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Moderna and J.& J. Boosters: What Are the Next Steps?

todayOctober 14, 2021 1

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An independent panel of experts advising the Food and Drug Administration will examine data on Moderna’s coronavirus vaccine booster shot on Thursday, and on Johnson & Johnson’s on Friday. Each day will culminate in a vote by the panel on whether to recommend emergency authorization for that booster for recipients of that vaccine.

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

The F.D.A.

  • The F.D.A., a federal agency of the Department of Health and Human Services that controls and supervises medications and other elements related to public health, takes up the advisory panel’s recommendation, which includes the question of who should be eligible. The advisory panel’s votes are not binding, but the F.D.A. typically follows them.

  • The F.D.A.’s top official — its acting commissioner, Dr. Janet Woodcock — issues the agency’s final determination on whether to authorize the boosters and for whom. Such decisions are typically issued within a few days of advisory committee meetings.

The C.D.C.

  • An advisory panel to the Centers for Disease Control and Prevention, the United States’ public health agency, reviews the F.D.A.’s decision. On Thursday and Friday of next week, that panel is scheduled to meet and vote on its recommendations regarding boosters.

  • The C.D.C. takes up that panel’s recommendations, and the agency’s director, Dr. Rochelle P. Walensky, issues the agency’s guidance on whether boosters should be used and who should be eligible. That guidance is deeply influential for states, doctors, pharmacies and other health care institutions and the general public. As with the process at the F.D.A., the panel’s recommendations are not binding, but the C.D.C. usually follows them.

    However, there was a rare exception last month: When a C.D.C. advisory panel rejected the F.D.A.’s recommendation that frontline workers be included among those eligible for the Pfizer-BioNTech booster, Dr. Walensky overrode her own agency’s advisers and sided with the F.D.A.

The states

State health departments generally follow the recommendations of the C.D.C. In the case of the Pfizer-BioNTech booster, the shots began being administered widely immediately after Dr. Walensky announced the C.D.C.’s guidance to allow them for people over 65, patients in nursing homes and other institutional settings, those with underlying medical conditions, and frontline workers.

Original story from https://www.nytimes.com

Written by: admin

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todayOctober 14, 2021


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