FDA clears Pfizer vaccine for young kids
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 kidsize 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.
“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 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’ 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 kids 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. 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. “The vaccine will protect them and also protect our communities.”
The American Academy of Pediatrics also applauded FDA’s decision, and said pediatricians were “standing by” to talk with parents.
Vaccinating this age group is “an important step in keeping them healthy and providing their families with peace of mind,’’ said Dr. Lee Savio Beers, the academy’s president.
Earlier this week, FDA’s independent scientific advisers voted that the pediatric vaccine’s promised benefits outweigh any risks. But several panelists said not all youngsters will need to be vaccinated, and that they preferred the shots be targeted to those at higher risk from the virus.
A Pfizer study of 2,268 schoolchildren found the vaccine was nearly 91 percent effective at preventing symptomatic COVID-19 infections, based on 16 cases of COVID-19 among kids given dummy shots compared to just three who got vaccinated.