We can run trials much more efficiently than we usually do. Particularly with a vaccine now being rolled out. We are talking about a trial of tens of thousands, to potentially improve access and early receipt for billions. We can do these trials if we wanted.
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Replying to @michaelmina_lab @zeynep and
Makes sense. So let’s get granular about the “we.” The NIH is pretty much at max capacity. So how about we turn abroad? That’s where pharma will likely go. And the ethics of placebo there? Seriously asking because the studies have to happen, we know this. But how?
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Replying to @k_stephensonMD @michaelmina_lab and
The question I have is mRNA vaccines have brutal cold chain logistics and high costs. Are single dose mRNA trials (taking 6 months at best speed) going to trump the ones with better logistics?
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Replying to @Canadian_JACD @k_stephensonMD and
The cold chain requirements for mRNA vaccines further enforces the argument that we should be trialing single dose. A single dose is much much less burdensome all around, including on cold chain resources.
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Replying to @michaelmina_lab @Canadian_JACD and
The question is about the trade-offs. Start a trial now. With current set of resources, this pushes other things out of the queue. Results won't come in for months even under best circumstances. Will question still be critical in Sept 2021? Will the trade-off have been worth it?
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Replying to @gregggonsalves @Canadian_JACD and
We can do this well before September. It took 10 months to start even thinking about the vaccine to completing phase 3. We can start today and have decent results in a few months. Why September? That doesn’t make sense. Unless we are going to fall back into our normal ways now.
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Replying to @michaelmina_lab @gregggonsalves and
Correct me if I’m being dense - isn’t there an alternate study we can do first: Model vaccinating pop with 2 doses vs. 1. You could estimate how effective 1 dose needs to justify new strategy. Then compare that estimate with existing trial data. That would be helpful, right?
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Replying to @ml_barnett @gregggonsalves and
Yes - exactly. We need to focus on public health efficacy, not individual level efficacy, and that is where models come in (but FDA and most vaccine evaluations do not consider) But we don’t have the 1 dose data in a way that is particularly useful - yet. Hence need for trial.
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Replying to @michaelmina_lab @gregggonsalves and
Can’t we extract an estimate with a wide confidence interval from the existing 2 dose trials? Modeling might suggest that single dose with far lower efficacy, below lower bound of CI would be justifiable. not arguing against RCT but this analysis seems doable now.
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Replying to @ml_barnett @michaelmina_lab and
Agree. We can run those numbers fairly quickly and Moderna, at least, is supposed to give us more data on single dose followup soon. Once again, the comparison is no vaccination—not individual non-inferiority. That is the unfortunate reality for billions at the moment.
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Also an adaptive trial (with volunteers) for delaying booster is an option.
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Replying to @zeynep @michaelmina_lab and
Agree with you but - I don’t think that no vaccination is the control group anymore, the control group is proceeding with 2 doses as the standard because that is where we are now.
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