The Food and Drug Administration postponed its meeting to discuss authorizing the Pfizer-BioNTech COVID-19 vaccine for children under 5 years old after the companies said they wanted to wait until additional clinical trial data on a third dose became available.
The delay means that the vaccine will not be available for young children until April at the earliest.
The clinical trial data to support the authorization of a three-dose regimen had been missing results from administering the third dose, though the FDA was controversially slated to debate expanding the authorization to this age group regardless.
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“Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic … and evaluating these initial data have been useful in our review of these vaccines,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research. “But, at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered.”
Children 6 months through 4 years old are the only age group for whom COVID-19 vaccines have not been authorized, with the exception of infants. Pfizer-BioNTech had initially tested a two-dose regimen for children but said in December that adding a third dose would be necessary to prompt an immune response.
Parents concerned about their unvaccinated children, particularly now that in-person schooling and daycare have returned, are expected to be frustrated by the delay. But Marks said the change to consider more clinical data should give parents some comfort.
“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,” Marks said. “Rather than having any issue of causing anyone to question the process, I hope this reassures people that … we follow the science.”
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Parents of young children are increasingly willing to get them vaccinated as soon as the shots are deemed safe and effective by the FDA. About 31% of parents whose children are under 5 said they will get their children vaccinated right away, up from 20% last July, according to Kaiser Family Foundation polling. Another 29% said they will “wait and see” before getting their child under 5 vaccinated, down from 40% in July.
Still, parents’ eagerness to vaccinate their children should not be overstated. Slightly over 31% of children 5 to 11 have received at least one dose, while just 28% have been fully vaccinated, according to federal data. Children are at a far lower risk of getting seriously ill due to a COVID-19 infection than seniors and adults with underlying health conditions.
The companies expect to have additional data on third doses of the vaccine by April, pushing back the FDA panel of vaccine experts’ Tuesday meeting to a new unknown time.
“What we’re dealing with is taking the approach that we very much should take as a public health agency, which is to constantly take in the data that comes to us and adjust to that, so what we’re doing now is adjusting to this. And yes, some of this was late-breaking, but that’s what our job is,” Marks said.
The agency’s decision to accept clinical trial data from Pfizer-BioNTech on a rolling basis sparked controversy because of worries that it was sidelining science for the sake of getting shots in arms quicker. The FDA went on the defensive, with spokesman Michael Felberbaum insisting that “nothing has changed about our process for evaluating COVID-19 vaccines and we are not changing our rigorous scientific standards.”
