Janssen Investigational COVID-19 Vaccine: Phase 3 Interim Analysis Releasing Clinical Data – tech2.org

Janssen Investigational COVID-19 Vaccine: Phase 3 Interim Analysis Releasing Clinical Data

News release

Friday, January 29, 2021

An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals, according to an interim analysis of phase 3 clinical data, appears to be safe and effective in preventing moderate and severe COVID-19 in adults. 21. Vaccine, called Ad.26. COV2.S or JNJ-78436725, requires only one injection and can be stored in the refrigerator for months.

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 investigative vaccine was reportedly 66% effective at preventing the combined endpoints of moderate and severe COVID-19 after 28 days of vaccination among all volunteers infected with an emerging viral variant. Moderate COVID-19 was defined as any of the laboratory-confirmed SARS-CoV-2 Plus: evidence of pneumonia; deep vein thrombosis; Difficulty in breathing; Abnormal oxygen saturation or respiratory rate equal to or greater than 20; Two or more signs or symptoms of COVID-19, such as cough, sore throat, fever or chills. Severe COVID-19 was defined as evidence of laboratory confirmed SARS-CoV-2 as well as clinical signs indicating severe systemic disease, respiratory failure, trauma, significant organ dysfunction, hospital intensive The care unit is a sign of admission or death.

Geographically, the level of protection for the combined endpoint of moderate and severe illness varied: 72% in the United States; 66% in Latin American countries; And 57% in South Africa, 28 days post-vaccination. The investigated vaccine was approximately 85% effective in preventing severe / significant COVID-19 in all geographic areas. There were no deaths related to COVID-19 in the vaccine group, whereas 5 deaths in the placebo group were related to COVID-19. In total, 16 deaths occurred in the placebo group, and 3 deaths in the vaccine group.

Johnson & Johnson’s Janssen Pharmaceutical companies developed the experimental vaccine and served as the regulatory sponsors of the Phase 3 clinical study known as ENSEMBLE. Janssen; 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 for Assistant Secretary of Preparedness and Response, which conducted approximately 55% of the trials 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 respiratory and gastrointestinal tract infections; 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 major-boost vaccine regimen against Ebola virus disease (Ad26 ZEBOV and MVN-BN-Filo) in a long-standing partnership with BARDA Developed under and provided marketing authorization. By the European Commission in July 2020. Unlike the two COVID-19 vaccines currently authorized by the US Food and Drug Administration for emergency use (Pfizer and Moderna vaccine), the Janssen screening vaccine requires only a single vaccination.

Key investigators for the ENSEMBLE clinical trial include: Paul A., director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham. Goeffert; Beatriz Grinszeten, MD, PhD, director of the Laboratory of 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, MBBC, is the President and Chief Executive Officer of the South Africa Medical Research Council and co-head investigator of the HIV Vaccine Trial 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 have been included in the oversight group that receives recommendations from the Independent Data and Safety Monitoring Board (DSMB) of the trial. The same DSMB also oversees other federally supported Phase 3 clinical trials evaluating COVID-19 vaccine candidates.

More detailed information about the ENSEMBLE test, including more comprehensive data, will be available in upcoming reports. For more information about the study, visit Clintrials.gov and identify the finder: NCT04505722.

NIAID supports and supports research at the NIH, across the United States, and around the world – to study the causes of infectious and immune-mediated diseases, and to develop better tools to prevent, diagnose and treat these diseases For. News releases, fact sheets and other NIAID related material 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, provide effective health and human services, and advancement in medical, public health, and social services. ASPR’s mission is to save 21 lives and protect AmericansSt. Century Health Safety Threats Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures, drugs, therapeutics, diagnostic equipment, and non-pharmaceutical products necessary to combat health safety threats. is. To date, BARDA-supported products have received 57 FDA approvals, licenses, or approvals. For more information about BARDA’s portfolio for COVID-19 diagnostics, vaccines and treatments, and to partner with BARDA, visit medicalcountermeasures.gov. To learn more about federal support for all United States COVID-19 responses, visit coronavirus.gov.

About National Institutes of Health (NIH):The NIH, the nation’s medical research agency, consists of 27 institutions and centers and is a component of the US Department of Health and Human Services. The NIH is the primary federal agency conducting and supporting basic, clinical and translational medical research, and investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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