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At issue was the FDA’s planned instruction that vaccine developers follow patients enrolled in their trials for at least two months to rule out safety issues before seeking emergency approval from the agency. A senior administration confirmed the move Monday evening, saying the White House believed there was “no clinical or medical reason” for the additional requirement.
White House blocks updated FDA guidelines on vaccine approval
Considering that the first vaccines will be given to health care workers and the most vulnerable people, it is critical that the vaccines are proven to be safe and effective.