Novavax Stock: FDA Approval Triggers Financial Windfall

The U.S. Food and Drug Administration has granted full approval (Biologics License Application) for Novavax's COVID-19 vaccine Nuvaxovid, marking a significant breakthrough for the biotech company. This approval, announced on May 19, 2025, authorizes the vaccine for adults aged 65 and older, as well as individuals between 12 and 64 years with high-risk conditions. The development carries substantial financial implications, as it immediately triggers a $175 million milestone payment from pharmaceutical giant Sanofi, stemming from their May 2024 partnership agreement. Novavax now holds the distinction of offering the only protein-based, non-mRNA COVID-19 vaccine available in the United States, potentially capturing market share among those seeking alternatives to mRNA technology.

Strategic Partnership Benefits

Looking forward, Novavax and Sanofi are preparing for the commercial launch of the 2025-2026 seasonal vaccine formulation this fall, pending FDA advisory committee recommendations expected on May 22. The partnership extends beyond the immediate financial injection, with Novavax set to receive ongoing tiered royalties from Sanofi's future vaccine sales. This strategic collaboration represents a potential turnaround opportunity for Novavax, whose stock had previously suffered a dramatic 93% decline from pandemic-era peaks. The FDA has requested an additional Phase 4 study examining the vaccine's efficacy in adults aged 50-64 without high-risk conditions, which both companies are currently evaluating.

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Source StockWorld