Warp Speed Lives Up To Its Name: FDA Planning Late October Vaccine Advisory Committee
Preliminary plans for an Oct. 22 meeting of US FDA's vaccine advisory committee suggest a fast evaluation of COVID-19 immunizations, bringing mixed reactions from onlookers who say it could be a positive sign of needed public transparency or an indication the agency is rushing to approve a product ahead of the November presidential election.
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The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
Beyond vaccine experts, specialists in medical areas where there might be safety concerns, as well as epidemiologists, could be helpful to aid the FDA in understanding the data in a coronavirus vaccine application.
Agency commissioner appeals to AMA audience to communicate message that FDA review decisions are based on good science.