FDA Issues Emergency Use Authorization for Single-dose J&J Vaccine

February 27 the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

The Janssen COVID-19 Vaccine is administered as a single dose, and according to FDA data, is 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination. The Janssen Vaccine is the first authorized vaccine that can be stored unfrozen.

The FDA has published a fact sheet for Janssen COVID-19 vaccine recipients.

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