the period covered by the report cited by [redacted] et al. (29 April 2021 and 28 February 2021 respectively), this 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 [redacted] et al. make it appear.

moment after the injection. [fn 98] That does not yet mean that the side effects mentioned in the report were actually caused by vaccination. This is all the more so since, in the initial period of vaccination – which this report covers – it was mainly the elderly and the vulnerable who were vaccinated. [redacted] et al. make a fundamental error by confusing correlation with causation, whereas the one does not prove, or even necessarily suggest, the other. Instead, reports of this kind are usually used as part of post-authorisation pharmacovigilance to determine whether there are safety signals that warrant further investigation.

93. Fourth, [redacted] et al. misrepresent even the most elementary statistical and demographic data in the report.

For example, they suggest that 2,990 children “took part” in the analysis. In reality, the Pfizer report speaks of 2,990 persons whose sex was not stated in the adverse event report. [fn 99] It further states that there were 175 persons under the age of 18 for whom side effects were reported. [fn 100]

In addition, [redacted] et al. claim, for example, that 11,361 persons suffered serious permanent physical injury. Nothing in the report indicates serious permanent injury, or even the physical nature of a side effect.

94. The assertion that the report was “hidden” by Bourla is also incorrect, as is the date on which the report was supposedly released to the public. [fn 101] Pharmaceutical companies, including Pfizer, do not issue their reports to the public, but to the relevant regulatory authorities. For the avoidance of doubt: neither Bourla nor Pfizer took any steps to prevent the eventual publication of the

[fn 98] The FDA has confirmed that “In fact, reviews by FDA and CDC have determined that the vast majority of the deaths reported are not directly attributable to the vaccines. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it's unclear whether the vaccine was the cause.” See Reuters, Pages of suspected side effects released about Pfizer's COVID-19 vaccine [...], 17 March 2022 (Bourla-49), available at www.reuters.com/article/factcheck-coronavirus-pfizer-idUSL2N2VK1G1/.

[fn 99] Exhibit 40, p. 7.

[fn 100] Exhibit 40, p. 7.

[fn 101] Summons, no. 144.

Pfizer report under the Freedom of Information Act procedure in the US. [fn 102] Moreover, the analogous document in the EU – the PSUR – is publicly available on the EMA website. [fn 103]

3.3.5 The vague remarks of [redacted] et al. about allegedly differing qualities of vaccine batches are irrelevant and incorrect

95. [redacted] et al. claim that Pfizer did not maintain consistent manufacturing quality across the various batches of Comirnaty. [fn 104] Specifically, they refer to batch EM0477 as a “particularly deadly” variant. [fn 105] These assertions are incorrect.

96. First of all, [redacted] et al. have not asserted that they were vaccinated against COVID-19, let alone which batch of Comirnaty they allegedly received. [fn 106] Nor have they asserted that their vaccinations came from a batch that they consider to be of inferior quality. The assertions of [redacted] et al. about the allegedly differing qualities of vaccine batches therefore evidently bear no relation to the damages claimed, and are therefore irrelevant. In addition, [redacted] et al. have not properly substantiated that batch EM0477 differed from other batches of Comirnaty. [fn 107]

97. More importantly, a large part of the story of [redacted] et al. rests on an incorrect interpretation of a scientific report by Peter Riis Hansen (“Hansen”), [fn 108] and the subsequent question from a Member of the European Parliament to the European Commission referring to Hansen’s report. [fn 109] [redacted] et al. wrongly claim that Hansen’s report proves “[t]hat there are very large differences in deadliness and side effects between Pfizer Covid-19

[fn 102] Requests under the US Freedom of Information Act are comparable to requests under the Open Government Act (Wet open overheid, Woo) in the Netherlands.

[fn 103] See above, no. 90.

[fn 104] Summons, nos. 245 et seq.

[fn 105] Summons, no. 246.

[fn 106] The only exception is Ms [redacted], in respect of whom page 7 of exhibit 91 states that she was administered Comirnaty doses from batches FC3143 and FF0688.

[fn 107] Summons, nos. 245 et seq.

[fn 108] Exhibit 83, second document. Hansen is, incidentally, one of the three authors.

[fn 109] Exhibit 83, first document.

injection batches [exist].” In reality, Hansen’s conclusion is:

“In conclusion, the results suggest the existence of a batch-dependent safety signal for the BNT162b2 vaccine, and more studies are warranted to explore this preliminary observation and its consequences.” [fn 110]

98. Hansen’s report also reflects the basic scientific understanding that analyses of side effects are not intended to establish a causal link between the vaccine and health problems. This is all the more the case when it comes to self-reporting systems, which by definition are susceptible to reporting biases and data deficiencies. Hansen rightly acknowledges that the purpose of such systems, and of his report, is to identify a potential safety signal for further investigation:

