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zeynep's profile
zeynep tufekci
zeynep tufekci
zeynep tufekci
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@zeynep

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zeynep tufekciVerified account

@zeynep

Complex systems, wicked problems. Society, technology, science and more. @UNC professor. @NYTimes columnist. My newsletter is @insight: http://www.theinsight.org 

floating in a most peculiar way
theinsight.org
Joined August 2009

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    1. Singh‏ @lulzcakes 11 Dec 2020

      Singh Retweeted zeynep tufekci

      .@zeynep Ignoring that there were only 1256 people in the single-dose leg (effectively = to 0 people for a vaccine study), what likely happened is $PFE had already completed late Phase 2b and started planning for Phase 3 when this mishap occurred.https://twitter.com/zeynep/status/1337047714341785605 …

      Singh added,

      zeynep tufekciVerified account @zeynep
      The BioNTech/Pfizer data is out—NEJM & FDA report. I understand this wasn't in the design & the long-term protection from single dose is open question. But given this sharp drop after 14 days after one dose, can someone explain why single dose isn't very very high on the agenda? pic.twitter.com/sxqwACGulz
      Show this thread
      1 reply 0 retweets 0 likes
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    2. Singh‏ @lulzcakes 11 Dec 2020

      Even if a single-dose use-case could be proven to be effective, $PFE would have to commit to another new trial with another 20k-30k participants.

      1 reply 0 retweets 0 likes
      Show this thread
    3. Singh‏ @lulzcakes 11 Dec 2020

      And also, drug efficacy does not work linearly like that, so basically everything that happened in the year would need to be repeated, other than safety tests.

      1 reply 0 retweets 0 likes
      Show this thread
    4. Singh‏ @lulzcakes 11 Dec 2020

      The chance of producing worse data is not worth the trade-off, which you mentioned later on in your thread. The vaccine supply shortage is not projected to last nearly as long as it would take to complete another trial.

      1 reply 0 retweets 0 likes
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    5. Singh‏ @lulzcakes 11 Dec 2020

      Repeating a full trial based on limited efficacy for 1256 people would take $PFE more time and resources than it would take to approve a two-dose regimen and then conduct a Phase 4/post-approval study to determine efficacy of single-dose use.

      1 reply 0 retweets 0 likes
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    6. Singh‏ @lulzcakes 11 Dec 2020

      It is far more economical and efficient for companies to gain approval first based on their original trial design, and *then* try to expand their label for broader use -- or in this case, less doses for similar efficacy.

      1 reply 0 retweets 0 likes
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      zeynep tufekci‏Verified account @zeynep 11 Dec 2020
      Replying to @lulzcakes

      No please read the paper. The 1256 people are those who missed the second dose and are not included in this analysis of all. At all. (A similar number in the placebo arm also missed the second dose and they’re also not included at all).

      3:59 PM - 11 Dec 2020
      1 reply 0 retweets 1 like
        1. New conversation
        2. Singh‏ @lulzcakes 11 Dec 2020
          Replying to @zeynep

          Oh, I see. I was mistaken about the source of the single-dose error. I'll read the study later tonight, but I was specifically replying to your tweet about trade-offs. Pursuing another study for single-dose is ineffective because it wouldn't solve our supply issues any faster.

          1 reply 0 retweets 0 likes
        3. Singh‏ @lulzcakes 11 Dec 2020
          Replying to @lulzcakes @zeynep

          You may be right (there's no way to tell) that single-dose is an effective trade-off, but it's better if $PFE gains approval with their current trial design and then conducts another study to expand their label. It would be much faster than repeating Phase 3 based on a hunch.

          0 replies 0 retweets 0 likes
        4. End of conversation

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