I'd say the way to figure out the "some may" risk is to communicate clearly, not avoid the trade-off discussion. One twist for this is the age risk is well-defined and exponential so we can make sure to communicate that. (In fact, more boosters for 65+? Anyone looking at that?)
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Replying to @zeynep @rvenkayya and
I get durability risk without booster(s?) but severe disease is not equally distributed, and dampening the outbreak rapidly is worth a lot (both the disease risk and the downsides to the world of this situation). If we don't put this on agenda now, it won't even be considered.
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Replying to @zeynep @rvenkayya and
What Michael and I are urging is to have the mindset, now, to start whatever we can to put this on a sound(er) footing—something we should have started earlier. Start recruiting Monday for a volunteer placebo arm for the second dose among lower-risk HCW to be vaccinated, for ex.
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Replying to @zeynep @JonLoflin and
That's a new efficacy study, which can certainly be done but not overnight. We'll have more data to inform this discussion soon. The immunogenicity data will allow us to compare kinetics of response and potential correlates of protection in single- vs two-dose recipients.
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Replying to @rvenkayya @JonLoflin and
Yeah it should be a discussion and rapid action before two-dose ossifies simply due to inertia rather than data against. We got a vaccine in basically nine months (amazing!!) but the lack of urgency in conducting more and many trials on everything is very frustrating.
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Replying to @K_G_Andersen @rvenkayya and
Single dose trial won't be launched unless there's pressure—there is already inertia, before even trying! (I've seen science journalists already confusing statistical lack of power with lack of efficacy). Lack of urgency=I think we should have started in Nov. given prelim data.+
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Replying to @zeynep @K_G_Andersen and
Also think of what UK/NHS did (and give us dexa!) and what we did not do here—randomize and do clinical trials even when we didn't know what was what. We could have done cluster studies for masks/hepa filters/ventilation etc. too.
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Replying to @zeynep @K_G_Andersen and
Also immunologists raise durability & high-risk groups—I get it, very real concerns—but a lot of the broader conversation is already mired in that 52.4% efficacy figure and the statistical illiteracy already surrounding it. I'm hoping we move to conversation to the real issues!
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Yeah. But every side of this is peril. I'm also worried about losing the placebo arm after the EUA, and that we're not doing some regular/random swabs in the trials. Also why a unified protocol? The age risk gradation is steep for 65+ (maybe another booster? Anyone checking?)
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Replying to @zeynep @K_G_Andersen and
At this juncture it is ALL tinkering. 'Initial protocol' is hardly a real reason not to be flexible and pragmatic.
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Replying to @GentleMutt @zeynep and
Configurable variables: — 3 vaccines, either order [or single dose] — Each dose 50% or 100% [or 200%?] — Interval: 21d 2m 3m 6m 9m 12m … 100s of permutations. Score: — Efficacy — Duration — Tx Blocking & weigh vs nearterm scale [half-dosing doubles scale, et cetera]… 1/
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