A committee of scientists and doctors that advises the US Food and Drug Administration voted Tuesday to recommend that the FDA authorize the Novavax COVID-19 vaccine for adults 18 and up.
If the FDA accepts the panel's recommendation and authorizes Novavax, a two-dose vaccine administered three weeks apart, it will be the fourth COVID-19 vaccine to win emergency use authorization in the US.
It will also make Novavax the first protein-based COVID-19 vaccine, a more traditional technology used in vaccines for shingles and more.
Because it's a more established vaccine type, the hope is that Novavax may fill an unmet need for people who are hesitant about receiving mRNA vaccines made by Pfizer and Moderna. Use of the third authorized vaccine, from Johnson & Johnson, has been limited over concerns of a rare but dangerous side effect.
The protein-based vaccine is also easier to store and distribute than other vaccines. The Novavax vaccine was 90% effective against symptomatic COVID-19 in a clinical trial against older variants of COVID-19 (mostly alpha), but more research is needed to determine its response against omicron.
Novavax was an early beneficiary of the Operation Warp Speed program, but the company has experienced manufacturing problems that the FDA will need to sign off on before authorizing its vaccine, The New York Times reports. Then, vaccines typically go through the same vote-and-recommend process with the US Centers for Disease Control and Prevention and its advisory committee before they become available to the public.
Novavax submitted to the FDA for emergency use authorization in January, and it's authorized for use in other countries, including Canada.
Cases of COVID-19 in the US were rising sharply in recent weeks, but have started to level off in some areas, specifically on the East Coast and in the Midwest. Experts are anticipating another surge in the fall or winter, and the FDA's committee is scheduled to meet later this month to discuss new formulations for COVID-19 vaccines that may better-target omicron and its subvariants.
About 83% of the US population has received at least one dose of a COVID-19 vaccine, according to the CDC.
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