Pfizer and BioNTech announced on Wednesday that they have begun the process to seek approval from the Food and Drug Administration (FDA) for a third dose of their coronavirus vaccine.
In a statement, the companies said they plan to seek the approval for a third dose of Comirnaty to prevent COVID-19 in individuals aged 16 years and older. They intend to complete their submission by the end of this week.
Earlier this month, the Centers for Disease Control and Prevention (CDC) cleared a third vaccine dose from Pfizer-BioNTech and Moderna for people with moderate to severely compromised immune systems.
These people include those undergoing treatment for solid tumors or blood cancers, organ transplant patients and people with advanced or untreated HIV.
The CDC has estimated that roughly 2.7 percent of U.S. adults are immunocompromised, or about 7 million people.
The Biden administration will begin rolling out the third dose on Sept. 20.
However, the move has not been without controversy; the World Health Organization earlier this week called for a two-month moratorium on booster shots as poorer countries are still struggling to get their citizens initial doses of the vaccine.
In their announcement, Pfizer and BioNTech cited data from a phase 3 trial of 306 participants who received a third dose of the vaccine between 4.6 and 8 months after the two-dose regimen.
The results showed that protection after the third dose was three times higher than the second dose.
Pfizer and BioNTech’s announcement comes days after the FDA granted full approval of Comirnaty for people aged 16 and older, a highly anticipated move after a roughly three-month review. The vaccine is currently authorized under emergency use for those between the ages of 12 to 15.