FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine Action Advances Fight Against COVID-19, Follows Comprehensive Evaluation of Available Safety, Effectiveness and Manufacturing Quality Information by FDA Career Scientists, Input from External Experts Today, the FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older. "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," said Acting FDA Commissioner Janet Woodcock, M.D. "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." The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine's known and potential benefits outweigh its known and potential risks, supporting the company's request for the vaccine's use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information. Additional resources:  Listen live to a media call about this EUA 7:15 p.m. ET, Saturday, February 27, 2021 Acting FDA Commissioner Janet Woodcock, M.D and Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research will participate in a media briefing to discuss the EUA issued for the Janssen Biotech Inc. COVID-19 vaccine for individuals 18 years of age and older. The EUA allows the Janssen Biotech Inc. COVID-19 Vaccine to be distributed in the U.S. This media briefing will be live streamed over the FDA's YouTube page. |
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