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FDA authorizes Moderna and Pfizer COVID-19 vaccines for children down to 6 months of age

FDA authorizes use of Pfizer and Moderna vaccines for children 6 months and younger
Posted at 3:28 PM, Jun 17, 2022
and last updated 2022-06-17 18:39:37-04

LAS VEGAS ( KNTV) — The U.S. Food and Drug Administration has authorized the emergency use of Moderna and Pfizer-Bio-Tech COVID-19 vaccines to prevent the virus in children down to six months of age.

Moderna vaccine amended the use of the vaccine in individuals aged six months to 17 years old. According to the FDA, the vaccine has been authorized for adults 18 years of age.

The Pfizer-BioNTech amended the use of the vaccine now includes individuals six months to 4 years old. According to the FDA, the vaccine has been authorized to benefit individuals five years old and older.

The agency determined the potential benefits of the Moderna and Pfizer-BioNTech vaccines outweigh the potential risk for pediatric populations for the use of each vaccine.

RELATED: Health officials prepare for FDA approval of pediatric COVID-19 vaccines

“Many parents, caregivers, and clinicians have been waiting for a vaccine for younger children, and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will protect them from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D.

The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”