The Director of the National Institutes of Health said a COVID-19 vaccine for kids might not be available until the end of 2021
When the COVID-19 vaccine was approved for children over 12, it was a game-changer. And the swiftness with which it happened was a godsend for parents and families everywhere. There had been rumors and rumblings that an approved COVID-19 vaccine for the under 12 set would follow imminently, but the latest update is that it might not be available until the end of 2021.
The FDA recently granted full FDA approval to Pfizer’s COVID-19 vaccine for people 16 and up and the vaccine is still under emergency use authorization for children ages 12-15, but the biggest question mark is when will kids under 12 be able to get the vaccine.
Dr. Francis Collins, director of the National Institutes of Health, said in an interview with NPR’s Morning Edition that Pfizer and Moderna are still doing trials of the vaccine on kids under 12.
Older kids and teens receive the same exact dose of the vaccine that all adults receive, but the concern with the 5 to 11-year-old set is whether or not they need a smaller dose of the vaccine. Dr. Bob Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital told CNN that they’re finding in the studies that kids ages 5-12 get a strong immune response with just a third of the dose that is given to adults, but again — studies are still underway.
Though the data is promising, Collins stated that simply looking at the timeline, if Pfizer submitted its data to the FDA for review by the end of September (as they’ve stated they likely will, assuming all trials go to plan), the actual FDA approval may not come until the end of the year. “I’ve got to be honest, I don’t see the approval for kids — 5 to 11 — coming much before the end of 2021,” he explained.
Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, corroborated those facts and told NBC News that the vaccine makers are still running trials on vaccine efficacy and dose strength, so there’s not much they can do if the vaccine data isn’t submitted to them yet.
“[The FDA will] obviously move swiftly once those data are submitted, but first the trials have to be finished up, or at least the parts of the trials that can be submitted to us have to be finished up, and then the data needs to be submitted to us,” Marks explained. Also, the FDA has asked for four to six months of follow-up safety data from the children’s clinical trials. For comparison, adult vaccine trials only required two months’ follow-up data.
Despite this kinda bummer news about the timeline for kids and the COVID-19 vaccine, the American Academy of Pediatrics, said in a statement Monday that it “has called on the FDA to work aggressively to authorize a vaccine for ages 11 and younger.”
Like all things coronavirus pandemic, it seems — as always — we must take it day by day.