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Former FDA chief on FDA report on Moderna's Covid-19 vaccine
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The staff of the Food and Drug Administration on Tuesday endorsed the emergency use of Moderna’s coronavirus vaccine, a critical step forward in winning formal clearance to be administered to the public as early as next week.
The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Thursday to review Moderna’s request for emergency use authorization.
The group of outside medical advisors recommended Pfizer’s vaccine for emergency use last Thursday, and the FDA approved it the next day. The committee is expected to recommend Moderna’s vaccine. The FDA doesn’t have to follow the committee’s recommendation, but it often does.
The FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.”
“FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” it said.
The announcement helped Moderna’s stock rise 1.5% just before the opening bell.
The documents are “enormously encouraging,” said Dr. Paul Offit, a voting member on the committee, adding they show there are now two highly effective vaccines. He voted in favor of recommending Pfizer’s vaccine last week.
Moderna is asking the FDA to approve the use in people age 18 and over, while Pfizer’s vaccine was cleared for use in people age 16 and older. The scant data in younger teens was a sticking point for the few members of the advisory committee who voted against authorizing Pfizer’s vaccine last week.
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