FDA committee recommends authorizing Novavax to be fourth COVID-19 vaccine approved in the U.S.
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FDA committee recommends authorizing Novavax to be fourth COVID-19 vaccine approved in the U.S.
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FDA committee recommends authorizing Novavax to be fourth COVID-19 vaccine approved in the U.S.
On June 07, a committee of scientists and physicians advising the U.S. Food and Drug Administration (FDA) voted to recommend that the FDA authorize the Novavax COVID-19 vaccine for adults 18 and older, CNET reported .
If the FDA accepts the committee’s recommendation and authorizes Novavax, two doses of the vaccine given three weeks apart, it would be the fourth COVID-19 vaccine to win emergency use authorization in the United States.
It would also make Novavax the first protein-based COVID-19 vaccine, a more traditional technology used for vaccines such as shingles. Since it’s a more established type of vaccine, it’s hoped Novavax will fill an unmet need for those who are hesitant to receive an mRNA vaccine made by Pfizer and Moderna. Use of Johnson & Johnson’s third licensed vaccine has been limited.
This protein-based vaccine is also easier to store and distribute than other vaccines. In a clinical trial, the Novavax vaccine was 90 percent effective against symptomatic COVID-19 (primarily Alpha) variants, but more research is needed to determine its response to Omicron.
Novavax was an early beneficiary of the Operation Warp Speed program, but the company ran into manufacturing issues that the FDA needed to confirm before authorizing its vaccine, The New York Times reported. Vaccines then typically go through the same voting and recommendation process by the Centers for Disease Control and Prevention (CDC) and its advisory committees before they are made available to the public.
Novavax filed an emergency use authorization application with the FDA in January, and it has been authorized for use in other countries, including Canada.
COVID-19 cases in the U.S. have risen sharply in recent weeks but have begun to level off, especially on the East Coast and Midwest. Experts expect another surge in cases in the fall or winter, and an FDA committee is scheduled to meet later this month to discuss new formulations of a COVID-19 vaccine that may better target Omicron and its subvariants.
About 83 percent of the U.S. population has received at least one dose of the COVID-19 vaccine, according to the CDC.
FDA committee recommends authorizing Novavax to be fourth COVID-19 vaccine approved in the U.S.
(source:internet, reference only)
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