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by SeanLuke
1 hour ago
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Note that Prasad didn't reject their application: he prevented Moderna from even applying. Prasad overrode a phalanx of FDA career scientists who had studied and approved Moderna's study approach and were ready to review it. He did so suddenly and without warning: the FDA up to that point had not raised any concerns about Moderna's trial protocol. He didn't cite any safety or efficacy issues. This wasn't the only time he stepped in and overrode experts with seemingly no justification. Just the most prominent example. I think it's good he's gone. |
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Americans who are 65+ years old only use the high dose flu vaccine. Moderna only wanted to test against the low dose vaccine, so we would have no data as to the efficacy of this new vaccine for 65+ year olds vs the standard therapy. Prasad demanded that Moderna include this.
Explain to me why this is wrong? Should we let multi billion dollar drug companies do what they want? Prasad did exactly what he was supposed to do, which is use his judgement to protect Americans. And Moderna did it, and now everyone is happy.
> He did so suddenly and without warning: the FDA up to that point had not raised any concerns about Moderna's trial protocol.
This is not true. FDA previously asked Moderna to add the results of the high dose vaccine and somehow it got removed. All Prasad did was insist on this. This was not suddenly and without warning.