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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But new study finds increased risk of non-hemorrhagic stroke in those receiving high-dose adjuvanted flu vaccines, and another study detects new signal for seizures/convulsions among younger children who received COVID vaccine. Authors say findings warrant more investigations.
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.