FOI release

Freedom of information request on updating the Regulation 174 authorisations for the COVID-19 vaccines made by Pfizer and AstraZeneca in relation to booster doses (FOI 21/1157)

Published 26 May 2022

FOI 21/1157

1st November 2021

Dear,

Thank you for your email.

In updating the Regulation 174 authorisations for the COVID-19 vaccines made by Pfizer and AstraZeneca in relation to booster doses, 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 Public Health England (PHE) data regarding waning vaccine effectiveness. These data were reviewed by the independent Commission on Human Medicines (CHM). These data are not published yet, however, MHRA is currently updating the relevant Public Assessment Reports with these changes to the Regulation 174 authorisations. Unfortunately, due to this the information is exempt from release under section 22:

Section 22 – Information intended for future publication: the information you have requested is due to be published. Section 22 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information.

If you have a query about the information provided, please reply to this email

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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