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Kevin is conflating clinical trial design & outcomes (on which he is inexperienced) with liability to a for-profit business operating under non-profit conditions, to regulatory monitoring & post-EUA decision making. Let me explain: In a phase I or II clinical trial it is the... https://twitter.com/kevin_mckernan/status/1337263776232566785
... norm to exclude underlying conditions to avoid confounding factors in the outcomes. At phase III they *may* have allowed allergics, but the lack of anaphylaxis severe adverse events implies otherwise. This would make sense: you wouldn’t put a spanner in your own spokes to...
... find out if this might affect your bike rolling DURING a race to help humanity. And since there is no profit element to the manufacturers here, this justifies the government decision to protect them from liability. The regulators filled that gap and acted IMMEDIATELY to...
...prevent any further such risks even at an anaphylaxis incidence of 0.013% (2/15,000 doses in day 1), and statistically inadequate event numbers. In sum, it looks like the response in severe allergies was not evaluated in the trials for good reason, the government rightly...
... protected these manufacturers acting in a Good Samaritan way, abs the regulators immediately filled that gap with careful monitoring of the outcomes to mop up any risk, immediately.
