Full FDA approval for Pfizer vaccine expected in early September — report

The US drug regulator is set to fully approve the Pfizer/BioNTech COVID-19 vaccine by early next month, the New York Times reported Tuesday.

The Food and Drug Administration has set an “unofficial deadline” of the September 6 Labor Day holiday “or sooner” to give the shot the final green light, the newspaper reported, citing sources familiar with the plan.

The vaccine is currently being administered via an emergency use authorization that was granted in December.

The FDA had said in a statement last week that granting the Pfizer vaccine final approval was one of the agency’s highest priorities and anticipated being finished with the final review soon.

Full approval could boost vaccine-hesitant people’s confidence in getting the shot as the ultra-contagious Delta variant sweeps through the world, driving case counts to levels not seen since the winter.

Pfizer is by far the most widely administered shot in Israel, followed by another two-dose mRNA shot from Moderna, which is also allowed under an emergency use authorization and is seeking full approval from the FDA, which is expected to come after Pfizer’s.

As of Tuesday night, 5,792,727 Israelis had received at least one shot of the vaccine, 5,383,109 had received a second shot, and 155,509 had received a third booster shot.