EMA Transparency Scandal: Violation of EU Transparency Law for 1000+ Participants of the EMA Transparency Initiative
Background of the EMA Transparency Initiative of February 2025
What is the EMA Transparency Initiative?
In February 2025, more than 1,000 EU citizens—backed by initiatives such as the North Group, the Global Health Responsibility Agency, MWGFD, Slovenian Lawyers, the Swedish Doctors' Appeal, Germany’s Anwälte für Aufklärung and many others—jointly launched the EMA Transparency Initiative (ETI).
The ETI formally demands access under Regulation (EC) No. 1049/2001 to the Common Technical Dossier (CTD) modules of the mRNA vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna). It was launched after independent scientific studies revealed excess residual DNA levels and highlighted serious shortcomings of qPCR control methods. Earlier analyses also uncovered the SV40 promoter sequence in the DNA plasmid—information that BioNTech had originally withheld from EMA in the CTD files. Once these findings became public, EMA requested BioNTech to update the SV40 promoter information in the CTD file through a variation of the market authorisation, rather than revoking the authorisation as EU pharmaceutical law would require in cases of such grave misconduct.
What was the exact content of the request?
Pursuant to Regulation (EC) No. 1049/2001, the request demanded immediate and unredacted disclosure of the CTD modules for Comirnaty and Spikevax, along with substantial additional data regarding the Critical Quality Attributes (CQAs). All documents must be provided in their most current and officially active version at the time of release.
Priority in disclosure should follow this ranking:
qPCR assay for residual DNA measurement, or any other methods applied to quantify residual DNA for Spikevax and Comirnaty as outlined in Procedure EMEA/H/C/005735/II/0202 of 29 February 2024, including full laboratory data from the 236 batches to validate the results submitted to EMA.
CTD Modules 2 and 3, particularly regarding CQAs (specifications, acceptance criteria, control procedures and analytical results regarding RNA integrity, dsRNA content, residual DNA levels, RNA sequence identity, RNA concentration, bioburden, pH balance, 5’ CAP structure and Poly(A) tail composition) for Comirnaty and Spikevax. With regard to Comirnaty, Modules 3.2.S.2–3.2.S.7, please note the re-releases under ASK-257127 and ASK-112278.
CTD Modules 4 and 5 for Comirnaty and Spikevax.
Why were unredacted documents requested under an overriding public interest?
An overriding public interest exists when the protection of public health outweighs commercial confidentiality. In the case of the ETI, this principle applies directly: unresolved safety concerns require transparency and independent scrutiny. Regulation (EC) No. 1049/2001 makes clear that under such circumstances redactions are not permissible and EMA is legally obliged to disclose all relevant regulatory documents.
Meaningful transparency and independent scientific validation are impossible with redactions. The 1,000 ETI participants therefore officially invoked an overriding public interest under Regulation (EC) No. 1049/2001. In such cases, EMA cannot apply redactions due to commercial confidentiality. The request underlines the need for full access to control methods, critical quality attributes, non-clinical study reports, and other regulatory documents, as potential risks to public health cannot be properly assessed without independent validation—especially given the growing body of literature indicating possible harm.
EMA's inactivity, disregard for transparency, and violation of EU citizens' rights
Instead of fulfilling its clear legal obligations under EU transparency law, EMA remained silent for months and thereby violated its binding duties. The 1,000+ participants received neither individual replies nor any documents through the official Eudralink system, even though such a reply is explicitly required within 15 working days. Requesters also have the right to be informed about their legal remedies—yet nothing was provided.
Instead, EMA issued only generic mass emails with no option to respond. After more than six months, on 13 August 2025, EMA informed all participants that old re-releases had simply been reposted on the product website of Comirnaty and Spikevax.
Please find EMA’s redacted list of documents for Comirnaty here and for Spikevax here.
