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Why COVID-19 vaccines for children under 12 have not been approved yet

New demands from the FDA have slowed down the process.

HOUSTON — As more and more children come down with COVID-19, many parents are asking why a vaccine has not been approved for kids under 12.

FDA demanded larger trials

A big cause of delay is the U.S. Food and Drug Administration changed the rules. In July, the agency asked Moderna and Pfizer to double the number of children in their clinical trials. Reportedly, the change is an effort to have a better chance of finding any rare side effects that might pop up. It has also asked for four to six months of follow-up safety data from the kid’s trials —  instead of the two months required for adults. Now the head of the National Institutes of Health says vaccines for kids will probably not be approved before the end of the year.

Spread simulation in elementary schools

This comes as a simulation released from a CDC funded lab predicted that, in elementary schools without masks or regular testing, 75% of kids could be infected within three months. Even with masking and tests that number only fell to 22%. The team behind the simulation says imperfect mask usage and a lack of quarantining was factored into their results.

Leaders want kids prioritized

Some experts think the NIH timeline is too pessimistic — one Stanford pediatric infectious disease expert told the New York Times she thought Pfizer would be able to apply for emergency use authorization for kids in October. And members of congress, governors and even the American Academy of Pediatrics are asking the FDA to prioritize vaccines for kids and to give parents a clearer timetable.