Reports: Pfizer to submit data on vaccine trials for 5- to 11-year-olds to FDA in coming weeks

Posted at 8:13 AM, Sep 13, 2021

SAN DIEGO — Pfizer is close to submitting data from the clinical trials of its COVID-19 vaccine on 5- to 11-year-olds to the Food and Drug Administration (FDA), according to Reuters and CNBC.

In March, Pfizer began testing 4,500 children in a three-age group trial for their COVID-19 vaccine. The groups included school-age children from 5 to 11, preschool-age children from 2 to 5, and infants from 6 months to 2 years old.

Pfizer said the vaccine for school-age kids is the same formula as the vaccine approved for adults, but with a smaller dose. On Friday, reports emerged that Pfizer was preparing to submit data for 5- to 11-year-olds in the coming weeks.

"The FDA wants to see data on the safety and side effects and the immunogenicity, how strong is the vaccine, in the older age group first, before they generally take it down," said Dr. John Bradley, the infectious diseases medical Director at Rady Children's Hospital in San Diego.

The FDA also announced Friday a new standard for pediatric COVID-19 vaccine trials. Clinical trials must include a two-month follow-up period after giving the final dose, where manufacturers monitor the effects of the vaccines. Bradley said that is the time frame for side effects to show up.

"If there's fever, arthritis, myocarditis, any of those, generally [it appears] within the first two months," Bradley said.

Some parents question if vaccines are even necessary for children if the COVID-19 death rate of kids is less than 0.1%. But Bradley said infected children can still spread the virus to higher-risk people like grandparents. He believes vaccinating the youth would get the community back to normalcy.

"I want kids to get back to just being kids and playing with each other. And the key to that is immunization of all children," Bradley said.

Bradley believes that the FDA will grant Pfizer the EUA for its vaccine for 5- to 11-year-olds by next month. He thinks the COVID-19 vaccine will become a required shot for all children like Hepatitis and Tetanus within a few years.

Pfizer's COVID-19 vaccine has already received full approval from the FDA and CDC for everyone aged 12 and up.

This story was originally published by Rina Nakano on Scripps station KGTV in San Diego.