FDA Panel Votes To Back Pfizer's COVID-19 Vaccine For Kids 5-To-11
WASHINGTON (CBS) - The first COVID-19 vaccine for children under 12 earned the backing of a Food and Drug Administration advisory panel on Tuesday.
Seventeen members of the committee voted in favor of authorizing the shots, and one abstained, CBS News reported. The FDA still needs to decide to formally authorize the vaccine for young children.
"I do think we need it as a tool in our armamentarium for high risk children, for equity issues, for parents who really would like to protect their children, and because of the long term, very profound implications of schools being disrupted," Dr. Mark Sawyer, one of the panel's members, said ahead of the vote.
Early data from Pfizer shows their pediatric shot, which is a smaller dose, is more than 90 percent effective at preventing symptomatic cases of coronavirus.
Children are less likely than adults to get seriously ill from Covid-19, but hospitalizations and deaths have occurred among this age group.
"This afternoon, I really want to assure the public, how carefully these experts considered the data before voting. There is a lot of spirited debate, they don't always agree with each other," said Dr. Mallika Marshall. "In the end, the voting members really had only one question to consider, that is do the benefits of the vaccine outweigh the risks in this age group, and based on current data available, almost everyone said yes."
One panel member abstained from voting.
Pfizer says its trials showed mostly mild side effects and no cases or myocarditis, a type of heart inflammation that has been reported after the mRNA vaccines.
"I've had a chance to look at some of the materials they're going to be reviewing," Dr. Shira Doron, an infectious disease expert at Tufts Medical Center, told WBZ-TV. "I think the key pieces to that is an extensive risk benefit analysis that was done for this age group. Looking at the known adverse events in particular, the myocarditis which has been seen in younger individuals moreso males than females, and comparing that with a risk of a hospitalization due to Covid-19."
Even if the FDA approves emergency use of Pfizer's vaccine, the Centers for Disease Control and Prevention still has to sign off on it next week. If that happens, then children ages 5 to 11 could start getting the shot by the end of next week.
