Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability
CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.
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CDC’s universal recommendation for XBB COVID vaccines means that Novavax’s protein-based vaccine can enter the market immediately upon FDA authorization, but some final questions from the agency are keeping the review going.
The companies are all preparing to make available vaccines targeted to Omicron XBB subvariants, with the expectation that demand in the US will be about 50 million to 100 million doses.
Also, Novavax looks to turn its also-ran vaccine into a contender by banking on tolerability as government support recedes and the US COVID market goes commercial.