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The Food and Drug Administration has granted full approval to Novavax, Inc. (NASDAQ:NVAX) COVID-19 vaccine, but with notable limitations.
Previously available under emergency use authorization for individuals aged 12 and up, the shot is now fully approved only for adults 65 and older, or for those between the ages of 12 and 64 who have underlying health conditions that heighten their risk of severe COVID-19.
The outlook for the vaccine became uncertain after the FDA failed to meet its April 1 approval deadline. Adding to the uncertainty, U.S. Health and Human Services Secretary Robert F. Kennedy Jr., known for his skepticism toward vaccines, questioned the shot’s effectiveness during an interview with CBS.
Novavax, Inc. (NASDAQ:NVAX)'s vaccine stands out as the only protein-based COVID-19 shot available in the U.S., offering an alternative to the mRNA-based vaccines from Pfizer and Moderna. Both of those vaccines already have full FDA approval for individuals 12 and older, and are authorized for use in children as young as 6 months.
The news came after Novavax, Inc. (NASDAQ:NVAX) recorded strong earnings in the first quarter of 2025. The company posted revenue of $666.6 million, which showed a significant growth of 610.3% from the same period last year. The revenue also beat analysts' estimates by $322.8 million. Its EPS of $2.93 also surpassed the estimates by $1.52. The company also enhanced its partnership with Takeda in Japan, which is ranked as the world’s third-largest pharmaceutical market, bringing notably better financial terms.
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