The move is a key step toward beginning vaccinations for youngsters, but authorization for COVID vaccines in kids under 12 is likely still weeks away.
Pfizer and its German partner BioNTech said in a joint release that formal submission to request emergency use authorization of the companies' vaccine for this age group is expected to follow in the coming weeks. They also plan to make submissions to the European Medicines Agency and regulatory authorities in other countries.
The FDA is expected to take at least several weeks to analyze data collected in a trial that included more than 2,000 kindergartners and elementary school-aged kids.
Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data “hopefully in a matter of weeks” to decide if the shots are safe and effective enough for younger kids.
If the FDA signs off, shots could be authorized for the younger age group by Halloween.
"I would guess at this point that we will have Pfizer vaccine available for 5- to 11-year-olds on that same timeframe that we've been talking about- early November, possibly late October," Chicago Department of Public Health Commissioner Dr. Allison Arwady said last week. "The FDA has said publicly, they are throwing a lot of extra resources at this trying to move this just as quickly as they can. But let me be super clear: everybody wants to see this data - the FDA, the CDC, [CDPH], the public."
The two-dose vaccine is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.
Last week, the Pfizer and BioNTech announced topline results of trial data that found the vaccine to be safe, while prompting a "well tolerated" and "robust" antibody response among the younger, targeted group.
The latest timeline follows earlier predictions from health care experts who said authorization could come this fall for kids under 12.
Dr. Scott Gottlieb, a Pfizer board member, also told CNBC late last month that he expects U.S. drug regulators to clear the Pfizer-BioNTech COVID-19 vaccine for emergency use in children ages 5 to 11 by late fall or early winter.
Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what's the right dose and that it works safely. Cuba recently began immunizing children as young as 2 with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age 3.
Both Moderna and Pfizer have clinical trials underway for their coronavirus vaccines for kids under the age of 12 that have been going on for months.
According to a Pfizer spokesperson, Phases 2 and 3 of their clinical studies were launched in June, testing the vaccine on children between the ages of 6 months and 11 years old.
The results of studies on both vaccines were pushed back when the Food and Drug Administration asked both manufacturers to enroll more children. The request came after reports of myocarditis in some vaccine recipients under the age of 30.
“That really caused the pediatric studies to just slow down a little bit and say 'okay what do we have to do to make sure that this is not going to be a problem,'" Dr. Bill Muller, an associate professor of pediatrics at Lurie Children's Hospital, said. "And I think that really was disappointing for a lot of people who are hoping to have a vaccine in time for school."
When it comes to the current timeline, Muller said Pfizer was expected to seek an emergency use authorization first, as they’ve been ahead of Moderna by several weeks.
While kids are at lower risk of severe illness or death than older people, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant swept through the country.
For elementary school-aged kids, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.
The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said.
“I think we really hit the sweet spot,” said Gruber, who’s also a pediatrician.
Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune “bridging" study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That's what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven't yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo — something that might offer additional evidence.
“AAP is eager to see the FDA review the full set of data as a next step for approval for the 5-11 children’s age group. Pediatricians are well-aware of the power and importance of vaccines. Vaccines have the power to stop epidemics,” said Dr. Lee Savio Beers, AAP President.
Moderna is still studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.