FDA to consider two Pfizer COVID-19 vaccine shots for children under 5
Pfizer and its partner BioNTech are seeking federal authorization to allow children 6 months to 4 years old to receive two COVID-19 shots. The move comes at the request of the Food and Drug Administration, the companies said, and as pediatric COVID-19 cases top 10 million.
The companies on Tuesday asked the FDA to review data on the safety and efficacy of their vaccine, given in a low-dose format, for younger children.
In late December, the companies said the two-dose vaccine provided to 2- to 4-year-olds had not been shown to be effective against COVID-19. The children in the trial did not mount enough of an immune response to suggest they would be protected against severe disease.
But children ages 6 months to 2 years did show an adequate immune response.
The vaccine dose depends upon age. Everyone 12 and older gets a 30-microgram dose. Children 5 and older get a 10-microgram dose. Children younger than 5 would receive a 3-microgram dose if it is approved.
The companies said they thought a third shot would make the vaccine effective for children ages 2 to 4 and were testing it in both groups. At the time, a Pfizer scientist told a federal advisory committee the third dose would be given eight weeks after the first two shots, pushing back trial results until late March or early April.
It's not yet clear what changed to allow earlier consideration of the vaccine for younger children.
The FDA's Vaccines and Related Biological Products Advisory Committee, which must vote on the submission, has scheduled a public meeting to discuss it on Feb. 15.
Pfizer has been in extensive discussions with the FDA about the authorization, said Mark McClellan, the FDA commissioner under President George W. Bush.
"It’s going to take a few weeks for FDA to go over it very, very carefully. It includes data on hundreds of kids who have now been followed for a long time. It integrates data we’ve seen around the country and around the world on the experience of kids generally with the COVID vaccine, which looks very good from a safety standpoint, especially at these low doses," said McClellan, director of the Margolis Center for Health Policy and the Margolis Professor of Business, Medicine and Health Policy at Duke University.
It's also possible that if the two-dose regimen is authorized, parents could begin immunizing their children sooner and wouldn't have to wait as long to get a third booster dose.
Dr. Scott Gottlieb, FDA commissioner during the Trump administration and now a Pfizer board member, said on CBS' “Face the Nation” this week that if the government authorized a two-dose vaccine for younger children, it would expedite the rollout.
“If the goal of the vaccine is to get baseline immunity in the kids to prevent really bad outcomes, and you're really not using the vaccine as a tool to prevent infection in the first place, two doses could do that,” Gottlieb said.
Contact Karen Weintraub at kweintraub@usatoday.com and Elizabeth Weise at eweise@usatoday.com.
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This article originally appeared on USA TODAY: FDA to consider authorizing Pfizer's COVID vaccine for kids under 5
