The vaccine will be administered in the U.S to 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., according to a statement on the agency’s website.
“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.”
According to Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, the FDA determined that the vaccine has met the statutory criteria for issuance of an EUA.
“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.”
“The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19,” FDA said, adding that “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.”
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