FDA approves COVID vaccine for young children

by Will Tubbs

Willie R. Tubbs, FISM News


The U.S. Food and Drug Administration announced Friday that it was clearing two COVID-19 vaccines for use in children as young as 6 months.

According to a release from the FDA, the existing emergency use authorization for the Moderna vaccine has been amended to include use in children ages 6 months through 17 years (prior to today, it was available only to adults) while the Pfizer-BioNTech authorization has been expanded to included children ages 6 months through 4 years (previously this vaccine was available to individuals ages 5 and older).

“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,” FDA Commissioner Robert M. Califf, M.D., said in a statement. “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.”

The FDA touted the vaccines’ effectiveness and said potential benefits outstripped the chance of harm to young patients.

“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.”

Califf and Marks appeared in a virtual press conference, during which they discussed the policy change in greater detail.

Friday’s announcement came a day after Sen. Rand Paul (R-Ky.) and White House chief medical adviser had their latest row on Capitol Hill. During a meeting of the Senate Health, Education, Labor, and Pensions Committee, Paul asked Fauci if there was any indication that children needed vaccinations against COVID.

“Right now, there’s not enough data that has been accumulated, Senator Paul, to indicate that that’s the case,” Fauci answered.

This prompted Paul to reply, “So there are no studies. And Americans should all know this. There are no studies on children showing a reduction in hospitalization or death with taking a booster.”

As reported earlier today on FISM, research exists that indicates natural immunity is far superior to a vaccination.

The Moderna vaccine will be administered in children in the same manner as it has been for adults, two doses separated by one month. The Pfizer-BioNTech COVID-19 Vaccine will be administered as two doses separated by three months with a booster shot eight weeks after the second dose.