Novavax’s COVID-19 Vaccine Approved for Older Adults and At-Risk Individuals

After a six-week delay, the U.S. Food and Drug Administration approved Novavax’s COVID-19 vaccine, but only for people 65 and older and those 12 years and older who have at least one underlying condition, such as asthma, diabetes, lung disease, obesity and pregnancy, that puts them at higher risk of severe illness.

“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,” Novavax President and CEO John Jacobs said. “This significant milestone demonstrates our commitment to these populations and is a significant step toward availability of our protein-based vaccine option.”

The vaccine, which uses more traditional protein-based technology than the mRNA vaccines from Pfizer/BioNTech and Moderna, has been subject to emergency use authorization since 2022. Pfizer and Moderna’s vaccines have been FDA-approved for people 12 years and older and remain available under emergency use authorization for children as young as 6 months.

Novavax’s vaccine had been on track for full approval April 1, but FDA delayed the decision while it sought more data. This approval requires Novavax to conduct postmarketing studies looking at the risk of myocarditis and pericarditis — inflammation of the heart muscle and of the membrane surrounding the heart — in people who receive the vaccine. While these conditions have rarely been reported after COVID-19 vaccination, according to the Centers for Disease Control and Prevention (CDC), a handful of cases were reported in trials of the Novavax vaccine, suggesting an increased risk. However, CDC and its Advisory Committee on Immunization Practices have said the benefits of COVID-19 vaccination outweigh the rare risk of heart inflammation in all groups recommended for vaccination.

The CDC’s vaccine advisers are considering changes to the agency’s guidance for who should get an annual COVID-19 vaccine. At
April’s meeting, the committee discussed a recommendation focused on older adults, those with weakened immune systems and possibly those who are more likely to be exposed to the SARS-CoV-2 virus.