FDA authorizes COVID-19 vaccine for children aged 5 to 11

The vaccine is just awaiting a recommendation from the CDC before they can be rolled out.

There’s only one more regulatory hurdle that lies between children aged 5 to 11 and being vaccinated against COVID-19 after the Food and Drug Administration (FDA) authorized smaller doses of Pfizer’s Comirnaty.

According to a news release, the shots now need only to receive a clinical recommendation from the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices, which will meet this week.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, says in the release. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

COVID-19 cases in children aged 5 to 11 make up 39 percent of all cases seen in patient younger than 18. About 8,300 cases of COVID-19 in this group have led to hospitalization and there have been 146 deaths as of Oct. 17, according to the release.

“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, says in the release. “We are confident in the safety, effectiveness and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated.”

Previously, the FDA’s Vaccines and Related Biological Products Advisory Committee gave their approval to the vaccine in an Oct. 26 meeting.

The juvenile shots would be a third the size of those given to adults and teens. At least two months after the two-dose regimen, the vaccine proved to produce more neutralizing titers against the original strain of COVID-19 and the Delta variant than the larger doses did in teenagers.

The vaccine was shown to be 90.7 percent effective against COVID-19 at least seven days after the second dose.

The Biden administration has already set its sights on an all-out push for juvenile vaccination against COVID-19.

As previously reported, the administration as well as local health authorities will make the vaccine available to more than 25,000 pediatricians’ offices and other primary care sites.

“Pediatricians, and other doctors, are some of the most trusted sources for families when it comes to COVID-19 vaccines for children,” the White House says. “These providers will play a critical role in the nationwide effort to get children vaccinated.”

The administration will also be supplying vaccines to more than 100 children’s hospitals and health systems, tens of thousands of pharmacies, hundreds of schools and community-based clinics, and hundreds of community health centers and rural health clinics.