Johnson and Johnson Single-Dose Vaccine Authorized for Emergency Use Thanks to the Results of the ENSEMBLE Study:
Johnson & Johnson, 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. This was made possible by the support of government agencies such as the National Institute of Health and capital infusion from the Biomedical Advanced Research and Development Authority (BARDA). Moreover, the large ENSEMBLE trial’s success couldn’t have occurred without the significant execution by a couple hundred trial site organizations as well commitment to participate by over 40,000 vaccine trial participants.
The FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information are available at: Here
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS).
The VAERS toll-free number is 1-800-822-7967 or report online Here