(NEXSTAR) — School-aged children could be fully vaccinated before the start of 2022 if Pfizer and its German partner BioNTech get approval to administer the shots to children as young as 5 years old under emergency use authorization.
Pfizer officially asked the Food and Drug Administration for clearance after testing a lower dose vaccine – about a third of the standard dose given to adults – on elementary school children, according to the Associated Press. After their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults, Dr. Bill Gruber, a Pfizer senior vice president, told the AP.
So what happens now? While there is no set timeline for the emergency use authorization approval, we do know that the initial EUA for adults was submitted in November 2020 and approved for Americans 16 and older on Dec. 11. Additional studies allowed the companies to request a drop in the age threshold to 12 in early April of this year. That approval was granted a month later.
The FDA’s advisers are scheduled to debate the evidence on Oct. 26, the AP reports. A decision could follow within days.
“For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine,” the FDA said of the emergency use vetting process.
The FDA has provided an overview of the emergency use authorization process on its website.
The Pfizer-BioNTech vaccine is the lone vaccine to move past the EUA and earn full approval from the FDA. The two-shot Moderna and single-shot Johnson & Johnson vaccines remain under emergency use authorization for older age groups. Moderna is also studying its shots in elementary school-aged children.
It remains to be seen how quickly parents will rush to get their children vaccinated once the lower dose injections are approved. As of last week, 56% of eligible children between the ages of 12 and 17 had received at least one vaccine dose, according to the American Academy of Pediatrics.
Rare instances of heart inflammation have been reported with mRNA vaccines, such as Pfizer’s, but the AP reports that the company’s lower dose study of 2,268 kindergartners and elementary school-aged kids isn’t large enough to detect such extremely rare side effects.
As of Sept. 30, 5.9 million children had tested positive for coronavirus, according to the AAP. Nearly 850,000 children tested positive over the last four weeks of September.
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