Over 100 million Moderna shots have been administered to patients and just recently, Moderna reached out to the FDA for their full approval.
Tuesday, June 1st, Moderna asked the FDA for a full approval of their COVID-19 Vaccine—the second drug producer in the U.S. to seek a biologics license that will allow it to market the shots directly to consumers.
The Moderna shot is currently allowed for distribution due to the U.S. market using it under an emergency authorization—the FDA granted this authorization in December 2020. Emergency authorization can be granted when manufacturers show 2 months of safety data. This differs from a biologics license application as well as a request for full approval, due to the need of this vaccine. A biologics license application or request for full approval requires at least 6 months of data tracked.
Moderna looks forward to working with the FDA and submitting data from the Phase 3 study of the vaccine—which will complete the submission. This process is likely to take months.
As vaccines continue to be manufactured and distributed, Moderna will continue to submit more data information to the FDA to help support the Biologics license application. Having full U.S. approval will allow Moderna’s vaccine to stay on the market beyond the pandemic. Moderna will be allowed to advertise their product on TV along with other media platforms.
Moderna will be the second company that has requested FDA’s approval to their COVID-19 Vaccine—Pfizer and BioNTech started working with the FDA on May 7th, 2021.