(NEXSTAR) – Fall has brought anxiety for parents and students across the country as children return to the classroom without the protections of a COVID-19 vaccine, but the option to get children as young as five fully vaccinated may not be far away.
On Monday, Pfizer said it's prepared to seek emergency authorization for children ages 5 to 12. That's the same clearance that allowed millions of adult Americans to opt for injections in the winter and spring.
Pfizer decided to make the move 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.
Gruber said Pfizer and German partner BioNTech aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.
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 of 2020 and approved for Americans 16 and older on December 11th. 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.
"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 says of the emergency use vetting process.
If the companies do submit within the month, a similar approval timeline could allow vaccinations for elementary school children in time for the holidays.
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, 54% 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 inflamation 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 September 9th, 5.3 million children had tested positive for coronavirus, according to the AAP. The Washington Post reports 20,000 child hospitalizations and 460 deaths since the start of the pandemic.
The Associated Press contributed to this report.
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