TUESDAY, June 14, 2022 — The U.S. Food and Drug Administration’s vaccine advisory panel will decide on Tuesday whether to recommend the agency approve the emergency use of Moderna’s COVID-19 vaccine in children aged 6 to 17.
The panel will analyze Moderna’s two-dose vaccine for children aged 6 to 11 at half the strength of the adult shot, and for youth aged 12 to 17 at the adult dose, and then vote on whether to give its blessing to both. Typically, the FDA follows the recommendations of its expert panels. Once the FDA has authorized the shots, as expected, expert advisers to the U.S. Centers for Disease Control and Prevention will discuss the best use of the Moderna vaccine in older children and teens this weekend.
Moderna first asked the FDA to approve its vaccine for adolescents and older teens last June, a month after Pfizer won emergency authorization for its COVID-19 vaccine to be used in 12- to 15-year-olds. The FDA then approved the emergency use of the Pfizer vaccine for children aged 6 to 12 last October.
But regulators were worried about reports of myocarditis that were seen mostly in young men who had been given the Moderna vaccine, so they chose to delay a decision while more research was conducted. The company said concerns about myocarditis have now subsided after further research and real-world evidence, The New York Times reported.
In a second meeting on Wednesday, the same FDA panel will weigh Moderna’s vaccine for children under 6 and Pfizer’s vaccine for children under 5.
The New York Times Article
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Posted June 2022
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