The Director of the National Institutes of Health recently indicated that a COVID-19 vaccine for children under 12 may not be ready until the end of this year. When the vaccine was authorized for those aged 12 and over, it brought great relief to many families. However, despite earlier hopes for a quick rollout for younger children, it appears approval could still be months away.
The FDA has granted full approval for Pfizer’s COVID-19 vaccine for individuals aged 16 and up, while the vaccine remains under emergency use authorization for adolescents aged 12-15. The pressing question now is when the vaccine will be available for those under 12. Dr. Francis Collins stated in a recent NPR interview that trials for Pfizer and Moderna’s vaccines are ongoing for this age group.
Older kids and teens receive the same dosage as adults, but there are concerns about whether younger children, specifically those aged 5 to 11, require a smaller dose. Dr. Sam Thompson, head of the Pediatric Vaccine Research Center at Cincinnati Children’s Hospital, explained that preliminary studies show that children in this age range may achieve a robust immune response with just one-third of the adult dosage. However, these studies are still ongoing.
Collins noted that if Pfizer submits its data to the FDA for review by the end of September, as planned, actual approval may not occur until late 2021. He candidly remarked, “I don’t see the approval for kids aged 5 to 11 coming much before the end of this year.” Dr. Linda Marks, who oversees the FDA’s Center for Biologics Evaluation and Research, reinforced this timeline, indicating that trials must be completed before any data can be submitted for review. The FDA has also requested four to six months of follow-up safety data from the pediatric trials, compared to the two months required for adult trials.
Despite this somewhat disappointing news regarding the timeline for younger children, the American Academy of Pediatrics has urged the FDA to expedite the authorization process for children aged 11 and younger. As always during this pandemic, it seems we must take things one day at a time.
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Summary
The timeline for COVID-19 vaccination for kids under 12 appears to extend into late 2021, as ongoing trials by Pfizer and Moderna must conclude before data submission for FDA approval. The American Academy of Pediatrics is advocating for expedited review, but families may have to wait longer for a vaccine.
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