FDA Issues EUA for Third COVID-19 Vaccine

March 01, 2021

The Food and Drug Administration issued an emergency use authorization (EUA) for Johnson & Johnson’s COVID-19 vaccine candidate on Saturday for use in individuals aged 18 and older. Authorization of the one-dose vaccine followed the recommendation of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26. It is the third vaccine authorized against COVID-19 and the first to require only basic refrigeration. 

According to an FDA analysis of data from 39,321 clinical trial participants in Mexico, South Africa, the United States and some countries in South America, the vaccine is 67% effective in preventing moderate to severe COVID-19 after 14 days and 66% effective in preventing moderate to severe COVID-19 after 28 days. In addition, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 after 14 days and 85% effective in preventing severe/critical COVID-19 after 28 days.