Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine

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Pharmaceutical giant Johnson & Johnson submitted its single-shot coronavirus vaccine to U.S. regulators Thursday afternoon for emergency use authorization after the vaccine was shown to be robustly effective against illness in a global trial — and especially at preventing severe disease and death.

The submission is “a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” Paul Stoffels, chief scientific officer of Johnson & Johnson, said in a statement. If the vaccine receives regulatory clearance by the Food and Drug Administration, it would be the third authorized shot in the United States — a much-needed addition to the tools public health officials have to build immunity as virus variants spread.

FDA officials announced that outside experts would discuss the vaccine at a public meeting three weeks from now, on Feb. 26. Continue reading.