Moderna, Pfizer/BioNTech Submit Data For FDA Approval

Moderna has completed their submission for full FDA approval of their vaccine. The company announced yesterday that it completed it’s submission to the U.S. Food and Drug Administration for full approval of it’s Covid-19 vaccine for people ages 18 and older. Moderna requested “priority review” from the FDA after they began submitting their data for it’s biologics license application in June. According to the company’s CEO Stephane Bancel it 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.” The Moderna vaccine is currently available for people ages 18 and older under emergency use authorization and has been filed with the FDA for emergency use authorization for ages 12 and older.

Pfizer/ BioNTech has also announced it has begun submitting data for full FDA approval of a third dose of their vaccine. The company described a trial of 306 people who got a booster five to eight months after getting their second dose and found it generated higher levels of antibodies and was safe with ‘mild to moderate’ effects. Pfizer plans to submit the data to a peer-reviewed journal and file it with the European Medicines Agency and other authorities in the upcoming weeks.