Toxicokinetics

No toxicokinetic studies have been performed with the vaccine. This is consistent with WHO guidelines on the nonclinical evaluation of vaccines (WHO 2005).

Genotoxicity

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).

Carcinogenicity

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).

Reproductive and developmental toxicity

Fertility and early embryonic development and embryofoetal development

In the general toxicity studies, macroscopic and microscopic evaluation of male and female reproductive tissues showed no evidence of toxicity.

A combined fertility and developmental study (including teratogenicity and postnatal investigations) in rats is ongoing.

Prenatal and postnatal development, including maternal function

No such studies have been done.

Studies in which the offspring (juvenile animals) are dosed and/or further evaluated

No such studies have been done.

Local tolerance

No such studies have been done. The assessments made as part of the general toxicity study should suffice and a separate study is not needed.

Other toxicity studies

No such studies have been done.

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