The stakes are high: polls show the relentless politicization of the race to develop a vaccine is taking its toll. Pew Research Center recently reported that the percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 percent from 72 percent in May.
The guidance, which is far more rigorous than what was used for emergency clearance of hydroxychloroquine or convalescent plasma, is an effort to shore up confidence in an agency that has made missteps during the pandemic. With the vaccines, the FDA is expected to ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot, according to two individuals familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public. – READ MORE
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