FDA Approves COVID Vaccine for Children Under 5

Infants and toddlers can receive both the Pfizer and Moderna vaccine as of Friday.

The U.S. Food and Drug Administration June 17 approved the vaccines for children as young as 6 months.

“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 Dr. Peter Marks, 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.” 

The Moderna vaccine consists of a series of two doses taken one month apart, with a third dose available for the immunocompromised. Pfizer’s vaccine consists of three total doses, with the first two doses administered three weeks apart, and the last dose administered eight weeks later.

“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 provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Dr. Robert M. Califf. “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.” 

In other news:

  • UT Southwestern’s infectious diseases experts advise that individuals should weigh their personal health and risk levels when deciding whether to receive a second booster. You can read more here.
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