Why the Secrecy? The Dark Side of Regulatory Authorities Revealed by Pfizer Document Redactions from the European Medicines Agency (EMA)

The European Medicines Agency (EMA) had repeatedly promised "exceptional transparency." However, looking at the technical documents for Pfizer/BioNTech's Comirnaty (mRNA vaccine) re-disclosed in December 2025, the actual measured values of residual DNA, detailed qPCR data, and batch-to-batch variations—the critical figures directly linked to safety—remained entirely redacted.
Using commercial confidentiality as a shield to make independent verification impossible cannot be explained by mere caution. Is the EMA disregarding the public's right to know and their health, while being overly deferential to the interests of pharmaceutical companies?
As experts like Kevin McKernan point out, "If there is nothing to hide, why redact it?" This opaque stance clearly demonstrates that regulatory agencies are on the side of the manufacturers, not the public.
Dr. Silvia Behrendt (former WHO legal officer and transparency activist), in an article published on Substack on December 14, strongly criticized the fact that while the EMA partially re-disclosed the Common Technical Document (CTD, detailed technical documents for regulatory submission) for Pfizer/BioNTech's Comirnaty, it was provided not only with key parts redacted as Commercially Confidential Information (CCI), but also in a format that is difficult for the public to access.
https://drsilviabehrendt751446.substack.com/p/update-dec-25-ctd-comirnaty-new-disclosures
Dr. Behrendt argues that although the EMA promised "exceptional transparency," it has infringed upon the rights of over 2,100 EU citizens who participated in the EMA Transparency Initiative (ETI) and filed information disclosure requests by making the documents difficult to obtain in ZIP file format and providing them only to individual requesters. She exclusively published the individually shared documents on Substack.
The new/updated documents include the Process Validation and the Residual DNA Characterization Report.
▲ Issues with the newly released documents
1. Contradictions regarding the importance of plasmid DNA
The documents state that plasmid DNA is essential for mRNA production, which contradicts past claims. Moreover, some details are hidden by redactions.https://x.com/Kevin_McKernan/status/2000619799039086641?s=20

2. Specific measured values of residual DNA are all redacted
In the "Comirnaty Residual DNA Characterization Report," numerical data in the table of residual DNA levels in commercial batches (ng DNA/mg RNA) (e.g., the section showing Min/Max/Mean values per batch) is entirely redacted.
https://www.ghr.agency/wp-content/uploads/2025/08/comirnaty-residual-dna-characterization-report_en.pdf
Also, in Table 7 (PCR Primer Design) related to SV40 sequence detection, the details of the primer sequences are redacted as CCI.

Only the mention of "≤330 ng/dose" as a release criterion is partially visible, but the actual batch data is concealed.
Kevin McKernan shared this redacted table from the report and criticized it as "Confidential DNA levels."

https://x.com/Kevin_McKernan/status/2000620368910856625?s=20
https://x.com/Kevin_McKernan/status/2000621818386788605?s=20https://x.com/Kevin_McKernan/status/2000620368910856625?s=20

3. Details of measurement methods (Ct values, calculation formulas) are also redacted
In Table 8 of the same report (Detection results for SV40 sequence elements), the Mean Ct Value (cycle threshold) from qPCR measurements is redacted for each batch, and the conversion method from Ct value to ng amount and the estimation formula ("Estimation of SV40 Sequence Element Content in Residual DNA" section) are also entirely redacted.
Furthermore, the document states that DNase treatment ("purification" treatment) is performed before residual DNA measurement, which Kevin McKernan points out as "a trick to intentionally make the residual amount appear low."
Kevin McKernan shared this section and stated directly, "Why redact this unless you have something to hide?" strongly criticizing it by saying, "If there is no need to hide it, why redact this? It can only be because there is something they want to hide."

