An independent panel of experts advising the Food and Drug Administration will vote Wednesday on whether or not the agency recommends that very young children receive injections of the Moderna and Pfizer-BioNTech coronavirus vaccines.
But that’s just one step in a process that regulators must follow before the vaccines can become available to children as young as 6 months old.
The FDA, Centers for Disease Control and Prevention, and the states have more to do before the Moderna vaccine is available for children through age 5 and the Pfizer injection is available for children through age 4.
In a similar process, the panel of experts recommended Tuesday that the agency approve the Moderna vaccine for older children and adolescents.
Both the FDA and the Centers for Disease Control and Prevention will prioritize decisions about vaccines for the youngest children over Moderna injections for older youth and teens because of the unmet need, officials familiar with the schedule said.
Here are the next steps.
As the agency within the Department of Health and Human Services that oversees drugs and related matters, the FDA will consider the advisory panel’s recommendation. The agency usually follows the advice of the advisory committee, but is free to make changes or reject the recommendation outright.
Once the FDA has completed its review, it will issue a decision.
If the FDA approves the vaccines, another advisory panel set up by the CDC will review that decision and vote on whether or not to recommend the pediatric vaccines.
The CDC then adopts that panel’s recommendations and the agency’s director, Dr. Rochelle P. Walensky, provides the agency’s advice on whether the vaccines should be made available to the very young children.
Like the FDA, the CDC usually follows the non-binding recommendations of its advisory committee. But that hasn’t always been the case: Last September, after the CDC panel rejected the FDA’s recommendation to include frontline workers among those eligible for a Pfizer-BioNTech booster, Dr. Walensky’s advisors to her own agency and they agreed with the FDA
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The agency’s guidance greatly impacts states, physicians, pharmacies and other healthcare facilities, and the general public. State health departments generally follow guidelines, but can set their own rules.
Once the FDA’s advisory committee has issued its recommendation, the process can move quickly. The Biden administration has already prepared for the possibility of the two vaccines being approved soon for use in young children and has set a target for the first injections to be given the week of June 19. the states for 10 million pediatric doses, split equally between the Moderna and Pfizer-BioNTech vaccines.