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WASHINGTON — The Food and Drug Administration on Saturday authorized Johnson & Johnson’s single-shot Covid-19 vaccine for emergency use, beginning the rollout of millions of doses of a third effective vaccine that could reach Americans by early next week. The announcement arrived at a critical moment, as the steep decline in coronavirus cases seems to […]
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Johnson & Johnson’s Covid-19 vaccine was endorsed on Friday by a panel of experts advising the Food and Drug Administration, clearing the last hurdle before a formal authorization expected on Saturday, according to two people familiar with the agency’s plans. The nation’s first shipments will go out in the days after that. It will be […]
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The newly released documents, which include the F.D.A.’s first technical analysis of the company’s 45,000-person clinical trial, presented evidence that the vaccine was safe, with noticeably milder side effects than the Pfizer and Moderna vaccines and without any reports of severe allergic reactions like anaphylaxis. The vaccine’s protection was consistent across Black, Hispanic and white […]
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The Food and Drug Administration said on Monday that vaccine developers would not need to conduct lengthy randomized controlled trials for vaccines that have been adapted to protect against concerning coronavirus variants. The recommendations, which call for small trials more like those required for annual flu vaccines, would greatly accelerate the review process at a […]
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Two new antibody treatments have shown promise in keeping high-risk Covid-19 patients out of the hospital. But despite getting a publicity boost from President Trump, who received the Regeneron treatment in October and praised it as a “cure,” the drugs have not been widely used since being authorized for emergency use last month by the […]
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