Moderna completes submission for full FDA approval of Covid-19 vaccine; Pfizer seeks approval for booster dose

Moderna announced on Wednesday it has completed its submission to the US Food and Drug Administration for full approval of its Covid-19 vaccine for people age 18 and older, and Pfizer and BioNTech announced they have begun submitting data for full FDA approval of a third dose of their vaccine.

Moderna said it has requested priority review from the FDA. The company began submitting data for its Biologics License Application, or BLA, to the FDA in June.

Mandatory Credit: Photo by Stephen Zenner/SOPA Images/Shutterstock (12340890a) Mary Jo Vetorino, a Registered Nurse from Bellefontaine, Ohio loads the vaccine into a syringe, at 3840 Kimberly Parkway. OhioHealth's Wellness on Wheels mobile vaccine clinic visits communities with lower vaccination rates and a high social vulnerability index score to offer people free Pfizer coronavirus (COVID-19) vaccines. OhioHealth's Wellness on Wheels mobile vaccine clinic in Columbus, US - 19 Aug 2021

FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates

“This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history,” Moderna CEO Stéphane Bancel said in a statement.

The Moderna vaccine is currently available under emergency use authorization for people age 18 and older in the United States. Moderna has also filed with the FDA for an emergency use authorization for its vaccine in people age 12 and older.

Moderna’s vaccine would be the second one approved by the FDA. On Monday, the FDA approved the Pfizer/BioNTech vaccine for people age 16 an older, opening the door to more vaccine mandates.