Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic (jnj.com)
NEW BRUNSWICK, N.J., February 27, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.