Pfizer says three small doses of its Covid-19 vaccine protect children under 5. The company released preliminary results on Monday and said it plans to give the data to U.S. regulators later this week.
It's the latest step toward letting the youngest children get the shots.
"All of this is very positive for those parents who are looking forward to having a vaccine for their younger children in the coming months," said William Moss, a vaccine expert at the Johns Hopkins Bloomberg School of Public Health.
The 18 million tots under 5 are the only group in the U.S. not yet eligible for Covid-19 vaccination.
Pfizer and its partner BioNTech initially aimed to give the youngest kids just one-tenth of the dose adults receive, but discovered during its trial that two shots didn't seem quite strong enough for preschoolers.
So researchers gave a third shot to more than 1,600 youngsters, from age 6 months to 4 years, during the winter surge of the omicron variant.
The companies said in a press release the extra shot did the trick, revving up tots' levels of virus-fighting antibodies enough to meet FDA criteria for emergency use of the vaccine with no safety problems.
Preliminary data suggested the three-dose series is 80% effective in preventing symptomatic Covid-19. But the calculation is based on just 10 cases diagnosed among study participants by the end of April.
The study rules state that at least 21 cases are needed to formally determine effectiveness. Pfizer has promised an update as soon as more data is available.
The Food and Drug Administration has begun evaluating data from rival Moderna. That company hopes to offer two kid-sized shots by summer.
The FDA had set tentative dates in June for its scientific advisers to publicly debate Moderna's and Pfizer's data.
The latest target: June 14 to consider whether to allow Moderna vaccine for older kids and June 15 to debate vaccinations for tots under 5, from either or both companies depending on the status of the applications.
If either vaccine is cleared for the littlest kids, the Centers for Disease Control and Prevention would have to recommend whether all kids under 5 should receive them or only those at high risk.
While Covid-19 generally isn't as dangerous to youngsters as to adults, some children do become severely ill or even die. And the omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge.
It's not clear how much demand there will be to vaccinate the youngest kids. Pfizer shots for 5- to 11-year-olds opened in November, but only about 30% of that age group have gotten the recommended initial two doses.
Last week, U.S. health authorities said elementary-age children should get a booster shot just like everyone 12 and older is supposed to get, for the best protection against the latest coronavirus variants.
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