FDA approves Pfizer, Moderna COVID-19 vaccines for children as young as 6 months

This May 2022 photo provided by Pfizer shows production of the Pfizer's COVID-19 vaccine for children under 5 in Puurs, Belgium. U.S. regulators on Friday, June 17, authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week. (Pfizer via AP)

This May 2022 photo provided by Pfizer shows production of the Pfizer’s COVID-19 vaccine for children under 5 in Puurs, Belgium. U.S. regulators on Friday, June 17, authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week. (Pfizer via AP)

OAN NEWSROOM
UPDATED 2:15 PM PT – Friday, June 17 2022

The Food and Drug Administration authorized both Pfizer and Moderna’s COVID-19 vaccines for children as young as six-months-old. The agency announced its approval of the vaccines in a press release Friday. They asserted they found them to be both safe and effective.

FDA officials said the vaccines will provide younger children with “protection from the most severe outcomes of COVID-19, such as hospitalization and death.” They determined that the known and potential benefits of the COVID-19 vaccines outweigh the known and potential risks in the pediatric populations.

“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,” said FDA Commissioner Robert M. Califf, M.D. “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.  Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

However, the drugs still must be approved by the CDC’s vaccine advisement panel, which is set to vote on the issue Saturday. 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. The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose.

“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 that supports the authorization of these two vaccines for pediatric populations.”

If fully approved, the White House expects vaccinations to start as early as Tuesday.

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