Pfizer Asks FDA to Authorize COVID Vaccine for Young Kids

Decision expected between Halloween and Thanksgiving
By Arden Dier,  Newser Staff
Posted Oct 7, 2021 8:57 AM CDT
Pfizer Asks FDA to Authorize COVID Vaccine for Young Kids
A healthcare worker holds a vial of the Pfizer COVID-19 vaccine at Jackson Memorial Hospital in Miami, on Tuesday.   (AP Photo/Lynne Sladky, File)

Pfizer and BioNTech formally requested that the FDA authorize emergency use of a coronavirus vaccine for more than 28 million US children aged 5 to 11 on Thursday, keeping in line with a plan to have the doses available by Thanksgiving. The FDA will now gather its vaccines advisory committee for a meeting on Oct. 26, the New York Times reports, adding a ruling is expected "between Halloween and Thanksgiving." The CDC would then decide whether to recommend the doses, per CNN.

If authorized, this would be the first COVID-19 vaccine for children under 12. The companies propose giving young children a dose one-third as potent as those given to adults. In asking for emergency use authorization, they were expected to present information on how they would manufacture the 10-microgram doses. As the Times notes, "that might require adding more diluent to each injection or using a different vial or syringe." The companies also submitted information from a clinical trial of 2,268 children.

Two-thirds of participants received two 10-microgram doses of vaccine three weeks apart, while the rest received a placebo. The FDA will review the results, which Pfizer says show children developed antibody levels just as strong as 16- to 25-year-olds in a control group, who received two regular-strength 30-microgram doses, per the Wall Street Journal. A survey published last month by the Kaiser Family Foundation found 34% of parents of children aged 5 to 11 would vaccinate their kids as soon as possible, while 32% said they would wait and see how the vaccine performed. (The FDA approved emergency use of the regular-strength Pfizer-BioNTech vaccine for children aged 12 to 15 in May.)

Get the news faster.
Tap to install our app.
X
Install the Newser News app
in two easy steps:
1. Tap in your navigation bar.
2. Tap to Add to Home Screen.

X