India, May 19 -- Novavax, Inc. (NVAX) announced Monday that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi SA (SNY).

The approval triggers a $175 million milestone payment under the collaboration and license agreement between Novavax and Sanofi signed in May 2024.

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