J&J Sends One-Shot Vaccine to FDA, Emergency Use Authorization Expected End of February


Johnson & Johnson’s Janssen Biotech submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for its single-dose COVID-19 vaccine. The EUA submission is based on topline data from the Phase III ENSEMBLE trial. If the FDA grants authorization, J&J indicates it has the vaccine ready to ship immediately.

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