Pfizer, BioNTech ask FDA to authorize vaccine for children 5 to 11


U.S. pharmaceutical firm Pfizer and its German partner, BioNTech, have asked the Food and Drug Administration to authorize their coronavirus vaccine for emergency use for children 5 to 11 years old, the companies announced Thursday.

An estimated 28 million children in the United States would be eligible for the shots if regulators give the green light - a process expected to take several weeks. The coronavirus vaccine would be the first available in this country for children younger than 12 years old.

An FDA advisory committee is scheduled to meet Oct. 26 to discuss Pfizer-BioNTech's pediatric vaccine. Officials have said its authorization could occur between Halloween and Thanksgiving.

"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 tweet. Pfizer and BioNTech submitted initial data to the FDA last month for a regimen of two 10-microgram doses in children - one-third the amount given to older patients.

The companies expect to have top-line immunity and safety data for children 2 to 4 years old this fall and, shortly thereafter, results for children 6 months to 2 years old. It is anticipated shots for the youngest children will become available in 2022.

The two-dose vaccine, which delivers immune-provoking instructions to human cells via molecules called mRNA, is approved by the FDA for people 16 and up. Pfizer-BioNTech's vaccine is also available to 12- to 15-year-olds under emergency use authorization. Certain people, including those 65 and older, are also eligible for immunity-boosting third shots.

Jeff Zients, the White House coronavirus response coordinator, called the pediatric vaccine filing "an important development."

Zients, appearing Thursday on CNN, said the country has the supply to quickly distribute the shots once the FDA and the Centers for Disease Control and Prevention give the go-ahead. He said the Biden administration is working with states to make it easy for parents to immunize their children by setting up convenient times and places to administer the shots, including pediatricians' offices.

The authorization procedure "can seem long and arduous, but it really is an important process" to evaluate the benefits and risk of vaccination, said physician Lee Savio Beers, president of the American Academy of Pediatrics, which has urged the FDA to prioritize coronavirus vaccines for children amid the surge in infections from the delta variant.

Many parents have been anxiously awaiting the coronavirus vaccine for young children, in some cases imploring pediatricians for the shots: "There are the folks saying, 'Please, please, please give my kid the vaccine. Drop one on the floor. Don't tell anybody,' " Christoph Diasio, a pediatrician in Southern Pines, N.C., told The Washington Post last month.

Beers said she empathized with young children's caregivers, for whom this wait has felt interminable.

"As a pediatrician and a mother, I understand the feeling of urgency around having a safe and effective vaccine authorized for children," Beers said. The FDA is moving at an "appropriate" speed to regulate pediatric vaccines, she said.

Still, other parents and caregivers have expressed reluctance to vaccinate their children. Only about a third of parents who have children 5 to 11 say they would vaccinate their kids as soon as possible, a recent Kaiser Family Foundation report found.

"Families should feel confident that if there's a vaccine that's been authorized as safe and effective, it really is safe and effective," Beers said.

With the nationwide resumption of in-person schooling this fall, infections have risen among children, especially in regions where vaccination rates are low. In Tennessee, where only 17 percent of adolescents 12 to 17 are vaccinated, pediatric cases spiked to their highest levels yet in early September, The Post reported Monday.

Data from the American Academy of Pediatrics show that more than 5.7 million children have been infected with the coronavirus since the pandemic began. Schools can take steps to help protect children by having everyone wear masks, encouraging frequent hand-washing and improving ventilation, Beers said.

And, until a vaccine is authorized for children, "adolescents and adults can help protect the little ones around them" by getting immunized, she said. The more people who are vaccinated in a community, the harder it is for the coronavirus to spread to children.