Novavax Obtains U.K. Regulatory Clearance For Nuvaxovid In Adolescents Aged 12-17 Years

The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) has granted expanded conditional marketing authorization (CMA) for Novavax’s NVAX lead asset Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.

The expanded authorisation was support by the clinical data from the ongoing Phase 3 PREVENT-19 trial with 2,247 adolescents subjects aged between 12 and 17 years across 73 sites in the United States to evaluate the safety, effectiveness and efficacy of Nuvaxovid.

The lead drug, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the United States.

Initial safety data from the pediatric expansion showed the vaccine to be generally well-tolerated.

Stanley C. Erck, President and Chief Executive Officer, said, ”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 U.K. We believe that our vaccine, developed using an innovative approach to traditional technology, may help increase adolescent vaccination rates.”

The U.K. regulatory authorities previously granted conditional marketing authorization (CMA) for Nuvaxovid in adults aged 18 and older in month of February 2022. The vaccine is given as a primary vaccination in two doses administered 21 days apart.

Price Action : Novavax shares are trading around 5 percent down at $35.45 on Friday at the time of publication.