News Release
Saturday 27 February 2021
The U.S. Food and Drug Administration today issued an Emergency Permit (EUA) to Johnson & Johnson’s Janssen Pharmaceuticals Companies for its single-shot 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 peak 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 digestive 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 Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Responses, support clinical trials of the Janssen vaccine in the late stage. It is the third COVID-19 vaccine in the United States to have been granted 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., made the following statements:
‘This week was a devastating milestone of 500,000 deaths due to COVID-19 here in the United States. The loss attributed to the disease is almost unfathomable. Having a third vaccine that meets the expectations of an EUA for safety and efficacy to prevent serious diseases and death from COVID-19 brings us one step closer to protecting the American public, to prevent stay with regard to viral variants and to get us out of the pandemic. I thank the clinical staff who conducted the clinical trials with the vaccine, as well as the thousands of study participants who helped us find the scientific answers needed to achieve 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-injection vaccine was 77 percent effective in preventing severe / critical COVID-19 occurring at least 14 days after vaccination and 85 percent effective in severe / critical COVID-19 at least 28 days after vaccination. to prevent. The vaccine was approximately 67 percent effective in preventing moderate to severe COVID-19 disease at least 14 days after vaccination and 66 percent effective in preventing moderate to severe COVID-19 disease at least 28 days after vaccination. . What was important was that the vaccine was 100 percent effective in protecting the death of the disease wherever it was tested. In addition to the expectations of safety and efficacy to support emergency permits, the Janssen vaccine has the advantage of requiring only one injection, and can be easily transported and stored without special refrigeration. To gain control of the COVID-19 pandemic, to prevent worrying viral mutations and to protect the American public, we need to vaccinate as many Americans as possible. The Janssen vaccine offers another option to achieve these goals. ”- NIAID Director Anthony S. Fauci, Managing Director
‘The FDA’s emergency clearance for the Janssen COVID-19 vaccine is exciting news in many areas. A single-dose vaccine stored at refrigerated temperatures that prevents hospitalizations and deaths due to COVID could change the course of the pandemic in the US and worldwide. Janssen and BARDA have a history of working together to develop treatments and vaccines for flu and Ebola. To manufacture their COVID-19 vaccine in the United States, Janssen works with resources we set up after the 2009 flu pandemic: our centers for innovation in advanced development and manufacturing and our manufacturing network for fillers. With the development of this vaccine, we see the results of years of work on platform technologies and public-private partnerships coming into its own. ‘- 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 Biomedical Advanced Research and Development Authority (BARDA), in the HHS office of the Assistant Secretary for Preparedness and Response.
NIAID conducts and supports research – at NIH, across the United States and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better ways to prevent, diagnose, and treat these diseases. News reports, fact sheets and other NIAID-related material are available on the NIAID website.
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