March 1, 2021 -- Janssen Biotech's COVID-19 vaccine has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The move allows the vaccine to be distributed in the U.S. for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age or older.
The authorization quickly followed the February 26 meeting of the agency's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, where members unanimously voted in favor of the EUA. The FDA issued the EUA on February 27 based on the totality of scientific evidence that the potential benefits of the vaccine outweigh the known and potential risks of the vaccine.
The Janssen vaccine is the first viral vector-based vaccine authorized in the U.S., using a replication-incompetent adenovirus to elicit an immune response against the SARS-CoV-2 spike protein. Overall, the vaccine was approximately 67% effective in preventing moderate to severe or critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe or critical COVID-19 occurring at least 28 days after vaccination.
"With today's authorization, we are adding another vaccine in our medical toolbox to fight this virus," said Dr. Peter Marks, PhD, director of the FDA's Center for Biologics Evaluation and Research. "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."
As with the other authorized COVID-19 vaccines, the agency noted that the issuance of an EUA is different from an FDA approval (licensure) of a vaccine in that a vaccine available under an EUA is not approved.
"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," said Dr. Francis S. Collins, PhD, director of the U.S. National Institutes of Health.
On Sunday, February 28 the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices endorsed the safety and effectiveness of the Janssen vaccine. With this recommendation, distribution of the vaccine in the U.S. can officially begin.
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