“The present preliminary findings must be interpreted in the light of several limitations. The DKMA-managed spontaneous SAE reporting system in Denmark is a passive surveillance system [...], and reports from these systems are subject to reporting biases, with potential for both under- and over-reporting, as well as incomplete data and variable quality of the reported information. Owing to these inherent limitations, signals detected by these systems must be considered to be hypothesis-generating and generally cannot be used to establish causality. In addition, in the present study, the SAE case history of prior COVID-19 was unknown, and specific SAE types [...] were not examined. Notably, to our knowledge, the Danish Serum Institute has not issued recalls of BNT162b2 vaccine batches.” [fn 111] (underlining added, counsel)

99. In addition to misrepresenting this preliminary conclusion of Hansen as proof of the alleged “deadliness” of Comirnaty, [redacted] et al. ignore the fact that further investigation into the Danish batches mentioned by Hansen has been carried out by the relevant European authorities. This follows from the answer of the European Commissioner for Health and Food Safety [fn 112] to the question of a Member of the European Parliament, a question to which [redacted] et al., as stated, do

[fn 110] Exhibit 83, second document, p. 3.

[fn 111] Exhibit 83, second document, p. 3.

[fn 112] That answer was given on 3 July 2023. That is before the date on which the summons was served.

refer. [fn 113] That answer shows that no increased risk of side effects for specific batches has been demonstrated:

“As regards literature monitoring, if various sources of information point to a potential issue more in-depth review is initiated. This was not the case for the mentioned Danish study. In addition to the limitations mentioned in the study, analyses performed by the European Medicines Agency on the batches reported in suspected AR cases did not reveal an increased risk of side effects for specific batches.” [fn 114]

100. The European Commission further reiterated that every batch is subjected to a rigorous quality test before it is placed on the EU market. Each batch is first carefully tested by the manufacturer. The national competent authority then carries out an additional independent check, the so-called Official Control Authority Batch Release test:

“As for any other medicinal products authorised in the EU, once a COVID-19 vaccine has received approval, each vaccine batch can only be released following quality control testing to confirm that the product is in line with the specifications that were approved as part of the respective marketing authorisation. This control is carried out by the manufacturer. However, for most centrally authorised vaccines, the EU legislation requires that a Member State Official Medicines Control Laboratory performs an additional independent control for each batch before it is put on the EU market. This independent control is referred to as Official Control Authority Batch Release testing and includes testing of agreed quality parameters and a compliance check of the manufacturer's own test results.” [fn 115]

101. As mentioned in the question of the Member of the European Parliament, both vaccine manufacturers and regulatory authorities are extremely strict when it comes to ensuring consistently high manufacturing quality

[fn 113] Summons, no. 248, referring to exhibit 83, first document.

[fn 114] EU Parliament, Answer given by Ms Kyriakides on behalf of the European Commission, 3 July 2023 (Bourla-50), available at www.europarl.europa.eu/doceo/document/E-9-2023-001537-ASW_EN.html

[fn 115] EU Parliament, Answer given by Ms Kyriakides on behalf of the European Commission, 3 July 2023 (Bourla-50), available at www.europarl.europa.eu/doceo/document/E-9-2023-001537-ASW_EN.html; see also EMA, COVID-19 vaccines: development, evaluation, approval and monitoring (Bourla-51), available at 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

of vaccines. In one situation, for example, 1.6 million doses were recalled by Moderna because a foreign substance was found in just 39 doses. [fn 116]

102. In addition, the data and methodology used for Hansen’s report show serious shortcomings, as a representative of the Danish national competent authority – the Danish Serum Institute – has noted in a letter to the editor. That letter explains that Hansen’s report does not take into account the fact that some of the batches he examined were not used (or hardly used), while those batches logically had no or very few reports of suspected side effects. That makes the various batches examined incomparable. Moreover, when the first batches were administered, practitioners were encouraged to report all suspected side effects; later in the pandemic, however, the authorities no longer encouraged the reporting of mild side effects. As explained in the letter from the representative of the Danish Serum Institute, Hansen’s report does not take this into account either. For this reason too, the study cannot provide meaningful insights into the variability of batches. [fn 117]

103. At the same time, the Danish Serum Institute has not recalled any batches of Comirnaty, as Hansen confirms in his report. Indeed, no batches of Comirnaty have been recalled for safety reasons anywhere in the EU, or worldwide. This in itself is sufficient to dispel any reasonable concern about the quality of individual batches.

104. In short, the assertions of [redacted] et al. regarding alleged variations in quality between the various batches of Comirnaty are irrelevant and incorrect.

[fn 116] Exhibit 83, first document.

[fn 117] The letter is by Anders Hviid, received on 20 June 2023 and accepted on 9 July 2023. See Hviid, A., Inaccurate representation of shipped vaccines as administered, 20 June 2023 (Bourla-52), available at factreview.gr/wp-content/uploads/2023/07/Eur-J-Clin-Investigation-2023-Hviid-Inaccurate-representation-of-shipped-vaccines-as-administered.pdf

3.3.6 Incorrect statements about the relationship with the European Commission

105. [redacted] et al. make a number of unsubstantiated and incorrect statements about the contractual relationship between Pfizer and the European Commission with respect to Comirnaty. [fn 118] [redacted] et al. have also not explained what the relevance of this would be to their claims.

