FDA Panel Recommends Approval of First COVID-19 Vaccine

After nine hours of deliberation Thursday, a special panel of the U.S. Food and Drug Administration approved for emergency use a coronavirus vaccine developed by U.S. pharmaceutical giant Pfizer and Germany’s BioNTech. The decision was made as the U.S. continues to confirm record numbers of coronavirus cases. As of Thursday evening, the U.S. had recorded 15.5 million cases and more than 291,000 deaths, according to Johns Hopkins University data. Of the 22 people on the special panel of the Food and Drug Administration (FDA), 17 voted yes, four voted no and one abstained on the question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer/BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age and older?” With the recommendation of the emergency use authorization by the Vaccines and Related Biological Products Advisory Committee, the FDA will likely give its final consent as early as Friday or Saturday. The U.S. government will immediately ship 6.4 million doses of the vaccine across the country, with front-line health care workers receiving top priority for the first inoculations. The U.S. military will also prioritize its health care workers for its initial allocation of the Pfizer/BioNTech vaccine, which will be just less than 44,000 doses.  A Pentagon spokesman told reporters Wednesday that the military will start inoculations “within a day or two” after the FDA approves the emergency use authorization. The vaccinations will be voluntary at first but could become mandatory once the vaccine is fully licensed. Thursday’s meeting was held a day after the United States recorded more than 3,000 COVID-19 deaths in a single day for the first time in the nearly yearlong pandemic.   The Pfizer/BioNTech vaccine has jumped to the front of the line in the global effort to develop a vaccine against the novel coronavirus that causes COVID-19. Britain became the first Western nation to begin mass inoculations of the drug on Tuesday, just days after the government’s medical regulatory agency approved the drug.  VOA’s Richard Green and Esha Sarai contributed to this report.
 

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