FOI release

Freedom of Information request (FOI 22/1056)

Published 17 January 2024

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22nd November 2022

FOI 22/1056

Dear

Many thanks for your request 22/1056 under FOIA.

  1. Could you please confirm if you are considering the Moderna Covid-19 vaccine to be included in the child immunisation schedule for babies from the age of 6months as early as Christmas 2022?

  2. In terms of immunisation schedules, these are drawn up by the Joint Committee on Vaccines and Immunisations (JCVI) and are published on the UK-HSA website, there are also useful COVID specific resources that you can refer to. To be clear, a decision on the regulatory approval of a vaccine is within the remit of the MHRA, whereas the JCVI provides the advice to the Government on whether a vaccine should be used / included in the immunisation schedule.

  3. What risk/benefit assessment has been carried out?

  4. We have received an application from the Marketing Authorisation Holder to extend the use of the Moderna COVID-19 vaccine (Spikevax) to children aged 6 months to 5 years. Spikevax is authorised in the European Union for use in people from the age of 6 months. The application uses the European Commission Decision Reliance Procedure (ECDRP) which allows the MHRA to take account of the EC decision. We will conduct our own benefit-risk evaluation and publish our decision in due course

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Yours sincerely

MHRA Customer Experience Centre

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