FDA Committee Votes In Favor Of COVID-19 Vaccine For 5 To 11-Year-Olds
FRISCO, Texas (CBSDFW.COM) - A COVID-19 vaccine for children ages 5 to 11 has cleared one of its final hurdles.
In a nearly unanimous vote, an FDA advisory committee Tuesday, Oct. 26 found the benefits of Pfizer's pediatric vaccine outweighed any risks.
A CDC committee is scheduled to vote on its recommendations next week, and the vaccine could be available days later.
The decision was a difficult one for members of the FDA's Vaccine and Related Biological Products Advisory Committee, though, and one member of the 18-person committee abstained from voting.
"It's always nerve-wracking I think when you're asked to make a decision for millions of children based on studies that have only a few thousand children," said Dr Paul Offit who ultimately joined others in voting to green light the vaccine.
According the CDC, COVID-19 is currently the 8th leading cause of death for children between 5 and 11 years old, and clinical trials found the vaccine to be more than 90% effective against it.
The most common side effect was a sore arm. FDA advisors, though, worried about a far more rare, but more serious condition, myocarditis, swelling of the heart muscle.
None of the children in the Pfizer study for 5 to 11 year olds developed it. In rare case, though, vaccinated adolescents have, particularly teen boys.
"The rate of getting that very same condition after getting COVID is much much higher than it is after getting the vaccine," said Dr. Seth Kaplan, a Frisco pediatrician and former president of the Texas Pediatric Society.
COVID-19 patients who develop myocarditis, he said, also often take months to recover, whereas those who develop it after the vaccine generally return to normal within a week.
He's confident, he says, in the FDA's decision.
"Everything points toward this being a safe and effective vaccine for kids," said Kaplan.