Novavax, Inc. (Nasdaq: NVAX), a US-based biotechnology company, developing and commercialising next-generation vaccines for serious infectious diseases, announced on Wednesday that Health Canada has approved a supplement to a New Drug Submission (sNDS) for Nuvaxovid (COVID-19 Vaccine (Recombinant protein, Adjuvanted)) (NVX-CoV2373) for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series of two doses in adolescents aged 12 to 17.

The approval was based on data from the ongoing paediatric expansion of the Phase three PREVENT-19 trial of 2,247 adolescents aged 12 to 17 years across 75 sites in the United States. The trial was conducted to assess the safety and effectiveness of Nuvaxovid.

Nuvaxovid will be produced locally at the Biologics Manufacturing Centre in Montreal. The US Food and Drug Administration (FDA) has not approved the trade name Nuvaxovid.