Freedom of Information request on COVID-19 - Pfizer/BioNTech Vaccine (FOI 20-533)
Published 24 March 2021
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Thank you for your email.
We apologise for any misunderstanding as the previous response sent to you has been replaced by below.
Please see the responses from the MHRA in red below.
Planned date for the completion of animal reproductive toxicity studies
Data are now available from recently completed animal reproductive toxicity testing. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development.
The MHRA’s current assessment of risk to newborns / infants
The MHRA has no data to show that there is any risk to newborns or infant recipients of the vaccine. Animal studies do not indicate direct or indirect harmful effects to newborns or infants.
Administration of the vaccine in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. This decision should be made in consultation with the patient’s doctor.
Information on the clinical studies performed and their results are available in a peer-reviewed journal, the New England Journal of Medicine (NEJM). A link to this is provided below:
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home
As stated in the NEJM paper, additional studies are planned in other patient groups, including pregnant women.
An explanation why temporary authorisation has been granted by M H R A for roll-out of vaccine to the human population if the impact on fertility is unknown and the outcome of animal reproductive toxicity studies is awaited.
The Pfizer/BioNTech COVID-19 vaccine is not expected to affect fertility in humans. Data are now available from recently completed animal reproductive toxicity testing. Animal studies do not indicate direct or indirect harmful effects. Further information is provided in Sections 4.6 and 5.3 of the Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine. This is available online and can be accessed via the following link:
https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 .
The approval for use of the Pfizer/BioNTech COVID-19 vaccine in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution. The decision was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body.
The MHRA has published a Public Assessment Report (PAR), which consists of the non-confidential aspects of The MHRA’s assessment of this vaccine. A link to the MHRA PAR is provided below:
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944544/COVID-19_mRNA_Vaccine_BNT162b2UKPAR_PFIZER_BIONTECH__15Dec2020.pdf
Details on the administration of Pfizer/BioNTech COVID-19 vaccine (COVID-19 mRNA Vaccine BNT162b2), are available in the Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine. This is available online and can be accessed via the following link: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19
The vaccine should only be considered for use in pregnancy when the potential benefits outweigh any potential risks for the mother and baby. Women should discuss the benefits and risks of having the vaccine with their healthcare professional and reach a joint decision based on individual circumstances. Women who are breastfeeding can also be given the vaccine.
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Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000