FOI release

Freedom of Information request about Pfizer-BioNTech vaccine fatality data (FOI-21-151)

Published 7 May 2021

8th March 2021

Dear

Our Ref: FOI 21/151

Thank you for your recent request for data in relation to COVID-19 vaccines.

You have asked the total number of people who have died within 28 days of receiving the Pfizer vaccine, unfortunately we do not hold this information as we do not collect complete fatality data. The Office of National Statistics may be able to help with this part of your request.

Further to your request for a breakdown by country (England, Scotland, Wales and Northern Ireland), this is provided in Table 1. Please note that this information was extracted based on the postcode provided by the reporter.

Table 1: Suspected Adverse Drug Reaction (ADR) reports concerning the Pfizer/BioNTech COVID-19 vaccine reported via the Yellow Card scheme as of the 21st February 2021.

Country Number of reports

England 23953 Scotland 2173 Wales 1527 Northern Ireland 566 Unknown 1403

Please note totals may differ slightly compared to those included in the published data due to the date in which data was extracted and reports of suspected ADRs are held on a purpose designed pharmacovigilance database. Data held on the database is dynamic and is subject to change over time.

The accuracy of the data relies on the postcode being provided by the reporter on the original Yellow Card. If the postcode is incorrectly provided by a reporter, the Yellow Card will not be included in this analysis.

In addition, you have also asked for clarification of the total number of reactions specified on the published analysis prints. To confirm the numbers of the print, relate to the total unique reports received and the number of reactions reported within these reports. A report can contain more than one reported reaction. Thus, the current published print for the Pfizer/BioNTech vaccine specifies a total of 29715 reports containing 85179 reactions.

I would like to reassure you that the MHRA keeps the safety of all medicines and vaccines, under close and continual review. Any emerging evidence relating to possible risks associated with medicines or vaccines would be carefully reviewed and, if appropriate, regulatory action would be taken, and communicated to healthcare professionals and patients alike. I hope the information provided is helpful, but 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 of this response; and can be addressed to this email address. Yours sincerely,

FOI Team Vigilance and Risk Management of Medicines Division