After an FDA panel considers other Covid booster injections, what happens next?

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An independent panel of experts advising the Food and Drug Administration will review data on Moderna’s coronavirus vaccine booster on Thursday and Johnson & Johnson’s on Friday. Each day will end with a panel vote on whether to recommend emergency clearance for this recall for recipients of this vaccine.

So what happens after the panel votes? There are other steps at the FDA, then steps at the Centers for Disease Control and Prevention, and the process ends with the states. Here’s how it breaks down:

FDA

  • The FDA, a federal agency of the Department of Health and Human Services that controls and oversees drugs and other public health-related items, echoes the advisory committee’s recommendation, which includes the question of who should be eligible. Advisory committee votes are not binding, but the FDA generally follows them.

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

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CDC

  • An advisory committee from the Centers for Disease Control and Prevention, the United States’ public health agency, is reviewing the FDA decision. Thursday and Friday of next week, this panel is due to meet and vote on its recommendations for boosters.

  • The CDC takes up the recommendations of this panel, and the director of the agency, Dr Rochelle P. Walensky, issues the agency’s guidelines on the use of boosters and who is eligible. This direction is deeply influential for states, physicians, pharmacies and other health care facilities, and the general public. As with the FDA process, the panel’s recommendations are not binding, but the CDC generally follows them.

    However, there was a rare exception last month: When a CDC advisory committee rejected the FDA’s recommendation to include frontline workers among those eligible for the Pfizer-BioNTech recall, Dr. Walensky took the step on the advisers of his own agency and sided with the FDA.

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The states

State health departments generally follow CDC recommendations. In the case of the Pfizer-BioNTech recall, injections began to be widely administered immediately after Dr. Walensky announced CDC guidelines to allow them for people over 65, patients in nursing homes and other settings institutions, those with underlying medical conditions and frontline workers.

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