Reference:
Oldfield, P. R., & Gutschi, M. L. (2022). Fundamental flaws in Pfizer’s COVID-19 biologics license application submission, and the implications to the safety and effectiveness of these novel gene therapy vaccines. Canadian COVID Care Alliance. Retrieved from https://www.canadiancovidcarealliance.org/
Summary:
The article critiques Pfizer’s COVID-19 vaccine approval process, highlighting significant flaws in the Biologics License Application (BLA) submission. It argues that the mRNA vaccines employ gene therapy technology, which lacks essential studies to assess safety and effectiveness. Key issues include inadequate toxicology studies, inappropriate species used for testing, and a failure to determine the pharmacokinetics of the spike protein produced. The authors assert that Health Canada’s regulatory review compromised public safety due to reliance on unsuitable guidance documents. Moreover, they claim that the definition of vaccines was altered to fit the mRNA products, which do not reliably induce immunity. The article concludes that the long-term safety of these vaccines remains uncertain and calls for increased transparency from Health Canada regarding the risks associated with the mRNA COVID-19 vaccines.