News 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 Jan. 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.
In the interim analysis, 468 cases of symptomatic COVID-19 were assessed 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 post-vaccination in 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; trouble breathing abnormal oxygen saturation or a respiration rate equal to or greater than 20; or two or more signs or symptoms indicative 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 indicating severe systemic disease, respiratory failure, shock, significant organ dysfunction, hospital intensive care unit admission, or death.
Geographically, the level of protection varied for the combined endpoints of moderate and severe disease: 72% in the United States; 66% in Latin American countries; and 57% in South Africa, 28 days after vaccination. The study vaccine was reported to be 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. In total, 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 trial 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 US 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 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 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 prime-boost Ebola virus disease vaccine regimen (Ad26 ZEBOV and MVN-BN-Filo), developed in a long-term partnership with BARDA and has been granted a 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 Moderna vaccines), Janssen’s investigational vaccine requires only one vaccination .
The principal investigators for the ENSEMBLE clinical trial are: 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 chief executive officer of the South African Medical Research Council and co-principal investigator of the HIV Vaccine Trials Network (HVTN). The NIAID-supported 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 COVID-19 response effort, representatives from NIAID, BARDA and Janssen will be included in the oversight group that will receive recommendations from the trial’s independent data and security monitoring board (DSMB). The same DSMB also oversees the other federal-sponsored Phase 3 clinical trials evaluating COVID-19 vaccine candidates.
More detailed information on the ENSEMBLE study, including more comprehensive data, will be available in upcoming reports. For more information about the study, visit clinicaltrials.gov and search ID: NCT04505722.
NIAID conducts and supports research – at NIH, in the United States and worldwide – to study the causes of infectious and immune-mediated diseases and to develop better means to prevent, diagnose and treat these diseases. News releases, 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 wellness of all Americans, providing effective health and human services and promoting advancements in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from 21st threats to the health of the century. Within ASPR, BARDA invests in innovation, advanced research and development, procurement and production of medical countermeasures – vaccines, drugs, therapies, diagnostic tools and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 57 FDA approvals, licenses, or approvals. For more information on BARDA’s portfolio for COVID-19 diagnostics, vaccines and treatments and on partnerships 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 part of the United States Department of Health and Human Services. NIH is the premier federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments, and cures for both common and rare diseases. To learn more about NIH and its programs, visit www.nih.gov.
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