Letter to Executive Director of the European Medicines Agency, Re: Your Agency’s Continued Obstruction

World Council For Health Logo

July 28, 2026

Dear Executive Director Cooke,

World Council for Health writes in support of the Transparency4Safety initiative, spearheaded by Dr. Silvia Behrendt and backed by the German association Mediziner und Wissenschaftler für Gesundheit, Freiheit und Demokratie e.V. (MWGFD) and more than 2,100 EU citizens who have formally requested access to the Common Technical Document (CTD) for Comirnaty and Spikevax pursuant to Regulation (EC) No 1049/2001 (MWGFD, 2026).

Your February 2026 offer of a meeting with the Transparency4Safety applicants, rather than compliance with your legal transparency obligations, is not a genuine attempt to engage. The MWGFD rightly demanded concrete dates in May or June 2026, participation of the responsible European Medicines Agency (EMA) committees and product leads, a livestream for all applicants and the interested public, and – most critically – the immediate de-redaction and disclosure of the priority CTD documents (MWGFD, 2026).

Your letter of April 2026 stated that  „[…] we would like to underscore that, to date, EMA has not seen any reliable scientific data demonstrating safety concerns capable of overturning the current positive risk-benefit balance for Comirnaty and Spikevax.“.

This framing is disingenuous. The evidence was present from the very beginning. In the original Pfizer pivotal trial, during the blinded, placebo-controlled period, 15 participants died in the BNT162b2 group versus 14 in the placebo group – and during the open-label period, an additional 3 BNT162b2 recipients died versus 2 in the original placebo group who had since received the vaccine (Polack et al., 2020; Thomas et al., 2021). That is more deaths in the vaccinated group. Any competent pharmacovigilance system would have flagged this immediately. Instead of a halt, the rollout was accelerated globally.

The scientific literature was already sufficient in 2021 to demand an immediate moratorium. World Council for Health, on 9 November 2021, issued a formal Declaration, Cease and Desist and Notice of Liability calling for an immediate stop to the COVID-19 experimental injections, declaring them “dangerous and unsafe for human use” and stating that continued participation in their manufacturing, distribution, administration, or promotion violates the Nuremberg Code, the Helsinki Declaration, and basic principles of law. Dr. Tess Lawrie had already stated in June 2021 that there was “more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans.”

Yet you and your agency proceeded. The subsequent body of evidence has only confirmed these initial warnings. The biostatistician Christine Cotton, in her analysis of the Pfizer/BioNTech registration trial C4591001, identified severe methodological issues, including a lack of medium- or long-term tolerability data at the time of authorization and a lack of statistically significant efficacy against severe COVID-19 or death. Most critically, she documented that the commercial product manufactured via “Process 2” is not the same as the product used in the clinical trial, concluding that the public received a product for which there were no valid efficacy or safety data at the time of authorization.

The EMA’s current posture – offering meetings while continuing to withhold core safety data behind black redactions – perpetuates the same pattern of regulatory capture that enabled this catastrophe in the first place. The MWGFD is correct: the meeting must not serve as a substitute for compliance with Regulation 1049/2001. The redactions must be lifted now. The public has an overriding interest in understanding what the EMA knew, when it knew it, and why it acted as it did.

We await your prompt scheduling of the meeting under the conditions outlined by the MWGFD, and the immediate release of the unredacted CTD modules.

Sincerely,

The WCH Board

References

MWGFD. (2026, April 28). Transparency4Safety — MWGFD fordert Daten und Meeting von der EMA. Mediziner und Wissenschaftler für Gesundheit, Freiheit und Demokratie e.V. https://www.mwgfd.org/2026/04/transparency4safety-mwgfd-fordert-daten-und-meeting-von-der-ema/

Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Moreira, E. D., Zerbini, C., Bailey, R., Swanson, K. A., Roychoudhury, S., Koury, K., Li, P., Kalina, W. V., Cooper, D., Frenck, R. W., Jr., Hammitt, L. L., … Gruber, W. C. (2020). Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine, 383(27), 2603–2615. https://doi.org/10.1056/NEJMoa2034577

Thomas, S. J., Moreira, E. D., Jr., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Polack, F. P., Zerbini, C., Bailey, R., Swanson, K. A., Xu, X., Roychoudhury, S., Koury, K., Bouguermouh, S., Kalina, W. V., Cooper, D., Frenck, R. W., Jr., … Jansen, K. U. (2021). Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months. New England Journal of Medicine, 385(19), 1761–1773. https://doi.org/10.1056/NEJMoa2110345

World Council for Health. (2021, November 9). World Council for Health calls for an immediate stop to the Covid-19 experimental “vaccines” [Declaration, cease and desist and notice of liability]. https://www.worldcouncilforhealth.org/world-council-for-health-calls-for-an-immediate-stop-to-the-covid-19-experimental-vaccines/

World Council for Health. (2026, June 8). “One of the Greatest Manipulations Humanity Has Ever Known.” She Told the Truth About the Pfizer Vaccine. Then Her Body Broke. https://worldcouncilforhealth.substack.com/p/0f8d8ba1-c0ec-48eb-a0e7-a726b0179d01 [citation:1]

World Council for Health. (2026, June 26). The Greatest Medical Catastrophe Nobody Wants to Name: What the Data Actually Shows About the Pfizer COVID Injections. https://worldcouncilforhealth.substack.com/p/the-greatest-medical-catastrophe [citation:3]

World Council for Health. (2026). [Second Substack article]. URL: https://worldcouncilforhealth.substack.com/p/3287f897-4fa1-4a89-b830-8332b97a938b  [citation:2]

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