The FDA has granted emergency use authorization status for the first single-dose vaccine for COVID-19 in the United States.
The FDA has granted emergency use authorization (EUA) to Johnson & Johnson for its COVID-19 vaccine following an advisory panel meeting on Friday.
The vaccine, named Ad26.COV2.S, is the first single-dose COVID-19 vaccine and the third vaccine to be authorized in the US for the virus.
The EUA is based on the phase 3, randomized, double-blind, placebo-controlled ENSEMBLE clinical trials, which met all primary and key secondary end points; overall, the investigational vaccine demonstrated 66% efficacy in preventing moderate-to-severe COVID-19. Johnson & Johnson submitted its EUA request on February 4.
As part of its authorization, the FDA noted it is mandatory for Janssen Biotech and vaccination providers to report the following to the Vaccines Adverse Event Reporting System for Janssen COVID-19 Vaccine: serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD. “The FDA, through our open and transparent scientific review process, has now authorized 3 COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”
Read our coverage of the advisory panel meeting for more information on the vaccine’s efficacy and safety data.
1. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. News release. FDA; February 27, 2021. Accessed February 27, 2021. https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine