EU Citizens Unite against EMA’s Final Response and Answer the Meeting Offer with Conditions
Expanded Transparency4Safety Initiative against EMA
EU Citizens Fight for Transparency
Since February 2025, more than 2,100 Europeans have joined the Transparency4Safety initiative on access-to-documents (Regulation No 1049/2001) requesting a scientific re-evaluation of modRNA platform technologies against infectious diseases by opening the entire Common Technical Dossier (CTD) - authorised under the biologically inapplicable vaccine and antibody eliciting framework that does not align with the actual biological mode of action as gene therapy. We have already reported about this initiative here and here under the Substack website “Official Releases of the European Medicines Agency.” In order to expand this initiative, a new website has been launched.
EMA issued a “final response” in February 2026, seeking to close the initiative and silence 2.100 lawful requests without disclosing the regulatory files - instead, Executive Director Emer Cooke proposed a dedicated meeting.
Our response to EMA’s disregard for fundamental EU rights is simple: this initiative has not ended but now expands to all EU Member States because EU citizens cannot accept lower safety standards for biotechnological innovations against infectious diseases while higher standards apply against therapeutic indications like cancer. Therefore, EU citizens insist on appropriate, verifiable safety thresholds and on the exercise of the fundamental right of prior informed consent for medical treatments. Moreover, EU citizens are ready to meet with EMA/CHMP/PRAC and CAT to discuss the safety of modRNA technologies on our conditions.
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Who is Behind the Transparency4Safety Initiative?
This initiative has been launched by independent patient and drug safety organisations and associations, including the North Group, MWGFD, Slovenian Jurists, the Swedish Doctors’ Appeal, the GHRA and many others. Independent experts and concerned EU citizens joined - including individuals vaccinated with Comirnaty and Spikevax, with and without adverse events - simply anyone demanding the highest level of drug safety and a regulatory framework applied in accordance with the products’ mode of action.
The Initial Request of 2025
“In light of the above, pursuant to Regulation (EC) No. 1049/2001, the undersigned, on behalf of our organization, formally requests the 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 Module 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.”
This was followed by an explanation that redactions invoked to protect commercial interests cannot lawfully prevail where an overriding public interest in disclosure is established through safety concerns.
Disturbing Lines of Communication with EMA
Europeans invoke their fundamental rights to the highest attainable standards of health, to transparency and access to documents, and to good administration free from maladministration. Instead of disclosure and protecting fundamental rights, European citizens received what can only be described as procedural obstruction wrapped with unverified allegations of safety.
The initiative’s position is straightforward: safety conclusions that bind 450 million Europeans must remain open to verification. That requires a complete, verification‑enabling regulatory record, a lawful application of the Art 4(2) exception of an overriding‑public‑interest, and procedural guarantees that preserve effective remedies.
February 2025 – the formal request. GHRA submits a Regulation 1049/2001 request for CTD access and, in particular, the validation record and batch-level evidence underlying residual DNA quantification and other Critical Quality Attributes.
19 March 2025 – the mass‑email excuse. EMA replies with a generic message citing “the large number of requests” and asserts it will “revert to you individually in due course,” while pointing to the North Group’s refusal to act as a single contact point.
3 April 2025 – GHRA’s procedural reminder. GHRA replies that Regulation 1049/2001 requires individual procedural guarantees and reasoned handling, requests re-sending of the ASK number, and rejects the premise that a citizens’ initiative must be channelled through a single intermediary.
2 July 2025 – EMA pivots to selective publication. EMA announces it will publish selected materials “progressively” on its website after reviewing for personal data and commercially confidential information—treating proactive publication as a substitute for deciding individual 1049/2001 applications and for enabling confirmatory remedies.
8 July 2025 – GHRA’s objection to circumvention. GHRA responds that proactive publication cannot discharge EMA’s duties under Regulation 1049/2001; asks what concrete steps were taken on the pending applications; insists that the overriding public interest must be assessed on the record; and objects to heavy CCI redactions of the old re-releases.
