FDA Authorizes Pfizer Vaccine, Millions of Doses Ready To Be Shipped
What Vice President Mike Pence has termed “historic” and a “medical miracle” became reality Friday, as the Food and Drug Administration issued an emergency-use authorization that allows Pfizer’s COVID-19 vaccine to be distributed to Americans.
About three million doses will soon be on their way to Americans at the highest risk of the disease, including health care workers and nursing home residents, according to The New York Times.
The logistical minuet that set to take place soon will include Pfizer shipping the vaccine while keeping it at minus 94 degrees Fahrenheit. Meanwhile, medical supplier McKesson Corporation is shipping syringes and all of the other medical gear needed to administer the vaccine to delivery points selected by the states and six major U.S. cities.
As of Saturday morning, there was one more procedural step to be taken, according to CNN.
The Centers for Disease Control and Prevention’s immunization advisory committee must give its approval, and the CDC must formally accept the panel’s recommendation. The Advisory Committee on Immunization Practices was set to meet Saturday.
The vaccine will come to an America that has been waiting for one.
Dr. Samu Queen of Portland, Oregon, said her older patients “are all very anxious.”
“Pretty much everyone, at every appointment, is ready to get it,” Queen told The Times.
Developing a vaccine within months instead of the years-long process common to the industry has been the goal of President Donald Trump’s Operation Warp Speed.
FDA APPROVES PFIZER VACCINE FOR EMERGENCY USE!!!
— Donald J. Trump (@realDonaldTrump) December 12, 2020
On Tuesday, during a South Carolina forum, Pence spoke about “the speed with which Operation Warp Speed has moved.”
“And the truth is it is historic. It is nothing short of a medical miracle,” Pence said, according to a White House transcript of his comments.
“The truth is developing and manufacturing a vaccine can take up to eight to 12 years. And we are literally on track — because of extraordinary leadership at every level, because of the support of these members of Congress, and because of American scientific innovation, we’re literally on track to have a safe and effective vaccine available for the American people between eight and 12 months,” Pence said.
“That is unheard of, but it’s a testament to this president’s impatience as a leader, his willingness to say to everyone, ‘We’re going to do things safely, but we’re going to do them differently.'”
Pence said during the forum that doses for 20 million Americans should be available in December.
Pence urged Americans to look toward the future with hope.
“We’re living in a challenging time. We see cases rising, but you need to be assured we’ve never been more prepared to combat this virus than we are today. And people deserve to know that we are just a few short days away from what, I believe, will be the beginning of the end of the coronavirus pandemic in America,” he said.
FDA Commissioner Dr. Stephen Hahn noted in a statement that the FDA’s authorization followed a review that was as thorough as it was expeditious.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” he said.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” Hahn added.
“The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide,” he said.
Drugmaker Moderna has also developed a vaccine that is currently being reviewed by the FDA.
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