Group 1 - Novavax's COVID-19 vaccine, Nuvaxovid, received full approval from the FDA, leading to a nearly 26% surge in its stock price during pre-market trading [1] - The FDA approved Nuvaxovid for individuals aged 65 and above but restricted its use for those aged 12-64 with underlying health conditions [2] - The approval is based on data from a pivotal late-stage study demonstrating the vaccine's safety and effectiveness [3] Group 2 - Nuvaxovid is now the only non-mRNA-based COVID-19 vaccine available in the U.S., providing an alternative to mRNA vaccines from Moderna and Pfizer [6] - Sanofi acquired exclusive global marketing rights for Nuvaxovid, triggering a $175 million milestone payment upon full approval, along with ongoing tiered royalties on future sales [7] - Novavax faced delays in vaccine approval and launch, impacting its sales during the previous vaccination season, but aims to participate early in the upcoming season [9]
NVAX Stock Surges on Securing FDA Approval for COVID-19 Vaccine