US FDA Faces ‘Daily Challenge’ From Complexities Of EUA Fact Sheets For COVID-19 Vaccines
Doran Fink says FDA wants to transition the pandemic vaccines to more flu-like labeling under BLAs.
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Advisory committee tells FDA that the agency, not vaccine manufacturers, should dictate the conversation around variants and reformulations; panelists also want better government research on immune correlates of protection ahead of any decision on a composition change.
CBER director says agency understands 'we simply can't be boosting people as frequently as we are,' but wants to give older and immunocompromised individuals extra protection now while FDA considers whether and when formulations should be modified ahead of an expected surge this fall.
Advisory committee member says FDA's decision to authorize extra shots of Pfizer and Moderna vaccines for those 50 and older was a short-term solution and that VRBPAC should prioritize long-term issues related to the coronavirus.