WASHINGTON, D.C. — The U.S. Food and Drug Administration has confirmed Oct. 26 for its panel of outside advisers to meet and discuss the use of Pfizer’s COVID-19 vaccine in children as young as 5.
If approved by that advisory panel, children ages of 5- 11-years-old, numbering around 28 million, will begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.
“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 #COVID19,” Pfizer representatives wrote on Twitter.
Pfizer announced on Thursday that it had asked U.S. regulators to authorize emergency use of its COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed. It also said its application to the FDA has been completed.
The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up. The other two vaccines in the U.S. market, Moderna and Johnson & Johnson, currently do not have full regulatory approval for any age group, though that is likely to come in the near future.
Pfizer’s clinical trial has shown the vaccine to induce a strong immune response in 5- to 11-year-olds in a 2,268-participant clinical trial, the companies said on Sept. 20.
A rapid authorization of the Pfizer vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors.
If given regulatory authorization, the two-dose Pfizer vaccine would become the first COVID-19 shot made available to children ages 5 to 11 in the U.S.
The company is also testing the vaccine in children ages 2- to 5-years-old and children ages 6 months to 2 years, with data expected soon.
The vaccine could be ready for roll out as early as November, pending approval from federal regulatory health agencies, the White House has said.
“We are ready,” said White House COVID-19 response coordinator Jeffrey Zients. “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 U.S. leads the world in COVID-19 cases and deaths. Children currently make up about 27 percent of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the coronavirus Delta variant among unvaccinated people.
While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.
— Wire and staff