I agree. Too much uncertainty in short- and long-term efficacy. And the optics of changing the plan now, for a regimen that hasn’t been tested directly, are not great. Follow on studies can assess non-inferiority of a one dose regimen, but for now the data support two doses.
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Replying to @nataliexdean @CarlosdelRio7
Yes, the data support two doses. I agree. The data that we have also may support one dose. I'm the first to say that we don't have good data - even w two doses - that go out past a few months. I'm terrified that efficacy will fall fast once plasmablasts die off. 1/
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If we think about this globally - just how difficult its going to be to get the vaccine to most of the world - I do think it is very much worth taking a couple more months and trying the same study in people who otherwise wouldn't be first in line. We can only gain from it. 2/2
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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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Replying to @zeynep @michaelmina_lab and
I hear all the hesitations, but the other side of the equation—potentially doubling the number vaccinated in the short term—is not a minor number.
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Replying to @zeynep @michaelmina_lab and
A randomized blinded trial comparing 2 doses to 1 dose plus placebo is the obvious right thing to do. The infrastructure is in place and this could start in a couple of weeks. Whether vaccine rolls out as a 1-shot or 2-shot plan, this study simply needs to get done.
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Replying to @SteveJoffe @zeynep and
In fact,
@pfizer has >20,000 people in their trial who've received placebo; most likely want the vaccine. The company could call them tomorrow and invite them to this trial. Everybody wins.1 reply 0 retweets 2 likes -
Replying to @SteveJoffe @zeynep and
I would support this fully if I didn't also hope that we can ethically keep those arms as they are for as long as possible so we can best understand durability.
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Replying to @michaelmina_lab @zeynep and
I think that's likely to be a challenge--people, starting with the highest risk, will understandably start dropping out of the trial, making a gold-standard assessment of durability difficult.
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Replying to @SteveJoffe @michaelmina_lab and
On a related note--do you have clarity on what Pfizer's plans are re: offering vaccine to those in the placebo group?
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I believe they are offering, which is another thorny question. We're going to lose the placebo arm. The side-effect profile already kinda hurt the blind aspect. Plus I have on-the-ground telemetry from some of the trial countries that... it's not always that blind anyway.
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Replying to @zeynep @SteveJoffe and
That's right. fyi-here's the long version from the company BD, pls 16-17. https://www.fda.gov/media/144246/download …pic.twitter.com/Meeqo7vCcJ
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