FOI release

Freedom of Information request on first batch of COVID-19 vaccine (FOI 22/022)

Published 31 May 2022

FOI 22/022

4th February 2022

Dear

Thank you for your email.

Please find below answers to the questions in raise in blue below.

1- date batch testing started? The first batch of COVID-19 vaccine was certificated on 2nd December 2020.

2- product lines sample tested by manufacturer? All vaccines approved for use in the UK are tested by NIBSC

3- number of batches tested per manufacturer? Each batch available to the UK has been tested and certificated; over 210 batches in total

4- results of sample batch testing? We cannot make available raw data (see below)

5- total number of failed batches? 2 batches did not meet specification for one test for one product – these batches were therefore not certificated.

6- details of reason of vaccine batch failures? Covered in question 5.

7- recall notices or evidence that failed batches were pulled from UK vaccine supply chain? Only certificated batches are used in the UK supply chain.

Any release of the data or details of specific vaccines are subject to Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act.

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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