‘Writing a new playbook in real time’: FDA faces tough task in rushing a vaccine safely

In accelerating the approval process for a coronavirus vaccine, the Trump administration’s Operation Warp Speed is pushing the Food and Drug Administration to do the unprecedented. While drug approval has been rushed out the door before, the FDA has never done so while revamping the entire process. Yet many experts say that the expedited process is not likely to exacerbate the safety risks.

“I don’t think they are throwing out the playbook, more like writing a new playbook in real…

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