News release
Saturday, February 27, 2021
Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Johnson & Johnson’s Janssen Pharmaceuticals Companies for their one-time 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 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), 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 of the Assistant Secretary for Preparedness 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., released 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 inscrutable. Having a third vaccine that meets an EUA’s expectations for safety and effectiveness in preventing serious illness and death from COVID-19 takes us one step closer to protecting the American public, staying ahead of viral variants, and finding a way out of the pandemic. I would like to thank the clinical staff who conducted the clinical trials on the vaccine, as well as the thousands of study participants who helped us find the scientific answers needed 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 in 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 in preventing severe / critical COVID-19 occurring at least 28 days after vaccination. occurs. The vaccine was approximately 67 percent effective in preventing moderate to severe / critical COVID-19 disease occurring at least 14 days after vaccination and 66 percent effective in preventing moderate to severe / critical COVID-19 disease lasting at least 28 days. occurred later. vaccination. Importantly, wherever it was tested, the vaccine was 100 percent effective in protecting against death from the disease. The Janssen vaccine not only meets expectations of safety and effectiveness to support emergency authorization, but also has the advantage of requiring only a single injection and being easy to transport and store without special refrigeration requirements. To get the COVID-19 pandemic under control, stay ahead of worrying viral mutations, and protect the American public, we need to vaccinate as many Americans as possible as soon as possible. The Janssen vaccine offers yet another opportunity to help achieve those goals. – NIAID Director Anthony S. Fauci, MD
“The FDA approval for the Janssen COVID-19 emergency vaccine is exciting news on many fronts. A single-dose vaccine that is stored at refrigerated temperatures and that prevents hospitalization and deaths from COVID could change the trajectory of the pandemic in the US and worldwide. Janssen and BARDA have a history of collaboration in developing treatments and vaccines for influenza and Ebola. To manufacture their COVID-19 vaccine in the United States, Janssen works with resources we established after the 2009 flu pandemic: our Centers for Innovation in Advanced Development and Manufacturing and our bottling manufacturing network. With the development of this vaccine, we see the results of years of work on platform technologies and public-private partnerships blossom. – 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 Assistant Secretary’s Office for Preparedness and Response.
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