FDA experts recommend Johnson & Johnson single-dose vaccine, setting up imminent authorization

A panel of vaccine experts has voted unanimously to recommend authorization of Johnson & Johnson’s COVID-19 vaccine, setting it up for the Food and Drug Administration to allow its release within hours.

The vaccine, developed by Johnson & Johnson-owned Janssen Pharmaceuticals, takes a single shot to provide the full measure of protection from illness due to COVID-19. The Pfizer and Moderna vaccines already in use in the United States require two shots spaced out by three weeks and four weeks, respectively. The Johnson & Johnson vaccine is also much easier to store and transport than other vaccines because it doesn’t require ultracold temperatures to keep it viable for up to three months.

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While the FDA does not have to act on the panel’s recommendation, it often does. The consensus among experts on Friday indicates that the vaccine will likely be granted an emergency use authorization from the FDA on Saturday, just as the Moderna and Pfizer vaccines were authorized hours after the panel ended its all-day deliberations.

The FDA’s panel of vaccine experts reported on Wednesday that the vaccine was 66% effective in preventing moderate and severe COVID-19 cases and roughly 85% effective at preventing hospitalization. It was also found to be 100% effective at preventing death in all three regions where the shot was tested.

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Johnson & Johnson is prepared to distribute 20 million shots by late-March, with nearly 4 million doses ready to be shipped out immediately. The company is also on track to fulfill its deal with the federal government for 100 million shots by the end of June, according to Dr. Richard Nettles, the company’s vice president of U.S. medical affairs.

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