US COPD Coalition

FDA Grants Emergency Use Authorization for Single-Dose Vaccine


The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to the Janssen Pharmaceuticals Companies, a subsidiary of Johnson & Johnson, for its single-shot COVID-19 vaccine. This marks the third vaccine to be awarded an emergency use authorization by the FDA.

“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”, stated National Institutes of Health (NIH) Director Francis Collins, MD, PhD. “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.”

Dr. Collins comments were part of a joint statement released by NIH, the National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). “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”, noted NIAID Director Anthony S. Fauci, M.D. “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.”

“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”, added BARDA Director Gary Disbrow, Ph.D.