Press release
Saturday, February 27, 2021
Today, the U.S. Food and Drug Administration has issued an emergency use authorization (US) to Johnson & Johnson’s Janssen pharmaceutical 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 ear protein found on the surface of the SARS-CoV-2 virus that causes COVID-19. Adenoviruses are a group of viruses that cause respiratory and gastrointestinal infections; 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 Allergies and Infectious Diseases (NIAID), which is part of the National Institutes of Health, and the Biomedical Authority for Advanced Research and Development (BARDA), which is part of the attached preparation office of the Department of US Health and Human Services. and Response, supported final-stage clinical trials of the Janssen vaccine. It is the third COVID-19 vaccine in the United States that the FDA grants a US. NIH Director Francis S. Collins, MD, MD, NIAID Director Anthony S. Fauci, MD, and BARDA Director Gary Disbrow, MD, 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 U.S. expectations for safety and effectiveness in preventing serious illness and death from COVID-19 brings us closer to protecting the American public, keeping us 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. “- Director of NIH Francis S. Collins, MD, Ph.D.
“The Janssen COVID-19 vaccine is a very welcome addition to the COVID-19 vaccine arsenal and other prevention strategies. When tested among 45,000 volunteers, the single-injection vaccine proved 77% effective. in the prevention of severe / critical COVID-19 occurring at least 14 days after vaccination and 85% efficacy in the prevention of severe / critical COVID-19 occurring at least 28 days after vaccination. The vaccine was approximately 67% effective in preventing moderate to severe / critical COVID-19 disease occurring at least 14 days after vaccination and 66% effective in preventing COVID disease -19 moderate to severe / critical that occurs at least 28 days after vaccination.It is important to note that the vaccine was 100% effective in protecting against the death of the disease wherever it was tested. security and effectiveness expectations to support authorization or for emergency use, the Janssen vaccine has the advantage of requiring only a single injection and can be easily transported and stored without special refrigeration requirements. To get control of the COVID-19 pandemic, stay ahead of worrying viral mutations, and protect the American public, we need to vaccinate as many Americans as we can as quickly as possible. The Janssen vaccine provides another option to help achieve these goals. “- NIAID Director Anthony S. Fauci, MD
“The FDA’s emergency use authorization for the Janssen COVID-19 vaccine is exciting news on many fronts. A single-dose vaccine stored in refrigerated temperatures that prevents hospitalizations and deaths from COVID can change the trajectory of the pandemic in the U.S. and globally Janssen and BARDA have a history of working together to develop treatments and vaccines for the flu and Ebola To manufacture their COVID-19 vaccine in the United States, Janssen works with the resources we established after the 2009 flu pandemic: our Advanced Development and Manufacturing Innovation Centers and our filler manufacturing network.With the development of this vaccine, we see the results of years of work in platform technologies and public-private partnerships that come 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 of the National Institutes of Health in Bethesda, Maryland.
Gary Disbrow, Ph.D., is director of the Authority for Advanced Biomedical Development and Research (BARDA), in the office of the HHS Assistant Secretariat for Preparedness and Response.
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