An independent panel of experts advising the Food and Drug Administration will examine data on Moderna’s coronavirus vaccine booster shot on Thursday and Johnson & Johnson’s on Friday. Each day will culminate in a vote by the panel on whether or not to recommend emergency clearance for that booster for recipients of that vaccine.
So what happens after the panel votes? There are further steps with the FDA, then steps with the Centers 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 monitors and monitors drugs and other elements related to public health, is adopting the advisory panel’s recommendation, which includes eligibility. The votes of the advisory panel are not binding, but the FDA usually follows them.
The FDA’s most senior official – the Acting Commissioner, Dr. Janet Woodcock – gives the agency’s final decision on whether or not to authorize the boosters and for whom. Such decisions are usually taken within a few days of the meetings of the advisory committees.
An advisory panel from the Centers for Disease Control and Prevention, the United States’ public health agency, is reviewing the FDA’s decision. On Thursday and Friday of next week, that panel will meet and vote on its recommendations regarding boosters.
The CDC is adopting that panel’s recommendations and the agency’s director, Dr. Rochelle P. Walensky, provides the agency’s guidelines on whether boosters should be used and who qualify. That guidance has a profound impact on states, physicians, pharmacies and other healthcare facilities, and the general public. As with the FDA process, the panel’s recommendations are not binding, but the CDC usually follows them.
Last month, however, there was a rare exception: When a CDC advisory panel rejected the FDA’s recommendation to include frontline workers among those eligible for the Pfizer-BioNTech booster, Dr. Walensky’s consultants from her own agency and sided with the FDA
State health departments generally follow the CDC’s recommendations. In the case of the Pfizer-BioNTech booster, the injections were widely administered immediately after Dr. Walensky announced the CDC’s guidelines to allow them for people over age 65, patients in nursing homes and other institutional settings, those with underlying medical conditions, and frontline workers.