FDA approves Novavax's COVID-19 vaccine with limitations
The Novavax COVID-19 vaccine has had emergency use authorization since 2022, and an updated version was approved in August. The brand name is Nuvaxovid.
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The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay. (File Photo by Jim Lo Scalzo/EPA-EFE)
May 18 (UPI) -- The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay.
The agency approved the vaccine only for people 65 and older and those 12 and older with at least one underlying condition in which they are at a higher risk of severe illness. The company is based in Gaithersburg, Md.
The conditions include older age, asthma, diabetes, lung disease, obesity and pregnancy.
"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," Novavax President and CEO John Jacobs said in a statement Saturday to CNN.
"This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option."
The Novavax COVID-19 vaccine has had emergency use authorization since 2022, and an updated version was approved in August. The brand name is Nuvaxovid.
The FDA granted Pfizer-BioNTech full approval for those 12 and older in August 2021 and Moderna in January 2022. They remain available under emergency use authorization for children as young as 6 months.
Novavax uses more traditional protein-based technology than the mRNA vaccines of Pfizer and Moderna.
Pfizer was the first COVID-19 vaccine to receive emergency approval in December 2020 and Moderna was followed one week later.
The first Covid-19 case was reported in the United States on Jan. 20, 2020.
The CDC no longer tracks cases but examines SARS-CoV-2 levels in sewage, and limited data from hospitals and states. Cases now are hard to track because most people get tests at home and the results are not reported to state health agencies.
About 23% of U.S. adults are estimated to be up to date with the vaccine, according to the CDC through April. For children 6 months and up to 18, it is an estimated 13.% the CDC reported.
With Robert F. Kennedy Jr., a vaccine skeptic, leading Health and Human Services, the FDA and CDC are giving greater scrutiny to the shots.
The FDA delayed the decision on the vaccine as it sought more data, a source told CNN.
In the approval letter issued Friday, Novavax must conduct post-marketing studies looking at the risk of myocarditis and pericarditis in people who receive the vaccine. These are inflammation of the heart muscle and of the membrane surrounding the heart.
Only a few cases were reported in the 30,000-person clinical of the Novavax vaccine, the CDC notes. But the CDC and its Advisory Committee on Immunization Practices have said the benefits of the vaccination outweigh the rare risk of heart inflammation in all groups recommended for vaccination.
The CDC is considering whether to only recommend yearly vaccines for older people or ones with a compromised immune function. Everyone 6 months of age and older are now recommended to get the yearly dose.
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