"[Prasad] says he has evidence that this vaccine killed 10 children, but that's not the way it works," Offit said. "If you think you have an extraordinary claim, you should back it up with extraordinary evidence. He should have submitted it to an excellent journal where it can be reviewed by subject matter experts who can say, 'Yes, this is clear evidence,' then it can be published. That's the way it works."…
https://www.theguardian.com/society/2025/nov/29/regulator-fda-stricter-protocols-vaccine-approvals
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