The U.S. Food and Drug Administration (FDA) approved the Biologics License Application for the Nuvaxovid (Novavax) COVID-19 jab in adults 65 years and older and individuals 12 through 64 with at least one underlying condition.

“Today’s approval solidifies a pathway for Americans aged 65 and older and those aged 12 through 64 with an underlying condition that puts them at high risk for severe outcomes from COVID-19 to have access to a protein-based, non-mRNA COVID-19 vaccine,” said John C. Jacobs, President and Chief Executive Officer, Novavax.

“Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,” Jacobs added.

.@FDA @DrMakaryFDA how can you approve Novavax COVID-19 vaccines for elderly while knowing increased risks of Nervous system(15%),Cancers(17%), Respiratory(21%),vascular(84%),Viral(100%) and Covid-19 Infection(75%),Renal Disorders (350%) as adverse events compared to placebo?… pic.twitter.com/8Ot3yx4yC2

— VaccineMole (@VaccineMole) May 18, 2025

Per BioPharma Dive:

The vaccine, which uses an older protein technology than the mRNA shots of Pfizer and Moderna, has been available in the U.S. since 2022 under emergency use authorization.

While narrower, the approved indication is no more restrictive than what Leerink Partners analyst Daina Graybosch expects advisers to Centers for Disease Control and Prevention will recommend next month. In an April meeting, a panel of those advisers discussed adjusting their recommendations for COVID vaccination.

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News of the FDA’s approval send Novavax shares higher by double digits Monday.

#NEWS: Novavax announced the U.S. Food and Drug Administration (@FDA) has approved the Company’s Biologics License Application for its COVID-19 vaccine, Nuvaxovid™, triggering a Sanofi milestone payment.

Read the news release: https://t.co/QqGXrhfT3Q pic.twitter.com/7misZW7snS

— Novavax (@Novavax) May 19, 2025

From the Pharmacy Times:

An expansion of PREVENT-19 aimed to evaluate the safety, immunogenicity, and efficacy of Nuvaxoid in 2247 adolescents aged 12 to 17 years. Investigators found that neutralizing antibody responses to Nuvaxoid were noninferior compared with those of young adults aged 18 to 25 years. Additionally, vaccine efficacy was about 79.5%, with a strong 82.0% efficacy (95% CI, 32.4%-95.2%) against the Delta variant, indicating broad protection against multiple strains of SARS-CoV-2. Reactogenicity was observed to be mild to moderate and transient in nature only, with a trend towards greater frequency following a second dose of the vaccine, according to the investigators.

In addition to granting full regulatory approval, the FDA has also requested a new postmarketing commitment to conduct a phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19. The results of this trial could lead to the expansion of the FDA’s approval for Nuvaxoid to include more patients who could benefit from protection against COVID-19.