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FDA urged to authorize COVID-19 vaccine for children under 12

The American Academy of Pediatrics said the Delta variant has created "a new and pressing risk."

YORK, Pa. — As COVID-19 cases continue to surge across the country due to the highly transmissible Delta variant, pediatric groups are concerned about the growing risk the virus poses to children. 

The American Academy of Pediatrics wrote a letter Thursday to the U.S. Food and Drug Administration, highlighting that the Delta variant has created "a new and pressing risk" to children under age 12. 

Currently, only the Pfizer COVID-19 vaccine has an emergency use authorization for children 12 and up. Neither the Johnson & Johnson or Moderna vaccine have been approved for anyone under age 18.

In the letter, AAP said the U.S. experienced "the largest week-over-week percentage increase in pediatric COVID-19 cases since the start of the pandemic." 

Currently, Pfizer is testing its two-dose vaccine on children in the United States and Europe. The company expects the safety data from the trials to be available in September, but AAP says, that may be too late.

"Since the start of pandemic and millions of children have been negatively impacted by missed schooling, social isolation...while we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline."

Vaccine approval for this adolescent age group, while possibly only weeks away, has become a widely discussed topic at the start of the school year looms closer. 


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