FDA Approves Novavax COVID-19 Vaccine for Patients 65 Years and Older, Those With Underlying Conditions

Updated May 19, 2025, at 11:13 AM.

The FDA has approved the biologics license application for Nuvaxoid (VX-CoV2373; Novavax) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults 65 years and older and individuals 12 through 64 years of age with at least 1 underlying condition putting them at high risk of severe outcomes from COVID-19, according to a news release from Novavax. The approval marks the first traditional, protein-based COVID-19 vaccine available in the United States and previously carried an emergency authorization for patients 12 years and older.^1-3

Nuvaxoid is a traditional, protein-based vaccine that protects against COVID-19. | Image Credit: © Tom - stock.adobe.com

“Market research and US CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,” John C. Jacobs, president and CEO of Novavax, said in a news release. "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.”¹

Current CDC recommendations state that everyone aged 6 months and older should receive an updated COVID-19 vaccine. Moderna and Pfizer-BioNTech each have mRNA-based COVID-19 vaccines approved for such an indication, which could indicate a shift in FDA guidance for COVID-19 vaccines under new leadership. Adults aged 65 and older are at the highest risk for severe COVID-19, and another vaccine option will allow for more patients to get protected against the disease.^1,4

Two pivotal clinical trials evaluated the safety and efficacy of Nuvaxoid in a vast population of patients. In PREVENT-19, a phase 3, randomized, observer-blinded, placebo-controlled trial in the US and Mexico that took place in the first half of 2021, Nuvaxoid demonstrated nearly 100% protection against moderate-to-severe disease (95% CI, 87.0%-100.0%). Furthermore, vaccine efficacy against any variant of concern or interest was 92.6% (95% CI, 83.6%-96.7%), an important marker given the variable nature of SARS-CoV-2. This trial took place across a population of almost 30,000 adults 18 years and older, demonstrating broad and durable efficacy for these patients.⁵

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.⁶

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-19.¹

Pharmacists should stay aware of shifting FDA guidance regarding available COVID-19 vaccines in the US. COVID-19 vaccines remain safe and effective regardless of an mRNA- or protein-based formulation. Patients may express preference towards one form or the other, necessitating proper fact-based counseling and recommendations from pharmacists.

REFERENCES

1. Novavax. U.S. FDA approves BLA for Novavax’s COVID-19 vaccine. News Release. Released May 19, 2025. Accessed May 19, 2025. https://ir.novavax.com/press-releases/2025-05-19-U-S-FDA-Approves-BLA-for-Novavaxs-COVID-19-Vaccine

2. Neergaard L. FDA approves Novavax COVID-19 vaccine, but with unusual restrictions on its use. PBS News. Published May 18, 2025. Accessed May 19, 2025. https://www.pbs.org/newshour/health/fda-approves-novavax-covid-19-vaccine-but-with-unusual-restrictions-on-its-use

3. PT Staff. FDA issues emergency use authorization to Novavax’s COVID-19 vaccine 2023-2024 formula. Pharmacy Times. Published October 3, 2023. Accessed May 19, 2025. https://www.pharmacytimes.com/view/fda-issues-emergency-use-authorization-to-novavax-s-covid-19-vaccine-for-2023-24-formula

4. CDC. Staying up to date with COVID-19 vaccines. Updated January 7, 2025. Accessed May 19, 2025. https://www.cdc.gov/covid/vaccines/stay-up-to-date.html#cdc_vaccine_recommendations_section_2-recommended-covid-19-vaccines

5. Dunkle LM, Kotloff KL, Gay CL, et al. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. N Engl J Med. 2021;386(6):531-543. doi:10.1056/NEJMoa2116185

6. Áñez G, Dunkle LM, Gay CL, et al. Safety, immunogenicity, and efficacy of the NVX-CoV2373 COVID-19 vaccine in adolescents: A randomized clinical trial. JAMA Netw Open. 2023;6(4):e239135. doi:10.1001/jamanetworkopen.2023.9135