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Here’s a look at what’s next after F.D.A. advisers voted to recommend Moderna’s vaccine for children 6 to 17.


An unbiased panel of consultants advising the Food and Drug Administration voted on Tuesday on to recommend to the agency that Moderna’s coronavirus vaccine be approved for children and adolescents ages 6 to 17.

The panel’s advice was a key step as federal regulators weigh authorizing the vaccine for these children, however it isn’t the ultimate say. The F.D.A., the Centers for Disease Control and Prevention and state well being departments all nonetheless have roles to play in deciding whether or not to add the Moderna vaccine as a certified choice for that age group, which might already obtain the Pfizer-BioNTech vaccine.

And functions from these two producers are nonetheless pending for vaccines in youthful children, who aren’t but eligible for both one. They are being thought-about individually; the advisory panel is scheduled to make suggestions on them on Wednesday.

Here are the next steps for the Moderna utility for children and adolescents 6 to 17.

  • As the company throughout the Department of Health and Human Services that supervises medicines and associated issues, the F.D.A. will take into account the advisory panel’s advice. The company normally follows the advisory panel’s recommendation, however it’s free to make adjustments or reject the advice outright.

  • Once the F.D.A. completes its assessment, it points a dedication.

  • If the F.D.A. authorizes the vaccine for children and adolescents, another advisory panel, this one arrange by the C.D.C., will assessment that call and vote on whether or not to recommend the vaccine’s use for that age group.

  • Once the panel has weighed in, the director of the C.D.C., Dr. Rochelle P. Walensky, points the company’s steering to medical suppliers on whether or not and when to use the Moderna vaccine in children and adolescents.

  • Like the F.D.A., the C.D.C. normally follows the nonbinding suggestions of its advisory panel. But there have been exceptions: Last September, after the C.D.C. panel rejected the F.D.A.’s advice that frontline staff be included amongst these eligible for a Pfizer-BioNTech booster, Dr. Walensky overrode the C.D.C.’s advisers and sided with the F.D.A.

The C.D.C.’s steering is deeply influential for state well being departments, docs, pharmacies, well being care establishments and the general public. States typically comply with the steering, however can set their very own guidelines.

Once the F.D.A.’s knowledgeable panel points its advice, the method can transfer rapidly. When the Pfizer-BioNTech vaccine was thought-about final 12 months for use in adolescents 12 to 15, the F.D.A. approved it on May 10, the C.D.C. panel weighed in two days later, and Dr. Walensky issued guidance swiftly after that. By May 13, pictures have been being (*6*)to youngsters throughout the nation.



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