FOI release

Freedom of Information request on the original FastQ files that will confirm the batch to batch sequencing of the vaccines. (FOI 22/012)

Published 31 May 2022

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FOI 22/012

4th February 2022

Dear,

Please find our responses to your questions submitted under the FOI Act below:

1.  The original FastQ files that will confirm the batch to batch sequencing of the vaccines. This will be very valuable as it will either highlight batch to batch consistency or demonstrate batch to batch variation.

  1. Batch-to-batch consistency forms part of the quality data (specifically 3.2.P.2, 3.2.P.3, 3.2.P.4 & 3.2.P.5), which would be exempt from disclosure under Section 41 and Section 43 of the FOI Act. This is consistent with the HMA/EMA guidance on the release of information from the MAA dossier, see below link:

https://www.hma.eu/fileadmin/dateien/HMA_joint/02-_HMA_Strategy_Annual_Reports/07-Transparency/2012_03_HMA_EMA_Guidance_20120309_ComPersInfo.pdf

2.         All data for the batches of BNT162b2 tested by the NIBSC prior to authorising the product batches for deployment. Data includes:

  • The testing methods, specifications, and limits

  • The raw test data for every batch tested

  • The test results for every batch tested

  • The compliance certificates for every batch tested

As stated above the raw sequencing FastQ files for each batch of vaccine would be ideal.

  1. The test carried out on batches of the product referred to is a PCR-based method and each batch released to market has met the specifications detailed in the Regulation 174 authorisation.

Release of data, test results and compliance certificates is subject to Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

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

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