FDA closes the door on EUA requests for some future Covid-19 vaccines
The FDA late Tuesday said that for the remainder of the pandemic, it may decline to review and process further EUA requests for Covid-19 vaccines, unless a developer has already engaged with the agency.
The move ostensibly will push later Covid-19 vaccine entrants to go the long route and submit a full BLA with more manufacturing and safety data rather than use the shortened EUA process.
The decision also comes as Pfizer has already submitted its full BLA to the FDA (and Moderna will soon follow suit), and FDA’s top vaccine official Peter Marks previously told Endpoints News that it may only take a few months to review those applications.
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