Residual DNA: Independent Experts Confront EMA with Overriding Public Interest Report and Demand Full Disclosure

The EMA can no longer rely on commercial-confidentiality claims to conceal the data required for an independent re-evaluation of Comirnaty and Spikevax concerning residual DNA contamination

Two independent German experts request transparency & scientific re-evaluation

The Transparency4Safety Initiative (T4SI) is gaining momentum: with two new expert access-to-documents requests now formally submitted to the European Medicines Agency, (EMA) we have taken another decisive step towards full regulatory transparency and an independent call for scientific reassessment of Comirnaty and Spikevax.

Both Professor Dr Ulrike Kämmerer and Professor Dr Klaus Steger have filed individual requests with EMA, demanding the unredaction and disclosure of the regulatory data required to assess residual DNA independently. Their requests extend to the analytical procedures, validation reports, raw batch data, specifications, acceptance criteria and regulatory assessments on which EMA’s conclusions depend.

In support of these requests, Professor Steger, with the assistance of the Global Health Responsibility Agency under the T4SI, formally submitted the Overriding Public Interest Report on Residual DNA. The report draws on the peer-reviewed scientific work of Professors Kämmerer and Steger, together with a broader body of independent evidence, to demonstrate why claims of commercial confidentiality must yield to the overriding public interest in disclosure.

Photo by Greg Bulla on Unsplash

The purpose is to enable a genuinely independent scientific re-evaluation of the marketing authorisations for Comirnaty and Spikevax, including every residual-DNA limit, specification, analytical method, validation procedure, manufacturing control and regulatory assumption on which those authorisations depend.

The report demands the primary regulatory evidence behind the redactions in order to stop and re-evaluate the market authorizations of Comirnaty and Spikevax.

Professor Kämmerer and Professor Steger co-authored the peer-reviewed study “BioNTech RNA-Based COVID-19 Injections Contain Large Amounts of Residual DNA Including an SV40 Promoter/Enhancer Sequence.” Their analysis reported residual DNA levels of approximately 32.71–42.09 nanograms per dose after disruption of the lipid nanoparticles and treatment with RNase A—around three to four times the historical limit of 10 nanograms per dose. The study further reported that LNP-associated DNA, including an SV40 promoter/enhancer sequence, entered human cells under the experimental conditions applied.

On the strength of this peer-reviewed work, their scientific expertise and the wider body of evidence assembled in the OPIR, the experts can demand full transparency from EMA with professional authority.

The purpose is clear:

To enable a genuinely independent scientific re-evaluation of the marketing authorisations for Comirnaty and Spikevax—including every residual-DNA limit, specification, analytical method, validation procedure, manufacturing control and regulatory assumption on which those authorisations depend.

EMA’s safety allegations are no substitute for evidence

EMA has repeatedly stated that it has not seen reliable scientific evidence capable of overturning the positive benefit-risk balance of the authorised products, as already reported earlier.

That position can no longer be maintained by the EMA after the OPIR and its supporting evidence have been formally submitted.

Independent laboratory studies have produced alarming results depending on the method applied, while long-read sequencing has also revealed fragments far larger than assumed. This alone requires EMA to disclose and justify the analytical basis of its safety conclusions.

This leads to the question whether EMA’s authorised methods were actually capable of detecting and characterising the residual-DNA population present in the final LNP-formulated medicinal product.

EMA required the marketing-authorisation holders, BioNTech and Moderna, to use target-specific qPCR as the principal regulatory method for residual-DNA control. That method detects only fragments containing the selected primer-binding regions. The results submitted by the manufacturers are therefore necessarily constrained by the chosen target sequence, amplicon length, extraction procedure, efficiency of LNP disruption and DNA recovery, matrix interference, and the calculation model prescribed or accepted by EMA. They cannot, on their own, establish either the total residual-DNA burden or its full fragment-size distribution in the final product.

A low qPCR result cannot, by itself, establish that other plasmid-derived DNA fragments are absent.

EMA refers to 236 batches safe from residual DNA contamination —but redacts all data t

EMA has referred to an assessment of 236 Comirnaty batches manufactured between 2020 and 2023 and has claimed that those batches complied with the approved residual-DNA specification.

But the underlying evidence remains heavily redacted and cannot be used for the purpose to verify that no harm is done to human health.

The public and independent scientists still lack complete access to the analytical procedures, validation and transfer reports, primers and probes, raw Ct values, standard curves, recovery studies, matrix-effect data, calculation sheets, individual batch results, deviations, invalid runs and retesting records.

Without these unredactios, EMA’s 236-batch claim cannot be independently verified and remains an allegation by both the regulator and the manufacturers.

The OPIR therefore requests disclosure of the primary regulatory evidence necessary to determine whether the analytical procedures, method validations, specifications, acceptance criteria, manufacturing controls, batch analyses and regulatory assessments were scientifically adequate. Professor Kämmerer and Professor Steger’s application expressly seeks the raw data and supporting records required for that verification.

The overriding public interest is crystal clear from the evidence

Under Article 4(2) of Regulation (EC) No 1049/2001, commercial interests cannot lawfully justify secrecy where an overriding public interest has been explicitely invoked.

The OPIR substantiates the overriding public interest exception through concrete scientific findings, unresolved methodological limitations and material uncertainty concerning medicinal products administered prophylactically to a vast and predominantly healthy population.

For each maintained redaction, EMA must identify the precise commercial interest allegedly at risk, explain how disclosure would cause concrete and reasonably foreseeable harm, demonstrate why partial access is impossible and establish why that commercial interest should prevail over the protection of human health.

Scientific uncertainty requires disclosure—not secrecy

EMA cannot rely on the absence of conclusively proven harm while withholding the evidence required to investigate that harm.

That would turn the precautionary principle upside down.

The absence of publicly available proof cannot be treated as proof of safety where the crucial regulatory methods, validations and batch data remain inaccessible.

Scientific uncertainty is not a justification for secrecy. It is the reason why transparency is an obligation by law.

Professors Kämmerer and Steger have identified a serious regulatory issue. They have analysed the available evidence and demanded access to the primary data necessary to verify or refute their conclusions and challenge methods and specifications that are incapable for the modRNA plattform technology.

The experts call upon EMA to:

• Register and process each access-to-documents application individually under Regulation (EC) No 1049/2001.

• Disclose the complete residual-DNA regulatory record for Comirnaty and Spikevax, including the risk assessments, analytical procedures, method validations, batch analyses, raw data and EMA’s own scientific assessments.

• Release the CCI arguments submitted by BioNTech and Moderna, the related correspondence and EMA’s justification for every maintained redaction.

• Enable an independent scientific and regulatory verification of the residual-DNA limits, specifications, analytical methods, manufacturing controls and finished-product safety assessment.

• Reassess whether the conditions for maintaining the marketing authorisations remain fulfilled and implement any necessary regulatory measures, including variation, suspension or revocation under Article 116 of Directive 2001/83/EC and Article 20 of Regulation No 726/2004.

• Convene a dedicated and livestreamed meeting before the competent EMA scientific committees to examine the findings of the Residual DNA OPIR.

The public has the right to verify

As Rachel Carson wrote in Silent Spring:

“The obligation to endure gives us the right to know.”

In light of this principle, the evidence of potential harm from excessive residual DNA submitted by Professors Kämmerer and Steger gives the public the right to know—and to verify independently—whether these products may have caused and still cause harm to human health.