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Press release
Saturday February 27, 2021
Today, the United States Food and Drug Administration issued an Emergency Use Authorization (EUA) to the Janssen Pharmaceuticals Companies of Johnson & Johnson for its single-injection COVID-19 vaccine, called Ad.26.COV2S or JNJ-78436725. The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the spike protein found on the surface of the SARS-CoV-2 virus that causes COVID-19. Adenoviruses are a group of viruses that cause infections of the respiratory and gastrointestinal tract; the adenovirus vector used in the Janssen COVID-19 vaccine has been modified so that it can no longer replicate in humans and cause disease. 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 US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, supported advanced clinical trials of the Janssen vaccine. This is the third COVID-19 vaccine in the United States to benefit from an EUA by the FDA. NIH Director Francis S. Collins, MD Ph.D., NIAID Director Anthony S. Fauci, MD, and BARDA Director Gary Disbrow, Ph.D., have issued the following statements:
“This week marked a devastating milestone of 500,000 deaths from COVID-19 here in the United States. The loss attributed to illness is almost unfathomable. Having a third vaccine that meets EUA’s expectations for safety and efficacy in preventing serious illness and death from COVID-19 brings us closer to protecting the American public, staying one step ahead on viral variants and finding our way out of the pandemic. I would like to thank the clinical staff who conducted the vaccine clinical trials as well as the thousands of study participants who helped us find the scientific answers necessary to reach this important day. – NIH Director Francis S. Collins, MD, Ph.D.
“The Janssen COVID-19 vaccine is a very welcome addition to the arsenal of COVID-19 vaccines and other prevention strategies. When tested on 45,000 volunteers, the single injection vaccine was found to be 77% effective in preventing severe / critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing COVID- 19 severe / critical occurring at least 28 days after vaccination. The vaccine was found to be approximately 67% effective in preventing moderate to severe / critical COVID-19 disease occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe COVID-19 disease / critical occurring at least 28 days after vaccination. Importantly, the vaccine was 100% effective in protecting against death from the disease wherever it was tested. In addition to meeting the safety and efficacy expectations to support emergency use authorization, the Janssen vaccine has the advantage of requiring only a single injection and can be easily transported and stored without refrigeration requirements. particular. To control the COVID-19 pandemic, stay ahead of disturbing viral mutations, and protect the American public, we need to vaccinate as many Americans as possible as quickly as possible. The Janssen vaccine offers another option to help achieve these goals. – NIAID Director Anthony S. Fauci, MD
“The emergency use clearance for the Janssen COVID-19 vaccine by the FDA is exciting news on many fronts. A single-dose vaccine stored at refrigerated temperatures that prevents hospitalizations and deaths from COVID has the potential to change the trajectory of the pandemic in the United States and around the world. Janssen and BARDA have a history of working together, developing influenza and Ebola treatments and vaccines. To manufacture its COVID-19 vaccine in the United States, Janssen is working with the resources we established after the 2009 influenza pandemic: our innovation centers in advanced development and manufacturing and our fill manufacturing network. With the development of this vaccine, we see the results of years of work on platform technologies and public-private partnerships come to fruition. – Gary Disbrow, Director of BARDA, Ph.D.
Francis S. Collins, MD, Ph.D., is director of the National Institutes of Health in Bethesda, Maryland.
Anthony S. Fauci, MD, is director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Maryland.
Gary Disbrow, Ph.D., is Director of the Biomedical Advanced Research and Development Authority (BARDA), within the HHS Office of the Assistant Secretary for Preparedness and Response.
NIAID conducts and supports research – at the 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 the National Institutes of Health (NIH):NIH, the country’s medical research agency, comprises 27 institutes and centers and is a component of the US Department of Health and Human Services. The NIH is the principal 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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