Pfizer Asks FDA to OK COVID Vaccine for Youngest Kids

THURSDAY, June 2, 2022 (HealthDay News) -- 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 under the age of 5.

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 children who received a third dose of the vaccine when Omicron was the dominant variant.

The trial found that the vaccine triggered 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 mid-trial, the vaccine was 80.3% 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 The findings were released May 23, but they have not yet been peer-reviewed or published in a medical journal.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-microgram doses, with the first two doses given three weeks apart, and the third dose 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 5-12 receive two doses of a 10-microgram vaccine, and people 12 and older are given two doses of a 30-microgram vaccine. Both groups are eligible for booster doses, CNN reported.

Vaccine developers have been careful to adjust the dose for younger children to get "a good effect with a minimum of side effects," explained Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University School of Medicine.

"We're thinking of this as a three-dose vaccine, and the preliminary data acquired during the Omicron era say it's actually 80% effective," Schaffner told CNN. "We will want to look at that very carefully, but so far, that's good news."

Children younger than 5 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 Moderna and Pfizer's requests for the emergency use of COVID vaccines among these younger children.

More information

Visit the U.S. Centers for Disease Control and Prevention for more on COVID vaccines for children.