The first coronavirus vaccine is on the cusp of being deployed across the U.S. after an independent panel of experts reviewed trial data of the Pfizer-BioNTech vaccine Thursday and formally recommended the Food and Drug Administration approve the vaccine. The advisory panel made up of scientists, doctors, and statisticians, voted 17 to 4 in favor of the FDA granting emergency use authorization for the vaccine for Americans 16 years old and up. Two of the dissenting votes cited concerns about the lack of data for the vaccine’s impact on 16 and 17-year-olds. The FDA customarily adheres to the recommendations of such vaccine advisory panels and with the agency’s final approval, the vaccine could be rolled out nationwide as soon as early next week. Millions of doses of the vaccine are currently being stored in warehouses and waiting to be deployed; upon approval, federal officials say that more than 6 million doses will be shipped with around the country.
“More than 100 F.D.A. employees have worked nearly round the clock to review the application Pfizer submitted on Nov. 20, compressing months of analysis into weeks as they pored over thousands of pages of clinical trial and manufacturing data,” the New York Times notes. “During the daylong meeting on Thursday, panel members peppered company and agency experts with detailed questions about the safety and efficacy of the vaccine, which was found to be 95 percent effective in a late-stage clinical trial. Some members expressed concern that there was not enough data from 16- and 17-year-olds to know whether the vaccine would help them, but the committee decided the benefits for that group outweighed the risks.”
“After the FDA authorization, an advisory committee to the Centers for Disease Control and Prevention will vote on whether to recommend the vaccine and for which groups. First in line to be inoculated are health care personnel and residents and staff of long-term care facilities, according to its previous recommendations,” the Washington Post reports. “But states will have the final say on who gets the first shots and where they are administered. Those considerations are complicated by extreme logistics challenges, including the sub-Antarctic storage temperatures the vaccine requires.”
The Pfizer vaccine has already being used in the U.K. and Bahrain, and Canada approved it for use earlier this week.
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