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FDA Clears Third COVID-19 Vaccine From Janssen
Emergency use authorization for single-dose vaccine that uses unique adenovirus type 26 delivery system for DNA code to reduce severity of coronavirus
March 1, 2021 The U.S. Food and Drug Administration (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 issued Feb . 27, allows the Janssen Biotech COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
This vaccine is unique in that it only requires a single dose. The previously EUA cleared vaccines from Moderna and Pfizer required two doses. The Janssen vaccinator also in unique in its novel use of a modified adenovirus type 26 (Ad26) to safely deliver a piece of DNA to protect the patient from COVID infection.
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SILVER SPRING, Md., Feb. 27, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration 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 ne