March 1, 2021
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for the third vaccine for the prevention of COVID-19, which is caused by SARS-CoV-2. The Janssen COVID-19 Vaccine, administered as a single dose, can now be distributed in the U.S and given to adults age 18 and older.
The FDA analyzed data from an ongoing randomized study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The study included over 39,000 participants who had no evidence of COVID-19 prior to vaccination. Roughly half the participants received the vaccine and about half received a placebo. Findings show that overall, the vaccine was about 67% effective in preventing moderate to severe or critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe or critical COVID-19 occurring at least 28 days after vaccination.
“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said in an FDA press release. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus.”
Source: (February 27, 2021) FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine, FDA Press Announcement. Accessed March 1, 2021. Available online at https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine
