© Reuters. FILE PHOTO: A vial labeled “Modern COVID-19 Vaccine” is seen in this illustration taken Jan. 16, 2022. REUTERS/Dado Ruvic/Illustration/File Photo
(Reuters) – modern (Nasdaq: ) The company said Wednesday that it has submitted all necessary documents as requested by the U.S. Food and Drug Administration for the authorization of emergency use of its COVID-19 vaccine in adolescents and children.
The company is seeking approval for use of its vaccine in three different age groups — teens 12 to 17 years old, children 6 to 11 years old, and children 6 years to 6 months old. It said the submissions from all three groups were made on May 9.
While Moderna’s vaccine has been approved by the FDA for adults 18 and older, its use in other age groups has hit obstacles as U.S. regulators seek more safety data.
However, Australia, Canada and the European Union have approved the vaccine for children between the ages of 6 and 17.
The company sought U.S. approval in April for its COVID vaccine for children under 6.
The U.S. drug regulator’s expert advisory panel will meet in June to review the request.