Pfizer set to request emergency approval of COVID-19 vaccine for children younger than 5

U.S. regulators are planning to review and authorize Pfizer and BioNTech’s COVID-19 vaccine for children younger than 5 before data on a third — and potentially necessary — shot is available.

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The decision is a bid to jump-start vaccination among the youngest Americans by the end of February as the country attempts to return to normalcy.

The drugmakers are expected to apply for emergency authorization of a two-shot regimen as soon as Tuesday while the company gathers data on a three-dose course.

This way, shots could be approved sooner for children from ages 6 months to 5 years, giving the U.S. a head start on the rollout while data on an additional dose rolls in through late March, according to The Washington Post, which first reported the timeline.

The vaccines being studied in young children use one-tenth of the dose in existing jabs and proved to be safe in trials.

The two-dose course seemed effective in infants up to age 2 but not in children ages 2 to 5, so the companies are testing a third shot to see if it can combat the highly transmissible variants, akin to the boosters in adults.

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Pfizer declined Tuesday to say when it planned to file its request but Mark McClellan, a former Food and Drug Administration commissioner, said he expects the agency to pore over trial data in Pfizer’s application imminently and authorize another dose later on.

“It’s going to take a few weeks for FDA to go over it very, very carefully and thoroughly,” he said Tuesday in a webinar hosted by Duke University.

“I do expect FDA to keep looking at the data there. And just like we’ve seen in other age groups probably authorize a booster dose a couple of months after that second dose that would be considered right now,” he said.

It’s unclear how eager parents will be to vaccinate the youngest children, an age group that accounts for around 0.1% of COVID-19 deaths. The rollout of shots for kids ages 5 to 11 started hot in November but slowed dramatically, resulting in slightly less than a third of children in this age group getting at least one dose.

Uptake in the 5-11 age group ranges greatly by state, with 63.1% of children ages 5 to 11 in Vermont receiving at least one dose compared to 11.2% in Mississippi, according to the Kaiser Family Foundation.

Yet some parents say they’re eager to vaccinate the youngest children, who are the only Americans ineligible for the shots, heaping pressure on President Biden and his administration to start the rollout.

“It will come,” Mr. Biden said at a press conference marking his first year in office. “I can’t tell you when. But it is really very important that we get to that.”

The administration considers widespread vaccination as key to pushing the virus into the background and getting back to normal, yet there are nearly 20 million Americans who are younger than 5 and ineligible for shots right now.

Roughly 68% of eligible Americans aged 5 and older are fully vaccinated.

The American Academy of Pediatrics said pediatric cases of the virus surged during the omicron wave, including over 808,000 child cases in the week ending Thursday, or triple the peak level during the delta wave.

Children accounted for 1.6%-4.4% of total hospitalizations, while 0.1%-1.5% of all child COVID-19 cases resulted in hospitalization in the 24 states, plus New York City, that reported data to the academy.

The 0-to-4 age group accounts for 392 deaths, or 0.1% of COVID-19 deaths overall, according to Centers for Disease Control and Prevention data that is available for about 750,000 of the 886,000 U.S. deaths that have occurred.

Panagis Galiatsatos, assistant professor at Johns Hopkins School of Medicine in Baltimore, said infections and cancers typically afflict the elderly more than children but that any pediatric death is cause for alarm, so society should push to prevent them if they can.

“The COVID vaccine is by far the right move, and a move made that is consistent with how we approach pediatric-related diseases,” the doctor said. “Do I see parents clamoring for it? Of course — those with kids under 5 live in a very different world than those with [vaccine-eligible] kids. So yes, I do seem them asking a lot.”

For its part, Pfizer early Tuesday declined to confirm reports that a filing was imminent.

“At this time, we have not filed a submission and we’re continuing to collect and analyze data from both two and three doses in our younger age cohort. As part of our ongoing commitment, we will share new updates as they become available,” the company said.
Dr. Scott Gottlieb, a former FDA commissioner who sits on Pfizer’s board, said Sunday that regulators were trying to speed up the process.
“I’m hopeful that you could see some movement on trying to entertain that application earlier,” he said on the CBS show “Face the Nation.”

“Ultimately, the decision resides with FDA, but there is some indication that there may be an early reaction on that application.”
He said it is clear that vaccination will not protect people from any infection at all but said two doses might build up enough immunity to stave off severe disease in kids in the near term.

“If the goal of the vaccine is to get baseline immunity in the kids to prevent really bad outcomes, and you’re really not using the vaccine as a tool to prevent infection in the first place — two doses could do that,” Dr. Gottlieb said. “Getting two doses into a child can provide baseline immunity that protects them from severe disease.”

For more information, visit The Washington Times COVID-19 resource page.

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