BRIEF—Moderna COVID-19 vaccine approved by MHRA in 12-17 year olds

An extension to the current UK approval of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) from US mRNA-based biotech Moderna, that allows its use in 12- to 17-year-olds has today been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA).

This Conditional Marketing Authorization (CMA) extension granted by the MHRA is valid in Great Britain only and was approved via the  European Commission (EC) Decision Reliance Route.

This is when the marketing authorization application made by the company references the decision made by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Spikevax is authorized in children aged 12-17 years in Northern Ireland under the CMA extension granted by the European Medicines Agency on 23 July 2021.

The Spikevax vaccine is already  authorized in adults aged 18 years and over.

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.