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Wednesday, October 27, 2021

After an F.D.A. panel considers more Covid booster shots, what happens next?

An independent panel of experts advising the FDA will examine data on the Moderna coronavirus booster vaccine on Thursday and Johnson & Johnson on Friday. Each day will conclude with a committee vote on whether to recommend an emergency authorization of this booster vaccine to recipients of this vaccine.

So what happens after the commission’s vote? This is followed by steps at the FDA, then steps at the Centers for Disease Control and Prevention, and the process ends with conditions. This is how it goes wrong:

FDA

  • The FDA, the federal agency of the Department of Health and Human Services that monitors and monitors drugs and other public health items, accepts the advisory group’s recommendation, which includes the question of who should be eligible. Advisory panel votes are optional, but the FDA usually follows them.

  • The top FDA official – its acting commissioner, Dr. Janet Woodcock – makes the agency’s final decision on whether and for whom boosters are allowed. Such decisions are usually taken within a few days after the meetings of the advisory committee.

CDC

  • An advisory panel from the Centers for Disease Control and Prevention, the US public health agency, is reviewing the FDA’s decision. This group is scheduled to meet Thursday and Friday next week and vote on their booster recommendations.

  • The CDC accepts the group’s recommendations, and the agency’s director, Dr. Rochelle P. Walenski, issues the agency’s recommendations on whether to use boosters and who should be eligible for them. This guide is important to states, doctors, pharmacies and other healthcare providers, and the general public. As with the FDA, the panel’s recommendations are optional, but the CDC usually follows them.

    Last month, however, there was a rare exception: when the CDC advisory panel rejected the FDA’s recommendation to include frontline workers among those eligible for the Pfizer-BioNTech booster, Dr. Walenski rejected her own agency’s advisers and sided with the FDA.

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States

State health departments generally follow CDC guidelines. In the case of the Pfizer-BioNTech booster, vaccinations began to be widely used immediately after Dr. Walenski announced the CDC’s guidelines allowing them to be allowed for people over 65, patients in nursing homes and other settings. institutions, people with underlying medical conditions, and frontline workers.

World Nation News Deskhttps://www.worldnationnews.com
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