An independent panel of experts advising the Food and Drug Administration voted Tuesday to recommend to the agency that Moderna’s coronavirus vaccine be approved for children and adolescents ages 6 to 17.
The panel’s recommendation was an important step as federal regulators weigh in on allowing the vaccine for those children, but it’s not the final word. The FDA, the Centers for Disease Control and Prevention, and the state health departments all have a role to play in the decision to add the Moderna vaccine as an authorized option for that age group, who already have the Pfizer-BioNTech vaccine. could get.
And applications from those two manufacturers are still pending for vaccines in younger children, neither of whom qualify. They are viewed separately; the advisory committee will make recommendations on this on Wednesday.
These are the next steps for the Moderna application for children and adolescents from 6 to 17 years old.
As the agency within the Department of Health and Human Services that oversees drugs and related matters, the FDA will consider the advisory panel’s recommendation. The agency usually follows the advice of the advisory committee, but is free to make changes or reject the recommendation outright.
Once the FDA has completed its review, it will issue a decision.
If the FDA approves the vaccine for children and adolescents, another advisory panel, set up by the CDC, is expected to hear the matter next week, officials familiar with the schedule said. The panel would then vote on whether or not to recommend the use of the vaccine for that age group.
Once the panel has weighed in, the director of the CDC, Dr. Rochelle P. Walensky, the agency’s guidelines to health care providers on whether or not to use the Moderna vaccine in children and adolescents.
Like the FDA, the CDC usually follows the non-binding recommendations of its advisory panel. But there were exceptions: Last September, after the CDC panel rejected the FDA’s recommendation to include frontline workers among those eligible for a Pfizer-BioNTech booster, Dr. Walensky’s advisers to the CDC and sided with the FDA.
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The CDC’s guidelines greatly affect state health departments, physicians, pharmacies, healthcare facilities, and the public. States generally follow the guidelines, but can set their own rules.
Once the FDA expert panel has issued its recommendation, the process could move quickly. When the Pfizer-BioNTech vaccine was being considered for use in adolescents ages 12 to 15 last year, the FDA approved it on May 10, the CDC panel weighed in two days later, and Dr. Walensky gave advice soon after. On May 13, shots were administered to teenagers across the country.