The U.S. Food and Drug Administration (FDA) on Friday approved the emergency use of a new coronavirus vaccine developed by Pfizer Inc. and BioNTech. This is a major turning point in this once-in-a-century global epidemic. The outbreak has already claimed the lives of nearly 300,000 Americans in less than a year and has also caused significant harm to the U.S. economy.
Denise Hinton, the FDA’s chief scientist, wrote in a letter sent Friday to Pfizer that she authorized the emergency use of a vaccine developed by the company.
President Trump called it a “medical miracle” in a video tweet. He wrote, “We delivered a safe and effective vaccine in 9 months. This is one of the greatest scientific achievements in history.”
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the decision “promises to change the course of the epidemic in the United States.”
He said, “With the science guiding our decision, the available safety and efficacy data support the authorization of Pfizer and BioNTech’s new coronavirus vaccine because the known and potential benefits of the vaccine clearly outweigh the known and potential risks. “
The FDA’s emergency use authorization will now initiate federal distribution of potentially life-saving doses to 64 states, territories and major cities across the country. The government plans to distribute 2.9 million doses of the vaccine within 24 hours and then distribute another 2.9 million doses as a second dose 21 days later.
Gen. Gustave Perna oversees the operation of President Trump’s vaccine program. He said Wednesday that two doses of Pfizer’s vaccine are needed, with three weeks in between.
The authorization of emergency use of this vaccine is at the most critical time. The number of patients with the new coronavirus in hospitals across the U.S. is already higher than at any previous time, and the U.S. outbreak is at a record level of severity.
An analysis based on data from Johns Hopkins University shows that the United States reported 3,124 new coronavirus deaths on Wednesday, the deadliest single-day record of the pandemic to date. Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, warned earlier this month that the coming months of the pandemic will be “the toughest in the history of public health in this country.”
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