Press release
Friday, January 29, 2021
An experimental COVID-19 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 21. The vaccine, called Ad.26. COV2.S or JNJ-78436725, requires only a single injection and can be stored in the refrigerator for months.
The provisional 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 experimental vaccine was reported to be 66% effective in preventing the combined endpoints of the moderate and severe COVID-19 study 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 a cough, sore throat, fever, or chills. Serious 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 a hospital intensive care unit or death.
Geographically, the level of protection for the combined outcomes 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 experimental vaccine was reportedly 85% effective in preventing severe / critical COVID-19 in all geographic regions. No deaths related to COVID-19 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 acted as regulatory sponsors of the Phase 3 clinical study known as ENSEMBLE. Janssen; the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health; and the Advanced Biomedical Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response in the United States Department of Health and Human Services, funded approximately 55% of the study through a cost-sharing agreement. The ENSEMBLE trial, which began on September 23, 2020, is being conducted as part of the federal response COVID-19.
The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike 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 tracts; 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 employed the same vector used in the first dose of its first booster vaccine regimen against Ebola virus disease (Ad26 ZEBOV and MVN-BN-Filo), developed under a long-standing partnership with BARDA is granted marketing authorization by the European Commission in July 2020. Unlike the two COVID-19 vaccines currently authorized by the Food and Drug Administration for emergency use (Pfizer and Moderna vaccines), the Janssen experimental vaccine requires only a single vaccination.
Key investigators for 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 National Institute of Infectious Diseases Evandro Chagas – Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh., president and executive director of the South African Medical Research Council and principal co-investigator of the HIV Vaccine Trials Network (HVTN). The clinical trial centers supported by NIAID in the ENSEMBLE study were part of the COVID-19 Prevention Network (CoVPN).
As part of Janssen’s collaboration with the federal response effort COVID-19, representatives from NIAID, BARDA and Janssen are included in the oversight group that receives recommendations from the study’s independent data and security monitoring board (DSMB). The same DSMB also oversees other Phase 3 clinical trials with federal support that evaluate COVID-19 candidate vaccines.
More detailed information about the ENSEMBLE trial, including more comprehensive data, will be available in the next reports. For more information about the study, visit clinictrials.gov and search for the identifier: NCT04505722.
NIAID conducts and supports research – at NIH, the United States and around the world – to study the causes of infectious and immune-mediated diseases and to develop better ways 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, providing effective human and health services and promoting advances in medicine, public health and social services. ASPR’s mission is to save lives and protect Americans from 21st threats to health security of the century. Within ASPR, BARDA invests in innovation, advanced research and development, acquisition and manufacture of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools and non-pharmaceutical products necessary to combat threats to health security. To date, BARDA-supported products have obtained 57 FDA approvals, licenses or releases. For more information about the BARDA portfolio for diagnostics, vaccines and COVID-19 treatments and the partnership 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 country’s medical research agency, includes 27 institutes and centers and is a component of the United States Department of Health and Human Services. NIH is the leading federal agency that conducts and supports basic, clinical and translational medical research, and is investigating 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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