I also suspect there is some concern now about a placebo controlled high-risk group as the trial would take months (e.g., 2 months of safety data). Perhaps it needs to be non-inferiority, now. If it is inferior, it might not get an EUA, so a lot of risk is involved.
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Replying to @Canadian_JACD @gregggonsalves and
There are literally billions of people not getting vaccinated at the moment. We do not need an inferiority trial to do this ethically. There are many many ways to do this.
4 replies 3 retweets 72 likes -
Replying to @michaelmina_lab @Canadian_JACD and
Hey, just one option. Was responding to idea we needed placebo.
3 replies 0 retweets 10 likes -
Replying to @gregggonsalves @michaelmina_lab and
It’s worth trialing, but let’s be clear about the priors. The scant data we have are consistent with the expectation of a short-lived and non-anamnestic immune response after a first priming dose. It would be great if the SARS-CoV2 spike protein is the exception to this rule.
10 replies 20 retweets 177 likes -
Replying to @jallepap @michaelmina_lab and
This is
#publichealth#epitwitter at its best.7 replies 5 retweets 61 likes -
Replying to @gregggonsalves @jallepap and
The durability of the immunity is the biggest concern we heard—also even with a booster. When is the next booster? In addition, one option is spacing the booster a little farther—especially for younger cohorts and/or people with prior infections: aka front-loading the supply.
6 replies 1 retweet 56 likes -
All I can say is, this needs to be explored in a trial(s). But here you meet the dilemma, what is the question you want to ask first?
1 reply 0 retweets 8 likes -
Replying to @gregggonsalves @jallepap and
I think what Michael was getting at is the shortage, sadly, gives us a lot of options for multiple trials. Look at RECOVERY in UK. They took the kitchen sink phase of the clinical response and did trials *through* that phase. We got dexa out of that. US did no such trials.
2 replies 0 retweets 11 likes -
Well, don't get me started. Months of bullshit when we could have randomized thousands of people to potential treatments. I am still so angry we didn't do any of this.
2 replies 0 retweets 25 likes -
Replying to @gregggonsalves @jallepap and
Right! Exactly! We’re trying to advocate for not repeating that with vaccines. The initial results are so much better than anything we expected, which I think gives us more flexibility and even more upside, potentially, if we can take advantage of it and if it pans out in trials.
2 replies 2 retweets 17 likes
People thought dexa wouldn’t work and they had perfectly good reasons to think so. Instead, we got 1/3 reduction in mortality in severe disease simply because somebody ran a trial during the initial phase. Potentially front loading/doubling vaccine supply, is not a minor issue.
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