Pfizer asked the FDA to clear its vaccine for kids between 5 and 11. Now what?

John Tlumacki/Globe Staff/file

With children back in school and COVID-19 vaccines still unavailable for those younger than 12, many parents are asking the same question: When will my child be able to get the shot?

Pfizer on Thursday asked the Food and Drug Administration to authorize its vaccine for children between the ages of 5 and 11 for emergency use, paving the way for millions of children to gain protection from the virus within weeks if the shots are cleared. The company last week submitted its clinical trial data on its vaccine in children between the ages of 5 to 11 to the agency.

Both Moderna and Pfizer launched clinical trials of the vaccines for children younger than 12 earlier this year. Moderna has yet to submit its data to federal health officials.

Here’s what we know about when the vaccines might be approved for children younger than 12.

What happens now that Pfizer submitted its request?

A panel of outside experts will convene on Oct. 26 to discuss Pfizer’s vaccine in children 5 to 11.

“With new cases in children in the US continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer said on Twitter when announcing the request.

With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19. pic.twitter.com/5QCRwfYbR5

— Pfizer Inc. (@pfizer) October 7, 2021

The FDA announced it had scheduled the meeting last week in anticipation of Pfizer’s request.

After the FDA’s Vaccines and Related Biological Products Advisory Committee meets, it will issue a recommendation on whether the vaccine should receive emergency use authorization. That will be followed by a clearance decision from the FDA. Then, a CDC committee will issue a recommendation on whether kids 5 to 11 should receive the shots before the go ahead from the director of the CDC. The administration of shots can begin after the CDC director’s approval.

When might Pfizer’s shot get clearance for kids?

A White House official said Thursday that the rollout of shots for children 5 to 11 could begin before Thanksgiving, depending on what the CDC and FDA decide.

“The FDA has scheduled a time to review this with its advisory panel at the end of the month,” White House COVID-19 Coordinator Jeff Zientssaid on CNN Thursday morning. “That would be followed by the CDC’s recommendation. So it’s dependent upon the science, and the medicine, and the FDA and the CDC’s actions, but those are all at the end of the month, and if there is authorization and the CDC recommendation, we are ready. We have the supply, we’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites, so we’ll be ready pending the CDC and FDA action.”

Zients was then asked if the shots could begin to be administered before Thanksgiving.

“Again, up to the FDA and CDC scientific processes, but yes, it could, and we will be ready as soon as the FDA and CDC give the go ahead,” Zients said.

"Vaccine requirements work. They're also good for the economy, and it gets people back into the workplace," White House Covid-19 response coordinator Jeff Zients says.

Current vaccine mandates in place "cover two out of three workers" across the US, he added. pic.twitter.com/Wn820JMTOl

— New Day (@NewDay) October 7, 2021

Where do cases among children stand?

Pfizer’s request to the FDA comes as the American Academy of Pediatrics warned earlier this week that cases among children remain “exceptionally high.”

“The number of new child COVID cases remains exceptionally high,” the group said. “Over 173,000 cases were added the past week, with nearly 850,000 child cases added over the past 4 weeks.”

“Since the pandemic began, children represented 16.2% of total cumulated cases,” the group continued. “For the week ending September 30, children were 26.7% of reported weekly COVID-19 cases (children, under age 18, make up 22.2% of the US population).”

While children can become infected with COVID-19, the group noted that “it appears that severe illness due to COVID-19 is uncommon among children.”

Pressure has been mounting for officials to give the vaccines approval for younger children

As public health officials repeatedly warn that unvaccinated people are at risk for COVID-19 and infections in schools continue to disrupt learning for children who may have been exposed to the virus, experts have been pressing for authorization of the vaccines in children for months.

In a Twitter thread at the end of August , Dr. Ashish Jha, dean of Brown University’s School of Public Health, described why it was urgent for the FDA to move forward with authorizing the vaccines for children.

“I know [the] FDA [is] being very careful about making sure vaccines are safe in kids 5-11,” Jha wrote. “Good. But there is a cost to waiting until every box is checked. Young kids [are] getting infected at very high rates [and] need the protection of vaccines.”

Raises urgency of vaccinating this population

I know FDA being VERY careful about making sure vaccines are safe in kids 5-11

Good

But there is a cost to waiting until every box is checked

Young kids getting infected at very high rates

And need the protection of vaccines

End

— Ashish K. Jha, MD, MPH (@ashishkjha) August 31, 2021

In an August letter to FDA acting commissioner Janet Woodcock, Representatives Ro Khanna and Katie Porter of California requested a briefing on the status of emergency approval on vaccines for children ages 2 to 11. Dozens of members of Congress, including Representatives Jake Auchincloss, Ayanna Pressley, and Lori Trahan of Massachusetts, cosigned the letter.

“As transmission rates increase and schools reopen for in-person instruction, parents need to know when their kids will be able to get vaccinated,” the letter stated.

The @US_FDA seems to be oblivious to the urgency that millions of parents with young kids feel about vaccination. Their communication has been very poor. Parents need a timeline. The FDA has still not responded to 108 members of Congress including @katieporteroc & me. https://t.co/sWzTE33gTh

— Ro Khanna (@RoKhanna) August 25, 2021

The American Academy of Pediatrics also wrote to Woodcock in August urging the agency to “continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible.”

The letter noted that pediatricians and families have been waiting for a vaccine for children under 12, especially with the rise of the Delta variant, which “has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults.”

“In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children,” the letter stated.