FDA paves way for Pfizer vaccine in 5- to 11-year-olds
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 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.
A few countries have begun using other COVID-19 vaccines in children younger than 12, including China, which just began vaccinations for 3year-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’ childsize doses.
With the 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. Cihildren will get two shots, three weeks apart.
Although children are at lower risk of severe illness or death from COVID-19 than older people, 5- to 11-yearolds still have been seriously affected. – including more than 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 coronavirusrelated school closings since the start of the school year, affecting more than a million children.
Earlier this week, the 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% effective at preventing symptomatic COVID-19 infections, based on 16 cases of COVID-19 among children given placebos compared to just three who got vaccinated. The child dosage also proved safe, with similar or fewer temporary reactions, such as sore arms, fever or achiness, that teens experienced.
But the study wasn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second fullstrength dose, mostly in young men and teen boys. It’s unknown if younger children getting a smaller dose also will face that rare risk.
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