The Pfizer-BioNTech COVID-19 vaccine was fully approved on Monday by the Food and Drug Administration for people 16 and older, but it will still be some time before it's authorized for use in young children.
The Pfizer vaccine is available for kids between the ages of 12 and 15 under an emergency use authorization. Before emergency use authorization can be expanded to kids under 12 — which is expected this fall or winter, NBC News reports — clinical trials must be completed. Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told reporters on Monday the agency needs to have a "good safety dataset, because we certainly want to make sure we get it right in the children ages 5 through 11 and then even in younger children after that."
Pfizer and Moderna are both conducting vaccine trials in kids to determine the proper dosage and whether it is safe and effective for younger people. Pfizer CEO Albert Bourla told NBC News on Monday he expects studies on children ages 5 to 11 will finish in September, and the data will then get submitted to the FDA. Following adult vaccine trials, the FDA asks for two months worth of follow-up safety data, but for the children's trials, the FDA is requesting four to six months of data.
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In the week ending last Thursday, there were 180,000 new cases of COVID-19 among kids and teenagers, the American Academy of Pediatrics said in a statement on Monday, and the organization is urging the FDA to "work aggressively to authorize a vaccine for ages 11 and younger."
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