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Pfizer/BioNTech ’s COVID-19 Vaccine Gets a Major Endorsement from FDA Committee
In a 17-4 vote (with one abstention) the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee recommended that Pfizer/BioNTech’s COVID-19 vaccine should be distributed to the American public. With that recommendation hand, an FDA team led by the agency’s commissioner Dr. Stephen Hahn will now make a final decision about whether to issue an emergency use authorization (EUA) for the vaccine for anyone 16 years and older. The committee vote is not binding, but the agency is likely follow its advice, especially given the urgent need for a vaccine to stave off a rising tide of new infections. T...
Source: TIME: Health - December 11, 2020 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news

The First Authorized COVID-19 Vaccine in the U.S. Has Arrived
Late in the evening on Dec. 11, the U.S. Food and Drug Administration (FDA) authorized the first COVID-19 vaccine for use in the country. The emergency use authorization means that doses of the vaccine—made by Pfizer/BioNTech—can be shipped at any time; certain Americans could be vaccinated as soon as next week. In a statement, FDA commissioner Dr. Stephen Hahn said “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.” In the same pr...
Source: TIME: Health - December 11, 2020 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 Source Type: news