What about an immediate call for volunteers for a randomized group among the many millions who'll get the first shot? Data-wise, some of the initial groups aren't that high risk at the moment (<65 HCWs). The vaccine shortage is going to have huge implications on overall deaths.
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Yes, this is exactly what is meant by a follow on study to assess the non-inferiority of a single dose. I think we’re all saying the same thing! This is worth studying further in a rigorous trial. But I don’t think we should tinker with the current rollout for EUA populations.
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Replying to @nataliexdean @zeynep and
The concern I have with this is the phase I data showing high total IgG titer but low nAb. Short term protection after dose 1 may be due to high levels of lower quality Abs, whereas much more potent Abs after 2nd dose may provide good longer term protection, plus the higher nAb
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Replying to @stgoldst @nataliexdean and
All of this strikes me as reason to risk just-in-time delivery of a timely shot #2 (so more people can get vaccinated sooner) if that seems likely to be fulfilled on time, but not strong enough data to change regimens and forgo shot #2.
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This seems better for optics as well. The plan is to give the second shot, but if we ran out of vaccine due to unmet deadlines, at least we get the pandemic far more under control while waiting for more doses in the pipeline.
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Yes, that's an important point. "We did a clinical trial but decided to take a guess at an alternative regimen" is not the way to start a campaign about how safe and well tested vaccines are.
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I wish I could like this more than once.
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Replying to @nataliexdean @RidleyDM and
Sociologically speaking, of course we can't start with "we didn't test this" but I think we can certainly start with rapid trial and intermediate data, along with explaining the trade-offs. The public mistrusts arrogance and lack of transparency, not complexity and honesty.
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Replying to @zeynep @nataliexdean and
I think the medical profession (not addressing you guys at all!) really conflates these. They assume we can't tell people about uncertainty and trade-offs and then we end up in suboptimal positions, but we don't even get the trust because complexity/uncertainty isn't the problem.
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Replying to @zeynep @nataliexdean and
My guess is that if we had prelim data & asked for volunteers in non high-risk groups (for example, HCW: risk by exposure status not age), we'd be surprised by the update. The public can absolutely follow discussions of trade-offs under uncertainty if it's truly transparent.
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IMO we often get "oh, no, the public trust will be damaged if we include uncertainty" and then we get stuck on rigid but suboptimal or worse protocols. Masks, distance rules, no in-person K-5 schools, hybrid teaching with Wednesdays off for deep cleaning, no rapid tests, etc.
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