Stephen I. Feller , 2025-05-19 19:23:00
Key takeaways:
- Nuvaxovid becomes the only non-messenger RNA COVID-19 vaccine approved by the FDA.
- The approval restricts use to older people and adolescents or adults with risk factors — a first for a COVID-19 vaccine.
The FDA has approved Novavax’s protein-based COVID-19 vaccine, giving some Americans another option besides messenger RNA vaccines to prevent SARS-CoV-2 infection.
The approval came with restrictions that the other COVID-19 vaccines do not have, reducing the number of people who will be eligible to receive the shot, branded as Nuvaxovid, which had been available under an emergency use authorization since 2022.
The FDA approved Novavax’s protein-based COVID-19 vaccine, which had been available under an emergency use authorization since 2022. Image: Adobe Stock
The FDA restricted approval of the single-dose adjuvanted vaccine to people aged 65 years or older, and adolescents or adults aged 12 to 64 years with at least one risk factor for severe COVID-19. The agency also will require Novavax to conduct post-approval studies to evaluate the occurrence of two heart conditions, myocarditis and pericarditis, rare side effects of COVID-19 vaccines.
The approval came more than 6 weeks after the FDA’s deadline to review the vaccine had passed and was made without input from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which typically advises the agency on vaccines.
“We did not refer your application to the VRBPAC because our review of information submitted in your [application], including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion,” the FDA told Novavax in a letter.
The CDC’s Advisory Committee on Immunization Practices (ACIP) discussed last year whether the United States should switch from universal to risk-based recommendations for COVID-19 vaccines, but did not vote on the issue.
The CDC did not respond to a request for comment on whether the ACIP will vote on recommendations for the Novavax vaccine at its next meeting, which is scheduled for June 25 through 27.
According to the CDC, risk factors for severe COVID-19 can include age, cancer, chronic kidney disease, chronic liver disease, chronic lung disease, diabetes, HIV, overweight and obesity, pregnancy, being a current or former smoker, and substance use disorder.
In a press release, Novavax touted the approval and said that it expects to be ready for commercial delivery of its vaccine for the 2025-2026 respiratory season.
The FDA approval triggered a commercialization deal between Novavax and Sanofi that the former said will allow it to manufacture and deliver shots based on the new vaccine formula it expects the VRBPAC to recommend at a scheduled May 22 meeting.
“[This] 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 form COVID-19 to have access to a protein-based, non-mRNA COVID-19 vaccine,” John C. Jacobs, MBA, Novavax president and CEO, said in a press release.
References:
Perspective
The FDA’s approval of Novavax’s COVID-19 vaccine — the only non-mRNA COVID-19 vaccine now authorized for use in the U.S. — is a critical development in the ongoing fight against COVID-19. Its protein-based platform offers an important alternative for individuals who are medically ineligible for or hesitant about mRNA vaccines.
Notably, this is the first COVID-19 vaccine approved without a universal recommendation, instead targeting those aged 65 years or older or 12 to 64 years with underlying comorbid/high-risk conditions. This selective approval reflects a shift in public health strategy — moving from mass vaccination to a more risk-based “nuanced’ immunization schedule, in part recognizing that COVID-19 is now an endemic public health threat best served by a more tailored protection approach. This shift is important because it better aligns vaccination efforts with current epidemiologic realities and individual risk, though it may raise concerns about decreased population-level immunity and potential public confusion over who should receive which vaccine.
Aaron E. Glatt, MD, FACP, FIDSA, FSHEA
Chairman of the Department of Medicine
Chief of Infectious Diseases and Hospital Epidemiologist
Mount Sinai South Nassau
Professor of Medicine
Icahn School of Medicine Mount Sinai
Disclosures: Glatt reports no relevant financial disclosures.
