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 dose of vaccine as part of 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 Donald 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.

The agency posted new guidance for manufacturers that says they need to provide at least two months of follow-up safety data after vaccinating volunteers before even asking the FDA to consider giving emergency use authorization (EUA) for a vaccine.

It made similar suggestions in documents for an October 22 meeting that has long been scheduled for vaccine advisers to meet and discuss requirements for either emergency use authorization or a full biologics license application for any potential coronavirus vaccine.

Source : CNN


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