Moderna (MRNA) - Get Moderna, Inc. Report shares were rising after the company said it had completed its submission to the U.S. Food and Drug Administration for full approval of its COVID-19 vaccine for individuals 18 and older.
The Cambridge, Mass., company's vaccine is currently available for people 18 years and older under the FDA's emergency-use-authorization guidelines.
Its COVID-19 vaccine "is showing durable efficacy of 93% through six months after dose 2," Chief Executive Stephane Bancel said in a statement.
Moderna has requested priority review in its Biologics License Application. The BLA submission is the first in the company's history. The company was founded in 2010.
Moderna received FDA Fast Track designation for the vaccine on May 12, 2020. It began the submission process for the vaccine in June 2021.
In its application Moderna included clinical data from the Phase 3 Cove study of its vaccine, which enrolled more than 30,000 participants in the U.S.
The FDA said the Pfizer-BioNTech vaccine can now be marketed as Comiranty and will be eligible for use by all U.S. citizens 16 and older.
"While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency-use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Acting FDA Commissioner Janet Woodcock said of Pfizer's vaccine.
Moderna shares at last check were 1.2% higher, just under $400.