FDA Panel Endorses COVID-19 Vaccine

A Food and Drug Administration advisory panel recommended approval of the COVID-19 vaccine developed by Pfizer Inc. and BioNTech SE, clearing the way for the FDA to grant emergency authorization of the vaccine as early as Friday, reports the Wall Street Journal . The approval—by a vote of 17-4 with one abstention after a daylong hearing—came as COVID-19 infections continued surging, claiming about 290,000 American lives. In its vote to approve, the panel said the benefits of the vaccine outweigh the risks for people 16 years of age and older. "The efficacy is overwhelming" for the vaccine, said Eric Rubin, a Harvard microbiologist and panel member. "It's very strong." The prospect of relief from the coronavirus came on a day when 107,000 people were hospitalized with COVID-19, and a record 3,347 deaths were reported by state health departments, topping the milestone reached one day earlier. Within days, the country will likely surpass 300,000 deaths since the pandemic's arrival. The worsening situation has riveted attention on the final steps of the vaccine approval process. The thumbs' up from the FDA's vaccine advisory committee was the culmination of an all-day meeting during which the panel heard presentations on the safety and effectiveness of the vaccine, including plans to monitor its longer-term safety.