Resource: FDA Issues Emergency Use Authorization for First COVID-19 Vaccine
Source: U.S. Food and Drug Administration
Synopsis: The FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
Comment: The much-anticipated emergency use authorization (EUA) of this vaccine — the first such approval in the United States — was greeted with optimism by infectious disease and pulmonary experts, although unanswered questions remain regarding use in people with allergic hypersensitivity, safety in pregnant women, and how smooth distribution will be. Two healthcare workers in the United Kingdom developed severe allergic signs and symptoms; however, they had a history of severe allergic reactions and both of them carried an EpiPen. At this time the FDA committee is not recommending this vaccine for anybody with a history of severe allergies.
