FDA Delays Action on Pfizer Vaccine for Kids Under 5

Aaron Gould Sheinin

February 11, 2022

The FDA said Friday it would delay a decision on authorizing the use of the Pfizer vaccine for younger children until data on the effects of three doses is available.

Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, said the plan for a meeting next week of the FDA’s Vaccines and Related Biological Products Advisory Committee was to “understand if two doses would provide sufficient protection to move forward.”

Pfizer has asked the FDA to authorize the use of its mRNA vaccine for children under the age of 5. But, Marks said, “in looking through the data we realized now … that at this time it makes sense for us to wait until we have the data of the evaluation of a third dose before taking action.”

In response to a question, Marks said the decision should be reassuring for parents and the public.

“If we feel something doesn’t meet (our) standard, we can’t go forward,” he said. “Rather than an issue of having anyone question the process, I hope this reassures people that the process has a standard.”

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, predicted in January that the Pfizer vaccine for younger kids could be available this month. But, he also predicted three doses would be required.

Pfizer announced in mid-December that it planned to submit data to the FDA during the first half of 2022 if the three-dose study was successful. At that time, Pfizer said it didn’t identify any safety concerns with the 3-microgram dose for children ages 6 months to 4 years, which is much lower than the 30-microgram dose given to adults.


News briefing, FDA, Feb. 11, 2022.


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