Pfizer Formally Asks Drug Regulators to Let Kids as Young as 5 Get Its COVID-19 Vaccine

A health care worker holds a vial of the Pfizer COVID-19 vaccine at Jackson Memorial Hospital in Miami, Fla., on Oct. 5, 2021. Lynne Sladky/AP Photo

Pfizer said on Oct. 7 that it had submitted a request to U.S. drug regulators to expand the authorization for its COVID-19 vaccine to children between the ages of 5 and 11.

The U.S.-based pharmaceutical company and its German partner BioNTech sent the request to the Food and Drug Administration (FDA) about a week after submitting data they said show that the vaccine triggered antibody responses in children in a Phase 2/3 clinical trial. The full results for the trial, which was run by the companies, haven’t yet been released.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer said in a statement.

Pfizer’s vaccine is already authorized for children aged 12 to 17 and approved for adults aged 18 and older, though the approved version isn’t yet available in the United States.

Some experts and parents are pushing for a vaccine for younger children, arguing that they can spread COVID-19 to others, even if they’re at little risk of severe disease themselves. But opponents note the low risk of danger COVID-19 poses to children and the elevated chances kids have of suffering heart inflammation if they receive a COVID-19 vaccine. Some European countries are now recommending just one dose of COVID-19 vaccines that utilize messenger RNA technology, such as the Pfizer vaccine, because of potential side effects.

Pfizer’s trial gave children a two-dose regimen of 10 micrograms each, while older populations were given doses of 30 micrograms each. The lower dosage “was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children,” Pfizer and BioNTech stated in September.

Dr. Janet Woodcock, the acting commissioner of the FDA, recently said that the vaccine “may need a different dosage or formulation from that used in an older pediatric population or adults.”

“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population,” Woodcock said.

The agency’s vaccine advisory panel will meet on Oct. 26 to review the efficacy and safety data. A meeting of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee to discuss the matter hasn’t yet been scheduled.

White House COVID-19 response coordinator Jeffrey Zients told CNN that the new Pfizer request could be granted before Thanksgiving.

“We will be ready as soon as the CDC and the FDA give the go ahead,” Zients said. “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated, including pediatricians’ offices and community sites.”

The submission comes after new studies show that Pfizer vaccine’s effectiveness against infection and severe disease sharply wanes over time. In addition, three scientists from the company were recently recorded acknowledging that natural immunity, or the protection bestowed from getting COVID-19 and recovering, is similar to or better than the protection from the company’s vaccine.

COVID-19 is the disease caused by the CCP (Chinese Communist Party) virus.