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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 performed on January 21. The vaccine, called Ad.26. COV2.S or JNJ-78436725, requires only one injection and can be stored in the refrigerator for months.
The interim 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 investigational vaccine was reportedly 66% effective in preventing the combined study 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 has been defined as laboratory-confirmed SARS-CoV-2 plus one of the following: evidence of pneumonia; deep vein thrombosis; difficulty in breathing; abnormal oxygen saturation or respiratory rate equal to or greater than 20; or at least two 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 clinical signs at rest indicating severe systemic illness, respiratory failure, shock, significant organ dysfunction, hospitalization in intensive care unit or death.
Geographically, the level of protection for the combined parameters of moderate and severe illness 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 COVID-19 related deaths 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 Pharmaceuticals Janssen developed the investigational 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), which is part of the National Institutes of Health; and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the office of the Assistant Secretary for Preparedness and Response of the US Department of Health and Human Services, funded about 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 human adenovirus to express the SARS-CoV-2 spike protein. SARS-CoV-2 is the virus responsible for COVID-19. Adenoviruses are a group of viruses that cause infections of the respiratory tract 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. To develop the vaccine, Janssen used the same vector as that used in the first dose of its Ebola virus disease vaccination schedule (Ad26 ZEBOV and MVN-BN-Filo), developed through a long-term partnership. date with BARDA and obtained a 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 vaccines), the experimental Janssen vaccine requires only one vaccination.
Principal investigators of 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 HIV / AIDS clinical research laboratory 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 Council for Medical Research 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 are included in the watchdog that receives recommendations from the independent data and security oversight committee. (DSMB) of the test. The same DSMB is also overseeing the other federally-supported Phase 3 clinical trials evaluating COVID-19 vaccine candidates.
More detailed information on the ENSEMBLE trial, including more complete data, will be available in future reports. For more information about the study, visit Clinicaltrials.gov and search for the ID: NCT04505722.
NIAID conducts and supports research – at NIH, in 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 materials related to NIAID 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 by promoting advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from 21st threats to the 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-pharmaceuticals needed to combat threats to health security. To date, the products supported by BARDA have obtained 57 approvals, licenses or authorizations from the FDA. To learn more about BARDA’s portfolio for COVID-19 diagnostics, vaccines and treatments and the partnership with BARDA, visit medicalcountermeasures.gov. To learn more about federal support for the Pan American response to COVID-19, visit coronavirus.gov.
About the National Institutes of Health (NIH):NIH, the country’s medical research agency, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.
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