Pfizer says three small doses of its COVID-19 vaccine protect kids under 5 and that it plans to give the data to U.S. regulators later this week. It’s the latest step toward allowing the littlest kids get the shots.
The 18 million tots under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.
“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” Pfizer Chairman and CEO Albert Bourla said in a statement.
Pfizer said in the phase 2/3 trial, 1,678 children received a third dose of the 3-microgram formula. It was given at least two months after the second dose. The study was done when Omicron was the dominant variant.
The company also claimed that any adverse effects were mild or moderate.
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 has set tentative dates next month for its scientific advisers to publicly debate data from Pfizer and Moderna.
Travis Pittman contributed to this report.