FOI release

Freedom of Information request on the number of batches of the Moderna and Janssen vaccines were authorised under Regulation 174 and the conditions for authorisation ( FOI 21/1187)

Published 26 May 2022

FOI 21/1187

11th November 2021

Dear,

Thank you for your email.

Please find below our responses to your questions

  1. No batches of the Moderna and Janssen vaccines were authorised under Regulation 174, as these were granted marketing authorisations following a European Commission (EC) decision. Information concerning this has been sent in response to a previous request.
  2. Conditions for Authorisation linked below are updated as needed on a regular basis:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/conditions-of-authorisation-for-pfizerbiontech-covid-19-vaccine

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/conditions-of-authorisation-for-covid-19-vaccine-astrazeneca

  1. Please see answer to question 2.
  2. Additional batches that have been used in the UK through the marketing authorisations that have been granted for the Pfizer and AstraZeneca vaccines do not need to be listed in the Conditions of Authorisation, which refers to batches authorised for use under Regulation 174.
  3. Please see answers above.

Kind regards,

MHRA Customer Service Centre