The FDA approved Johnson & Johnson’s 1-dose COVID-19 vaccine for Emergency Use Authorization, Saturday, making it the third approved vaccine in the U.S.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Acting FDA Commissioner Janet Woodcock, M.D., said. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
A total of 43,783 people enrolled in Johnson & Johnson’s eight week randomized, placebo-controlled study conducted in South Africa, South America, Mexico and the U.S.
The results found the vaccine to be 66% effective in prevention of moderate to severe COVID-19 effects, a number that increases to 85% against the most serious effects from the virus.
Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The EUA allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. https://t.co/QooSCJWSX0 pic.twitter.com/MWcCdt5n9U
— U.S. FDA (@US_FDA) February 27, 2021
In a press briefing Wednesday, the White House COVID-19 response team said upon approval, Johnson & Johnson may roll out 3 to 4 million vaccine doses starting next week. Johnson & Johnson also said it believes it can produce 20 million doses by the end of March and 100 million in the first half of 2021.
On Tuesday, U.S. President Joe Biden announced that the number of weekly vaccines distributed to states would increase from the minimum of 13.5 million to 14.5 million, starting next week.