Freedom of Information request on the COVID-19 vaccines and pregnancy (FOI 21/827)
Published 20 January 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-23-august-2021/freedom-of-information-request-on-the-covid-19-vaccines-and-pregnancy-foi-21827
25th August 2021
FOI 21/827
Dear
Our apologies for the delay in our response.
The MHRA’s rigorous safety monitoring of COVID-19 vaccines in pregnancy shows that the vaccines are safe and there is no increased risk of miscarriage or stillbirth. There is no available evidence to suggest that COVID-19 vaccines will affect the unborn baby. We publish a weekly summary of Yellow Card reports we have received this includes a section on pregnancy and miscarriage which you may wish to read
Women who were known to be pregnant were excluded from the clinical trials for the PfizerBioNTech vaccine. Nevertheless, 23 participants in clinical trials of the Pfizer-BioNTech vaccine reported exposure during pregnancy.
With regards to the administration of the authorised vaccines to women of childbearing potential, Section 4.6 of the Summary of Product Characteristics/Information for Healthcare Professionals for each of the approved vaccines states 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.
With regards to the administration of the authorised vaccines to pregnant women, Section 4.6 of the Summary of Product Characteristics/Information for Healthcare Professionals for each of the approved vaccines states that “Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3).”
In reference to your third question, the MHRA do not hold any information and we would suggest you contact the Office for National Statistics who hold full data on death they can be contacted at info@ons.gov.uk.
Public Health England gave the following press release regarding vaccination in pregnancy which can be found below. Should you have any query’s on this press release, please contact enquiries@phe.gov.uk
https://www.gov.uk/government/news/jcvi-issues-new-advice-on-covid-19-vaccination-for-pregnant-women
In addition, Public Health England has recently released data showing that 51,724 pregnant women in England have received at least one dose of COVID-19 vaccine. Data from the United States, where more than 130,000 pregnant women have had a COVID-19 vaccine (using Pfizer BioNTech or Moderna vaccines), has also not raised any safety concerns.
If you have a query about the information provided, please reply to this email.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre