US FDA Communication Ahead Of Major Actions Could Counter Misinformation, Ex-Official Says
Instead of waiting until after regulatory events like COVID boosters and Aduhelm, FDA should describe its decision-making process along the way to help restore public faith in the agency, former deputy commissioner Josh Sharfstein says.
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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.
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.
The idea seems to stem from thinking that human interaction is the best way to combat rumors and false statements.