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The director of the National Institutes of Health has indicated that a COVID-19 vaccine for children under 12 is unlikely to be accessible until the end of 2021. Following the approval of the vaccine for those aged 12 and older, there was optimism that younger children would soon have access as well. However, recent updates suggest a longer wait.
The FDA has fully authorized Pfizer’s COVID-19 vaccine for individuals aged 16 and above, while it remains under emergency use authorization for those aged 12-15. The pressing question now is when children under 12 will receive their vaccine. Dr. Frank Roberts, director of the National Institutes of Health, shared in an NPR interview that both Pfizer and Moderna are currently conducting trials for this age group.
While older children and teens receive the same dosage as adults, the situation for 5 to 11-year-olds raises concerns about whether a smaller dose is necessary. Dr. Sarah Lee, director of pediatric vaccine research at a leading children’s hospital, stated to CNN that preliminary studies indicate children aged 5-12 exhibit a robust immune response with just one-third of the adult dosage; however, these studies are still ongoing.
Despite the encouraging findings, Dr. Roberts mentioned that if Pfizer submits its data to the FDA by the end of September, the actual approval may not occur until late 2021. “I honestly don’t expect the approval for children ages 5 to 11 to come before the end of this year,” he noted.
Dr. Emily Carter, head of the FDA’s Center for Biologics Evaluation and Research, echoed these sentiments, stating that vaccine manufacturers are still finalizing trials on effectiveness and dosage. “The FDA will act quickly once the data is submitted, but the trials must be completed first, or at least the parts that can be submitted to us,” she explained. Furthermore, the FDA has requested four to six months of follow-up safety data from the pediatric trials, compared to just two months for adult trials.
While this news may be disappointing for parents waiting for the vaccine for their young children, the American Academy of Pediatrics has urged the FDA to expedite the authorization process for children aged 11 and younger. As with many aspects of the ongoing pandemic, the situation remains fluid, and we must approach it day by day.
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Summary
The availability of a COVID-19 vaccine for children under 12 is not expected until late 2021, as ongoing trials by Pfizer and Moderna continue. The FDA is awaiting data submission, which will determine the approval timeline. Parents are encouraged to stay informed as developments occur.