UK Regulator MHRA Approves Moderna COVID-19 Jab for Adolescents

The United Kingdom’s medicine regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds. The decision was announced in an Aug. 17, 2021 press release.

Confirming the vaccine (Spikevax) is safe and effective in adolescents, the conditional marketing authorization extension granted by the MHRA is valid for Great Britain. The approval was made via the European Commission Decision Reliance Route, which is when a marketing authorization application references the decision made by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

“I am pleased to confirm that that the COVID-19 vaccine made by Moderna has now been authorized in 12–17 year olds. The vaccine is safe and effective in this age group,” said June Raine, MHRA chief executive, in the press release. “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 program.”