A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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Yeah, it's unclear to me - definitely appear to be "not safe", but as you say - it could be even worse. I'm super worried this is going to be Trump's next political trick - he would have _no_ hesitation pushing a vaccine through where we have very little or no data on population-wide safety
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A small controlled trial of 300 people - maybe fewer- would get you the same information - does it work? you could have an answer in less than a month then move on to the next one if it doesn't. What are they telling these 30,000people - go out to bars? try to get infected. Probably not, but if they are giving them the proper advice - mask upsocial distance etc - you should have VERY FEW infections in the 30,000. Who did the power calculation to get30K?
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Population-wise safety another issue - I doubt that any of the 30,000 are in at risk groups - old - respiratory illness,obesity etc.
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Yup, very true - I'm just very worried that those 300 people wouldn't fully understand what they're signing up for. Need the safety data on the vaccine in any case, which already requires a lot of people - but I guess it depends onwhether we want (a) safety, or (b) efficacy data first. If the latter, challenge trial makes sense.
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2020-07-23 09:01
Robert F. Garry
Yes - it's definitely Trumps next trick for sure....
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He'd push it through - _even_ if we knew it was unsafe or even dangerous. No doubt. And that's bloody terrifying.
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Enough safety data should be there in the Phase I and II trials - you're right that the Moderna safety data is HIGHLY suspect.
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If I were a betting man, I'd put my money on ChAdOx1 and Sinovac - I'd forget anything RNA- or DNA-based for now- it's just too early for those platforms.
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"fully understand what they're signing up for" - lay it out for them - they might die. We've got a 1000 dying each day just in the US. Yes - some trial participants could die - I think it's less likely with the better treatment regiments -dexy, remdesivir if they get in trouble - give them Ho or Crowe's MAbs.