Pfizer-BioNTech's Vaccine Is the First COVID-19 Shot to Get Full Approval From the U.S. FDA
Pfizer-BioNTech's Vaccine Is the First COVID-19 Shot to Get Full Approval From the U.S. FDAn Aug. 23, the U.S. Food and Drug Administration approved the first COVID-19 vaccine, one made by Pfizer-BioNTech, for anyone 16 years and older. The vaccine requires two doses and according to company studies, is 91% effective in protecting people from COVID-19 disease, including from severe illness.
With full approval, little in the way of how the vaccine is made will change, according to Pfizer. The two companies are discussing with the FDA how the labels on the approved vials will be revised to reflect the full licensure, but the manufacturing process will not change appreciably. What may also change are vaccine mandates from both public and private agencies including governments, schools, and businesses. Having an approved vaccine may provide stronger support for such entities to require vaccination for employees, students and customers. While some already do have such mandates in place, the FDA approval may lead more organizations to adopt similar requirements.
With an approved vaccine, Pfizer-BioNTech can also start selling and distributing its shot through its own channels. However, Pfizer said it has an agreement with the U.S. government to provide doses through April 2022, at no cost to Americans, and expects the U.S. government to remain the sole distributor of its vaccine through that time.
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