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The U.S. Food and Drug Administration (FDA) on Dec. 11 granted an emergency use authorization (EUA) to Pfizer and BioNTech's coronavirus vaccine, making it the first that will be available to the American public to help combat a virus that has so far infected more than 15.7 million in the U.S. this year.
The vaccine's authorization coincides with some of the country's deadliest days since the start of the pandemic — more than 3,400 people in the U.S. succumbed to COVID-19 on Dec. 9; 2,760 lost their lives to it a day later. So far, 95 percent of COVID-19 deaths in the U.S. have occurred in people 50 and older, data from the Centers for Disease Control and Prevention (CDC) shows.
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“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,” FDA Commissioner Stephen M. Hahn, M.D., said in a statement. "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 added.
Pfizer’s vaccine has been scrutinized and endorsed by a panel of independent external experts, known as the Vaccines and Related Biological Products Advisory Committee, who on Dec. 10 voted in favor of an EUA for Americans 16 and older, concluding that the benefits of the vaccine outweigh the risks. An FDA analysis showed that Pfizer’s two-dose vaccine far exceeds the agency’s previously established EUA standards: It was about 95 percent effective at preventing illness caused by the coronavirus in clinical trial participants, regardless of age, race or health risks known to complicate COVID-19, and no major safety concerns were uncovered.
Trial participants did experience side effects after vaccination including injection site pain, fever, chills, headaches, muscle aches and joint pain. However, these symptoms were temporary and are in line with side effects that accompany other common vaccines, experts say. British health officials, who began vaccination efforts this week with Pfizer's medicine, have documented two cases of anaphylaxis in vaccine recipients. Its government is now advising people in the U.K. who have had a serious allergic reaction to medicines, vaccines or food to hold off on getting the vaccine until more is understood.
In addition to the U.S. and Britain, Canada has authorized Pfizer's vaccine, as well.