Pfizer asks FDA to OK COVID-19 vaccine for under 5s

Pfizer asks FDA to OK COVID-19 vaccine for under 5s

Pfizer Inc. said Wednesday that it has asked the U.S. Food and Drug Administration to approve the emergency use of its COVID-19 vaccine in children younger than the age of 5 years.

The company said in a statement that it has provided the agency with data from a phase 2/3 trial that included almost 1,700 who received a third dose of the vaccine when omicron was the dominant variant.

The trial showed that the vaccine triggers a strong immune response and is safe. A month after the third dose, antibody levels in the children were similar to those seen in 16- to 25-year-olds after two doses, according to the company. At midtrial, the vaccine was 80.3 percent effective in preventing symptomatic COVID-19. The findings were released May 23, but they have not yet been peer-reviewed or published in a medical journal.

The children in the trial received three 3-mcg doses, with the first two doses given three weeks apart= and the given at least two months after the second dose. The doses for children ages 6 months to 5 years are smaller than those in older groups. Children ages 5 to 12 years receive two doses of a 10-mcg vaccine, and people 12 years and older are given two doses of a 30-mcg vaccine. Both groups are eligible for booster doses, CNN reported.

Children younger than 5 years are the only age group in the United States not eligible for COVID-19 vaccination. In late April, Moderna provided the FDA with trial data on the use of its COVID-19 vaccine in children ages 6 months to 5 years. An FDA panel of vaccine experts is set to meet on June 15 to discuss both the Moderna and Pfizer requests for the emergency use of COVID-19 vaccines among these .


Explore further

Pfizer seeks FDA approval of COVID-19 boosters for children ages 5 to 11

More information: CNN Article

© 2022 HealthDay. All rights reserved.

Citation: Pfizer asks FDA to OK COVID-19 vaccine for under 5s (2022, June 3) retrieved 2 October 2022 from https://medicalxpress.com/news/2022-06-pfizer-fda-covid-vaccine-5s.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
5 shares

Feedback to editors