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Report: COVID vaccines for kids 5-11 could be approved by end of October

Pfizer has been conducting clinical trials of its two-dose vaccine for children since March 2021.

WASHINGTON — Pfizer Inc. is expected to turn over its clinical study that researched the coronavirus vaccine in kids to the Food and Drug Administration, the Associated Press reports.

The FDA Vaccine Chief, Dr. Peter Marks said he is hopeful that vaccinations for kids ages 5 to 11 years old will be underway by the end of the year.

Sunday, the former FDA Commissioner Dr. Scott Gottlieb predicted that the agency will authorize Pfizer's COVID-19 vaccine for emergency use in children by the end of October, CBS News said. Gottlieb now serves on Pfizer's board of directors.

During an interview with "Face the Nation," Gottlieb said Pfizer will have the study data before the end of September, "so they'll file very quickly with the FDA." Once it's filed, the FDA said it will take a matter of weeks, not months, to determine if it will authorize the vaccine for kids ages 5 to 11. 

Gottlieb said he interprets that to be between four and six weeks before the FDA makes the final decision. If given the green light, that could mean children will be eligible for a first Pfizer vaccine dose before Halloween.

In an interview with the Associated Press, Dr. Marks said the FDA will not cut corners when determining the authorization for children.

Pfizer began studying the COVID-19 vaccine for children 6 months to 11 years old in March 2021.

While COVID-19 vaccines for adults have been available since January 2021, the vaccine for children takes longer due to a few major factors, the Cleveland Clinic says.  

When the coronavirus emerged in 2019, kids weren't involved in the original adult clinical trials because, according to data, children didn't produce the same severe illness from the virus the way adults did. However, research shows that some kids have developed serious illnesses linked to the coronavirus, the CDC reports

The Cleveland Clinic also said there are more layers to involving children in clinical trials since kids are not allowed to make decisions for themselves. It often takes the child and both parents to agree to participate in a trial.

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