Novavax, Inc. (NASDAQ:NVAX) shares jumped 26% in premarket trading on Monday after the U.S. Food and Drug Administration granted full approval for its COVID-19 vaccine, though with narrower eligibility than expected.
The company’s protein-based vaccine, previously available under emergency authorisation for those aged 12 and over, is now fully licensed only for adults aged 65 and older, or individuals aged 12 to 64 with underlying health conditions that raise their risk from Covid-19.
Rival vaccines from Pfizer and Moderna remain approved for broader use, including for children as young as six months.
The move comes ahead of a June meeting where federal health advisers are due to review whether annual Covid-19 vaccinations should be limited to higher-risk groups. The Novavax decision may indicate the Trump administration’s direction ahead of that discussion.
Chief executive John C. Jacobs called the approval “a significant milestone” and said the company remains focused on reaching vulnerable populations.
The shares are set to open at $8.47, up $1.74.