Congressional Democrats Press US FDA For Transparency In Review Of COVID-19 Vaccines
FDA should have all coronavirus vaccines evaluated by Vaccines and Related Biological Products Advisory Committee before approval, Democratic senators and representatives say; House subcommittee also wants FDA to require 30,000 participants in Phase III trials.
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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.
US FDA’s ‘may be effective’ standard for granting an emergency use authorization is expected to be comparable to the substantial evidence of effectiveness needed to support full licensure of a COVID-19 vaccine, although EUA allows for a more rapid review, agency officials say.
The granting of fast-track status is a clear signal that the US FDA wants to maintain its high standards of drug and vaccine appraisal.