Moderna Completes Submission for FDA Approval of its COVID-19 Vaccine

Moderna officially submitted its COVID-19 vaccine to the FDA for full approval.

While the company requested a priority review, it could still take several months to complete.

Moderna’s vaccine is already available in the U.S. to people 18 and older. The company also filed for emergency use for children as young as 12.

The FDA approved Pfizer-BioNTech COVID-19 vaccine for prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.