FOI release

Freedom of Information request on the product information for the COVID-19 vaccines (FOI 22/523)

Published 21 December 2023

© Crown copyright 2023

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-20-june-2022/freedom-of-information-request-on-the-product-information-for-the-covid-19-vaccines-foi-22523

FOI 22/523

24th June 2022

Dear

Thank you for your email of 5 March 2022 where you requested:

In respect of the Pfizer / BioNTech, AstraZeneca and Moderna inoculations:

  1. Copy of the original “Product Information Sheet” and date of issue.
  2. Copy of the updated “Product Information Sheet” based on MHRA latest analysis of adverse event data; and date of sheet modification.

Please accept our apologise for the delay in responding to you. Only the latest version of the product information for each COVID-19 vaccine is provided on the MHRA website. There is also a list of dates on which each sequential update was made.

Please find attached the requested documents. For (2) we have provided the version as of 19 February 2022.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information.

For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the agency who has not previously been involved in your request. If you wish to pursue that option, please write to the Communications Directorate, Medicines and Healthcare products Regulatory Agency (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The 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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