FDA paves way for COVID-19 vaccinations in children ages five-11

WASHINGTON — The Food and Drug Administration, on Friday, paved the way for children ages five 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.

“The rationale here is protect your children so that they can get back towards normal life,” said FDA vaccine chief Dr. Peter Marks. “The tremendous cost of this pandemic has not just been in physical illness, it’s been in the psychological, the social development of children” too.

A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for three-year-olds. But many that use the vaccine made by Pfizer and its partner BioNTech are watching the US decision, and European regulators just began considering the companies’ kid-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, five- to 11-year-olds still have been seriously affected — including over 8,300 hospitalizations, about a third requiring intensive care. The FDA said 146 deaths have been reported in that age group.

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 children.

“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.