Moderna Submits Application For Full FDA Approval Of Its COVID Vaccine
CAMBRIDGE (CBS) -- Days after Pfizer received FDA backing for its COVID vaccine, Moderna has submitted an application for full approval of its own two-dose shot regimen.
The Cambridge-based biotech company says a final study of its mRNA vaccine shows it is 93% effective against the coronavirus for six months after a second dose.
"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," CEO Stéphane Bancel said in a statement.
The Moderna vaccine is currently available to anyone 18 years and older under Emergency Use Authorization. Moderna is seeking emergency use authorization for the vaccine on adolescents 12 and older. Nearly 65 million in the United States have been fully vaccinated via Moderna, according to the CDC.
Pfizer finished its application to the FDA in May; approval for Moderna could take months.
A recent CDC study found that COVID vaccines are less effective against the highly contagious Delta variant, but still reduce infection risk by about two-thirds.