The Director of the National Institutes of Health has indicated that a COVID-19 vaccine for children under 12 may not be ready until late 2021. The approval of the vaccine for those over 12 was a significant milestone, bringing relief to many families. However, the anticipated approval for younger children has faced delays.
The FDA recently granted full approval for Pfizer’s vaccine for individuals aged 16 and older, while the emergency use authorization remains in place for kids aged 12-15. The pressing question is when the vaccine will be accessible for younger children. Dr. Francis Collins, NIH director, mentioned in an NPR interview that trials for the vaccine on children under 12 are still ongoing.
While older children receive the same dosage as adults, researchers are examining whether a lower dose is necessary for children aged 5 to 11. Dr. Lisa Adams, who leads the Pediatric Vaccine Research Center at a leading institution, stated that preliminary studies suggest that children in this age group exhibit a robust immune response with just one-third of the adult dose. However, further research is still required.
Despite this encouraging data, Collins noted that if Pfizer submits its findings to the FDA by the end of September, actual approval is unlikely to occur before the year’s end. “Honestly, I don’t foresee approval for children aged 5 to 11 happening much before the end of 2021,” he explained.
Dr. Mark Thompson, who oversees the FDA’s vaccine evaluation, echoed these sentiments, emphasizing that until the trials are completed and data submitted, the approval process cannot move forward efficiently. The FDA has requested four to six months of follow-up safety data from these children’s trials, compared to just two months for adult trials.
In response to the timeline, the American Academy of Pediatrics has urged the FDA to expedite the authorization process for a vaccine for children 11 and younger. As is the case with everything related to the pandemic, we must remain patient and vigilant.
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In summary, while there is promising data regarding the COVID-19 vaccine for children under 12, approval may not come until late 2021. The ongoing trials and data submissions are crucial steps in ensuring the vaccine’s safety and efficacy for younger age groups.