Policy & Regulation
Novavax receives UK approval over Nuvaxovid COVID-19 vaccine for adolescents
29 August 2022 -

Novavax Inc (Nasdaq: NVAX), a biotechnology company, announced on Friday that it has received expanded conditional marketing authorisation (CMA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the company's Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunisation in adolescents aged 12 through 17.

The product will be the first protein-based vaccine available for adolescents aged 12 through 17 in the UK.

The approval was granted based on data from an ongoing Phase 3 PREVENT-19 trial of 2,247 adolescents assessing the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. The company achieved its primary effectiveness endpoint and showcased 80 percent clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in its pediatric expansion.

The vaccine now requires policy recommendation for use from the UK Joint Committee on Vaccination and Immunisation (JCVI) before becoming available.