The FDA’s panel of vaccine advisers recommended emergency use authorization of Pfizer’s Covid-19 vaccine for children 5 to 11 years old on Tuesday.
The FDA’s Vaccines and Related Biological Products Advisory Committee’s recommendation comes after a vote was held on Tuesday where the panel decided 17-0 (with one abstention) that vaccinating young children was worth the risk.
Despite the big turnout in support of authorizing the vaccine for younger children, doctors and medical experts are not without reservations, as some fear the risk of side effects– especially myocarditis– and are made wary at the prospect of vaccinating millions of children after only running tests on thousands.
“We’ve identified a lower dose which we expect is going to decrease the frequency of the rare side effect of myocarditis,” said Dr. Arnold Monto, who is the chairman of the FDA’s committee.
“I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school and I do not agree with that,” said Dr. Cody Meissner, a professor at Tufts University School of Medicine. “I think that would be an error at this time.”
But Dr. Peter Marks, who leads the FDA’s Center for Biologics Evaluation and Research, doubted that that would transpire.
“Just to reassure the committee, because we are taking an emergency use authorization rather than an approval, in general, although it’s possible that mandates could be put in place, I suppose, in general people have not done mandates with emergency use authorizations and there are certain governors who have already announced that they would not do a mandate until there was an approval as opposed to an emergency use authorization,” Marks said to the committee after their meeting.
Although the committee’s vote has landed on the side of authorization, the FDA itself must make the decision, though historically they follow their adviser’s recommendation.
If the FDA grants the authorization, the Pfizer product would be the very first Covid-19 vaccine to become available to younger children; the vaccine already has full approval for all those 16 and over and was granted an emergency use authorization for all those between 12 and 15.
Pfizer study found its vaccine was safe and effective for younger children
In September, Pfizer publicized its findings from Phase Two of its three trials, showing that the product was not only safe but activated a “robust” antibody response in those aged 5 to 11.
A total of 2,268 volunteer subjects, aged 5 to 11 received a two-dose regimen of the Pfizer inoculation, administered 21 days apart, according to a report from CNN. Unlike the adult doses, however, the trial geared to much younger children used 10-microgram doses, one-third of the amount of vaccine given to all those 12 and up.
Pfizer officials say that they measured the immune responses as seen in the amounts of neutralizing antibodies in participants’ blood, contrasting those levels to what had already been seen in a control group comprised of 16- to 25-year-olds who had received the larger 30-microgram shot series.
The company says that the immunity levels detected in the youngest children were comparable to those seen in the other group, making for a “strong immune response in this cohort of children one month after the second dose.”