An independent committee of experts advising the Food and Drug Administration is meeting on Tuesday for discussion whether to recommend authorizing the Pfizer-BioNTech coronavirus vaccine for children 5 to 11 years old, which could open the way to inoculating 28 million children in the United States.
An evaluation of data released by regulators on Friday from a clinical trial showed that Pfizer’s vaccine was very effective at preventing symptomatic Covid-19 in children in that age range, and that the vaccine’s benefits outweighed the risk of rare side effects. Experts will almost certainly raise concerns about those side effects in the meeting.
More needs to happen at the F.D.A. and the Centers for Disease Control and Prevention before children 5 to 11 will be able to receive the vaccine. But if both federal agencies rule in favor, the children could become eligible for shots in the first week of November.
Here’s what comes next.
At the F.D.A.
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The panel of experts advises the F.D.A., part of the federal Department of Health and Human Services, whether to authorize the vaccine for children 5 to 11.
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The F.D.A. considers the advisory panel’s recommendation. The panel’s votes are not binding, but the F.D.A. typically follows them.
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Dr. Janet Woodcock, the acting commissioner of the F.D.A., issues the agency’s final decision, usually within a few days of the advisory committee’s meeting.
At the C.D.C.
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An advisory panel to the C.D.C., the United States’ public health agency, reviews the F.D.A.’s decision and makes recommendations. That panel is scheduled to meet to consider the issue next week.
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The C.D.C. considers its panel’s recommendations, which are not binding, though the agency usually follows them. There was a rare exception in September, when Dr. Rochelle P. Walensky, the director of the C.D.C., endorsed Pfizer-BioNTech booster shots for frontline workers even though the C.D.C.’s panel had not recommended the step. That move by Dr. Walensky aligned the C.D.C.’s guidance with the F.D.A.’s authorization.
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Dr. Walensky issues the agency’s guidance, which is powerfully influential for states, the general public and health care institutions and professionals.
In the states
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State health departments generally follow the recommendations of the C.D.C.
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Federal officials have said that if pediatric doses of the Pfizer-BioNTech vaccine are authorized, 15 million doses of vaccine will immediately be shipped to the states for distribution.
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What Happens Next as F.D.A., C.D.C. Weigh Covid Shots for Children - The New York Times
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