106. [redacted] et al. claim that the European Commission bought Comirnaty for EUR 71 billion. This is incorrect. This amount represents the value of the EU’s orders for vaccines from eight manufacturers. Moreover, this amount includes purchase options that were not exercised and that relate to almost half of the 4.6 billion doses actually purchased. [fn 119] [redacted] et al. also claim that the EU Member States are jointly and severally liable as guarantors for this alleged payment. That is likewise incorrect. Finally, [redacted] et al. claim that the EU, represented by the European Commission, did not pay Pfizer for the vaccines. That too is incorrect.

3.3.7 Comirnaty is not gene therapy

107. [redacted] et al. repeatedly claim that Comirnaty is “based on gene therapy”. [fn 120] They do not substantiate this assertion. Moreover, this assertion is incorrect.

108. The term gene therapy has a specific and established meaning under EU legislation. Annex I to Directive 2001/83/EC defines a “gene therapy medicinal product” as follows:

“(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; (b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence. Gene therapy medicinal products shall not include vaccines against infectious diseases.” (underlining added by counsel)

[fn 118] Summons, nos. 165 et seq.

[fn 119] ECA, Special report, EU COVID-19 vaccine procurement: Sufficient doses secured after initial challenges, but performance of the process not sufficiently assessed, 2022 (Bourla-53), available at www.eca.europa.eu/Lists/ECADocuments/SR22_19/SR_EU_COVID_vaccine_procurement_EN.pdf

[fn 120] Summons, nos. 131 et seq., no. 169.

109. Comirnaty does not fall within this definition, because it does not regulate, repair, replace, add or delete the gene sequence of vaccinated persons – and cannot do so. The mRNA in the vaccine does not enter the cell nucleus, where the human genome, that is DNA, is located. Instead, the mRNA is rapidly broken down by the body of the vaccinated person. [fn 121] Moreover, the definition expressly excludes vaccines against infectious diseases.

4 [REDACTED] ET AL. HAVE NOT ESTABLISHED A SINGLE ELEMENT OF AN UNLAWFUL ACT

110. [redacted] et al. ask your court to order that the damages be assessed in separate follow-up proceedings (schadestaatprocedure). [fn 122] This means that it must be established in these proceedings that Bourla acted unlawfully towards [redacted] et al. in a manner attributable to him, and that it is plausible that the latter may have suffered damage as a result.

111. None of these requirements has been met. Bourla did not mislead [redacted] et al., let alone intentionally. Comirnaty – like, incidentally, the other COVID-19 vaccines – was developed through the usual careful process and meets the statutory standards for safety, efficacy and manufacturing quality (see section 3.2).

112. Insofar as the assertions of [redacted] et al. would amount to (derivative) liability of Bourla in his capacity as CEO of Pfizer, any relevant assertion regarding alleged liability of Pfizer is lacking. Those claims founder on that alone. Insofar as Bourla is held liable by [redacted] et al. in any other capacity, Bourla puts forward his defence below.

[fn 121] See for example Reuters, mRNA vaccines are distinct from gene therapy, 10 August 2021 (Bourla-54), available at www.reuters.com/article/idUSL1N2PH16N.

[fn 122] See paragraph 7 for the claim of [redacted] et al.

4.1 No unlawful conduct

4.1.1 No torture or cruel, inhuman or degrading treatment or punishment under Article 7 ICCPR

113. Bourla understands the assertions of [redacted] et al. regarding Article 7 ICCPR to mean that only the State allegedly infringed it. The State allegedly tortured its citizens, or subjected them to cruel, inhuman or degrading treatment or punishment, by subjecting them to an ongoing medical and scientific (behavioural) experiment. [fn 123] Although Bourla is apparently not being held liable by [redacted] et al. for a breach of Article 7 ICCPR, he wishes to make the following observations on this point.

114. Comirnaty does not qualify as a medical or scientific experiment. [fn 124] Although the development process was accelerated, the vaccine went through all the regular development and testing phases, including those of clinical studies. Moreover, the vaccine was placed on the market only after a conditional approval had been granted by the European Commission in December 2020. [fn 125] The term “conditional approval” could give rise to misunderstandings, but means nothing other than that the vaccine meets all requirements as regards safety, effectiveness and manufacturing quality, but that additional data still have to be provided (see paragraphs 19-20 and 50-55). [fn 126]

115. Nor is there any question of torture or inhuman or degrading treatment or punishment. The government offered its citizens the opportunity to be vaccinated. There is no question of violence, there is no question of deprivation of liberty, and [redacted] et al. had the choice of whether or not to be vaccinated against COVID-19.

[fn 123] Summons, nos. 254-255.

