FDA grants Johnson & Johnson COVID-19 vaccine EUA

March 5, 2021
Keith A. Reynolds

The single-dose vaccine is the third granted emergency use authorization in an effort to end the COVID-19 coronavirus pandemic.

The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the single-dose COVID-19 vaccine from Johnson & Johnson.

According to a news release from the agency, the EUA allows the vaccine to be administered to patients over the age of 18.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Acting FDA Commissioner Janet Woodcock, MD, says in the release. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

Last week, the FDA released documents ahead of a Feb. 26 meeting of the Vaccines and Related Biological Products Advisory Committee detailing the vaccine’s effectiveness against the disease. They said that it was shown to be 66.9 percent effective against moderate to severe or critical COVID-19 and is 76.7 percent effective in preventing severe or critical instances of the disease.

The documents note that the vaccine has been highly effective in the prevention of severe or critical COVID-19 caused by emerging strains of the disease with 73.1 percent efficacy in South Africa. This is a 7 percent increase in efficacy against the South African strain of the disease from what the company believed in January.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, says in the release. “With (Saturday’s) authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”


This article was originally posted on Medical Economics®.