The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 18 years of age and older.

The Janssen COVID-19 vaccine uses adenovirus type 26 (Ad26) to deliver a piece of the DNA that is used to make the distinctive spike protein of the SARS-CoV-2 virus. Adenoviruses are a group of viruses that are relatively common; Ad26 has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. The Janssen COVID-19 vaccine is administered as a single dose.

The EUA is supported by results of a clinical trial which showed that the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

Food and Drug Administration (FDA). FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine [news release]. February 27, 2021. Available at: click here. Accessed March 1, 2021.