UNDATED – Full FDA approval for the Pfizer COVID-19 vaccine could come Monday, according to a report from the New York Times.
According to the report, regulators were aiming for approval Friday but were still finishing up paperwork. The report warns approval could slip past Monday if more time is needed.
Pfizer’s application for full approval, submitted in late May, includes the latest data from a large study that tracked participants 16 and older for six months after their second dose. The vaccine is given to people as young as 12, and Pfizer also intends to submit data needed for full approval in that age group.
The way the FDA’s vaccine program is designed should help it in its efforts to expedite the full approval of COVID vaccines. This is because manufacturers with COVID vaccines approved for emergency use—Johnson & Johnson, Moderna, and Pfizer—had to follow the same FDA guidelines used for all vaccines.
Full approval for Moderna’s COVID vaccine is likely to follow a few months after Pfizer’s. Pfizer announced that it had applied for full approval of its vaccine for people ages 16+ on May 7. It did not receive priority status from the FDA until two months later.
U.S. health officials Wednesday recommended all Americans get COVID-19 booster shots to shore up their protection amid the surging delta variant and evidence that the vaccines’ effectiveness is falling.
The Associated Press and NewsNation contributed to this report.