The Food and Drug Administration approved the emergency use of Pfizer’s COVID-19 vaccine Friday as a second surging of the coronavirus continues to batter a pandemic-weary nation.
The approval clears the way for the first wave of American recipients — millions of health workers and nursing home residents — to begin getting shots in mere days.
The historic go-ahead marks the beinning of the end of the pandemic in the United States, where more than 294,000 people have died of COVID-19.
The vaccine, developed by the Manhattan-based Pfizer and the German company BioNTech, and designed to be given in two doses three weeks apart, will be the first vaccine against the coronavirus distributed in the U.S.
Ongoing trials involving some 44,000 recipients show it is 95% effective in warding off illness, including for the elderly and for people with pre-existing health conditions; detailed data also show it is safe to take.
The rollout, however, will be slow, as initial supplies are scarce. An estimated three million doses are expected in the first shipments around the country.
Earlier Friday, a review of the clinical trial data ordered by Gov. Andrew Cuomo found that there were no problems with the vaccine, clearing the way for its distribution in New York.
Friday night’s approval comes after a government advisory panel backed the use of the vaccine, which paved the way for the FDA to grant its green light.
In a 17-4 vote with one abstention Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee concluded that the shot appears safe and effective for emergency use in people 16 and older.
Earlier Friday, Health and Human Services Secretary Alex Azar hinted approval was right around the corner and said people could be receiving the shot as early as Monday or Tuesday.
“I’ve got some good news for you,” Azar said on ABC’s “Good Morning America.”
“Just a little bit ago, the FDA informed Pfizer that they do intend to proceed toward an authorization for their vaccine.”
Last week, the booster was approved and immediately rolled out to citizens in the UK. Some British recipients have reported severe allergic reactions to the vaccine, but Pfizer reps told the FDA panel Thursday they’d seen no signs of such reactions in their trial.
With Post wires