Pfizer expected to ask FDA to authorize vaccine for children under 5

Pfizer and its partner BioNTech are expected as soon as Tuesday to ask the Food and Drug Administration to authorize a coronavirus vaccine for children ages 6 months to 4 years old as a two-dose regimen while they continue to research how well three doses work.

Federal regulators are eager to review the data in hopes of authorizing shots for young children on an emergency basis as early as the end of February, according to multiple people familiar with the discussions. If Pfizer waited for data on a three-dose regimen, the data would not be submitted until late March and the vaccine might not be authorized for that age group until late spring, according to multiple people familiar with the situation.

Federal officials and Pfizer executives had been suggesting for days that an application for emergency authorization of a vaccine for the youngest children was in the works. Scott Gottlieb, a Pfizer board member and former commissioner of the Food and Drug Administration, told CBS News on Sunday that the vaccine might be authorized as soon as March. The development was first reported by The Washington Post.

As the omicron variant has swept the country, there has been a sharp increase in pediatric cases of the virus, according to the American Academy of Pediatrics, which gathers state-level data. Even though young children tend to do well combating the virus, some can get very ill. Federal officials were anxious to begin a vaccination program for the youngest children, given that studies showed two doses provided a substantial level of protection against Covid disease with no safety concerns.

Pfizer and BioNTech in mid-December announced that two doses of the vaccine, given at one-tenth of the amount of an adult dosing, did not produce an immune response in children ages 2 to 5 comparable to that of young people ages 16 to 25. Children between 6 months and 2 years did show a comparable immune response.

The setback prompted the companies to test a third low dose of the shot in children 6 months to under 5 years of age. While federal regulators expect that a third dose will eventually be authorized, they took the unusual approach of encouraging Pfizer to apply for authorization before that research was finished in hopes of protecting more children from the omicron variant and other mutations that might follow, according to four people familiar with the strategy.

The FDA and Centers for Disease Control and Prevention are both expected to convene committees of outside vaccine advisers before a decision on whether to clear the shots. That will give the company and independent experts a chance to review and discuss data the companies have gathered. The majority of senior federal health officials are strongly behind the strategy, but want the outside experts to weigh in, several people said.

The way federal regulators consider the case for vaccinating young children could have enormous importance for uptake of the vaccine. The pace of vaccination for America’s 28 million children between 5 and 11 remains even lower than health experts had feared. Just over one-quarter of children in that age group have received at least one dose, according to CDC data.

Kathrin Jansen, Pfizer’s head of vaccine research, said in December that the company would seek FDA clearance for three doses for young children, a strategy that she said would allow for “a consistent three-dose vaccine approach for all ages.” The company switched its plan because the FDA was pressing for more urgent action, two people said. If authorized, young children will receive their second dose three weeks after the first, and a third dose two months after that.

The CDC now considers three doses of the vaccine as an “up-to-date” regimen for those eligible for extra shots, including those 12 and up, who are eligible for booster doses. Regulators have authorized booster doses given five months after second injections. Children as young as 5 who have weakened immune systems are also eligible for extra shots.

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