Pharmaceutical giant Pfizer is facing the threat of multiple major lawsuits after it failed to disclose information about a DNA sequence used in the Pfizer-BioNTech COVID-19 vaccine to regulators.
Testing by independent researchers at Health Canada earlier this year identified the presence of Simian Virus 40 (SV40) – used to enhance gene transcription during the vaccine manufacturing process – despite Pfizer failing to highlight its inclusion – a fact confirmed by both Canadian and European regulators. The United States Food and Drug Association refused to disclose whether it knew about the DNA sequence, however.
There is considerable disagreement on whether the DNA sequence is harmful to humans, with some scientists arguing it may have caused a number of adverse effects, including some cancers, whereas others suggest its inclusion is harmless.
The COVID-19 vaccinations fall under the protection of the Public Readiness and Emergency Preparedness Act (PERP), which protects vaccine manufacturers for the most part from legal liability.
However, pharmaceutical companies can be sued for “wilful misconduct,” which incorporates acts “intentionally to achieve a wrongful purpose,” providing some legal ground from which a lawsuit may be filed.
“I think what we have here is willful misconduct,” argues Mat Staver, chairman of Liberty Counsel, which has already been involved in multiple lawsuits over coronavirus vaccines. “I can’t imagine that the FDA knew about this. There’s nothing in the FDA documents that would that I am aware of yet where they knew about this contaminant.”
