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[Slashdot] - Vaccine Maker Novavax Enters Final Large-Scale Testing of Its Covid-19 Vaccine

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The New York Times reports: Vaccine maker Novavax said Thursday that it would begin the final stages of testing its coronavirus vaccine in the United Kingdom and that another large trial was scheduled to begin next month in the United States. It is the fifth late-stage trial from a company supported by Operation Warp Speed, the federal effort to speed a coronavirus vaccine to market, and one of 11 worldwide to reach this pivotal stage. Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials. The new study, known as a Phase 3 trial, is expected to enroll up to 10,000 people in the United Kingdom. Half of the volunteers will receive two doses of the experimental vaccine, 21 days apart, and the others will receive a placebo. Although Novavax is months behind the front-runners in the vaccine race, independent experts are excited about its vaccine because its early studies delivered particularly promising results. Monkeys that were vaccinated got strong protection against the coronavirus. And in early safety trials, published early this month in The New England Journal of Medicine, volunteers produced strikingly high levels of antibodies against the virus. It is not possible to make a precise comparison between early clinical studies of different vaccines, but John Moore, a virologist at Weill Cornell Medicine, said that the antibodies from Novavax were markedly higher than any other vaccine with published results. "You just can't explain that away," he said. The Phase 3 trials will determine if Novavax can live up to that promise.

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