Press release
Friday, January 29, 2021
A COVID-19 investigational vaccine developed by Janssen Pharmaceuticals appears to be safe and effective in preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted on January 21st. The vaccine, called Ad.26. COV2.S or JNJ-78436725, requires a single injection and can be stored in the refrigerator for months.
The interim analysis assessed 468 cases of symptomatic COVID-19 in 44,325 adult volunteers from Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. The investigational vaccine would have been 66% effective in preventing the combined objectives of the moderate and severe COVID-19 study 28 days after 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; difficult 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 laboratory-confirmed SARS-CoV-2 plus evidence of clinical signs at rest indicative of severe systemic disease, respiratory failure, shock, significant organ dysfunction, hospitalization in intensive care units, or death.
Geographically, the level of protection for the combined targets 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 investigational vaccine would have been 85% effective in preventing severe / critical COVID-19 in all geographical regions. No COVID-19-related deaths were reported in the vaccine group, while 5 placebo-group deaths 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 trial known as ENSEMBLE. Janssen; National Institute of Allergies and Infectious Diseases (NIAID), part of the National Institutes of Health; and the Authority for Advanced Biomedical Research and Development (BARDA), part of the U.S. Department of Health and Human Services, assistant secretary for training and response, funded approximately 55% of the study through a cost-sharing agreement. The ENSEMBLE process, which began on September 23, 2020, is part of the federal COVID-19 response.
The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 protein. SARS-CoV-2 is the virus that causes COVID-19. Adenoviruses are a group of viruses that cause infections in the respiratory 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 developing the vaccine, Janssen used the same vector used in the first dose of his first-boost Ebola vaccine regimen (Ad26 ZEBOV and MVN-BN-Filo), developed in a long-term partnership with BARDA and granted the authorization to be placed on the market by the European Commission in July 2020. Unlike the two COVID-19 vaccines currently authorized by the US Food and Drug Administration (Pfizer and Moderna vaccines), the Janssen investigational vaccine requires only one vaccination.
Lead investigators for the ENSEMBLE clinical trial include: Paul A. Goepfert, MD, director of the Alabama Vaccine Clinical Research at the University of Alabama at Birmingham; Beatriz Grinsztejn, MD, Ph.D., director of the Clinical Research Laboratory on HIV / AIDS at the National Institute of Infectious Diseases Evandro Chagas-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-investigator of the HIV Vaccine Testing Network (HVTN). The NIAID clinical trial sites 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, NIAID, BARDA and Janssen representatives are included in the oversight group that receives recommendations from the independent data monitoring and safety board (DSMB) of the process. The same DSMB also oversees other federally supported Phase 3 clinical trials evaluating candidates for COVID-19 vaccine.
More detailed information on the ENSEMBLE process, including more comprehensive data, will be available in future reports. For more information about the study, visit clinictrials.gov and the search identifier: NCT04505722.
NIAID conducts and supports research – at the NIH, throughout the United States and around the world – to study the causes of infectious and immune-mediated diseases and to develop better means of preventing, diagnosing and treating these diseases. Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.
About HHS, ASPR and BARDA: HHS works to enhance and protect the health and well-being of all Americans by providing efficient health and human services and promoting advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect 21-year-old AmericansSt. threats to health security of the century. Within ASPR, BARDA invests in innovation, advanced research and development, the purchase and manufacture of medical countermeasures – vaccines, medicines, therapeutic products, diagnostic tools and non-pharmaceutical products needed to combat health threats. To date, BARDA-supported products have received 57 FDA approvals, licenses or authorizations. For more about BARDA’s portfolio for COVID-19 diagnosis, vaccines and treatments, and to partner with BARDA, visit medicalcountermeasures.gov. To learn more about federal support for the COVID-19 response across America, visit coronavirus.gov.
About the National Institutes of Health (NIH):
NIH, the national medical research agency, includes 27 institutes and centers and is a component of the US Department of Health and Human Services. NIH is the first federal agency to conduct and support basic, clinical, and translational medical research and investigate the causes, treatments, and treatments for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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