EMA Transparency Initiative Scandal: EMA Tests No DNA in the Final Product While Violating Fundamental EU Citizens’ Rights

Emer Cooke confirmed that the final mRNA vaccines were never tested for residual DNA by EMA and refuses to initiate the standard procedure for EU citizens demanding transparency since months

The EMA Transparency Initiative (ETI) — a citizen‑led request under Regulation (EC) No. 1049/2001 for unredacted CTD records on the mRNA vaccines — was launched to rebuild trust in medicines safety by opening the regulatory basis of the marketing authorisations to independent scrutiny and to assess the available evidence on safety concerns related to mRNA vaccine technology, as reported earlier.

Photo by Alex on Unsplash

It has since become a major transparency and medicines‑safety scandal: EMA sidestepped legal access‑to‑documents guarantees and, in a follow‑up letter by Emer Cooke, Executive Director of the EMA, on 3rd September 2025, EMA/286067/2025, to Dr. Silvia Behrendt, Director of the Global Health Responsibility Agency (GHRA), disclosed that it assesses residual DNA at the active‑substance stage rather than in the finished, ready‑to‑inject product where the legal limit applies.

GHRA responded to Ms Cooke’s letter on 4th of October 2025, highlighting the legal and scientific errors of the EMA. A summary of the reply, key facts, and guidance for participants is provided below.

2,100 Citizens’ Push for Regulatory Transparency

Since February 2025, more than 2,100 citizens — from across the EU — and groups like the GHRA, NORTH Group, Slovenian Lawyers, MWGFD, EICHE, and others have joined the EMA Transparency Initiative (ETI) to obtain unredacted access to the Common Technical Dossiers (CTDs) for Comirnaty and Spikevax under Regulation (EC) No. 1049/2001. They invoked overriding public interest, arguing that unresolved safety questions require open scrutiny.

The request includes disclosure of finished‑product DNA assays, the validation protocols, and batch‑level results, as well as other validation materials and regulatory thresholds, to enable independent experts to reconstruct how purity and safety were concluded — not from summary claims, but from the underlying specifics.

To date, EMA has left these requests unanswered, thereby violating each EU citizen’s right to individual access to EU documents under Regulation (EC) No. 1049/2001. Instead, EMA’s portrayed itself as “exceptionally transparent” by re‑posting old, heavily redacted releases on the product websites for Comirnaty and Spikevax — and, according to the EMA’s letter, it considers the 2,100 access‑to‑documents requests adequately processed.

Under EU case‑law, disclosures made pursuant to Regulation (EC) No. 1049/2001 are, by default, public. Yet EMA maintains no public register of requests and releases. It cannot credibly claim to be “exceptionally transparent” when, months later and only after pressure from 2,100 requesters, it merely republishes selected documents on the product webpages of Comirnaty and Spikevax. Moreover, those re‑releases are provided only as compressed ZIP archives that cannot be previewed online and offer no version history or update tracking, requiring local downloads and unpacking. The effect is predictable: access is cumbersome and analysis impractical. Therefore, these re-releases have been posted at this Substack to guarantee an easy and user friendly access to the public at large - see update Comirnaty here and Spikevax here (no updates yet).

Residual DNA Scandal

A central trigger for the ETI was concern over residual DNA contamination in mRNA COVID‑19 vaccines, following independent tests by groups in Europe and North America on finished vials that reported DNA levels above the 10‑ng/dose threshold using orthogonal methods (qPCR, ddPCR, sequencing), including detections of residual plasmid DNA exceeding accepted per‑dose limits. The latest evidence is the peer‑reviewed study in Autoimmunity (Speicher, Rose & McKernan, 6 Sept 2025) which quantified residual plasmid DNA and SV40 promoter/enhancer sequences across 32 vials from 16 lots in Ontario, Canada, finding totals roughly 371–1,548 ng/dose (Pfizer) and 1,130–6,280 ng/dose (Moderna), with SV40 sequences detected only in Pfizer vials.

EMA’s Executive Director, Emer Cooke, responded to GHRA with statements that are, frankly, scandalous:

Read this original excerpt from Cooke’s letter: ”In this connection, we would like to underscore that, to date, EMA has not seen any reliable scientific evidence of DNA exceeding approved levels for either of the concerned COVID-19 vaccines. EMA is aware that some researchers have claimed that levels of residual DNA in mRNA COVID-19 vaccines exceed approved levels. It is our understanding that these claims are however based on results from unvalidated tests. As DNA is only used during the manufacture of the active substance, it is important to test the active substance itself. Some researchers have instead tested the final product (which includes excipients) and have obtained incorrect results because of interference from excipients.” (emphasis added)

EMA’s stated position, in brief: “No reliable scientific evidence” and “unvalidated tests” — even as independent laboratories worldwide have reported residual plasmid DNA in finished vials. Taken at face value, this stance signals an unwillingness to engage with potential harms in line with scientific integrity and the precautionary principle.

