The FDA's advisory committee voted unanimously to recommend Novavax's Covid-19 vaccine for use in the U.S.
Novavax's vaccine was 90% effective at preventing illness from Covid across the board and 100% effective at preventing severe illness, according to the company's clinical trial results from the U.S. and Mexico. However, the trial was conducted from December 2020 through September of 2021, months before the highly contagious omicron variant and its various sublineages became dominant in the U.S.
"The study was conducted quite a while ago and said the cases that accrued were not during the time that omicron was circulating," Dr. Lucia Lee, an official with the FDA's division of vaccine research, said during her presentation to the committee. Novavax's Chief Medical Officer Dr. Filip Dubovsky told the panel that data from the company's trials showed that two doses induced an immune response against omicron, though it was lower than against the Wuhan strain. A third dose boosted the immune response against omicron to levels comparable to the first two doses which had 90% effectiveness against illness, Dubovsky saidNovavax plans to ask the FDA to authorize a third dose if the agency clears the primary series for use in the U.S.
The most common side effects of Novavax's shots were injection site pain, fatigue, headache and muscle pain, according to FDA briefing documents. However, FDA officials also raised a red flag that Novavax's vaccine might be associated with a risk of heart inflammation as is the case with Pfizer and Moderna's shots.
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