FDA issues approval for Pfizer COVID-19 vaccinations in young kids, one U.S. hurdle remains

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FDA issues approval for Pfizer COVID-19 vaccinations in young kids, one U.S. hurdle remains
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The FDA cleared kid-size doses for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week

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.

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.

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. The question of how broadly Pfizer’s vaccine should be used will be a key consideration for the CDC and its advisers, who set formal recommendations for pediatricians and other medical professionals.

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 full-strength dose, mostly in young men and teen boys. It’s unclear if younger children getting a smaller dose also will face that rare risk.

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