Enlarge / The head office of Janssen pharmaceutical company on February 5, 2021 in Leiden, the Netherlands. The American mother company of Janssen, Johnson & Johnson, has requested quick approval in the United States for the coronavirus vaccine that was developed by Janssen Vaccines in Leiden. (credit: Getty | BSR Agency)
Johnson & Johnson on Thursday announced it has applied to the US Food and Drug Administration for an Emergency Use Authorization for its one-shot COVID-19 vaccine.
If the EUA is granted, the vaccine will be the third authorized for use in the US against the pandemic coronavirus, likely boosting the vaccine supply in the coming months and helping to hasten immunization country-wide.
J&J’s application to the FDA comes just a week after the company revealed top-line results of its Phase III clinical trial, which found the vaccine to be 66 percent effective overall at preventing moderate and severe COVID-19. J&J’s vaccine—made by its vaccine developer Janssen Pharmaceuticals—was 85 percent effective at preventing severe disease. In the trial, severe disease was defined as testing positive for the virus as well as having signs consistent with severe systemic illness, respiratory failure, shock, or organ failure, or being admitted to an intensive care unit, or dying. The company reported that no one who received the vaccine was hospitalized or died during the trial.
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source https://arstechnica.com/?p=1740000