Pfizer Submits Data to FDA for 5-12 Year-Old Vaccine Trial

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Brent students are greeted by the Brent bear. File.

On Monday, Pfizer announced that they have submitted data to the US Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to 12 years of age.

It could be a game-changer. But though there is light at the end of the tunnel for elementary-school aged kids, the vaccine still has to make it through a few hurdles before it can be administered to children.

“These results are the first from a pivotal trial of any COVID-19 vaccine in this age group,” Pfizer Chairman and CEO Albert Bourla wrote as he tweeted the announcement. “Our formal submission to request Emergency Use Authorization (EUA) will follow in the coming weeks.”

The Companies announced positive topline results from the pivotal trial on September 20, 2021. Pfizer said that in the trial, which included 2,268 participants from 5 to under 12 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses.

These results – the first from a pivotal trial of any COVID-19 vaccine in this age group – were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with doses of three times the volume.

The trial used a dose of 10 μg (micrograms, or millionth of a gram). Adult dosage is 30 μg. Pfizer said the amount “was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children from 5 to 12 years of age.”

Still Months Before Approval

At a press conference last week, DC Health Director LaQuandra Nesbitt said that despite these hopeful signs, it will still be a while before kids 5 to 12 are lining up to take the shot.

“Let’s be abundantly clear: if Pfizer plans to submit in the coming weeks data to the FDA on the 5-11 population, there are still weeks that FDA has to go to review the data and make a decision,” Nesbitt said. “And I think that’s important to emphaze, so we don’t create the expectation that in a couple of weeks, 5 to 11 year olds will be vaccinated.”

When that time does come, however, Nesbitt said, the District’s outreach to those children will be about their parents. “Getting parents to have confidence in vaccinating their children and recognizing that is the best way to eliminate a lot of the discussions we’re having in terms of disruption of school and in-school time and isolation –it’s the best protection that they’ll have.

Our strategy will be to communicate to parents what that risk is, and how the benefits of vaccination will outway their risks. She said parents generally prefer to go to their pediatricians for this service, so the health care workers will be part of District outreach to families of younger children once the vaccination receives EUA for younger age groups.

In the meantime, she encouraged parents to be patient and stay in touch with their providers. “I’ve been more in the business of expectation management in this job in the last month than ever in my professional career,” Nesbitt said.

See the full Pfizer release here.