The US FDA made clear it will want to see two months of follow-up data after volunteers get their second dose of vaccine as part of clinical trials testing potential coronavirus vaccines.
The US Food and Drug Administration made clear Tuesday it will want to see two months of follow-up data after volunteers get their second vaccine doses for clinical trials testing potential coronavirus vaccines.
That would make it difficult, if not impossible, for any vaccine maker to apply for emergency use authorization by Election Day, as President Trump has suggested, or by the end of October, as the CEO of Pfizer has hinted.The process will also make it"pretty darn hard for mischief," National Institutes of Health Director Dr. Francis Collins said Tuesday.
"If we tell them it's got 70% efficacy, they may change their behavior, And if they are going to take their guard down a notch, we better make sure it does what it says it's supposed to do," Marks said. FDA officials have repeatedly said they will not skimp on safety considerations for a coronavirus vaccine even as Trump tries to promise one by Election Day.
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