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Vaccines for Kids Under 12 Are Still Months Away

FDA official says emergency approval could be granted by midwinter
By Rob Quinn,  Newser Staff
Posted Jul 16, 2021 12:01 AM CDT

(Newser) – Coronavirus vaccines for children under 12 are still months away, with emergency authorization for at least one vaccine expected by midwinter and full approval likely coming soon afterward, a Food and Drug Administration official says. The official tells NBC that many families are hesitant because no COVID vaccine has received full approval instead of emergency authorization so they hope to reach that step quickly. The official says the FDA is seeking up to six months of follow-up data from vaccine trials among under-12s, compared to the two months required for trials in adults. Pfizer and Moderna began vaccine trials in under-12s in March.

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A Pfizer spokesperson tells NBC that the company expects to have data on clinical trials in children aged six to 11 by September and results for younger children a month or two later. "I understand parents' concern in wanting their children to get vaccinated, but we have to make sure we're doing the best and safest thing for children," pediatrician Chip Walker, an investigator for the Pfizer trials, tells CNN. Researchers say the biggest issue is the maturity of the immune system, not the size of the child, and it is taking time to find the "Goldilocks dose" for different ages. (Read more coronavirus vaccine stories.)

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