Today, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the single-dose Janssen COVID-19 vaccine from Johnson & Johnson. This authorization suggests that the benefits outweigh its risks for use in individuals 18 of age or older and permits the vaccine to be distributed in the U.S., making it the third vaccine available in the country.
“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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. Read more.