COVID-19 Vaccine Strain Updates Don’t Exactly Fit Flu Model
Manufacturers have different production timelines and US FDA advisory committee members worry a June strain selection may not fit the timing of COVID-19 case surges.
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Instead of the 50% threshold, the FDA in updated guidance says that efficacy confidence intervals and point estimates should be ‘appropriately justified.’
It took little convincing for FDA advisors to support changing COVID-19 vaccines to monovalent XBB formulations, but the committee still isn’t sold on the agency’s annual influenza-like campaign strategy for COVID vaccines and raised several harder calls that FDA and CDC will need to make including when to cut off bivalent shots use and who should get XBB.
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.