FOI release
Request for information - Ref: FOI2025/00874
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2025/01031
Received 22 September 2025
Published 5 November 2025
Request
I am submitting this Freedom of Information (FOI) request to seek updates on safety assessments of the SV40 promoter in mRNA vaccines, particularly related to the Pfizer/BioNTech COVID-19 vaccine. I refer to previous FOI responses, specifically FOI 24/212, which confirmed that the SV40 promoter is inactive and within safety limits (<10 ng/dose), and FOI 24/115, which provided pharmacovigilance inspection reports for the period 1 December 2022 to 1 February 2024. I also note the study by Igyártó and Qin (2024), which supports the safety of SV40 promoter residuals in. In light of your advice, I am refining my original request to make it more specific and manageable while continuing to address the significant public interest in transparency regarding the safety of mRNA vaccines, particularly concerning the SV40 promoter and its potential health impacts. Below is the refined request: Safety Assessments and Reports Related to SV40 Promoter in Comirnaty: The MHRA assessment report and documentation submitted with the variation (PLGB 53632/0002-0273) related to the sequence elements in the plasmid DNA used in the Comirnaty drug substance manufacturing, as referenced in your response. Any additional safety assessments, reports, or documents produced or received by the MHRA since FOI 24/212 (up to 16 August 2025) that specifically address the presence of the SV40 promoter in DNA residuals of the Comirnaty vaccine, with a focus on potential health impacts such as cancer risk or gene expression. If no such documents exist, please confirm this. Monitoring and Testing Protocols for DNA Residuals: Documents outlining the monitoring and testing protocols (e.g., using qPCR or similar methods) for DNA residuals, specifically the SV40 promoter, in the Comirnaty vaccine, covering the period from 1 January 2024 to 16 August 2025. If these protocols are part of the documentation for the variation (PLGB 53632/0002-0273), please include them or indicate where they can be found. Update on Pharmacovigilance Inspection Report (FOI 24/115): Confirmation of the current status of the pending pharmacovigilance inspection report withheld under FOIA Section 30 in FOI 24/115. If the report is still unavailable, please provide an estimated timeline for its release. I understand that some information may be subject to exemptions under FOIA, such as Section 40 (personal data) or Section 43 (commercial interests). However, I kindly request the fullest possible disclosure, as public concerns about the SV40 promoter and its perceived risks are significant for maintaining trust in vaccine safety. If any information cannot be released, please provide specific reasons and, where applicable, an estimated timeline for availability.
Response
See attached
Documents
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