Covid-19 Vaccines For Children Under 5 Approved By FDA

The FDA expanded the authorizations for the vaccines Friday to include children as young as 6 months old.

The Moderna and Pfizer/BioNTech Covid-19 vaccines have now officially cleared for emergency use in young children. On June 17, the US Food and Drug Administration (FDA) expanded the authorizations for the vaccines to include children as young as 6 months.

Vaccinations began today.

The clearing of the vaccines came after the FDA’s committee of independent experts voted to recommend the Moderna vaccine for kids under 6, which is a two-dose vaccine, and the Pfizer vaccine for kids under 5, which is a three-dose vaccine, on Wednesday, June 15. Both votes were unanimous, ABC News reports. 

In the recent FDA news release, Commissioner Rober M. Califf, M.D. said the following about the clearance of the vaccines for young children:

“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 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.” 

The FDA news release also said that information about each vaccine is available in the fact sheets for healthcare providers administering the vaccine and for recipients and caregivers.

Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D.,Ph.D., said more about this. 

“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,” Marks said. “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.”

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