Press release
Saturday, February 27, 2021
Today, the US Food and Drug Administration issued an Emergency Use Authorization (USA) to Johnson & Johnson’s Janssen Pharmaceutical 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 Office of the Secretary of Preparation for the US Department of Health and Human Services and Response , supported the Janssen vaccine final stage clinical trial. It is the third COVID-19 vaccine in the United States to receive the USA by 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 for 500,000 COVID-19 deaths here in the United States. The loss attributed to the disease is almost unfathomable. Having a third vaccine that meets the expectations of a USA for safety and efficacy 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 our way out of 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 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 among 45,000 volunteers, the single injection vaccine proved 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 severe / critical COVID-19 that occurs at least 28 days after vaccination. 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 occurring at least 28 days after vaccination. It is important to note that the vaccine was 100 percent effective in protecting against death from the disease everywhere it was tested. In addition to meeting 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 special refrigeration requirements. To gain control of the COVID-19 pandemic, stay ahead of worrying viral mutations and protect the American public, we must vaccinate as many Americans as possible as soon as possible. The Janssen vaccine offers yet another option to help achieve these goals. ”- Director of NIAID, Anthony S. Fauci, MD
“FDA authorization for emergency use of the Janssen COVID-19 vaccine is exciting news on many fronts. A single-dose vaccine stored at a refrigerated temperature that prevents hospitalizations and deaths from COVID has the potential to change the trajectory of the pandemic in the United States and worldwide. 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 resources that 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 coming to fruition. ”- 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 HHS Office of the Assistant Secretary for Preparedness and Response.
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