Janssen COVID-19 Vaccine Issued Emergency Use Authorization by the FDA

The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to the Janssen Pharmaceuticals Companies of Johnson & Johnson 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 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 it no longer can replicate in humans and cause illness. 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 Response, supported late-stage clinical testing of the Janssen vaccine. It is the third COVID-19 vaccine in the United States to be granted an EUA by FDA. NIH Director Francis S. Collins, M.D. Ph.D., NIAID Director Anthony S. Fauci, M.D., 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 unfathomable. To have a third vaccine that meets the expectations of an EUA for safety and effectiveness at preventing severe disease and death from COVID-19 brings us one step closer to protecting the American public, staying ahead of concerning viral variants, and finding 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 necessary to reach this important day.” – NIH Director Francis S. Collins, M.D., 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 77 percent effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85 percent effective in preventing severe/critical COVID-19 occurring 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. Importantly, the vaccine was 100 percent effective in protecting against death from the disease everywhere it was tested. In addition to meeting the expectations of safety and effectiveness 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 get control of the COVID-19 pandemic, stay ahead of worrisome viral mutations, and protect the American public, we must vaccinate as many Americans as we can as quickly as possible. The Janssen vaccine provides yet another option to help achieve those goals.” – NIAID Director Anthony S. Fauci, M.D.

“The FDA’s emergency use authorization of the Janssen COVID-19 vaccine is exciting news on many fronts. A single dose vaccine stored at refrigerated temperatures and that prevents hospitalizations and deaths from COVID has the potential to change the trajectory of the pandemic in the U.S. and globally. Janssen and BARDA have a history of working together, developing treatments and vaccines for influenza and Ebola. To manufacture their COVID-19 vaccine in the United States, Janssen is working with resources we established after the 2009 influenza pandemic: our Centers for Innovation in Advanced Development and Manufacturing and our fill-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.

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