It may seem surprising to stop a multimillion-dollar, 30,000-person trial because one person fell ill, but 'it's not at all unprecedented,' said Dr. Francis Collins, director of the National Institutes of Health. Here's what we know.
is the first major setback in pursuit of a vaccine against a disease that has now killed 190,000 in the U.S. and nearly 900,000 worldwide.
It may seem surprising to stop a multimillion-dollar, 30,000-person trial because one person fell ill, but"it's not at all unprecedented," said Dr. Francis Collins, director of the National Institutes of Health, speaking Wednesday morning to a Senate committee. If any vaccine fails to meet standards of safety and effectiveness, those pre-made doses will be thrown out. The governmentwith AstraZeneca in May that calls for the company to make 300 million doses of its vaccine It's not clear whether AstraZeneca has already begun making doses of its vaccine, currently called AZD1222.
It will be challenging to determine whether the person's problem was coincident to the trial or caused by it, Bloom and others said. All of the COVID-19 vaccine trials have proceeded without any problems for months. But it is not unexpected that some trial participants would have health problems. The company did the right thing to stop its trial and investigate whether the vaccine may have caused the problem or simply happened around the same time, Offit said."It's prudent of the company to take a step back," he said."They're doing testing now to try and figure out how to explain this disease."The result will depend on whether the trial is stopped permanently, or just for a little while.
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