Published: 2021-10-19 01:36:13 BdST
So what happens now? There are further steps at the FDA, then steps at the Centres for Disease Control and Prevention, and the process ends with the states. Here’s how it breaks down.
— The FDA, 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 FDA typically follows them.
— The FDA'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.
— An advisory panel to the CDC, the United States’ public health agency, reviews the FDA's decision. On Thursday and Friday, that panel is scheduled to meet and vote on its recommendations regarding boosters.
— The CDC takes up that panel’s recommendations, and the agency’s director, Dr Rochelle 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 FDA, the panel’s recommendations are not binding, but the CDC usually follows them.
However, there was a rare exception last month: When a CDC advisory panel rejected the FDA's recommendation that front-line workers be included among those eligible for the Pfizer-BioNTech booster, Walensky overrode her own agency’s advisers and sided with the FDA.
State health departments generally follow the recommendations of the CDC. In the case of the Pfizer-BioNTech booster, the shots began being administered widely immediately after Walensky announced the CDC's guidance to allow them for people older than 65, patients in nursing homes and other institutional settings, those with underlying medical conditions, and front-line workers.
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