Freedom of Information request on reproductive toxicity from Cominarty vaccine (FOI 21/804)
Published 29 December 2021
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22nd July 2021 FOI 21/804
Dear
Thank you for your email.
Please see below answers to the questions you have raised.
- Please provide the conclusive report for the animal reproductive toxicity studies for mRNA BNT162b2 demonstrating its safety for use in pregnant women and women of child bearing age.
Data from the animal toxicity study to show the effects of the Pfizer vaccine on fertility and prenatal and postnatal offspring development in rats has been published. A link to the abstract of this article is provided below:
https://pubmed.ncbi.nlm.nih.gov/34058573/
An assessment of the data was made by the European Medicines Agency (EMA) and is available in the Public Assessment Report (PAR) published by the EMA. A link to this is provided below:
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
- Any information demonstrating that mRNA BNT162b2 is not excreted in human breast milk.
The SmPC for Cormirnaty is provided below:
https://mhraproducts4853.blob.core.windows.net/docs/f38c6e4938a325d1a0794bb8bac22932019d240a
The SmPC states in Section 4.6 that “It is unknown whether Comirnaty is excreted in human milk.
- Any information regarding mRNA BNT162b2 impact on fertility.
The SmPC for Cormirnaty states in Section 4.6 that “Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.” Section 5.3 of the SmPC provides additional information on the data submitted. Please see our response to Q1 for further information.
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Yours sincerely
MHRA Customer Service Centre