These documents were already published years ago, are heavily redacted, and are useless for any meaningful scientific validation of the regulatory data. EMA nevertheless portrayed this as an “exceptional transparency measure” — apparently this is what EMA itself considers transparency. It did not inform participants if or when genuine new disclosures as requested without redactions would ever be made. This conduct is not only inadequate and embarrassing, but also an outright affront to EU citizens’ rights and a blatant violation of binding transparency obligations.
Why is the ETI unique in holding EMA to account for transparency?
This case is historic: for the first time, EU citizens collectively confront a regulator with their legal right to regulatory evidence—and EMA openly resists. It offers unprecedented proof that EMA shields pharmaceutical interests while disregarding the rights and health of EU citizens. The imbalance is laid bare: protection for industry, neglect for the public.
The public is aware that EMA secretly updated BioNTech/Pfizer’s market dossier after independent scientists revealed the SV40 promoter in its DNA plasmid. Therefore, the public demands independent validation through open access to all regulatory aspects of the market dossier. This step is indispensable to restore public and vaccine confidence. Independent scientists have already verified excess residual DNA levels due to EMA's reliance on the flawed qPCR method as official regulatory control. These are not minor issues; they go to the core of vaccine safety and regulatory credibility.
By shielding the companies instead of enforcing transparency, EMA places pharmaceutical interests above public health. By pointing to the mid-August re-releases as proof of transparency, the EMA claims to have met its duty—while in reality every day of secrecy corrodes trust in its market authorisations and damages public confidence in vaccines.
The European Ombudsman, the institution tasked with defending citizens, has compounded the problem by failing to act on formal complaints filed since spring 2025. This leaves EU citizens without protection against overly powerful institutions and forces them toward legal escalation.
The pattern is unmistakable: deliberate secrecy, documented inaction, and open defiance of EU transparency law. Far from being a neutral regulator, EMA is breaking the law—and in doing so, confirms severe regulatory failure and its unwillingness to defend the rights of EU citizens and vaccine safety.
What comes next
Unless EMA and the Ombudsman change course immediately, litigation is inevitable. The EMA Transparency Initiative is not only about documents; it is about EU citizens confronting the regulatory failures of fast-tracked mRNA vaccines, asserting the overriding public interest, demanding the highest standards of safety, restoring the rule of law, and ensuring independent scientific scrutiny of vaccines whose safety profile has been tested in real time on the EU’s and the global population.
Conclusion: The EMA Transparency Initiative is the first major test of EU citizens against the EMA, whose sole mandate is to ensure a high level of protection of public health—not to commit violations of binding transparency laws and the precautionary principle. The result so far is damning: instead of transparency, EMA chooses secrecy; instead of building vaccine confidence, it destroys it. Until the CTDs are fully released without redactions, EMA’s credibility—and Europe’s trust in vaccine oversight—remain fatally compromised.
Call to Participants
Please reply to EMA’s mass email communication of 13 August 2025 and make these points clear in your own words:
Thank EMA for the old re-releases (2024 and 2023). Note that while interesting, they are incomplete and do not match the original request or the indicated ranking order.
Urge EMA to provide the documents exactly as requested in February, in full compliance with transparency rights under Regulation 1049/2001.
Stress the urgency: independent scientific safety analysis cannot proceed without these documents.
Remind EMA that withholding the requested data undermines both vaccine safety and public confidence.
Ask for immediate confirmation of receipt and a timeline for full disclosure.
I'd like to remind You again: https://curia.europa.eu/jcms/upload/docs/application/pdf/2024-07/cp240113de.pdf
Seen in this way the refusal is an advantage in lawsuits.
Has anyone found the following document, which the EMA cited in their Public Assessment of Comirnaty (https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf)?
On page 47: "The biodistribution was also studied in rats using radiolabeled LNP and luciferase modRNA (study185350)."
On page 54: "In line with this, results from the newly transmitted study 185350, indicate a broader biodistribution pattern with low and measurable radioactivity in the ovaries and testes.".
So far I have not been able to find said study 185350 on the EMA servers. One can download it though from the phmpt.org servers, though that is the version which stemmed from the FDA lawsuit.