Chemistry Professors Call for Transparency: Letter with Evidence about Safety Concerns sent to the EMA under the T4S Initiative

Professors of Chemistry and Physics provided to the EMA an 'overriding public interest' evidence report which substantiates the core claim of the T4S to stop and re-evaluate all mRNA authorisations

Great news for Transparency4Safety (T4S) Initative: the chemists have sent a letter to Ms. Emer Cooke, the Executive Diretor of the European Medicines Agency (EMA), dated May 26th 2026, — and with it, a body of ‘overriding public interest’ evidence that goes to the heart of the transparency debate around mRNA/LNP products under the T4S initiative

Photo by Vitaly Gariev on Unsplash

The letter was sent by five respected chemistry and physics professors and copied to the German Paul Ehrlich Institute, as reference laboratory for Comirnaty. They have spent years asking the Paul Ehrlich Institute and other state authorities concrete evidentiary questions - but never received real answers.

Prof. Jörg Matysik, Prof. Gerald Dyker, Prof. Andreas Schnepf, Prof. Tobias Unruh and Prof. Martin Winkler deserve real recognition for their truthful revelations. They followed the evidence, asked precise questions, persisted despite incomplete answers, and have now brought their chemical, analytical and regulatory concerns into the formal EMA process and are awaiting an answer and an invitation to a meeting to discuss their findings.

Since 2022, they have published various articles in the German newspaper Berliner Zeitung and elsewhere as courageous and persistent critical questioners who bring important scientific concerns about COVID-19 vaccines, public health institutions and pandemic policy into the mainstream media outlets. Through their work, they advance transparency, encourage accountability, and foster much-needed public and scientific debate on issues of outstanding importance, particularly regarding drug safety.

Their independent expert contribution to the EMA constitutes the backbone of the T4S initiative — by showing, in scientific terms, why unredacted access to the Common Technical Dossier of the mRNA authorisations is a prerequisite for meaningful re-evaluation due to safety concerns.

As explained already explained in this substack, the T4S initiative rests on two mutually reinforcing pillars:

The first consists of EU citizens who are called upon to exercise their fundamental citizens’ right of access to EU documents and request the regulatory files needed to scrutinise mRNA/LNP products. Please find the call for action to EU citizens and further guidance here.

The second pillar is formed by the overriding public interest reports authored by experts in the respective fields, who provide evidence as to why the marketing dossier needs to be stopped and re-evaluated. Especially where unresolved safety questions, analytical uncertainties and possible regulatory gaps are identified, the regulators have an obligation to disclose and make these data available for scientific re-evaluation.

This letter is the first ‘overriding public interest’ report. Actually, the professors already have a long history with EMA access-to-documents requests. They filed various access-to-documents requests in 2022 under Regulation 1049/2001 but the releases have neiter included the necessary regulatory documents nor transparent, but only with extensive redactions, preventing independent assessment of the relevant CTD record.

At the centre of the chemists’ submission are three scientific concerns that are of direct relevance for the regulatory assessment:

• The first is dose definition. The professors argue that the nominal RNA dose printed in regulatory documents cannot, by itself, describe what is biologically delivered. In an mRNA/LNP product, the decisive question is not merely how much RNA is placed in a vial, but how much intact and encapsulated RNA is actually capable of entering cells, how consistently the lipid nanoparticle system performs, and how much spike-protein expression may result from that delivery process. Their submission points to substantial variation in intact and encapsulated mRNA, a broad pH range, and possible variation in essential lipid and formulation components. These are variables that may determine batch consistency, biological activity, tolerability and safety margins. If the underlying specifications, batch data and validation reports remain redacted, independent scientists cannot verify whether the product released within regulatory limits was sufficiently defined, reproducible and comparable across batches.

• The second issue is ALC-0315, the ionisable lipid used in the Pfizer/BioNTech lipid nanoparticle formulation. The professors challenge the adequacy of any regulatory conclusion that genotoxicity testing was unnecessary unless the scientific reasoning behind that conclusion is fully disclosed. They provide evidence that ALC-0315 is a functional component of the delivery system, designed to bind, protect, transport and help deliver nucleic acid material into cells. That alone, they argue, requires transparent toxicological justification. The concern becomes sharper in light of stereochemistry. If ALC-0315 was used as a mixture of stereoisomers, then its chiral structure needs further assessment in line with pharmaceutical science, as stereoisomers can differ in biological behaviour, distribution, metabolism and toxicity. The professors therefore request from the EMA to disclose the unredacted record on stereochemical control, impurity profiles, genotoxicity reasoning, toxicological qualification and the committee assessment behind the original regulatory position.

• The third issue is official product analysis and batch release. Here, the submission asks whether the control system applied to Comirnaty was truly independent, sufficiently product-specific and scientifically adapted to the novelty of mRNA/LNP technology. The professors question reliance on manufacturer-submitted samples, the limited scope of official testing, visual inspection of a light-scattering nanoparticle dispersion, PCR-based identity testing, RNA integrity criteria, potency assays based on in-vitro expression, and the handling of residual DNA. Their argument is not that one isolated test was missing. It is that a complex delivery platform requires a control strategy capable of measuring the critical quality attributes that actually define the product: RNA integrity, encapsulation, lipid composition, particle characteristics, residual nucleic acids, potency, stability and batch variability. Without unredacted access to the official protocols, validation data, batch-release reports and regulatory correspondence, it is impossible to determine whether the authorities independently verified the product’s safety-relevant parameters or merely relied on a partial and manufacturer-dependent control framework.

As of now, specifications, validation data, batch-release results, acceptance criteria, analytical ranges, stability data, residual DNA reports and regulatory correspondence remain withheld or heavily redacted, as the official releases of EMA regarding Comirnaty and Spikevax verify. Thus, independent scientists cannot test the conclusions that regulators and manufacturers ask the public to accept. The professors are demanding access to the evidence in line with the T4S initiative, and with other overriding public interest reports to be submitted in the near future.

In light of these concerns, they request a dedicated meeting, as EMA has offered to the T4S in their final response letter to the Global Health Responsibility Agency. Such a meeting must be substantive and should involve the competent scientific body, including CHMP, PRAC and, where relevant, CAT/ATMP expertise, and should lead to a documented regulatory outcome.

We all owe a debt of gratitude to the professors for bringing evidence to the EU level and for their commitment to transparency and safety. They have translated public concern into scientific language. They have moved the debate from suspicion to verification, from assertion to documentation, from unanswered questions to concrete requests for evidence.

Ms. Emer Cooke maintained in her final response letter dated 13 February 2026 that ‘no such serious doubts have been identified in connection with Spikevax and/or Comirnaty to safety concerns’, as chronologically reported here. With receipt of this letter, the EMA has a legal obligation to open the regulatory record for scientific re-evaluation and immediately change this position.

Therefore: Call to action to EMA: Stop the mRNA market authorisations until all scientific safety concerns have been fully addressed and invalidated. Unredact the regulatory data of mRNA authorisations, allow independent experts to review the full regulatory record, and introduce new safety standards for mRNA authorisations, as agreed upon at the dedicated T4S meeting between EMA and independent experts!