The MHRA has confirmed the Moderna vaccine is safe and effective in people aged 12–17 years
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised an extension to the current UK approval of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) that allows its use in young people aged 12–17 years.
On review, the MHRA identified no new side effects 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.
Spikevax is also authorised in children aged 12–17 years in Northern Ireland under the conditional marketing authorisation extension granted by the European Medicines Agency on 23 July 2021.
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 12–17-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.’
The Spikevax vaccine is already authorised for use in adults aged 18 years and over.