Pfizer, Moderna expand vaccine trials for children per FDA request

After being urged by the FDA, Pfizer and Moderna are expanding the number of participants in their clinical trials testing COVID-19 vaccines in children, The Washington Post  reported July 26.

Federal regulators have requested that the drugmakers expand their trials so the vaccines are tested in several thousand children who are ages 5 to 11, although the exact number of children the FDA is asking them to enroll is unclear, according to The Washington Post

An anonymous federal official told The Washington Post the FDA could grant emergency use authorization for COVID-19 vaccines' use in children 5 through 11 by late October or early November. They also said the government is not expecting enrolling more children to be an issue, as many parents are eager to get their children vaccinated against COVID-19.

In June, Pfizer said it hopes to apply for FDA approval for its vaccine's use in children ages 5 to 11 in September. A Moderna spokesperson told The New York Times July 26 the drugmaker would be ready to seek emergency authorization for its COVID-19 vaccine's use in this age group in the winter or 2021 or early 2022.

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars

>