[fn 124] See to the same effect District Court of The Hague, 5 March 2021, ECLI:NL:RBDHA:2021:1920, para. 4.7 in conjunction with 4.5, and upheld on appeal by the Court of Appeal of The Hague, 22 June 2021, ECLI:NL:GHDHA:2021:1094, para. 5.6.

[fn 125] In October 2022, the conditional marketing authorisation granted to Comirnaty was converted into a standard marketing authorisation; see no. 33 above.

[fn 126] See also CBG-MEB (Medicines Evaluation Board), Column ‘Over medicijnen’: Coronavaccins experimenteel?, 2 June 2021 (Bourla-55), available at www.cbg-meb.nl/actueel/nieuws/2021/06/02/column-over-medicijnen-coronavaccins-experimenteel.

4.1.2 No breach of a statutory duty

Article 97a Sr (Dutch Criminal Code) – seeking support abroad for a revolution

116. [redacted] et al. apparently claim that Bourla, like the other defendants, had the aim of supporting the alleged interests of Schwab and the WEF in The Great Reset. [fn 127] He would thereby have violated Article 97a Sr. [fn 128] That makes no sense whatsoever.

117. Article 97a Sr is intended to protect the Dutch constitutional form of government and the order of succession to the throne against unlawful change or destruction. [fn 129] [redacted] et al. have not explained at all why there would be any such revolution, what Bourla’s role in it would be, and why violation of this provision would constitute a basis for obtaining compensation for damage allegedly suffered as a result of a COVID-19 vaccine.

Article 300 Sr – simple assault

118. [redacted] et al. further claim that Bourla is guilty of assault within the meaning of Article 300 Sr. [fn 130] That is incorrect.

119. Assault consists of intentionally inflicting bodily pain or bodily injury without any ground of justification for doing so. [fn 131] Assault presupposes the unlawfulness of the conduct. As explained earlier, Comirnaty meets the statutory standards for safety, efficacy and manufacturing quality (section 3.2), and the purpose and effects of the vaccine have been communicated to the general public consistently and transparently (section 3.3.2). Moreover, [redacted] et al. consented to their vaccination, insofar as they were indeed vaccinated.

[fn 127] See also paragraph 6 on this point.

[fn 128] Summons, nos. 58-59 in conjunction with 155.

[fn 129] Van der Woude, T&C Strafrecht, commentary on Article 97a Sr, under 1 (online, updated to 1 August 2023). See also Article 80bis Sr, which shows that “revolution” (omwenteling) means “the destruction or unlawful alteration of the constitutional form of government or the order of succession to the throne.”

[fn 130] Summons, no. 277.

[fn 131] C.P.M. Cleiren, in: T&C Strafrecht, Art. 300 Sr, notes 1 and 9 (online, updated to 1 August 2023).

Consequently, the administration of a vaccine does not, in general terms either, qualify as assault.

120. Even if the administration of COVID-19 vaccinations were to qualify as assault (quod non), this conduct cannot be attributed to Bourla. Bourla did not himself administer any COVID-19 vaccinations. Incidentally, [redacted] can in any event not have been assaulted within the meaning of Article 300 Sr, since by their own account they have been left with no complaints from the vaccinations. [fn 132]

Article 308 Sr – grievous bodily harm through negligence

121. [redacted] et al. claim that Bourla is guilty of causing grievous bodily harm to [redacted] within the meaning of Article 308 Sr. [fn 133] That too is incorrect. Even if they had a medical condition (read: Parkinson’s disease or a TIA), they have not substantiated that it arose from Bourla’s conduct (see further section 4.3 on causation), or at least that it is due to his fault.

Article 3 WIM (International Crimes Act) – genocide

122. [redacted] et al. further claim that it is “plausible” that Bourla (and the other defendants) are guilty of violating Article 3(1)(b) and (c) of the International Crimes Act. [fn 134] This is nonsense and, moreover, has not been explained any further.

4.1.3 No conduct contrary to what is proper in society according to unwritten law

123. [redacted] et al. further claim that the pharmaceutical industry cooperated in carrying out The Great Reset and the widespread deception of citizens required for it, whereby that industry grossly betrayed their trust. This conduct

[fn 132] They have not suffered material damage (see section 4.2.2). The non-material damage allegedly suffered is apparently merely the result of the alleged deception and not of the vaccinations themselves, and not knowing the precise consequences of the vaccinations is not damage (see paragraph 134).

[fn 133] Summons, no. 278.

[fn 134] Summons, nos. 280-281.

would be contrary to what is proper in society according to unwritten law. [fn 135] Why the conduct of the entire “pharmaceutical industry” can be attributed to Bourla is not explained. For that reason alone, the claims of [redacted] et al. on this ground must be dismissed.

124. Incidentally, there is no question of unlawful conduct either. As mentioned earlier, [redacted] et al. proceed from a conspiracy theory surrounding The Great Reset (see paragraph 6) that is not based on any truth. Moreover, neither Bourla nor the pharmaceutical industry is guilty of deception. See in this regard sections 3.2-3.3, which explain, among other things, that Comirnaty has been extensively tested and found to be safe and effective.

4.2 No damage

125. For referral to follow-up proceedings for the assessment of damages, the possibility of damage must be plausible (and the basis for liability must have been established). [fn 136] At first sight, that does not sound like a high threshold. However, Tjong Tjin Tai makes clear that the threshold must not be too low either. The extent of the damage need not yet be entirely clear, but it must be clear that damage has been suffered. [fn 137] [redacted] et al. do not meet that threshold.

4.2.1 Graphene oxide is not a component of the COVID-19 vaccines

126. [redacted] et al. claim that through the COVID-19 vaccines they were injected with “the toxic graphene oxide”, which it is supposedly “plausible” causes permanent adverse health consequences in humans. [fn 138] On this basis alone, it would be plausible that [redacted] et al. suffer damage. This assertion of [redacted] et al. is, however, incorrect. As explained in section 3.3.3, the COVID-19 vaccinations do not contain graphene oxide.

[fn 135] Summons, no. 284.

[fn 136] See also summons, no. 268.

[fn 137] T.F.E. Tjong Tjin Tai, De schadestaatprocedure, Deventer: Kluwer 2012, nos. 422-423.

[fn 138] Summons, no. 265.

4.2.2 [redacted] et al. do not meet their burden of allegation; moreover, the majority of them admit that they have not suffered material damage [fn 139]

127. Two of the six female claimants claim to have suffered grievous bodily harm. [fn 140] The other four female claimants do not claim to have suffered grievous bodily harm, but are said to have less serious complaints. [fn 141] It is also said to be plausible that the health of the female claimants will suffer in the long term from the COVID-19 injections. [fn 142]

128. What the grievous bodily harm, the less serious complaints and the long-term effects consist of has not been stated. There is merely a bare reference to exhibit 91, which supposedly contains “diagnoses” by “medical specialists”. However, those “diagnoses” cannot be regarded as neutral, objective, reliable and expert, and should therefore be disregarded.

Statements of Van Walraven

129. Exhibit 91 contains seven statements by occupational physician A.H. van Walraven (“Van Walraven”), which are to a large extent identical. [fn 143]

130. In his “diagnoses”, Van Walraven does not hesitate to air his own opinion on the COVID-19 vaccinations and the government policy pursued, and apparently subscribes to the same theories as [redacted] et al. [fn 144] For instance, he says that [redacted] et al. rightly feel misled by the government, he suggests that the government does not have its people’s best interests at heart, there supposedly never was an emergency, and the mortality rate of corona was supposedly in line with that of flu and this rate in itself did not justify any measure taken by the government. Such passages do not belong

[fn 139] [redacted] et al. apparently base this claim on Article 6:106(b) DCC.

[fn 140] ([redacted] and [redacted], according to the “diagnosis” in exhibit 91).

[fn 141] [Footnote text not legible in the source.]

[fn 142] Summons, no. 265.

[fn 143] Those of [redacted] are even completely identical.

[fn 144] See also, if desired, Van Walraven’s Manifesto to all doctors in the Netherlands; available at www.youtube.com/watch?v=sOpflZOaqmU

in medical statements and in themselves constitute sufficient grounds for disregarding them.

131. In addition, Van Walraven’s assertions are insufficient, both medically and legally, to assume a causal link. First, Van Walraven very easily lumps correlation and causation together. As a doctor, he ought to know better. It follows from Van Walraven’s “diagnoses” that [redacted] allegedly contracted Parkinson’s disease and [redacted] a TIA. According to Van Walraven, these diseases can be attributed to the COVID-19 vaccination because (i) the complaints arose (shortly) after the vaccination (in the case of [redacted] and [redacted]) and (ii) other causes have not been found (in the cases of [redacted]). For [redacted] it has not even been asserted that his complaints arose after a COVID-19 vaccination. Nevertheless, with regard to [redacted], Van Walraven concludes that there is “a vaccine side effect until the contrary is proven”. That is incorrect – and only serves to invalidate all of the positions taken by Van Walraven. The assertion that the complaints arose shortly after the vaccinations is merely a threshold requirement, but not substantiation of the assertion that the alleged complaints were caused by the vaccination. [fn 145] Bourla therefore disputes this. Second, Van Walraven’s statements are for the most part not (further) substantiated and are therefore unverifiable. See, for example, the assertion regarding [redacted] that no other causes have been found and the assertions regarding [redacted] about the negative family history and the rapid course. Incidentally, for such clinical pictures no causes can often be found, so the mere absence of an “other” cause in no way counts as an indication that the clinical pictures must therefore have been caused by a vaccine.

