FOI release

Freedom of Information request on a follow-up question to FOI 22/465 in relation to batch testing of COVID-19 vaccines (FOI 22/554)

Published 1 June 2022

FOI 22/554

24th March 2022

Dear

Thank you for your information request, dated 13th March 2022, where you asked a follow-up question to FOI 22/465 in relation to batch testing of COVID-19 vaccines:

How many batches have been rejected?

How many times has a manufacturer been notified of a failed batch?

I am pleased to provide you with the information requested.

We have obtained out of specification results for an individual test for two batches of a vaccine. The relevant manufacturer was notified on each occasion. In each case, the manufacturer withdrew their request for release of the batch and it was not necessary for NIBSC to formally reject the batch.

I hope this answers your question.

Yours sincerely

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000