WASHINGTON, February 28. /TASS/. The U.S. The Food and Drug Administration (FDA) approved the application of Janssen (owned by Johnson & Johnson) for an emergency use authorization of its vaccine against the novel coronavirus. That’s according to a statement released by the FDA under the US Department of Health and Human Services.
"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," according to the statement.
"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.
Janssen's drug has become the third coronavirus vaccine approved in the United States. Unlike the vaccines by Moderna, Pfizer, and BioNTech the Janssen COVID-19 vaccine is administered as a single dose. Previously, the FDA announced that the third phase of trials of the vaccine from Johnson & Johnson had been proven to be effective and safe.
Last week, the corporation posted a message on its website that it had submitted an application to the World Health Organization for approval for the emergency use authorization of the vaccine from its Janssen division. Johnson & Johnson submitted a package of documents including preliminary assessments of the safety and efficacy of the drug based on data obtained during the third phase of clinical trials. According to the corporation, during this phase the efficacy of the vaccine was up to 85%.