US FDA Expects COVID-19 Vaccines To Meet ‘EUA Plus’ Standards, Marks Says
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.
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Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.
ACIP defers vote on who should be inoculated first until it has data on a specific product, but vaccine acceptance among different groups could be weighed as factor in setting distribution priorities, committee members suggest.
The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.