MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization

Novavax announced on Aug. 26, 2022 that the company’s COVID-19 vaccine, Nuvaxovid, was granted expanded conditional marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency. This authorization allows for the use of the vaccine in adolescents aged 12 to 17.

According to a company press release, the authorization is based on data from the Phase III PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the United States. The trial reached its primary effectiveness endpoint and demonstrated 80% clinical effectiveness.

"As we start to prepare for a potential fall surge, we are pleased to offer the first protein-based COVID-19 vaccine to adolescents aged 12 through 17 in the UK," said Stanley C. Erck, president and CEO, Novavax, in the release. "We believe that our vaccine, developed using an innovative approach to traditional technology, may help increase adolescent vaccination rates."

Following this announcement, Nuvaxovid is now approved for use in adolescents in the UK, US, the European Union, India, Australia, Japan, Thailand, and New Zealand. It is currently under review in several other markets.

Source: Novavax