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Novavax Inc. (NASDAQ:NVAX) has received limited approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Nuvaxovid, marking a regulatory milestone and unlocking a $175 million milestone payment from partner Sanofi SA (NASDAQ:SNY).
The protein-based vaccine, distinct from mRNA options by Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), is now authorized for people aged 65 and older and for individuals 12 and up with underlying medical conditions that increase the risk of severe COVID-19.
The approval came after a six-week delay as regulators sought additional data.
Novavax CEO John C. Jacobs called the decision "a significant milestone" and emphasized the company's commitment to vulnerable populations. The CDC has noted that these groups will most likely seek seasonal COVID vaccinations.
The approval comes as CDC advisers weigh adjustments to annual COVID shot guidance, potentially narrowing recommendations to older adults and high-risk groups.
Novavax plans to begin commercial distribution of its 2025–2026 formula this fall, pending strain selection at the FDA advisory committee meeting on May 22. The company is also working with Sanofi to fund a Phase 4 study in adults 50–64 without high-risk conditions, as requested by the FDA.
Financially, Novavax reaffirmed its 2025 forecast for R&D and SG&A expenses between $475 million and $525 million. It plans to cut these to around $350 million in 2026 and $250 million by 2027, according to BZ Pro.
Related ETFs: iShares Biotechnology ETF (NASDAQ:IBB), SPDR S&P Biotech ETF (NYSE:XBI)
Price Action: NVAX shares are trading higher by 19.0% at $8.01 premarket at the last check on Monday.
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