Summary of the Public Assessment Report for COVID-19 Vaccine Pfizer/BioNTech

29/08/2022

GOV.UK, updated 16 Aug 2022 

Lay summary, COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection (BNT162b2 RNA)

This is a summary of the Public Assessment Report (PAR) for COVID-19 mRNA Vaccine BNT162b2. It explains how this product was assessed and authorised under Regulation 174 of the Human Medicine Regulations, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.

The product will be referred to as BNT162b2 in this lay summary for ease of reading.

For practical information about using BNT162b2 patients should read the Information for UK recipients or contact their doctor or healthcare practitioner.

(highlighted for attention on Toxicity conclusions)

3.4 Toxicology

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.

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.