Nuvaxovid, the adjuvanted protein subunit COVID-19 vaccine marketed by Novavax, has received full approval from the FDA to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in all adults ≥65 years old and in adults 12-64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The vaccine was previously available under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old.1 Nuvaxovid is the first protein-based COVID-19 vaccine to receive full approval from the FDA; the mRNA COVID-19 vaccines Comirnaty and Spikevax are approved for use in patients ≥12 years old.

A 2024-2025 formulation of the Novavax adjuvanted protein subunit COVID-19 vaccine that more closely targets currently circulating SARS-CoV-2 variants is available now under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old. The 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) were licensed by the FDA last month for use in persons ≥12 years old and made available under EUAs for use in persons 6 months to 11 years old.