132. Furthermore, Van Walraven proves to lack expertise regarding the side effects of Comirnaty. He points out that Parkinson’s disease and clotting problems, including TIAs, are on the list of side effects of the

[fn 145] This is also a well-known fallacy: post hoc ergo propter hoc.

vaccines, but that is incorrect, as is apparent from the lists of side effects published on the websites of the EMA and Lareb. [fn 146]

133. Incidentally, even if a side effect were on the list of side effects, it still does not necessarily follow that the vaccine causes that side effect. And even if it can be shown that a side effect is caused by the vaccine, that still does not lead to liability if the vaccine meets the prescribed safety standards and is not defective. Safety is not an absolute concept, especially not in the case of medicinal products, since they always entail both risks and benefits and are expressly authorised on the basis of evidence that the balance between them is favourable. Comirnaty meets the applicable safety standards. This is apparent from the grant of the marketing authorisation after the EMA had confirmed that the balance of benefits and risks of Comirnaty was favourable, and from post-authorisation pharmacovigilance. [redacted] et al. have put forward nothing against this: they have neither asserted nor explained that the vaccines allegedly administered were in any way defective.

4.2.3 Allegedly suffered non-material damage is not eligible for compensation

134. In addition to material damage, [redacted] et al. claim to have suffered non-material damage. This allegedly consists of (i) the mental harm experienced as a result of the deception brought about by the defendants (feelings of pain, suffering, shame, powerlessness and uncertainty about their health) and (ii) not knowing the precise consequences of the vaccinations. [fn 147]

135. [redacted] et al. apparently base these claims, first, on Article 6:106(b) DCC. Mental injury falls within the category mentioned there of ‘injury to the person in some other way’. [fn 148]

[fn 146] EMA, Comirnaty product information (selection) (Bourla-38), available at www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_nl.pdf and LAREB, Bijwerkingen coronavaccins (Bourla-56), available at www.lareb.nl/bijwerkingen-coronavaccins#pfizer, respectively.

[fn 147] Summons, no. 266.

[fn 148] S.D. Lindenbergh, in: T&C BW, Art. 6:106 BW, note 3 (online, updated to 1 September 2023).

136. The legislative history shows that mental injury must be “sufficiently serious” to be eligible for compensation. [fn 149] More or less severe psychological discomfort is insufficient, which is also settled case law. [fn 150] For that reason alone, the claims of [redacted] et al. must be dismissed. The Supreme Court (Hoge Raad) has moreover held that a person who relies on “injury to the person in some other way” will have to put forward sufficiently concrete facts from which it can follow that, in connection with the circumstances of the case, psychological damage has arisen, for which it is necessary that the existence of mental injury can be established according to objective standards. [fn 151] [redacted] et al. have not done so. The bare assertion that they experience mental harm and do not know the precise consequences of the vaccinations is insufficient for this purpose. Insofar as [redacted] et al. also refer to exhibit 91 in the context of non-material damage, Bourla refers to paragraphs 128 et seq., in which it is explained that these statements are not neutral, objective, reliable and expert.

137. Second, [redacted] et al. apparently rely on Article 6:106(a) DCC. They state that they have “given reasoned assertions that the defendants had the aim of causing them harm”. [fn 152] However, [redacted] et al. have nowhere asserted this, let alone given reasons for it. This assertion is unfounded and incorrect. [fn 153] Third, [redacted] et al. refer to Article 6:106(c) DCC and state that some claimants are married. [fn 154] The relevance is not clear from the summons.

[fn 149] Parl. Gesch. BW Boek 6 1981, p. 389 (EV I).

[fn 150] S.D. Lindenbergh, “Smartengeld wegens spanning, frustratie, ergernis en (ander) onbehagen? Over het begrip ‘persoonsaantasting’ buiten lichamelijk en geestelijk letsel”, NTBR 2019/20, pp. 122-130, p. 124, referring to HR 13 January 1995, NJ 1997/366, with annotation by C.J.H. Brunner (Ontvanger/B.) and HR 21 February 1997, NJ 1999/145, with annotation by C.J.H. Brunner (Wrongful birth).

[fn 151] HR 15 March 2019, ECLI:NL:HR:2019:376, NJ 2019/162 (EBI).

[fn 152] Summons, no. 267.

[fn 153] With this assertion, [redacted] et al. moreover fail to recognise that the aim must be directed at inflicting specifically the non-material damage. The mere circumstance that someone has intentionally created a situation – which, incidentally, is not the case here either – as a result of which harm other than financial loss has been inflicted cannot support the inference that he had the aim of inflicting such harm. (See HR 26 May 2020, ECLI:NL:HR:2020:868, NJ 2020/231, paras. 2.3.2-2.4. See to the same effect S.D. Lindenbergh, in: T&C BW, Art. 6:106 BW, note 2 (online, updated to 1 September 2023)). The scope of application of this provision is therefore limited in practice.

[fn 154] Summons, no. 267.

4.3 No causal link

138. [redacted] et al. have not asserted that:

(a) they took Comirnaty once or more than once; [fn 155]

(b) without the alleged deception they would not have taken those vaccinations (read: what information was decisive for them in taking the vaccines);

(c) Comirnaty can lead to the damage allegedly suffered (general causation); and

(d) Comirnaty led to the damage allegedly suffered by [redacted] et al. (specific causation).

