The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the use of Moderna's COVID-19 vaccine (now known as Spikevax) in 12- to 17-year-olds.
The extension to the current UK approval of Spikevax was approved via the European Commission (EC) Decision Reliance Route, based on the decision made by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 23 July, which authorised Spikevax in children aged 12-17 years in Northern Ireland.
The Spikevax vaccine is already authorised in adults aged 18 years and over.
Dr June Raine, MHRA chief executive, commented: “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," she added.