Moderna Concludes FDA Submission For Its COVID-19 Shot In Adolescents, Kids

  • Reuters reported that Moderna Inc MRNA had made required submissions to the FDA for emergency use authorization of its COVID-19 vaccine in adolescents and children.
  • An advisory panel of experts to the U.S. drug regulator will meet in June to review the request.
  • Related: FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA.
  • The company is seeking approval for its vaccines in adolescents aged 12 to 17 years, children aged six to 11, and those between six years and six months. 
  • The company said the submissions for all three groups were made on May 9.
  • Although the FDA approves Moderna's vaccine for use in adults 18 years and older, its use in the younger age groups has hit a roadblock as the agency asked for more safety data.
  • Australia, Canada, and the European Union have approved the vaccine for use in six- to 17-year-olds.
  • In April, the company sought U.S. authorization for its COVID shot in children under six years
  • Price Action: MRNA shares are up 4.76% at $129.30 during the market session on the last check Thursday.
  • Photo by Spencer Davis from Pixabay
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
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