U.S. drug regulators on Monday approved the COVID-19 vaccine from Pfizer and BioNTech for people 16 and older, making it the first such shot to receive approval in the country. The Food and Drug Administration (FDA) said the vaccine, which will be known as Comirnaty, proved effective in a clinical trial of approximately 44,000 people. The shot was 91 percent effective in preventing COVID-19 infection, regulators said, and was also effective in preventing severe disease and hospitalization. The agency didn’t immediately respond when asked for more details about the trial. FDA officials said they also reviewed safety data and determined the vaccine’s known and potential benefits outweigh its known and potential risks, including side effects. “As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Dr. Janet Woodcock, …
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