Pfizer's COVID vaccine (Comirnaty) is fully approved for patients ages 12 and up, and authorized for kids ages 6 months ...

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU Marketing Authorization includes use of Nuvaxovid™ as a ...

Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses.

Novavax secures full FDA approval for NUVAXOVID, unlocking a $175M Sanofi payment.

As for Nuvaxovid, this standalone Novavax Covid-19 vaccine received its FDA approval in May, a regulatory decision that covers its use in those age 65 and older.

Novavax (NVAX) and partner SK bioscience will provide the first protein-based COVID-19 vaccine approved for use in adolescents aged 12 through 17 years in South Korea GAITHERSBURG, Md., Aug. 12 ...

Novavax’s shares traded nearly 20% in pre-market trading at the time of writing. The long-awaited approval for Nuvaxovid restricts its use to adults aged 65 and older.

The FDA has approved the Novavax COVID-19 vaccine, called Nuvaxovid, mainly for adults 65 or older, but people ages 12 to 64 with medical conditions that increase their risk of serious illness ...

The FDA also requested Novavax conduct a phase 4 study in patients aged 50 to 64 years without high-risk conditions for severe COVID-19.

Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus ...