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EricTopol's profile
Eric Topol
Eric Topol
Eric Topol
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@EricTopol

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Eric TopolVerified account

@EricTopol

physician-scientist, author, editor http://drerictopol.com 

La Jolla, CA
scripps.edu/translational
Joined November 2009

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    Eric Topol‏Verified account @EricTopol 19 Sep 2020

    We have the protocols. Now we know how there will very likely be an Emergency Use Approval (EUA) for a vaccine prior to November 3. The company and political motivations are fully aligned. 1. The criteria for an EUA is that it "may be effective" https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#euas …pic.twitter.com/FhLbb79M7s

    11:10 AM - 19 Sep 2020
    • 765 Retweets
    • 1,287 Likes
    • didi claddaugh Ken P BTC Comics Shikha Kothari alendra chakramurty Julio Escobar Irishpenguin 陈美志..||. 진미지
    111 replies 765 retweets 1,287 likes
      1. New conversation
      2. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        2. Nearly every day we hear from @Pfizer's CEO @AlbertBourla that they will know if their vaccine is working by the end of October. Only the Data and Safety Monitoring Board is reviewing the data at specific intervals, the interim analyses So how will they (Pfizer) know that?

        8 replies 72 retweets 351 likes
        Show this thread
      3. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        3. The 1st interim analysis for that trial is at 32 events, infections, which can and likely will be mild. The stopping rules as reviewed by @biosbenk @EmoryRollins are "aggressive" and "unusual" for the number of interim analyses (4) and Bayesian approach https://github.com/benkeser/pfizerbounds …pic.twitter.com/lNErmSUxez

        6 replies 57 retweets 257 likes
        Show this thread
      4. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        Eric Topol Retweeted Eric Topol

        4. As presented in a poll, ≥ 26 infections in the placebo group at the 1st interim of 32 events would fulfill the stopping rule and support a claim of efficacy. But the EUA only requires *"May be effective"* so even <26 placebo events could qualifyhttps://twitter.com/EricTopol/status/1306986697800908802 …

        Eric Topol added,

        Eric TopolVerified account @EricTopol
        In coming weeks, at the 1st interim analysis of the Pfizer vaccine trial of >30,000 participants, the trial can be stopped at 32 events (infections) by the DSMB because of efficacy, if there are ≥ 26 in the placebo group. Do you agree the trial should be stopped on this basis?
        9 replies 65 retweets 229 likes
        Show this thread
      5. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        5. The DSMB reports to the sponsor. The trial data should not be unblinded unless it has been stopped (for futility, safety, or efficacy stopping rule) or completed. But it is easy to discern which group (vaccine or placebo) by the early adverse effects without unblinding.

        2 replies 32 retweets 209 likes
        Show this thread
      6. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        6. Note the similarity in some symptoms for #COVID19 (which are the endpoint) and the early adverse effects of the vaccine (dose of 100 ug was used in Phase 3) https://www.nejm.org/doi/full/10.1056/NEJMoa2022483?query=recirc_curatedRelated_article …pic.twitter.com/jBQotMMGPR

        7 replies 50 retweets 218 likes
        Show this thread
      7. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        7. So with or without fulfilling pre-specified efficacy criteria at the 1st interim look, which will occur within weeks, Pfizer can apply for an EUA with the low threshold of "may be effective" (If Pfizer hits the stopping rule and doesn't stop the trial, that's another story)

        2 replies 43 retweets 225 likes
        Show this thread
      8. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        8. The EUA criteria are so minimal that even the Phase 1/2 serology data (NEJM paper above) could fulfill "may be effective" and that would equate to the Russian vaccine approval and roll out.

        5 replies 98 retweets 311 likes
        Show this thread
      9. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        9. There has only been one FDA EUA for a vaccine in history, which was for anthrax, and that didn't go well https://www.theatlantic.com/health/archive/2020/08/the-emergency-use-loophole/615679/ … by @sarahzhangpic.twitter.com/Yyz2Y6kJ6S

        5 replies 178 retweets 399 likes
        Show this thread
      10. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        10. What if the FDA says NO, the data from 32 infections isn't enough? Clearly at that juncture there would be very limited data for the vaccine's safety. The HHS can override that an issue the vaccine approval. And we've already seen @HHSgov do that with FDA LDTs weeks ago.

        3 replies 77 retweets 259 likes
        Show this thread
      11. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        11. The same issues apply for the @moderna_tx first interim analysis at 53 events, but a conventional O'Brien-Fleming stopping rule is being used and the 1° endpoint definition of infections is tighter

        1 reply 33 retweets 185 likes
        Show this thread
      12. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        12. This is obviously a rush job—a race between companies with big political stakes. Once an EUA is issued for a vaccine, the whole landscape shifts. Safety issues could crop up later and engender mistrust. Ability to conduct placebo-controlled trials could be impaired.

        7 replies 140 retweets 414 likes
        Show this thread
      13. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        Eric Topol Retweeted Eric Topol

        12."Fast is Slow and Slow is Fast"https://twitter.com/erictopol/status/1263898556600991745?lang=en …

        Eric Topol added,

        Eric TopolVerified account @EricTopol
        '"Fast is slow, and slow is fast." This is a maxim that must be applied to vaccine development for #COVID19' wisdom and cautionary message from Douglas Green, @StJudeResearch https://advances.sciencemag.org/content/early/2020/05/22/Sciadv.abc7428/tab-pdf … @ScienceAdvances pic.twitter.com/XvHLQvw6Vv
        Show this thread
        2 replies 72 retweets 301 likes
        Show this thread
      14. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        13. These are the most important clinical trials of our lifetime. There's no need for this rush. We need to do them right; get the Phase 3 trials completed as planned at 150-160 events. That will only require waiting weeks, it'll give us more confidence about efficacy and safety

        10 replies 232 retweets 788 likes
        Show this thread
      15. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        14. Just as pressure was applied to @Pfizer @BioNTech_Group and @moderna_tx to release their protocols, we need to apply intense pressure to the companies, the FDA, and HHS to preempt any EUA until Phase 3 trials are *fully* completed.

        8 replies 155 retweets 562 likes
        Show this thread
      16. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        15. Translation, TLDR: We need a shot in the light, not in the dark. A matter of weeks to nail the efficacy issue down is well worth the wait. Zero tolerance for company or governmental shortcuts and related back door BS.pic.twitter.com/7RSh8X47aC

        9 replies 155 retweets 624 likes
        Show this thread
      17. Eric Topol‏Verified account @EricTopol 19 Sep 2020

        16. If there was any doubt about @HHSgov @SecAzar's plan to make sure there is an EUA for a vaccine before Nov 3 (see 10. above), then you can read this by @BySheilaKaplanhttps://www.nytimes.com/2020/09/19/health/azar-hhs-fda.html …

        20 replies 196 retweets 402 likes
        Show this thread
      18. Eric Topol‏Verified account @EricTopol 20 Sep 2020

        17. No.pic.twitter.com/jmdOH3Fziy

        26 replies 119 retweets 375 likes
        Show this thread
      19. End of conversation

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