After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.
“Market research and US C.D.C. 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 in a statement Saturday. “This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option.”
The US Centers for Disease Control and Prevention lists a wide range of conditions that may make someone more likely to become severely ill with Covid-19, including older age, asthma, diabetes, lung disease, obesity and pregnancy.
The Novavax Covid-19 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 and up 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 the FDA delayed the decision while it sought more data, a source told CNN. The new approval letter issued Friday 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.
These conditions have rarely been reported after Covid-19 vaccination, according to the US Centers for Disease Control and Prevention. A handful of cases were reported in trials of the Novavax vaccine, suggesting an increased risk, the CDC notes. However, the 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 shot. At last month’s meeting of, 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 coronavirus.
Robert F. Kennedy Jr., secretary of the US Department of Health and Human Services and a longtime anti-vaccine activist, has falsely called vaccines for Covid-19 “the deadliest vaccine ever made” and more recently made misleading statements about the safety of the measles vaccine amid a massive outbreak centered in West Texas.
HHS did not respond to a request for comment on the Novavax approval.
