Moderna and J&J Booster: What are the next steps?
An independent panel of experts advising the Food and Drug Administration will examine Moderna’s coronavirus vaccine booster shot on Thursday and data from Johnson & Johnson on Friday. Each day will end in a vote by the panel on recommending emergency authorization for that booster for recipients of that vaccine.
So what happens after the panel vote? The FDA steps in, then the Centers for Disease Control and Prevention steps in, 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 regulates and supervises drugs and other elements related to public health, seeks advisory panels’ recommendations, which include questions about who should be eligible. The advisory panel’s votes are not binding, but the FDA generally follows them.
The top FDA officials — its acting commissioner, Dr. Janet Woodcock — issue the agency’s final determination on whether to authorize boosters and for what. Such decisions are usually issued within a few days of the meetings of the advisory committee.
An advisory panel from the United States Public Health Agency, the Centers for Disease Control and Prevention, reviews the FDA’s decision. On Thursday and Friday of next week, that panel is to meet and vote on its recommendations regarding the booster.
The CDC takes the recommendations of that panel, and the agency’s director, Dr. Rochelle P. Valensky, issues agency guidance on whether boosters should be used and who should be eligible. This guidance is very effective for states, doctors, pharmacies and other health care institutions and the general public. Like the FDA’s 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 panel rejected the FDA’s recommendation that those eligible for the Pfizer-BioNTech booster be included in frontline workers, Dr. Valensky overruled his agency’s advisories and sided with the FDA.
State health departments generally follow the CDC’s recommendations. In the case of the Pfizer-BioNTech booster, the shots began to be widely administered soon after Dr. Valensky announced CDC’s guidance to allow them for people over 65, nursing homes, and other institutional patients. Can you settings, those with underlying medical conditions, and frontline workers.
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