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>Whether or not any central authority endorsed it is moot when 100 million doses have been given.

Not really when these administrations are not followed up in a systematic way. Basically 100 million doses is not a substitute for a clinical trial..

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I agree, but it's too late for the process to work to be protective of the population from a drug defect. If FDA finds that there is a critical issue, that's good to know, but what do we do now?

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