FDA approves 5-11

The U.S. Food and Drug Administration on Friday voted to recommend Pfizer-BioNTech’s COVID-19 vaccine to kids ages 5 to 11, but steps remain before children will be able to receive injections.

The FDA cleared kid-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 afterward.

“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.”

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