Key Takeaways
- Novavax received Food and Drug Administration approval for its new, protein-based COVID-19 vaccine.
- The shot, Nuvaxovid, is designed for older adults and those between the ages of 12 and 64 who have underlying conditions that puts them at higher risk from the disease.
- Nuvaxovid was developed in cooperation with Sanofi, which will pay Novavax $175 million in a milestone agreement. It could receive more royalties from sales in the future.
Novavax (NVAX) shares soared 25% at the opening bell Monday after the Food and Drug Administration (FDA) approved its new COVID-19 vaccine.
The drugmaker said the FDA approved its Biologics License Application (BLA) for Nuvaxovid, which is designed for people aged 65 and older, and those from 12 to 64 years old who have at least one underlying condition that puts them at high risk from the disease. Nuvaxovid differs from current COVID-19 vaccines on the market because it is protein-based, not mRNA-based.
The shot was developed in partnership with French biotech firm Sanofi (SNY), which will pay Novavax $175 million in a milestone agreement following the BLA approval. Novavax noted that the deal has “layers of value” for the company, with Sanofi leading the commercialization of Nuvaxovid beginning this year, and Novavax eligible to “receive ongoing tiered royalties from stand-alone COVID-19 vaccine sales for all future vaccination seasons.” It expects commercial delivery of the 2025-2026 version of Nuvaxovid this fall.
CEO John Jacobs explained that demand should be strong, since market research and federal health data show that “older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally.”
Novavax shares had been down 16% year-to-date entering Monday.
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