MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds

The UK’s Medicines and Healthcare product Regulatory Agency (MHRA) have authorised an extension to the current approval of the Spikevax vaccine, formerly COVID-19 Vaccine Moderna, that allows its use in individuals aged 12-17 years.

“I am pleased to confirm that that the COVID-19 vaccine made by Moderna has now been authorised in 12-17 year olds. The vaccine is safe and effective in this age group,” said MHRA Chief Executive Dr June Raine. “We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 17-year age group.

“It is for the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group should be vaccinated with the COVID-19 vaccine made by Moderna as part of the deployment programme.”

According to the MHRA, no new side effects were identified and the safety data in children was comparable with that seen in young adults. As in young adults, the majority of adverse events were mild to moderate and relating to reactogenicity, such as a sore arm or tiredness.

The MHRA has stated that this Conditional Marketing Authorisation (CMA) extension granted by the MHRA is valid in Great Britain only. It was approved via the European Commission (EC) Decision Reliance Route, wherein the marketing authorisation application made by the company references the decision made by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP).

Spikevax was previously authorised in children aged 12-17 years in Northern Ireland under the CMA extension granted by the EMA on 23 July 2021 and is already authorised in the UK for adults aged 18 years and over.