▲ Overall issues with redactions
Under EU regulation (Regulation (EC) No. 1049/2001), full disclosure is possible by overriding commercial confidentiality claims if there is an overriding public interest.
The public interest should clearly take precedence regarding vaccine quality and safety data (especially related to potential risks like residual DNA), yet the EMA/Pfizer stubbornly maintain the redactions. When specific figures and methods are hidden, third-party scientists cannot verify the data, leaving them with no choice but to blindly trust the regulatory authority's judgment. While promising transparency, the EMA keeps important batch data and measurement details private.
As a result, the actual levels and variations of residual DNA become unclear, undermining the reliability of safety assessments.
In short, this series of disclosures is being criticized not as "progress in transparency," but as an inadequate response that keeps the essential parts hidden. The frequent use of redactions further shakes the credibility of the regulatory process and effectively hinders checks by independent scientists.
▲ The misunderstanding that "Pfizer finally admitted to SV40 contamination"
On X, posts claiming "Pfizer finally admitted to SV40 contamination" can be seen, but this is not a fact. Pfizer has officially acknowledged since around 2023 that it uses non-infectious SV40 promoter (enhancer) fragments as starting material for manufacturing plasmid DNA, and the EMA disclosure documents also state that it is "as expected" for SV40 sequence elements to be detected in residual DNA in commercial batches.
● Pfizer's official comment
"The starting materials used by Pfizer and BioNTech contain non-infectious fragments of the SV40 sequence. This DNA starting material does not contain oncogenes, which are genes that have the potential to cause cancer. Many vaccines contain trace amounts of DNA (residual DNA), and regulatory authorities have set standard values for this. The amount of residual DNA in the Pfizer-BioNTech COVID-19 vaccine is within the range permitted by standard regulatory guidelines, as is required for all vaccines."
https://www.pfizer.com/about/responsibility/misinformation
● Original text of the newly released document:
"All DS batches were confirmed positive for SV40 sequence elements, as expected based on the understanding of the residual DNA composition."
(All drug substance batches were confirmed positive for SV40 sequence elements, as expected based on the understanding of the residual DNA composition.)
https://www.ghr.agency/wp-content/uploads/2025/08/comirnaty-residual-dna-characterization-report_en.pdf
That said, the reality is that we do not know if the vaccines are truly safe as they claim, and it is a natural right to demand information from the manufacturers and regulatory authorities.
The essence of the problem is not whether Pfizer admitted to the presence of SV40, but that in the documents released by the EMA, the specific measured values of residual DNA (ng/dose), qPCR Ct values, calculation methods, and batch-by-batch data are all redacted as Commercially Confidential Information (CCI). If it is a safe amount with no issues, why is there a need to hide it? Under EU law, redactions should be lifted when the public interest takes precedence, yet the EMA prioritizes the manufacturer's claims and makes independent verification impossible. This is nothing less than proof that regulatory agencies are not delivering the truth to the public and are being overly deferential to the interests of pharmaceutical companies. This lack of transparency also creates a breeding ground for misinformation and excessive reactions.
▲ The essence of the problem
Even though the presence of SV40 sequences is clearly stated as "as expected" in the newly released documents, the specific amounts (ng/dose), qPCR Ct values, conversion methods from Ct to amount, and batch-by-batch data are all redacted. Even though Pfizer admits the presence of SV40 is "as expected," why hide the essential measured values and methods as commercial secrets?
▲ Initial non-disclosure (insufficient emphasis on SV40 promoter)
As pointed out by Health Canada and the EMA, Pfizer provided the full sequence of the plasmid in its initial application but "did not particularly emphasize" the SV40 promoter.
Pfizer did not sufficiently disclose the use of the SV40 promoter at the beginning and provided follow-up explanations only in response to questions from regulatory authorities. This is a dishonest response that downplayed potential risks.
▲ Potential for risk
The SV40 promoter does not encode an oncogene (T-antigen), but there is literature on nuclear localization promotion and P53 binding, which is a concern in the context of residual DNA. "Even if it is by design, it is irresponsible for regulations to fail to fully evaluate the possibility of residual SV40 promoter entering the cell nucleus via LNP and to neglect genotoxicity testing. They do not prioritize the public interest and are deferential to the manufacturer.
▲ Collusive relationship between regulatory agencies (EMA/FDA) and manufacturers
Although redactions could be lifted if there is an "overriding public interest" under EU law, the EMA stubbornly maintains them. While promising transparency, the EMA is concealing important data. It is protecting manufacturers and infringing on the public's right to know.
Looking at this series of document disclosures (EMA's Comirnaty CTD-related materials revealed on Dr. Silvia Behrendt's Substack), one must say there is a serious problem with the stance of the regulatory agency.
The data in the redacted sections is directly linked to vaccine quality control and potential risk assessment, and is extremely important information related to public health. Nevertheless, the EMA does not disclose these and appears to prioritize the commercial interests of Pfizer/BioNTech. Under EU transparency regulations (Regulation 1049/2001), full disclosure is possible and even mandated when there is a clear "overriding public interest," overriding claims of commercial confidentiality.
In conclusion, the EMA's frequent use of redactions strongly suggests that regulatory agencies are putting the public's right to know and safety second, and prioritizing the interests of pharmaceutical companies. "Redacting means there is something they want to hide." If there is nothing to hide, it should be disclosed, and even if there is something they want to hide, it should be disclosed. As long as this lack of transparency continues, trust in the regulatory process will not be restored, and contrary to the authorities' propaganda, the safety of COVID-19 mRNA vaccines will not be proven.