Press release
Saturday, February 27, 2021
Today, the US Food and Drug Administration issued an emergency use authorization (EUA) 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 tract; the adenovirus vector used in the Janssen COVID-19 vaccine has been modified so that it can no longer be reproduced in humans and can cause disease. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and the Authority for Advanced Biomedical Research and Development (BARDA), part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Training and Response, late-stage clinical testing of the Janssen vaccine. It is the third COVID-19 vaccine in the United States to receive a 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 500,000 deaths due to COVID-19 here in the United States. The loss attributed to the disease is almost incomprehensible. Having a third vaccine that meets the expectations of a EUA in terms of safety and efficacy in preventing severe disease and death from COVID-19 brings us one step closer to protecting the American public, to staying ahead of the viral variants and find our 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 reach this important day. ”- NIH Director Francis S. Collins, MD, dr.
The Janssen COVID-19 vaccine is a very welcome addition to the COVID-19 vaccine arsenal and other prevention strategies. When tested in 45,000 volunteers, the single-injection vaccine was 77% effective in preventing severe / critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe / critical COVID-19 occurring in at least 28 days after vaccination. The vaccine was approximately 67% effective in preventing moderate to severe COVID-19 disease occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe COVID-19 disease occurring at least 28 days. days after vaccination. Importantly, the vaccine was 100% effective in protecting against disease death wherever it was tested. In addition to meeting safety and efficacy expectations to support emergency use authorization, the Janssen vaccine has the advantage that it requires a single injection and can be easily transported and stored without special refrigeration requirements. To gain control of the COVID-19 pandemic, keep us from worrying viral mutations, and protect the American public, we need to vaccinate as many Americans as we can. The Janssen vaccine offers yet another option to help achieve these goals. ”- NIAID Director, Anthony S. Fauci, MD
FDA authorization for emergency use of the Janssen COVID-19 vaccine is interesting news on many fronts. A single-dose vaccine stored in refrigerated temperatures that prevents hospitalizations and deaths caused by COVID has the potential to change the trajectory of the pandemic in the United States and globally. Janssen and BARDA have a history of working together to develop treatments and vaccines for the flu and Ebola. For the manufacture of COVID-19 vaccine in the United States, Janssen is working with the resources we established after the 2009 flu pandemic: Our centers for innovation in advanced development and manufacturing and our finishing production network. With the development of this vaccine, we see the results of many years of work on platform technologies and public-private partnerships that are materializing. ”- BARDA Director Gary Disbrow, Ph.D.
Francis S. Collins, MD, Ph.D., is the director of the National Institutes of Health in Bethesda, Maryland.
Anthony S. Fauci, MD, is the 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 Authority for Advanced Biomedical Research and Development (BARDA) in the HHS office of the assistant secretary for training and response.
NIAID conducts and supports research – at the NIH, throughout 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. Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.
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