Novavax’s ’23-’24 COVID Vaccine Can Bypass Another CDC Cmte Meeting – If FDA Authorizes It
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.
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FDA approval was swiftly followed by CDC advisory committee recommendation of the XBB.1.5. variant-based vaccines for all people aged 6 months and older.
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.
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.