Pfizer Shot for Kids May Not Be Here Until November

Drugmaker has submitted data to FDA
By Newser Editors and Wire Services
Posted Sep 28, 2021 7:27 PM CDT
Pfizer Submits Data to FDA on Vaccine for Kids 5 to 11
A certified medical assistant prepares doses of the Pfizer COVID-19 vaccine at a vaccination center at the University of Nevada.   (AP Photo/John Locher, File)

Pfizer has submitted research to the Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children, but the shots may not be available until November. The company said Tuesday it provided health regulators with data from a recent study of its vaccine in children 5 to 11 years old. Officials had said previously they would file an application with the FDA to authorize use in the coming weeks. Once the company files its application, US regulators and public health officials will review the evidence and consult with their advisory committees in public meetings to determine if the shots are safe and effective enough to recommend use, the AP reports.

That process may mean the shots may not be available until closer to Thanksgiving instead of by Halloween as earlier hoped, according to an AP source familiar with the process but not authorized to discuss it publicly. But it is possible that, depending on how quickly the FDA acts, the shots could become available earlier in November, the person said. The drugmaker and its partner, Germany’s BioNTech, say they expect to request emergency use authorization of their vaccine in children ages 5 to 11 "in the coming weeks." The companies also plan to submit data to the European Medicines Agency and other regulators.

Around 100 million people in the US have been fully vaccinated with Pfizer's two-dose vaccine. Pfizer tested a lower dose of the shots in children. The drugmaker said last week that researchers found the vaccine developed coronavirus-fighting antibody levels in children that were just as strong as those found in teenagers and young adults getting regular-strength doses. Moderna is also studying its shots in elementary school-aged children. Results are expected later in the year. Asked Tuesday when the Pfizer shot might be cleared for children, chief executive Dr. Albert Bourla said regulators should take as long as they think is appropriate to review the data, the New York Times reports. He said authorization by Halloween is "one of the options, and it’s up to the FDA."

(More Pfizer stories.)

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