MHRA approves the Moderna COVID-19 vaccine ‘Spikevax’ for use in 6 to 11-year olds

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an update to the current UK approval of the Moderna COVID-19 Vaccine, or ‘Spikevax’, that allows its use in Great Britain (GB) in 6 to 11 year-olds.

This approval takes into account the extension to use in children aged 6 to 11 years already approved by the European Medicines Agency on 2 March 2022, as the original GB licence for Spikevax in adults was approved by relying on the EU decision.

Spikevax is authorised in children aged 6 to 11 in Northern Ireland under the update granted by the European Medicines Agency on 2 March.

Dr June Raine, MHRA Chief Executive, said: “I am pleased to confirm that that the COVID-19 vaccine made by Moderna, ‘Spikevax’, has now been authorised in Great Britain in 6 to 11 year olds. The vaccine is safe and effective in this age group.

“We have in place a comprehensive surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance includes those aged 6 to 11.

“It is for the Joint Committee on Vaccination and Immunisation (JCVI) to advise in due course on whether 6 to 11s should be offered vaccination with the COVID-19 vaccine made by Moderna as part of the deployment programme.”

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