US FDA Investigating Concomitant Flu, COVID Vaccine Link To Stroke Safety Signal
No stroke risk has been identified, but FDA and CDC officials want to investigate whether concomitant administration of influenza and COVID-19 vaccines are related to the issue.
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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.
COVID vaccines saved the world and then became a liability. US FDA vaccine advisors cited COVID experience as they urge agency to slow down on approval of new RSV vaccines, due to worries of declining public vaccine confidence and coadministration complications.