(WTNH) — Pfizer and BioNTech have submitted a Biologics License Application (BLA) to have their COVID-19 vaccine fully approved by the US Food and Drug Administration. In December 2020, The FDA approved it for emergency use.
The two-dose vaccine is approved for emergency use in people ages 16 and older. Meanwhile, the FDA is reviewing Pfizer’s request for emergency use authorization of its vaccine for teens 12-15 years old.
Pfizer said it will continue to submit the necessary data over the next several weeks. And, it will take several months for the FDA to review the full set of data before granting full approval.
Moderna announced Thursday they are planning to submit a BLA for their emergency use approved, two-dose COVID vaccine later this month. The Johnson & Johnson COVID vaccine is also approved under FDA emergency use.
This is breaking news.