The US Food & Drug Administration wants 2 months of safety data before authorizing coronavirus vaccine

On Tuesday, The United States Food & Drug Administration expressed clearly that it will need to see 2 months of follow-up data after volunteers get their 2nd dosage of vaccine as part of clinical trials testing potential Covid-19 vaccines.

That would make it problematic, if not impossible, for any vaccine manufacturer to apply for emergency use authorization (EUA) by Election Day, as Trump has requested, or by the end of October, as the CEO of Pfizer has mentioned.

FDA released new guidance for developer that says they want to provide at least 2 months of follow-up safety data after vaccinating volunteers before even asking the agency to consider giving EUA for a vaccine.

It made similar requests in paperwork for an October 22 briefing that has long been scheduled for vaccine advisers to meet & discuss requirements for either EUA or a full biologics permit application for any potential Covid-19 vaccine.