Authorization

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use

NEW BRUNSWICK, N.J., Feb. 27, 2021 /PRNewswire/ --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 18A years of age and older.This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstratedA 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 daysA 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. "This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world a?? all of whom shared a goal of bringing a single-shot vaccine to the public," said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. "We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world."
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