139. Bourla points out once again that Van Walraven’s assertions are insufficient, both medically and legally, to assume (specific) causation (see paragraphs 128 et seq.), and that the positions Van Walraven is apparently prepared to take also otherwise mean that the evidential value of his statements is very slight to nil.

140. The allegedly suffered non-material damage – which, as explained, is not damage eligible for compensation at all (see section 4.2.3) – is not causally connected with Comirnaty or any of the other COVID-19 vaccines either. [redacted] et al. have taken no position on this. Moreover, it is common knowledge that psychological complaints can also be caused – and indeed have been caused on a large scale – by the corona crisis, and not so much by the corona vaccines. [fn 156]

[fn 155] With the exception of [redacted].

[fn 156] See for example Trimbos Instituut, Voortdurende coronacrisis leidt tot toename psychische klachten en behoefte aan perspectief, 25 February 2021 (Bourla-57), available at www.trimbos.nl/actueel/nieuws/voortdurende-coronacrisis-leidt-tot-toename-psychische-klachten-en-behoefte-aan-perspectief/#:~:text=gezondheid%20van%20volwassenen.-,Toename%20psychische%20klachten,jaar%20hebben%20de%20meeste%20klachten and Nederlands Jeugdinstituut, Onderzoek naar corona en mentaal welbevinden (Bourla-58), available at www.nji.nl/coronavirus/onderzoek-naar-corona-en-mentaal-welbevinden

4.4 No group liability (Article 6:166 DCC)

141. The alleged claims brought on the basis of Article 6:166 DCC also fail. For a successful reliance on Article 6:166 DCC, [redacted] et al. would have had to assert and prove:

(a) that Bourla participated in;

(b) conduct in a group context;

(c) the risk of thereby causing damage from which ought to have restrained the participants;

(d) that his participation in this conduct can be attributed to him; and

(e) that one of the participants in that conduct unlawfully caused damage to the injured party. [fn 157]

142. As explained, Bourla did not act unlawfully (see section 4.1). The same applies to the other defendants. Nor did Bourla and the other defendants cause any damage to [redacted] et al. (see section 4.2). For that reason alone, Bourla cannot be held (jointly and severally) liable under Article 6:166 DCC either.

5 BURDEN OF ADDUCING EVIDENCE AND OFFER OF PROOF

143. In support of the grounds of his defence, Bourla has the following evidence at his disposal:

Number — Description

Bourla-1 — WHO, WHO Director-General's opening remarks at the media briefing on COVID-19, 11 March 2020

Bourla-2 — EMA, COVID-19 medicines

Bourla-3 — WHO, Statement on the fifteenth meeting of the IHR (2005), 5 May 2023

Bourla-4 — The Lancet, Global impact of the first year of COVID-19, 23 June 2022

Bourla-5 — EMA, Conditional marketing authorisation

Bourla-6 — EMA, Good pharmacovigilance practices

Bourla-7 — EMA, Comirnaty risk management plan, October 2023 (selection)

Bourla-8 — EMA, Periodic safety update reports (PSURs)

[fn 157] A.J.B. Boonekamp, Stelplicht & Bewijslast, commentary on Art. 6:166 BW (online, updated to 2 October 2017).

Bourla-9 — EMA, COVID-19 vaccines development, evaluation, approval and monitoring

Bourla-10 — Pfizer, Pfizer Outlines Five-Point Plan to Battle COVID-19, 13 March 2020

Bourla-11 — Pfizer, Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine, 17 March 2020

Bourla-12 — Pfizer, Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate, 9 April 2020

Bourla-13 — ClinicalTrials.gov, A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults, 13 January 2022

Bourla-14 — ClinicalTrials.gov, Study to Describe the Safety, Tolerability, Immunogenicity [...], 28 February 2023

Bourla-15 — EMA, Comirnaty Assessment report, 19 February 2021

Bourla-16 — EMA, EMA starts second rolling review of a COVID-19 vaccine, 6 October 2020

Bourla-17 — OJEU, 24 December 2020

Bourla-18 — EMA, Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines

Bourla-19 — Watson O. et al., Global impact of the first year of COVID-19 vaccination: a mathematical modelling study, 23 June 2022

Bourla-20 — Gezondheidsraad (Health Council of the Netherlands), Advies – COVID-19 vaccinatie BioNTech-Pfizer, 24 December 2020

Bourla-21 — Lewis, L.M. et al., The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective, 18 September 2022

Bourla-22 — Institut Pasteur, Discovery of messenger RNA in 1961, 15 February 2021

Bourla-23 — BioNTech, The History of BioNTech – The Road to a New Era of Immunotherapy

Bourla-24 — Press release The Nobel Prize in Physiology or Medicine 2023, 2 October 2023

Bourla-25 — Science News, How COVID-19 vaccines were made so quickly without cutting corners, 29 June 2021

Bourla-26 — Bettini, E., SARS-CoV-2 mRNA Vaccines: Immunological Mechanism and Beyond, 2021

Bourla-27 — Wadhwa et al., Opportunities and Challenges in the Delivery of mRNA-Based Vaccines, January 2020

Bourla-28 — EMA, COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines, 4 May 2020

Bourla-29 — EMA, How are COVID-19 vaccines developed

Bourla-30 — Nature, Whither COVID-19 vaccines, 28 September 2020

Bourla-31 — NBC News, 3 vaccine executives say that after approval, distribution will be the main challenge, 3 December 2020

Bourla-32 — The Journal, Pfizer CEO says there is 'encouraging' data on whether its vaccine stops Covid transmission, 13 January 2021

Bourla-33 — EMA, Comirnaty, COVID-19 mRNA vaccine (nucleoside modified), 21 December 2020

Bourla-34 — FDA, FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine, 11 December 2020

Bourla-35 — WHO, Interim recommendations for use of the Pfizer-BioNTech COVID-19 vaccine, 8 January 2021

Bourla-36 — Reuters, Fact Check: Preventing transmission never required for COVID vaccines' initial approval

Bourla-37 — ECDC, Risk of SARS-CoV-2 transmission from newly-infected individuals with documented previous infection or vaccination, 29 March 2021

Bourla-38 — EMA, Comirnaty product information (selection)

Bourla-39 — FDA, Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum, 20 November 2020

Bourla-40 — Gov.UK, Summary of the Public Assessment Report COVID-19 Vaccine, December 2020

Bourla-41 — MIT Technology Review, What are the ingredients of Pfizer's covid-19 vaccine, 9 December 2020

Bourla-42 — EU Parliament, Answer given by Ms Kyriakides on behalf of the European Commission, 26 October 2021

Bourla-43 — EU Parliament, Answer given by Ms Kyriakides on behalf of the European Commission, 8 March 2022

Bourla-44 — Reuters, COVID-19 vaccines do not contain graphene oxide, 23 July 2021

Bourla-45 — AP, Pfizer vaccine does not contain graphene oxide, 8 July 2021

Bourla-46 — EMA, Periodic safety update report

Bourla-47 — EMA, Comirnaty periodic safety update report assessment 19 June 2022 to 18 December 2022 (selection)

Bourla-48 — EMA, Assessment report on the annual renewal of the conditional marketing authorisation (Comirnaty), 2021

Bourla-49 — Reuters, Pages of suspected side effects released about Pfizer's COVID-19 vaccine [...], 17 March 2022

Bourla-50 — EU Parliament, Answer given by Ms Kyriakides on behalf of the European Commission, 3 July 2023

Bourla-51 — EMA, COVID-19 vaccines: development, evaluation, approval and monitoring

Bourla-52 — Hviid, A., Inaccurate representation of shipped vaccines as administered, 20 June 2023

Bourla-53 — ECA, Special report, EU COVID-19 vaccine procurement: Sufficient doses secured after initial challenges, but performance of the process not sufficiently assessed, 2022

Bourla-54 — Reuters, mRNA vaccines are distinct from gene therapy, 10 August 2021

Bourla-55 — CBG-MEB, Column 'Over medicijnen': Coronavaccins experimenteel?, 2 June 2021

Bourla-56 — LAREB, Bijwerkingen coronavaccins

Bourla-57 — Trimbos Instituut, Voortdurende coronacrisis leidt tot toename psychische klachten en behoefte aan perspectief, 25 February 2021

Bourla-58 — Nederlands Jeugdinstituut, Onderzoek naar corona en mentaal welbevinden

144. By the foregoing, Bourla does not wish to be deemed to have voluntarily assumed any burden of proof that does not rest on Bourla as a matter of law.

145. Bourla takes the position that the burden of proof in these proceedings rests on [redacted] et al. Bourla expressly offers to provide evidence to the contrary.

146. Insofar as, in the court’s opinion, the burden of proof of any assertion should rest on Bourla, Bourla offers to prove it by all legal means, in particular by the hearing of witnesses.

ON THESE GROUNDS BOURLA MOVES:

that the court, by judgment that is provisionally enforceable insofar as legally possible:

(a) declare [redacted] et al. inadmissible in their claims, or at least dismiss those claims;

(b) order [redacted] et al. jointly and severally to pay the costs of the proceedings, as well as the usual subsequent costs (both without and with service), plus the statutory interest referred to in Article 6:119 DCC from fourteen days after the date of the judgment, on the understanding that if one claimant pays, the other claimants shall be released.

[signature] lawyer

This case is being handled by Ms D.C. Roessingh, T +31 20 577 1892, M [redacted], E Davine.Roessingh@debrauw.com, and Ms M.

Bredenoord-Spoek, T +31 20 577 1066, M [redacted], E Marieke.Bredenoord@debrauw.com. De Brauw Blackstone Westbroek N.V., Postbus 75084, 1070 AB Amsterdam