Summary:
A European regulator has confirmed that BioNTech, a partner of Pfizer, did not specifically highlight a DNA sequence in its COVID-19 vaccine, Comirnaty. The European Medicines Agency (EMA) stated that although the full DNA sequence was provided in the initial marketing authorization application, BioNTech did not highlight the Simian Virus 40 (SV40) sequence. The SV40 sequence has raised concerns, with some experts suggesting it could act as a mutagen. The EMA claims that fragments of the SV40 sequence, if present, are at acceptable levels and broken down during the manufacturing process. However, critics argue that the standards cited by the EMA were not designed for vaccines using modified messenger RNA (mRNA) technology, and concerns persist about the potential integration of SV40 fragments into the DNA genome. Despite conflicting views, the EMA maintains that there is no scientific evidence linking mRNA vaccines to adverse events related to the presence of DNA material.
October 10, 2023