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  • FDA to Discuss Emergency Approval for Vaccine

    The U.S. health regulator’s criteria for allowing emergency use of a COVID-19 vaccine and plans to monitor its safety after a regulatory go-ahead, are among the topics to be discussed at a closely watched meeting scheduled for Thursday • Full Story

    Reuters

    The U.S. health regulator’s criteria for allowing emergency use of a COVID-19 vaccine and plans to monitor its safety after a regulatory go-ahead, are among the topics to be discussed at a closely watched meeting scheduled for Thursday.

    Details posted on the Food and Drug Administration’s (FDA) website showed the U.S. Centers of Disease Control and Prevention has formulated plans to monitor safety and effectiveness of a vaccine even after the FDA allows for its emergency use.

    The FDA panel would make recommendations at the end of the meeting, according to the agenda, but did not specify details.

    The agenda also showed no specific application for a vaccine’s emergency use would be discussed at the meeting. The agency previously said it would hold multiple meetings in the future to discuss emergency use of a particular vaccine.

    Pfizer Inc, Moderna Inc and AstraZeneca could provide early analyses of late-stage trials of their experimental vaccines this month or the next, following which regulators will consider regulatory authorization.

    The companies did not immediately respond to a request for comment on whether they would be presenting at the meeting.

    The FDA earlier this month told coronavirus vaccine developers it wants at least two months of safety data before authorizing emergency use, a requirement that likely pushes any U.S. vaccine availability past the Nov. 3 presidential election.

    The meeting, which is open to the public for comments, is another example of steps health regulators are taking to assuage public distrust related to coronavirus vaccines, that are being developed at unprecedented speed.

    There are no approved vaccines for the coronavirus, except two in Russia that are yet to finish Phase 3 clinical testing.

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