What this means in practice: EMA confirms it measures residual DNA at the active‑substance stage and alleges that testing the final product is distorted by excipients. Yet by international standards (WHO TRS 978; European Pharmacopoeia) the per‑dose limit applies to the final medicinal product. Legally and scientifically, compliance must be demonstrated in the finished vial, not inferred from intermediates. EMA classifies the mRNA as the active substance and LNPs as excipients; residual plasmid DNA is a process/product‑related impurity. That EMA’s position departs from WHO and Pharmacopoeia standards is, in itself, scandalous.

Scientific Harms Beyond Residual DNA

Residual plasmid DNA is only one of several potential hazards discussed in the scientific literature on mRNA–LNP platforms. Others include double‑stranded RNA (dsRNA) contaminants that can engage innate immune sensors (e.g., TLR3, RIG‑I/MDA5) and amplify reactogenicity; lipid‑nanoparticle (LNP) biodistribution and organ tropism, with hepatic/splenic uptake and transfection outside the injection site; truncated or fragmented RNA species and process‑related impurities that may alter translation products; dose‑ or time‑dependent overexpression of the encoded antigen; PEG‑related and complement‑mediated hypersensitivity (CARPA); interactions with pre‑existing autoimmunity; and lot‑to‑lot variability in critical quality attributes (CQAs).

These hypotheses should be resolved by transparent, orthogonally validated analytics applied to the finished medicinal product — for example, quantitative dsRNA assays (e.g., RP‑HPLC/UPLC with nuclease digestion), RNA integrity/sequencing and length profiling, bioassays for protein expression, LNP composition and size distribution (DLS/EM), and full batch‑level release data. Whatever the eventual conclusions, the principle remains: medicines safety depends on finished‑product testing, method validation open to scrutiny, and unredacted regulatory dossiers that enable independent replication.

Overriding Public Interest Means Unredacted Documents

EU access‑to‑documents law (Regulation (EC) No. 1049/2001) is explicit: when public health is at stake, overriding public interest outweighs commercial confidentiality. That standard implies unredacted methods and results and a traceable administrative record (acknowledgement, case/ASK number, Eudralink disclosure, and a reasoned decision open to appeal). Recycling heavily redacted PDFs does not meet that bar — it advertises transparency while withholding substance.

From a medicines‑safety standpoint, Europe’s trust in the EMA — and in every EU marketing authorisation — will be rebuilt only if the evidence behind them can be independently verified end‑to‑end. After Covid, confidence returns through three non‑negotiables: unredacted records; transparent finished‑product DNA methods with published validation; and reasoned, auditable decisions.

If the public is denied independent verification of the regulatory evidence for these novel mRNA COVID‑19 vaccines, confidence in EMA’s medicines‑safety oversight cannot be sustained. Absent such verification, safety assurances ring hollow — and public trust, already thinned since the pandemic, will continue to erode.

Call to Participants or New Ones

Write to EMA using the online form here or use this eMail address: <AskEMAATD@ema.europa.eu>.

1) Ask EMA to immediately initiate the procedure under Regulation 1049/2001 (refer to your ASK-number if possible).

2) Invoke an overriding public interest based on publicly available evidence of potential mechanisms of harm associated with mRNA technology.

3) Request documents: the Common Technical Document for Comirnaty and Spikevax, particularly Modules 2 and 3; and, with reference to EMA/286067/2025, all records showing that DNA was assessed at the active‑substance (drug‑substance) stage rather than in the finished product; documents on any control strategy based solely on drug‑substance testing (clearance studies, bridging justifications, and calculations that demonstrate per‑dose compliance in the finished product); documents on the standard extraction/quantification workflows to address “excipients interference”; and the batch‑level results.

4.) If you are a new participant with no prior request pending, please keep the ETI informed by forwarding EMA’s acknowledgement or response to this email: askEMA@NORTHgroup.info. This helps us stay in touch with all ETI participants and share the latest updates.

End: This is the first EU‑wide citizen initiative on drug safety to compel the EMA to open the regulatory dossiers for the two most improtant COVID‑19 vaccines Comirnaty and Spikevax. The EMA is bound to apply the precautionary principle and to act with demonstrable independence. Instead, the record so far reveals an authority unable—or unwilling—to meet its legal duties versus 2.100 EU citizens, refusing to engage with independent research, while pharmaceutical interests remain conspicuously protected. This story is still unfolding.