Freedom of Information request on the safety of the COVID-19 booster vaccines (FOI 21/1029)
Published 25 February 2022
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22nd September 2021
FOI 21/1029
Dear
Thank you for your email.
The Covid-19 booster vaccines are identical to those given as 1st and 2nd doses.
In updating the Regulation 174 authorisations for the COVID-19 vaccines made by Pfizer and AstraZeneca in relation to booster doses, the MHRA reviewed published data on immunocompromised patients, data from the manufacturers’ trials, data from the UK COV-Boost and ComFluCOV trials conducted by UK University Hospitals and a summary of published and PHE data regarding waning vaccine effectiveness. These data were also reviewed by the independent Commission on Human Medicines (CHM).
Some of the data the MHRA has needed to rely on have not been generated by the manufacturers but by UK University Hospitals, they are not publicly available yet. The Regulation 174 information for Healthcare Professionals will be updated as soon as the data are published.
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU