FILE - This October 2021, photo provided by Pfizer shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium. The U.S. moved a step closer to expanding vaccinations for millions more children as a panel of government advisers on Tuesday, Oct. 26, endorsed kid-size doses of Pfizer's shots for 5- to 11-year-olds. (Pfizer via AP, File)

WASHINGTON — The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer’s COVID-19 vaccine.

The FDA cleared child-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week.

One more regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which youngsters should get vaccinated, with a final decision by the agency’s director expected shortly afterwards.

“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Dr. Janet Woodcock, the acting FDA commissioner, said in a statement. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for 3-year-olds. But many that use the vaccine made by Pfizer and its partner BioNTech are watching the U.S. decision, and European regulators just began considering the companies’ child-size doses.

With FDA’s action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine — in orange caps to avoid mix-ups with the purple-capped doses for everyone else — to doctors’ offices, pharmacies and other vaccination sites. Once the CDC issues its ruling, eligible children will get two shots, three weeks apart.

While children are at lower risk of severe illness or death from COVID-19 than older people, 5- to 11-year-olds still have been seriously affected — including over 8,300 hospitalizations, about a third requiring intensive care, and nearly 100 deaths since the start of the coronavirus pandemic, according to the FDA.

And with the extra-contagious delta variant circulating, the government has counted more than 2,000 coronavirus-related school closings just since the start of the school year, affecting more than a million students.

“With this vaccine kids can go back to something that’s better than being locked at home on remote schooling, not being able to see their friends,” said Dr. Kawsar Talaat of Johns Hopkins University. “The vaccine will protect them and also protect our communities.”

Earlier this week, FDA’s independent scientific advisers voted that the pediatric vaccine’s promised benefits outweigh any risks.