Pfizer: COVID Vaccine Makes the Grade in Younger Kids

A lower dose of the Pfizer/BioNTech COVID-19 vaccine was safe and produced an immune response in children ages 5 to 11 years, according to topline data released by the companies on Monday.

Data from 2,268 children ages 5 to 11 in a phase II/III trial found that a two-dose regimen of 10 μg, administered 3 weeks apart, produced an immune response in this age group comparable to the 30 μg dose in individuals ages 16 to 25.

The vaccine was also well tolerated, with Pfizer noting similar side effects in the younger age group compared with older individuals.

Pfizer said it plans to submit the “full results” to a peer-reviewed journal, as well as to the FDA for emergency use authorization, and will continue to collect “the safety and efficacy data required to file for full FDA approval in this age group.”

Pfizer Chairman and CEO Albert Bourla noted in a statement that pediatric cases of COVID-19 rose 240% in the U.S. since July, and added that the Delta variant poses a “substantial threat” to children.

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Ugur Sahin, MD, PhD, CEO and co-founder of BioNTech.

The full phase II/III study enrolled 4,500 children ages 6 months to 11 years in the U.S., Finland, Poland, and Spain. Pfizer said SARS-CoV-2-neutralizing antibody geometric mean titers in kids ages 5 to 11 were non-inferior to those ages 16 to 25, who were used as a control group, at 1 month following the second dose.

Pfizer said that based on the results of the phase I dose-escalation part of the study, children under age 5 received a 3 μg dose for each injection.

The Pfizer/BioNTech vaccine (Comirnaty) is approved for individuals ages 16 and up, and authorized for individuals ages 12 to 15. FDA action on the company’s application for a third booster dose for either high-risk groups or all individuals ages 16 and up is expected shortly.

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    Molly Walker is deputy managing editor and covers infectious diseases for MedPage Today. She is a 2020 J2 Achievement Award winner for her COVID-19 coverage. Follow








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