- Reuters reported that Moderna Inc (NASDAQ: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
