Last Updated: October 08, 2020 Johnson & Johnson - Janssen Research & Development, LLC (Branch Office) 1400 McKean Rd. The prescribing information included here may not be appropriate for use outside the United States. Janssen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are funding the trial. To learn more about federal support for the nationwide COVID-19 response, visit www.coronavirus.gov. An independent Data and Safety Monitoring Board (DSMB) will provide oversight to ensure the safe and ethical conduct of the study. Janssen Pharmaceuticals, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. Johnson & Johnson - Janssen Biotech, Inc. (Main Office) 800 Ridgeview Drive Horsham, PA 19044 (800) 526-7736. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. “To have just one candidate vaccine in Phase 3 trials less than a year after a virus was first reported would be a remarkable accomplishment; to have four candidates at that stage is extraordinary,” said HHS Secretary Alex Azar. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov. Browse jobs and read about the Janssen Research & Development Spring House location with content posted anonymously by Janssen Research & Development employees in Spring House, PA. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19. About Operation Warp Speed: OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. “By building a portfolio of candidate vaccines, Operation Warp Speed is maximizing the chances that we will have substantial supplies of a safe and effective vaccine—and maybe multiple vaccine options—by January 2021.”. Janssen uses the same vector in the first dose of its prime-boost vaccine regimen against Ebola virus disease (Ad26.ZEBOV and MVA-BN-Filo) that was recently granted marketing authorization by the European Commission. The prescribing information included here may not be appropriate for use outside the United States. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a …
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