FOI release

FOI Serum Institute

Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.

Case reference FOI2025/00270

Received 20 March 2025

Published 6 July 2025

Request

This is a Freedom of Information request regarding the delivery of Covid vaccines from the Serum Institute, Pune , India, to the UK. Three batches of the Oxford/Astra Zeneca vaccine, batch numbers 4120Z001/002/003 were manufactured in India in October 2020, prior to authorisation. They were subsequently supplied to different countries under the brand name Covishield. On March 5th 2021 4.5. millions doses were delivered by air to the UK and deployed within a week. Prior to that, the MHRA had expressed concerns about aspects of manufacturing at the Serum Institute; as a consequence the SII provided " a robust corrective action plan" according to Dame June Raine's evidence to the Hallett Inquiry. Dame June also told the inquiry that inspectors had been sent to India. My questions are as follows: 1 Exactly when were these inspectors sent to the SII? 2 How was MHRA convinced by SII's action plan? 3 Given that the three aforementioned batches were manufactured in October 2020 and were nearing their expiry dates, how could the action plan be applied, retrospectively, to them? 4 How and where were these batches tested for efficacy and safety? 5 What were the contents of a letter to Dame June from Professor Van Tam and Antonia Williams mentioned at the inquiry (INQ000400201) which have not yet been made public, even though this is a public inquiry?

Response

see attached

Documents

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