Press release
Friday, January 29, 2021
A researched COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective in preventing moderate and severe COVID-19 in adults, according to a preliminary analysis of Phase 3 clinical data conducted on January 21st. The vaccine, called Ad.26. COV2.S or JNJ-78436725, only requires a single injection and can be stored in the refrigerator for months.
The interim analysis evaluated 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The research vaccine was reported to be 66% effective in preventing the combined final criteria of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infected with an emerging viral variant. Moderate COVID-19 was defined as laboratory-confirmed SARS-CoV-2 plus one of the following: evidence of pneumonia; deep vein thrombosis; difficulty breathing; abnormal oxygen saturation or respiratory rate equal to or greater than 20; or two or more signs or symptoms suggestive of COVID-19, such as cough, sore throat, fever, or chills. Severe COVID-19 was defined as SARS-CoV-2 confirmed in the laboratory plus evidence of clinical signs at rest indicative of severe systemic disease, respiratory failure, shock, significant organ dysfunction, admission to the care unit hospital intensive care or death.
Geographically, the level of protection of the combined endpoints of moderate and severe disease varied: 72% in the United States; 66% in Latin American countries; and 57% in South Africa, 28 days after vaccination. The research vaccine was reported to be 85% effective in preventing severe / critical COVID-19 in all geographic regions. No COVID-19-related deaths were reported in the vaccine group, while 5 deaths in the placebo group were related to COVID-19. Overall, there were 16 deaths in the placebo group and 3 deaths in the vaccine group.
Johnson & Johnson’s Janssen pharmaceutical companies developed the experimental vaccine and served as a regulatory sponsor of the phase 3 clinical study known as ENSEMBLE. Janssen; the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health; and the Advanced Biomedical Development and Research Authority (BARDA), which is part of the U.S. Department of Health and Human Services office of the U.S. Department of Health and Human Services, funded approximately 55% of the trial through a cost-sharing agreement. The ENSEMBLE trial, which began on September 23, 2020, is being conducted as part of the COVID-19 federal response.
The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 ear protein. SARS-CoV-2 is the virus that causes COVID-19. Adenoviruses are a group of viruses that cause infections of the airways and gastrointestinal tract; the adenovirus vector used in the experimental vaccine has been modified, so that it can no longer replicate in humans and cause disease. In the development of the vaccine, Janssen used the same vector used in the first dose of his vaccine regimen against Ebola virus disease (Ad26 ZEBOV and MVN-BN-Filo), developed as part of a long collaboration with BARDA and that obtained a marketing authorization. by the European Commission in July 2020. Unlike the two COVID-19 vaccines currently authorized by the U.S. Food and Drug Administration for emergency use (Pfizer and Moderna vaccines), the Janssen research vaccine it only requires a single vaccine.
Lead researchers at the ENSEMBLE clinical trial include: Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama at Birmingham; Beatriz Grinsztejn, MD, Ph.D., director of the Clinical Research Laboratory on HIV / AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh., president and CEO of the South African Medical Research Council and lead co-researcher of the HIV Vaccine Testing Network (HVTN). Clinical trial sites with NIAID support from the ENSEMBLE study were part of the COVID-19 Prevention Network (CoVPN).
As part of Janssen’s collaboration with the federal COVID-19 response effort, representatives from NIAID, BARDA, and Janssen are included in the oversight group that receives recommendations from the Independent Data Control and Security Committee (DSMB). of the essay. The DSMB itself also oversees other federally supported Phase 3 clinical trials evaluating candidates for COVID-19 vaccines.
More detailed information on the ENSEMBLE test, including more complete data, will be provided in future reports. For more information about the study, visit clinictrials.gov and identify the search: NCT04505722.
NIAID conducts and supports research — at NIH, throughout the United States, and around the world — to study the causes of infectious and mediated diseases by immunity and to develop better means to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About HHS, ASPR and BARDA: HHS works to improve and protect the health and well-being of all Americans by providing effective health and human services and fostering advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect 21-year-old Americansc security threats to the health of the century. Within ASPR, BARDA invests in advanced innovation, research and development, acquisition and manufacture of medical countermeasures: vaccines, medicines, therapeutic products, diagnostic tools and non-pharmaceutical products needed to combat health security threats. To date, BARDA-compliant products have received 57 FDA approvals, licenses, or authorizations. For more information on BARDA’s portfolio for diagnosis, vaccines and COVID-19 treatments and the association with BARDA, visit medicalcountermeasures.gov. For more information on federal support for the U.S.-wide COVID-19 response, visit coronavirus.gov.
Regarding the National Institutes of Health (NIH):
NIH, the country’s medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services. NIH is the leading federal agency that conducts and supports basic, clinical, and translational medical research and investigates the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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