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Vaccine for children under 5 delayed so FDA can review data on 3rd dose

February 12, 2022

Editor’s note: For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19.

The Food and Drug Administration (FDA) on Friday postponed a Feb. 15 meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the Pfizer-BioNTech COVID-19 vaccine for children ages 6 months to 5 years and said the meeting likely will occur later this spring.   

FDA officials said the delay will allow more time to review data on a third dose and help decide whether three doses should be considered as part of its decision on emergency use authorization (EUA).

In a press release issued today, Pfizer said its independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well-tolerated and support a potential three-dose regimen.

In December, Pfizer and BioNTech said their two-dose series with a 3-microgram (µg) dosage did not meet non-inferiority criteria for those ages 2-4 years, leading the company to begin studying a third dose for all young children that would be given eight weeks after the second dose. At the FDA’s request, however, the company submitted an application for an EUA for the first two doses on Feb. 1, with hopes vaccinations could begin sooner.

“Since the early days of the pandemic, we’ve always followed the science in this everchanging situation,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said during a press conference. “Data has come in so rapidly and we need to be able to look through the data. It makes sense for us to wait until we have the data from the evaluation of a third dose before taking action.”

Three-dose protection data are expected to be available by early April, Pfizer said. Dr. Marks said the FDA is committed to moving “rapidly” once Pfizer submits a request for EUA.

“We know many families are eager to offer this protection to their children and feel frustrated by the need for additional study,” said AAP President Moira A. Szilagyi, M.D., Ph.D., FAAP. “A careful, robust and transparent process to evaluate the evidence for the vaccine in this age group is essential in order for parents to have confidence in offering the vaccine to their children, and AAP is committed to a thorough review of the data.” 

Dr. Marks agreed.

“We take our responsibility for reviewing these vaccines very seriously because we’re parents as well, and in looking over the data, I think parents can feel reassured that we have set the standard by which we feel that if something does not meet that standard, we can’t proceed forward,” Dr. Marks said.

In the meantime, the AAP encourages families to continue to mask, including at school, and to vaccinate everyone who is eligible now.

“This virus is still infecting children, and there’s a need to make sure all children are protected, including the youngest children who are still unable to be vaccinated,” said Dr. Szilagyi. “This is a challenging time for families who hear different messages about COVID-19 risks in the media or from public officials. Parents should seek advice from their pediatrician about what’s best for their child."



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