NIH and BARDA Statement Regarding FDA Emergency Use Authorization of Janssen COVID-19 Vaccine – tech2.org

NIH and BARDA Statement Regarding FDA Emergency Use Authorization of Janssen COVID-19 Vaccine


Press release

Saturday, February 27, 2021

Today, the US Food and Drug Administration issued an Emergency Use Authorization (USA) to Johnson & Johnson’s Janssen Pharmaceuticals Companies 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 in the respiratory and gastrointestinal tracts; 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), part of the National Institutes of Health, and the Advanced Biomedical Research and Development Authority (BARDA), part of the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness. USA and Response, supported late-stage clinical trials of the Janssen vaccine. It is the third COVID-19 vaccine in the United States to receive an EUA from the FDA. NIH Director Francis S. Collins, MD Ph.D., NIAID Director Anthony S. Fauci, MD, and BARDA Director Gary Disbrow, Ph.D. 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 the disease is almost unfathomable. Having a third vaccine that meets US expectations for safety and efficacy in preventing serious illness and death from COVID-19 brings us one step closer to protecting the American public, getting ahead of the worrisome viral variants and finding the right one. way out of the pandemic. I would like to thank the clinical staff who conducted the clinical trials of the vaccine, as well as the thousands of study participants who helped us find the scientific answers needed to get us to 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 among 45,000 volunteers, the single-shot vaccine was shown to be 77 percent effective in preventing severe / critical COVID-19 that occurs at least 14 days after vaccination and 85 percent effective in preventing COVID- 19 severe / critical occurring at least 28 days after vaccination. The vaccine was approximately 67 percent effective in preventing moderate to severe / critical COVID-19 disease that occurs at least 14 days after vaccination and 66 percent effective in preventing moderate to severe COVID-19 disease / critical that occurs at least 28 days after vaccination. vaccination. Importantly, the vaccine was 100 percent effective in protecting against death from the disease in all locations where it was tested. In addition to meeting safety and efficacy expectations to support emergency use authorization, Janssen vaccine has the advantage of requiring a single injection and can be easily transported and stored without special refrigeration requirements. To control the COVID-19 pandemic, stay ahead of worrying viral mutations, and protect the American public, we must vaccinate as many Americans as we can as quickly as possible. The Janssen vaccine offers yet another option to help achieve those goals. “- NIAID Director Anthony S. Fauci, MD

“The FDA emergency use authorization of the Janssen COVID-19 vaccine is exciting news on many fronts. A single dose vaccine stored at refrigerated temperatures and that prevents COVID hospitalizations and deaths has the potential to change the trajectory of the pandemic in the US and around the world. Janssen and BARDA have a history of working together, developing treatments and vaccines for influenza and Ebola. To manufacture its COVID-19 vaccine in the United States, Janssen is working with the resources we established after the 2009 influenza pandemic: our Advanced Manufacturing and Development Innovation Centers and our fill and finish manufacturing network. With the development of this vaccine, we are seeing the results of years of work on platform technologies and public-private partnerships that materialize. ” – BARDA Director Gary Disbrow, 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 Advanced Biomedical Research and Development Authority (BARDA), in the Office of the Assistant Secretary for Preparedness and Response at HHS.

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 means of preventing, diagnosing, and treating these diseases. NIAID-related press releases, fact sheets, and other materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services.The NIH is the primary federal agency conducting and supporting basic, clinical, and medical research. translational, and is researching 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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