2/4, 11:57 PM (Source: TeleTrader)
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J&J applies for approval of single-shot vaccine in US

Johnson & Johnson announced on Thursday that it applied to the United States Food and Drugs Administration (FDA) for an emergency use authorization (EUA) of its single-shot coronavirus vaccine candidate. The submission is based on results efficacy and safety data from a phase 3 clinical trial, "demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints," the company stated. It added that it has initiated submissions outside of the US as well and that it will apply for a conditional authorization with the European Medicines Agency (EMA) in the coming weeks.

"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible," said Chief Scientific Officer at Johnson & Johnson Paul Stoffels.

Breaking the News / DJ