Pfizer vaccine data for ages 5 to 11 shared with FDA for initial review

Data from Pfizer and BioNTech’s COVID-19 vaccine trial for children between 5 and 11 years old has been shared with the U.S. Food and Drug Administration for an initial review, the companies announced Tuesday.

Pfizer and BioNTech said they made the submission after their Phase 2/3 trial showed the vaccine produced a “robust neutralizing antibody response” among kids in that age group and had a “favorable safety profile.”

A request for emergency use authorization of the vaccine for kids aged 5 to 11 is “expected to follow in the coming weeks,” according to Pfizer and BioNTech.

Pfizer and BioNTech said 2,268 participants in the age group were included in the trial, which involved two doses of 10 micrograms.

“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 30 μg doses,” the companies said in Tuesday’s announcement.

“The 10 μg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age.”

Dr. Anthony Fauci laid out a possible timeline that kids between 5 to 11 years old could get vaccinated, saying Tuesday on MSNBC’s “Morning Joe” that the FDA takes “the importance of getting vaccines shown to be safe and effective in children” seriously.

“I would imagine in the next few weeks they will examine that data and hopefully they’ll give the OK so that we can start vaccinating children, hopefully before the end of October,” the infectious diseases expert said.

People aged 12 and up are currently eligible to receive the Pfizer vaccine in the United States.

Pfizer and BioNTech also plan to submit data from its 5-11 age group trial to the European Medicines Agency and regulatory groups, the companies said.