UK regulator approves Moderna COVID-19 vaccine for 12-17 year olds

The Moderna COVID-19 vaccine has been authorised for people in the UK aged between 12 and 17, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.

The Moderna vaccine is already authorised for people aged 18 years plus and was given the green light for children aged 12-17 years in Northern Ireland in July.

MHRA has said, “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 Joint Committee on Vaccination and Immunisation (JCVI) will now advise on whether those aged between 12 and 17 should be vaccinated with the COVID-19 vaccine made by Moderna as part of the deployment programme.

Both the UK and Welsh governments have to date, followed all the advice from the JVCI.

Moderna is authorised in children aged 12-17 years in Northern Ireland under the CMA extension granted by the European Medicines Agency on 23 July.

Dr June Raine, MHRA Chief Executive said:

“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.”

“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.”