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 first vaccine will be administered in less than 24 hours,” Trump said Friday night at 9:30 p.m.
“The governors decide where the vaccines will go in their state, and who will get them first. We want our senior citizens, health care workers and first responders to be first in line.”
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 that are three weeks apart, will be the first vaccine against the coronavirus distributed in the U.S.
“Today our nation has achieved a medical miracle,” President Trump said in a statement tweeted Friday night. “We have delivered a safe and effective vaccine in just nine months. This is one of the greatest scientific accomplishments in history.”
Ongoing trials involving some 44,000 recipients show it is indeed 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.
Trump credited Friday night’s success to “Operation Warp Speed,” which he called “the greatest medical manufacturing endeavor in American history.”
The program channelled $14 billion in federal funds into the race to develop, manufacture and distribute effective vaccines.
Nearly $2 billion funded Pfizer’s effort to produce 100 million doses now, with an option to produce an additional 500 million doses, Trump said Friday night. The doses will be free of charge, he said.
“It will save millions of lives and soon end the pandemic once and for all,” Trump said of the start of vaccinations.
“We have given Pfizer and other companies a great deal of money hoping this would be the outcome,” he said.
“And it was. On behalf of the American people, I would like to thank all of the brilliant scientists, technicians, doctors and workers who made this all possible. Pfizer and Moderna have announced their vaccines are approximately 95 percent effective, far exceeding expectations,” he noted.
“These vaccines are also very safe. American citizens participated in clinical trials that were far larger than normal, and had no serious side effects.
“The dedicated and independent experts at the FDA meticulously studied the results of the trials and it has now passed the gold standard of safety,” he said.
“The United States is the first nation in the world to produce a verifiably safe and effective vaccine. Today’s achievement is a reminder of America’s unlimited potential when we have the will and the courage to pursue ambitious goals,” he said.
“As I’ve said from the beginning, a vaccine will vanquish the virus, and return life back to normal.”
Friday night’s FDA 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