U.K. Government admits Pfizer covid vaccine is UNSAFE for pregnant and breastfeeding women
Toxicity conclusions
The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need. In principle, a decision on licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals, but there are studies ongoing and these will be provided when available. In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated. These judgements reflect the absence of data at the present time and do not reflect a specific finding of concern. Adequate advice with regard to women of childbearing potential, pregnant women and breastfeeding women has been provided in both the Information for UK Healthcare Professionals and the Information for UK recipients.
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).
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.
https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine