17 out of the 18 members of an advisory panel to the Food and Drug Administration (FDA) voted to amend Pfizer’s Emergency Use Authorization to include kids as young as 5 years old Tuesday. The Pfizer vaccine is currently recommended for everyone 12 years and up.
The video above shows clips from Tuesday’s panel debate.
According to details of a Pfizer study posted online last Friday, child-sized doses of the Pfizer COVID-19 vaccine were shown to be over 90% effective in preventing symptomatic COVID-19 infections in kids 5-11 years old. In the study, which tracked 2,268 kids in the 5-to-11 age group, kids who got the vaccine only received a third of the dose given to teens and adults.
The kid-sized dosage also proved safe, with similar or fewer temporary side effects to what teens experience. The study isn’t large enough to detect any extremely rare side effects, like the heart inflammation that occasionally occurs mostly in young men and teen boys after the second dose. However last week, FDA reviewers said protection would “clearly outweigh” the risk of those rare side effects.
While children are at lower risk of severe COVID-19 than older people, kids in the 5-to-11-year-old age group still have faced substantial illness.
“There have been over 1.9 million infections, over 8,300 hospitalizations, about a third of which have required intensive care unit stays, and over 2,500 cases of multisystem inflammatory disorder from COVID-19. And there have also been close to 100 deaths, making it one of the top 10 causes of death in this age range during this time,” FDA Deputy Director Doran Fink said at the beginning of Tuesday’s meeting. “In addition, infections have caused many school closures and disrupted the education and socialization of children.”
Also at the beginning of the panel meeting, FDA vaccine chief Peter Marks acknowledged the topic of vaccinating kids was a sensitive one.
“I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public, both for and against the use of the Pfizer-BioNTech vaccine under emergency use authorization for this age group of five to 11-year-old children,” Marks said. “To be clear, today’s discussion is going to be about the scientific data that are presented, and it’s not about vaccine mandates which are left to other entities outside of FDA.”
If the FDA takes the panel’s advice and authorizes the kid-sized doses, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots, as well as who should get them.