3 September 2025 – EMA hardens its line (and narrows residual DNA control to drug substance). EMA argues that processing 2,100+ requests individually would entail an “unreasonable workload” that “could paralyse the proper functioning” of the Agency. On residual DNA, EMA advances two positions that are as striking as they are consequential: first, that “DNA is only used during the manufacture of the active substance” and that “it is important to test the active substance itself”; second, that researchers who test the final product may obtain “incorrect results because of interference from excipients,” citing the Qubit approach as an example. In the same breath, EMA states it has “not seen any reliable scientific evidence of DNA exceeding approved levels” and labels independent findings as “unvalidated tests”—while the validation packages, batch datasets, and internal decision record needed to verify these assertions remain incomplete, fragmented, or redacted.
4 October 2025 – GHRA’s formal escalation (ETI follow‑up). GHRA reiterates that the ETI request is a Regulation 1049/2001 procedure requiring distinct handling and effective remedies; renews the demand for a verifiable dossier inventory and parallel access to disclosures; and calls on EMA to apply the overriding‑public‑interest test to safety‑relevant redactions.
3 December 2025 – EMA’s reply to GHRA’s 4 October follow-up (EMA/379667/2025). EMA rejects a duty to establish a public register, relying on Article 12(1) of Regulation 1049/2001 (“as far as possible”), and calls GHRA’s allegation of preferential treatment “exceedingly misleading”, noting that (statistically) fifty percent of 2024 access requests and appeals were submitted by the pharmaceutical industry.
15 December 2025 – GHRA’s structured rebuttal. GHRA objects that EMA’s replies omit the legally required overriding-public-interest balancing under Article 4(2) of Regulation 1049/2001; requests a verifiable dossier inventory (titles/identifiers/version histories); documents evidence of selective disclosure; and demands procedural guarantees (confirmatory applications) and publication practices that give practical effect to disclosure.
13 February 2026 – EMA’s “final response.” EMA again declines to provide what independent verification requires: a complete dossier inventory and a disclosure mechanism that ensures equal access. It further asserts that database‑codified version/identifier information “would not be useful for your purposes,” and proposes a meeting—while maintaining that it has “sufficiently explained” itself. It reveals a posture of delay, deflection, selective disclosure, and—above all—an insistence on safety conclusions while withholding the full, verification‑enabling regulatory record.
10 April 2026 – GHRA’s response and conditional acceptance of the meeting. GHRA has accepted the meeting in principle, but only on verifiable terms: a defined agenda, expert participation, livestream access, documentary deliverables, and a published meeting record capable of supporting reproducible scientific verification and, where warranted, regulatory action.
EMA’s Alleged “Exceptional Transparency Measures” and the Violation of Procedural Guarantees
As shown above, EMA tried to close this initiative through its “final response”, while none of the individual requesters ever received a procedurally lawful, reasoned decision under Regulation 1049/2001. Instead, EMA published a limited set of older re-releases at the respective product website Comirnaty and Spikevax, with redactions so extensive that they do not enable meaningful independent verification, but framed this approach as “exceptional transparency measures”. As a side information, EMA is required to grant the public access to all documents disclosed through Reg 1049/01 according to the jurisprudence of the European courts. However, it thinks it is exceptionally transparent if it is forced to publish a selected set thereof, while all others remain hidden.
All releases of the CTD, both under EMA’s alleged “exceptional transparency measures” (which are zipped and difficult to access) as well as releases to individuals under Reg 1049/01 that are still kept secret but provided to the GHRA are made available as posts of the “Official Releases of the European Medicines Agency” Substack website, see the latest updates for Comirnaty and Spikevax.
Besides the publication of re-releases, EMA uniquely disclosed the requested 236-batch residual-DNA document as ‘DNA characterization report —yet it remains heavily redacted and therefore not suitable for scientific re-evaluation, and none of the requesters was provided the procedural guarantees to make a confirmatory application to request unredaction under Reg 1049/01.
Since the PSUR4doctors initiative, with the releases published also under the “Official Releases of the European Medicines Agency” GHRA has publicly and formally called upon EMA—both in correspondence and in submissions to the European Ombudsman—that EMA needs to establish a transparency register that allows the public to verify what is disclosed, to whom, and when, and to give practical effect to the erga omnes effect of disclosure recognised in the Court’s case-law. However, the alleged transparency platform is still not active at EMA.
