NEW BRUNSWICK, NJ, February 4, 2021 / PRNewswire / – Johnson & Johnson (NYSE: JNJ) (The Company) announced today that Janssen Biotech, Inc., has filed an application to the U.S. Food and Drug Administration (FDA) seeking Emergency Use Authorization (EUA) for its Janssen COVID-19 single-dose vaccine candidate study. The Company ‘s EUA application is based on top – line efficacy and safety data from the ENSEMBLE Level 3 clinical trial, showing that the single – dose vaccine vaccination met all primary and primary endpoints. The Company expects a product to be available for dispatch immediately upon approval.
“Today’s application for Emergency Use Authorization of our single-dose COVID-19 surveillance vaccine is a critical step toward reducing the burden of disease for humans worldwide and stopping the pandemic,” he said. Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “With the approval of our COVID-19 surveillance vaccine for emergency use, we are ready to begin shipping. With our application to the FDA and our ongoing reviews with other health authorities around the world, we are working with emergencies. to make our screening vaccine available to the public as soon as possible. “
The Company has initiated ongoing applications with a number of health organizations outside the U.S., and will submit a Contemporary Marketing Authorization (cMAA) Application with the European Pharmaceuticals Agency in the coming weeks. .
Manufacturing and supply chain information
The Janssen surveillance vaccine is compatible with standard vaccine circulation channels. If authorized, the Janssen single-dose vaccine is considered to remain stable for two years at -4 ° F (-20 ° C), and at least three months may be stored in bulk. some conventional refrigerators at a temperature of 36 ° F – 46 ° F (2 ° -8 ° C). The Company will introduce the vaccine using the same cold chain technologies they use today to transport other innovative medicines.
JanVen Research COVID-19 Vaccine
The Janssen COVID-19 screening vaccine reduces the Company’s AdVac® vaccine platform, which was also used to develop and manufacture the Ebola vaccine regimen approved by the European Commission Janssen and its Zika, RSV vaccines, and raising HIV. The observed safety profile was consistent with other surveillance vaccines using AdVac Janssen® technology among more than 200,000 people to date.
Stage 3 ENSEMBLE Study Design
The ENSEMBLE Phase 3 study is a randomized, double-blind, placebo-controlled clinical trial in adults 18 years of age and older. The study was designed to evaluate the safety and efficacy of Janssen study vaccine in protecting against both moderate and severe COVID-19 infection, with evaluation of efficacy as day 14 and day 28 as co-termination points. primary school.
The trial, which was conducted in eight countries across three continents, covers a wide and diverse population.
Research and development activities for the Janssen COVID-19 vaccine included ENSEMBLE clinical trial and dose delivery for the U.S. funded in whole or in part by federal funding from the U.S. Department of Health and Human Services, The Assistant’s Office. Secretary for Preparation and Response, Advanced Biomedical Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in cooperation with the National Institute of Infectious and Infectious Diseases (NIAID), part of the National Institutes of Health ( NIH) at the U.S. Department of Health and Human Services (HHS).
Janssen has been working with BARDA since 2015 on innovative solutions for the threats of influenza, chemical, biological, radiation and nuclear and emerging infectious diseases such as Ebola. In February 2020, Janssen and BARDA began work on the development of the COVID-19 vaccine based on AdVac Janssen® technology.
For more information on the Company ‘s multifaceted approach to helping fight the pandemic, visit: www.jnj.com/coronavirus.
About Johnson & Johnson
At Johnson & Johnson, we believe that good health is the foundation of a vibrant life, thriving communities and progress. That is why for over 130 years, we have focused on keeping people well at all ages and stages of life. Today, as the largest and most comprehensive healthcare company in the world, we are committed to using our reach and size for good. We strive to improve accessibility and reach, create healthier communities, and place a healthy mind, body and environment within the reach of all, everywhere. We combine our heart, science and innovation to radically change the path of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.
About Johnson & Johnson’s Janssen pharmaceutical companies
At Janssen, we are creating a future where disease is a thing of the past. We are Johnson & Johnson Pharmaceutical Companies, working hard to achieve that future for patients everywhere by fighting ill with science, improving access with innovation, and healing despair with heart. We focus on areas of treatment where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neonatology, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.
Notice to investors regarding forward-looking statements
This press release contains “forward-looking statements” as defined in the Private Security Literature Reform Act 1995 in relation to the possible development of a protective vaccine. for COVID-19. The reader is warned not to rely on these forward-looking statements. These statements are based on the expectations of future events. If underlying assumptions indicate that erroneous or known or unknown risks or uncertainties arise, the actual results may materially alter from the expectations and projections of Janssen, and / or Johnson Medical Companies & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties that are part of outcome review and improvement, including uncertainties about clinical success and obtaining regulatory consent; uncertainty about commercial success; manufacturing problems and delays; competition, including technological advances, new products and patents acquired by competitors; challenges for patents; product efficiencies or safety concerns that result in product recall or regulatory action; changes in the behavior and spending patterns of consumers of healthcare products and services; changes to relevant laws and regulations, including global health care reforms; and trends in the cost of healthcare. A list and other descriptions of the risks, uncertainties and other items can be found in the Johnson & Johnson Annual Report on Form 10-K for the fiscal year ended. December 29, 2019. . Copies of these films are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen or Johnson & Johnson Pharmaceutical Companies undertakes any statement updates as a result of new information or future events or developments.
SOURCE Johnson & Johnson
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