Freedom of Information request on the regulatory approval of the COVID-19 Pfizer vaccine (FOI 22/593)
Published 14 June 2022
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FOI 22/593
7th April 2022
Dear
Thank you for your email.
This information is in the public domain.
The EMA PAR states “As per guidance, no genotoxicity nor carcinogenicity studies were performed. The components of the vaccine (lipids and mRNA) are not expected to have genotoxic potential. This is acceptable to the CHMP.”
Further, MHRA’s UK PAR states:
“Carcinogenicity studies with BNT162b2 have not been conducted as the components of all vaccine constructs are lipids and RNA that are not expected to have carcinogenic or tumorigenic potential. Carcinogenicity testing is generally not considered necessary to support the development and licensure of vaccine products for infectious diseases (WHO, 2005).”
“No genotoxicity studies are planned for BNT162b2, as the components of all vaccine constructs are lipids and RNA that are not expected to have genotoxic potential (WHO, 2005).”
We would suggest that you consult the WHO 2005 Guidelines on the Non-Clinical Evaluation of Vaccines:
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