Pfizer Has Requested the FDA to Authorize Covid Vaccine for Kids 5-11

Parents are getting more and more anxious about their young children being in school unvaccinated.

Now they may worry a little less as pharma giant Pfizer has asked the FDA on Thursday to authorize its COVID-19 vaccine with BionTech for kids ages 5-11.

It was in September that Pfizer released new data that showed a two-dose regimen of 10 micrograms, a third of the dosage used for teens and adults, is safe and generates a “robust” immune response in a clinical trial of young children.

Pfizer said the shots were well tolerated and produced an immune response and side effects comparable with those seen in a study of people ages 16 to 25.

The vaccines won’t be available until around November if the FDA spends as much time reviewing the data for that age group as it did for 12- to 15-year-olds.

Earlier this year Pfizer and BioNTech requested expanded use of their shot in adolescents on April 9 and were authorized by the FDA on May 10.

A key FDA vaccine advisory group is scheduled to meet on Oct. 26 to discuss Pfizer’s data and the shots could be approved shortly after that meeting.

“I wouldn’t foreclose the possibility that this could be out in October,” said Dr. Scott Gottlieb, who sits on Pfizer’s board and served as FDA commissioner for two years under Trump’s administration.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.