Moderna has made all necessary submissions required by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in adolescents and children, it said yesterday.
The company is seeking approval for the use of its vaccines in three distinct age groups – adolescents aged 12 to 17 years, children aged six to 11 years, and those between six years and six months. The submissions for all three groups were made on 9th May, it said.
Although Moderna’s vaccine is approved by the FDA for use in adults 18 years and older, its use in other age groups has hit a roadblock as US regulators have sought more safety data.
Australia, Canada and the European Union (EU) though have approved the vaccine for use in six-to-17-year olds.
The company sought US authorisation of its COVID shot in children under the age of six years in April.
An advisery panel of experts to the US drug regulator will meet in June to review the request.
Edits by EP News Bureau