What Happens Next as F.D.A., C.D.C. Weigh Covid Shots for Children
The Food and Drug Administration itself will make a decision, and then a similar process happens at the Centers for Disease Control and Prevention.
Now that the F.D.A. panel has recommended pediatric Covid shots, here’s what happens next.
Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention, will issue the agency’s guidance, which is powerfully influential for states and the general public.Credit…Pool photo by Jim Lo Scalzo
Oct. 26, 2021, 8:40 a.m. ET
An independent committee of experts advising the Food and Drug Administration met on Tuesday and voted to recommend authorizing the Pfizer-BioNTech coronavirus vaccine for children 5 to 11 years old, opening 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.
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.
The F.D.A. considers its advisory panel’s recommendation. The panel’s votes are not binding, but the F.D.A. typically follows them.
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.
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.
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.
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
State health departments generally follow the recommendations of the C.D.C.
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.