For Recombinants To Approach mRNA Speed, US FDA Urged To Select Monovalent COVID Boosters
US FDA and BARDA ask makers of recombinant protein SARS-CoV-2 vaccines how they could match mRNA vaccines in post-strain-selection turnaround time for annual booster doses. The reply: give them a fighting chance by selecting just one strain instead of two.
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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.
A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.
US CDC is starting to prepare for the transition of COVID vaccine deliver to more traditional commercial channels. It is noteworthy that the first discussion of what will change did not include any talk of prices.