The United States has approved the emergency use of a coronavirus vaccine, and it will begin arriving early Monday in U.S. states, officials said. It’s a landmark development in a country where COVID-19 has killed more than 295,000 people, according to Johns Hopkins University’s Coronavirus Research Center.
The chief operating officer of Operation Warp Speed, the Trump administration’s vaccine development program, Army General Gustave Perna, said at a news conference Saturday that shipping companies would begin delivering about 3 million doses of Pfizer’s vaccine to nearly 150 distribution centers, and an additional 450 or so facilities will get the vaccine by Wednesday.
The Food and Drug Administration late Friday approved Pfizer’s vaccine, developed with German partner BioNTech, for emergency use.
Health care workers and elderly people in long-term care facilities will receive the first shots first, when the first round of 2.9 million doses becomes available.
FDA chief Stephen Hahn said at a news conference Saturday just outside Washington that he would get inoculated as soon as the vaccine was available.
"With this authorization, we know that our federal partners are already moving to distribute the first doses of the vaccine throughout the country," Hahn said.
Hahn defended the fastest U.S. vaccine approval process ever, maintaining the agency did not prioritize speed over safety.
He said news accounts that White House Chief of Staff Mark Meadows had threatened to fire him if the agency did not authorize the vaccine for use by a certain date were inaccurate.
FDA likened to 'turtle'
Meadows’ reported warning to Hahn came on the same day President Donald Trump denounced the FDA on Twitter as a “big, old, slow turtle” and called on Hahn to get the "vaccines out NOW.”
The vaccine was 95% effective in preventing COVID-19 in a late-stage trial.
BioNTech Chief Executive Ugur Sahin said the vaccine “will help to save lives across the United States and could accelerate a return to normality.”
The U.S. federal government is planning to accelerate vaccinations in the weeks ahead, particularly if a vaccine from Moderna Inc. is approved soon.
CDC group's recommendation
A U.S. Centers for Disease Control and Prevention advisory group met Saturday and recommended the vaccine for widespread use for those 16 and older. It will later address whether groups like pregnant women and those younger than 16 should be vaccinated.
The top U.S. infectious-disease expert, Dr. Anthony Fauci, said Thursday that regulators and drugmakers would begin clinical trials in January, testing the safety of vaccines on pregnant women and young people.
Those two groups were excluded from initial trials until researchers could determine if the vaccine was relatively safe in healthy adults before testing it on more vulnerable groups.
The Pfizer/BioNTech vaccine was approved as cases are surging in the U.S. Thousands of people are dying daily, while intensive medical care units across the country are approaching capacity, threatening to overwhelm health care systems.
The vaccine was first approved in Britain earlier this month, and British residents began receiving vaccinations Tuesday. Canada also approved the vaccine and expects to begin inoculations in the coming days.
Bahrain, Mexico and Saudi Arabia have also authorized the use of the Pfizer vaccine.
Trump late Friday hailed the development as “a medical miracle.”
In a video message posted on Twitter, Trump said the first doses of the vaccine would be administered “within 24 hours” and would be “free [of charge] for all Americans.”
The president said the vaccine “will save millions of lives and soon end the pandemic once and for all.” The assertion contradicted health officials who noted that it would be months before many Americans could be inoculated and that eradication of COVID-19 was far from assured.
There was no immediate reaction from President-elect Joe Biden, who in a statement earlier this week called the vaccine a “bright light in a needlessly dark time” and promised in a briefing that 100 million vaccine doses would be administered in the first 100 days of his administration. Biden will be sworn in January 20.
The top Democrat in Congress, House Speaker Nancy Pelosi, said Americans "should have full confidence in this vaccine knowing that it has been reviewed and recommended by the independent experts of the FDA’s advisory panel.”
In a statement, Pelosi urged federal action to accelerate vaccine manufacturing, adding, “We must ensure that the vaccine will be free and distributed in a fair and equitable manner to as many Americans as possible as soon as possible.”
Health and Human Services Secretary Alex Azar, meanwhile, said that, despite the good news, Americans must “double down” on public health measures.
“As Americans get vaccinated, we need to continue taking steps like washing our hands, social distancing and wearing face coverings to protect ourselves, our loved ones and our communities,” Azar said in a statement.
Fauci said if distribution of the vaccine was effective and enough people got vaccinated, relief from the coronavirus crisis in the U.S. might be on the horizon.
“By the end of summer or end of the third quarter, we may actually have enough herd immunity protecting our society,” he said.