The Pfizer-bioNTech vaccine appears to be effective in preventing Covid illness in children under the age of 5, according to the FDA.
Ahead of Wednesday's meeting of vaccine experts, the F.D.A. posted an evaluation on its website.
The F.D.A. is expected to allow parents to choose between Moderna's and Pfizer's vaccines. After the F.D.A. acts, the CDC must weigh in with its recommendations. There are 18 million children who are not eligible for shots.
According to an analysis by the F.D.A., Pfizer and its German partner suggest that three doses are more effective than two. There were only a few cases of Covid among the children who received three doses of the vaccine during the clinical trial.
Pfizer said there were only eight children in the placebo group and two in the vaccine group that got sick. There were 21 cases that needed to make a judgement on efficacy.
The F.D.A. seems to like Pfizer and Moderna's requests for vaccine for children. Parents are so eager to have a coronaviruses vaccine for their youngest children that some have said they would accept even low rates of effectiveness if the vaccine was safe.
The agency found that rates of hospitalization and death due to Covid were higher for children under 5 than for children of the same age.
During the current year, when the Omicron variant and its rapidly evolving subvariants became the dominant forms of the virus, the shots have helped prevent hospitalization and other serious outcomes.
The vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on Covid-19-related morbidity and mortality. There were minimal side effects identified.
According to the F.D.A., Moderna's vaccine for children under the age of 6 was effective in preventing symptoms of coronaviruses. The vaccines are based on the same type of technology, but the dose and regimen are different. Moderna wants to give two doses at 25% of the strength of the adult dose. Pfizer wants to give three shots at a tenth of the strength of adult shots.