Our Demands and Meeting Conditions
Suspend the market authorisation until scientific re-evaluation by independent researchers is made possible: EMA has to initiate an immediate Article 20 risk procedure—initiation towards the Commission. We call upon EMA and its competent scientific committees, without delay, to prepare and submit to the European Commission a reasoned opinion requesting initiation of an Article 20 procedure under Regulation (EC) No 726/2004 for Comirnaty and Spikevax—and, where applicable, for other centrally authorised modRNA/sa-mRNA infectious-disease products (mResvia (mRNA, RSV); Kostaive (sa-mRNA, COVID-19); mNEXSPIKE (mRNA, COVID-19)). The evidentiary basis is twofold: documented, plausible mechanisms of harm linked to misaligned regulatory control strategies, and an exceptional volume of pharmacovigilance safety signals recorded in the Union system and described in peer-reviewed literature. This requires PRAC-anchored assessment where pharmacovigilance data trigger the procedure, and CHMP outputs capable of supporting immediate temporary measures where urgency demands.
Immediate unredaction of the CTD record under the overriding public interest exception. EMA must comply with Regulation 1049/2001 by providing verification-enabling access to the CTD market dossiers (including relevant versions), and accept that the Article 4(2) exception for “commercial interests” cannot lawfully displace disclosure where the public interest concerns safety governance of population-scale prophylactic products and where independent reproducibility is necessary to resolve contested methodological questions.
A meeting for a validated test protocol and presentations of plausible mechanisms of harm not yet sufficiently considered. EMA proposed a dedicated meeting. GHRA accepts in principle—on verifiable terms: fixed agenda, competent committee participation (PRAC/CHMP/CAT) and PEI, livestream access for requesters, documentary deliverables, and a published meeting record. The meeting must be scheduled without undue delay (proposed: May 2026) and structured into two sessions with implementable outputs.
Session 1 (DNA residues / SV40; validation by design): the core representatives present the analytical approach, the precise subject matter of analysis (analytes, matrices, sampling, endpoints), and a draft inter-laboratory ring-trial protocol. EMA/PEI must state, on the record, the scientific basis for dismissing independent findings as “unvalidated”, identify the evidentiary basis it relied upon, and propose methodological refinements. The outcome must be a single, harmonised, pre-registered ring-trial protocol—fixing methods and subject matter publicly—so results are reproducible, comparable, and suitable for regulatory reliance.
Session 2 (pharmacovigilance re-evaluation; plausible mechanisms of harm): the core representatives present a cross-cutting batch/lot-variability analysis (including DS/DP logic and matrix-effect considerations) and exemplar analyses of four priority issues: malignancy/cancer; myocarditis/pericarditis; in-vivo spike expression/persistence and biodistribution; and fertility/reproductive outcomes. EMA must state what has been assessed, what committee work products exist, what regulatory measures were taken (or considered), and what will be done next. The outcome must be a published consolidated list setting out EMA’s regulatory response for each priority issue—i.e., whether gene-therapy-relevant evidentiary/control requirements (ATMP-relevant standards) will be applied for the identified CTD/PV elements or whether EMA continues to rely on vaccine-framework requirements—together with PRAC/CHMP/CAT work products, timelines, and resulting regulatory measures.
These demands reflect the overriding public interest in disclosure and verification for the most consequential safety themes raised in GHRA’s correspondence: residual bacterial plasmid DNA (including the SV40 promoter/enhancer issue for Comirnaty), batch variability as the bridge between dossier and harm, and the four exemplar harm domains (cancer, myocarditis, in-vivo spike expression, fertility/reproductive outcomes).
Please Join
Soon, you can join at zero cost. Participation does only require time and energy submitting the request, responding to emails and sharing the ASK number with a national/regional coordinator for further legal actions. In the meantime, we prepare additional expert teams who will submit further thematic, mechanism-based analyses of plausible harms and the corresponding regulatory implications.