Pfizer to seek FDA EUA for COVID-19 vaccine for 5- to 11-year-olds in coming weeks

Posted at 5:16 PM, Sep 10, 2021
and last updated 2021-09-10 20:36:47-04

SAN DIEGO (KGTV) -- Children as young as five years old may soon get the COVID-19 vaccine. Friday, Pfizer announced that it would submit its clinical trials for their 5 to 11-year-olds to the Food and Drug Administration (FDA) in the coming weeks.

This March, Pfizer began testing 4,500 children in a three-age group trial for their COVID-19 vaccine. The groups include school-age children from five to eleven, pre-school age children from two to five, and infants from six months to two 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. The company said it plans to submit its trials for Emergency Use Authorization (EUA) to the FDA for the 5 to 11-year-old age group first 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," Dr. John Bradley, Infectious Diseases Medical Director at Rady Children's Hospital said.

Friday, the FDA also announced 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. Dr. 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," Dr. 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," Dr. Bradley said.

Bradley believes that the FDA will grant Pfizer the EUA its vaccine for five 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.