FDA Panel Weighs Moderna’s COVID-19 Vaccine

The same group of advisers to the Food and Drug Administration that voted to recommend the Pfizer-BioNTech COVID-19 vaccine for emergency use a week ago convenes again today to consider the Moderna vaccine. The agency frequently seeks advice from these committees of independent experts when considering whether to make available a new drug or vaccine. In this case, the agency will ask the committee to vote on whether the evidence shows that the benefits of the Moderna vaccine outweigh its risks. On Tuesday, the FDA released its analysis of the vaccine , along with an information packet from Moderna. The agency found the vaccine to be 94% effective and to have a “favorable safety profile” that raises “no specific safety concerns identified that would preclude issuance of an EUA,” or emergency use authorization. Some side effects were very common in the main clinical trial of the Moderna vaccine, which included more than 30,000 people, half of whom received two shots of vaccine and half

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