The Food and Drug Administration authorized both the Moderna and Pfizer COVID-19 vaccine for children ages 5 and under.
Pending a recommendation from the Centers for Disease Control and Prevention, an estimated 18 million children could soon be eligible for the shot.
“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 in a statement on June 17. “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 agency evaluated the vaccine's effectiveness in 230 children between the ages of 6 and 23 months as well as 260 children between 2 years old and 5 years old and found that “the immune response to the vaccine, of both age groups of children, was comparable to the immune response of the adults.”
Both Moderna and Pfizer are required to report serious adverse events, cases of Multisystem Inflammatory Syndrome, and COVID-19 cases that result in hospitalization or death as well as vaccine administration errors to the Vaccine Adverse Event Reporting System (VAERS).
“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, the 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,” Marks added.
In addition to this latest authorization, the CDC will review the FDA’s authorization of the Moderna vaccine for teens and school-age children next week, reports AP News.
Marks said parents should feel confident giving either vaccine to their children and acknowledge that there is a slight difference between the brands as each has “their own nuanced benefits and risks.”
“It may be that the Moderna vaccine brings an immune response slightly more rapidly,” he told UPI. “On the other hand, the three-dose Pfizer regimen may also bring a greater immune response after the third dose, and there are some subtle differences in the safety profile. But again these are relatively subtle.”
More than 10 million doses of the vaccines have been provided to state and local health authorities by the federal government, which has previously said the vaccine would be available to the age group by the end of June.
"We expect that vaccination will begin in earnest as early as June 21 and really roll on throughout that week," said Dr. Ashish Jha, who currently serves as the White House Coronavirus Response Coordinator, at a press conference on June 2.
