News Release
Friday 29 January 2021
A research COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective in preventing moderate to severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted on 21 January . 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 interim analysis assessed 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 study vaccine was reported to be 66% effective in preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days after vaccination among all volunteers, including those infected with an emerging viral variant. Moderate COVID-19 was defined as SARS-CoV-2 in the laboratory, plus one of the following: evidence of pneumonia; deep vein thrombosis; breathing problems; abnormal oxygen saturation or respiratory rate equal to or greater than 20; or two or more signs or symptoms that indicate 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 indicating severe systemic disease, respiratory failure, shock, significant organ failure, hospitalization-intensive care unit admission, or death.
Geographically, the level of protection differs for the combined endpoints of moderate and severe diseases: 72% in the United States; 66% in Latin American countries; and 57% in South Africa, 28 days after vaccination. The research vaccine was reportedly 85% effective in preventing severe / critical COVID-19 in all geographical regions. No COVID-19-related deaths were reported in the vaccine group, whereas 5 placebo-related deaths in the COVID-19 group. Overall, there were 16 deaths in the placebo group and 3 deaths in the vaccine group.
The Janssen pharmaceutical companies of Johnson & Johnson developed the experimental vaccine and served as the regulatory sponsor 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 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, 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 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 digestive tracts; the adenovirus vector used in the experimental vaccine has been modified so that it can no longer be repeated in humans and can cause disease. In developing the vaccine, Janssen used the same vector in the first dose of his first vaccine regimen against Ebola virus disease (Ad26 ZEBOV and MVN-BN-Filo), developed under a long-term partnership with BARDA and granted the marketing authorization. by the European Commission in July 2020. Unlike the two COVID-19 vaccines currently approved by the US Food and Drug Administration for emergency use (Pfizer and Modern vaccines), the Janssen research vaccine is only one vaccine necessary.
The principal 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 Laboratory for Clinical Research 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 co-principal investigator of the HIV Vaccine Trials Network (HRTN). The NIAID-assisted clinical trial sites 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 of NIAID, BARDA and Janssen are included in the oversight group that receives recommendations from the Independent Data and Security Monitoring Board (DSMB). The same DSMB also oversees the other federally supported Phase 3 clinical trials to evaluate the candidates for the COVID-19 vaccination.
More detailed information about the ENSEMBLE hearing, including more comprehensive information, will be available in future reports. For more information on the study, visit clinicaltrials.gov and search identifier: NCT04505722.
NIAID conducts and supports research – at NIH, across the United States and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better ways to prevent, diagnose, and treat these diseases. News reports, fact sheets and other NIAID related material 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 the promotion of medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans by 21st century health safety threats. Within ASPR, BARDA invests in the innovation, advanced research and development, procurement and manufacturing of medical countermeasures – vaccines, medicines, medicines, diagnostic tools and non-pharmaceutical products needed to combat health and safety threats. To date, BARDA products have obtained 57 FDA approvals, licenses or approvals. Visit medicalcountermeasures.gov for more information on BARDA’s portfolio of COVID-19 diagnostics, vaccines and treatments, and collaboration with BARDA. Visit coronavirus.gov to learn more about federal support for the COVID-19 response in America.
About the National Institutes of Health (NIH):
NIH, the country’s medical research agency, contains 27 institutes and centers and is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments, and drugs for common and rare diseases. Visit www.nih.gov for more information on NIH and its programs.
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