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FDA staff endorses Moderna’s COVID-19 vaccine

Agency officials will decide whether to issue formal emergency use authorization following a Thursday meeting

Photo (c) Chalffy - Getty Images
In documents released Tuesday, U.S. Food and Drug Administration (FDA) staff endorsed Moderna’s COVID-19 vaccine as safe and effective. The endorsement puts the vaccine closer to receiving the official regulatory green light so that it can begin going out to the public. 

In its report, FDA staff said the agency determined that 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,” the report said.

Meeting set for Thursday

The FDA is set to decide whether to issue formal emergency use authorization for Moderna’s vaccine on Thursday, following a meeting with a panel of outside advisers. Reuters notes that the FDA “typically follows the advice of the panel, but is not required to do so.” 

If the vaccine wins authorization, vaccines could be administered to the public as early as next week. 

Pfizer’s COVID-19 vaccine has already been authorized by regulators. Hospitals in the U.S. began giving the company’s shots on Monday. It was cleared for use in people aged 16 and older. Moderna is asking the FDA to approve its vaccine for use in people 18 and older. 

In its final analysis, Moderna said its clinical trials found that the vaccine was more than 94 percent effective in preventing COVID-19. Last week, the government announced its intent to purchase an additional 100 million doses of Moderna’s vaccine.

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