5 ms·

You're skipping over the safety aspect of phase-1/2/3 trials. In your proposed accelerated schedule, would we just throw safety testing out the window? > The l

You're skipping over the safety aspect of phase-1/2/3 trials. In your proposed accelerated schedule, would we just throw safety testing out the window? > The limiting factor in the speed of the clinical trials is the rate at which people acquire COVID naturally. That's only one of the factors. It takes weeks to go from infection to disease outcome. If you're also interested in safety, you have to enroll tens of thousands of people, give them the vaccine, and wait to see if there are side-effects. And of course, you have to scale up production. In the grand scheme of things, the wait for people to get naturally infected in phase-3 trials was relatively short (a few weeks). > Far fewer would have died and the colossal impact of lockdowns would have been mostly avoided. Countries that had extremely strict lockdowns were able to reopen nearly completely with extremely low virus prevalence, and then to control the virus with good tracing. China has been mostly open since last spring, and fewer than 5000 people have died in total in the country (almost all of them in the first 3 months of the outbreak).

tinus_hn 6y ago
One has to compare the risks of not testing against the risk of testing. We can now tell that testing, up to now, results in over 2 million deaths. What would the risks have been for not testing?
- mattkrause 6y ago
  I can’t even begin to imagine how you’d calculate that. We’ve got some vaccines that work, a few that don’t, and at least one candidate that looked promising but was abandoned for problematic side effects (false-positives on HIV tests). You can’t just divide those out though, because all of this work was done in systems where people expected thorough testing. In a world where we didn’t test, the ”honest” attempts might not be as careful and there would also be a number of outright scams.
  - tinus_hn 6y ago
    Right, so the people who voluntarily chose to take this risk would be exposed to the risk. Of testing false positive for HIV. How does this not beat 2 million deaths?
    - mattkrause 6y ago
      Stretch your imagination a bit. Suppose we did and HIV tests start going off like fireworks a month later. Rumors start spreading about how it gives you AIDS, and uptake craters, probably for other vaccines as well. You’re right that this isn’t even the worst outcome. We also could have rolled out GSK’s failed candidates—-or one of Merck’s two. We’d be back where we started, but poorer, with less public support, and potentially dealing with widespread immunity to the vector. Solid preclinical candidates go sideways all the time, so it could have been even worse. No argument whatsoever that 2MM deaths is awful and tragic. However, it’s the Slateist of Slate pitches to claim that “testing is the real killer.” We had plenty of easy ways to mitigate this (e.g., masks) but, for a variety of stupid reasons, chose not to use them.
      - tinus_hn 6y ago
        So it would have lead to a PR problem, rumors and fear. Beats 2 million deaths. And please, don’t give me the magical masks excuse. Masks might give additional protection, in no way do they solve the issue. And the ‘if only’ statements of some time ago have clearly been proven false. ‘If only we would have worn the masks corona would have been over’. No it wouldn’t because now it’s ‘if only we had worn three masks on top of each other’, which wouldn’t have been necessary if the first statement was true. It just isn’t. It’s easy blameshifting.
        mattkrause 6y ago
        Or the status quo. Or worse. You can't skip testing "because it worked" this one time; that's the whole point of testing! As for the rest, two words: New Zealand. Also Vietnam, Taiwan, Singapore, Atlantic Canada, and China (though you may not trust their numbers). A huge proportion of these deaths were avoidable.
- DiogenesKynikos 6y ago
  Are you really arguing for mass rollout of an untested vaccine? Most of the CoVID-19 deaths around the world have been avoidable, even without a vaccine. Countries that reacted properly (mostly in East Asia and Oceania) have had orders of magnitude fewer deaths per capita. Rather than rushing out a vaccine before doing any safety or efficacy testing, I'd rather that countries had controlled the virus with non-pharmaceutical interventions early on.
maxerickson 6y ago
Moderna began Phase I on March 16, Phase 2 in late May and Phase 3 on July 27. So counting from the design of the vaccine, it took 2 months to start the initial trial, 4 months to start the second phase, 6 months to start the third phase, and 10 or 11 months to get to a preliminary result in the phase 3 trial. I count 4 months of phase 1/2 and 5 months of phase 3 (also note that there is some degree of confidence in the safety from the initial results of the phase 2 study). I would think any challenge trial would be an additional study, not a replacement, a study that overlapped with phase 2 and 3 in information gathering (enrolling a smaller number of people but gathering more efficacy data per enrollee). 1 and 2: https://www.nih.gov/news-events/news-releases/experimental-covid-19-vaccine-safe-generates-immune-response https://www.nih.gov/news-events/news-releases/experimental-c... 3: https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid https://investors.modernatx.com/news-releases/news-release-d...

tinus_hn 6y ago

One has to compare the risks of not testing against the risk of testing. We can now tell that testing, up to now, results in over 2 million deaths. What would the risks have been for not testing?

mattkrause 6y ago
I can’t even begin to imagine how you’d calculate that. We’ve got some vaccines that work, a few that don’t, and at least one candidate that looked promising but was abandoned for problematic side effects (false-positives on HIV tests). You can’t just divide those out though, because all of this work was done in systems where people expected thorough testing. In a world where we didn’t test, the ”honest” attempts might not be as careful and there would also be a number of outright scams.
- tinus_hn 6y ago
  Right, so the people who voluntarily chose to take this risk would be exposed to the risk. Of testing false positive for HIV. How does this not beat 2 million deaths?
  - mattkrause 6y ago
    Stretch your imagination a bit. Suppose we did and HIV tests start going off like fireworks a month later. Rumors start spreading about how it gives you AIDS, and uptake craters, probably for other vaccines as well. You’re right that this isn’t even the worst outcome. We also could have rolled out GSK’s failed candidates—-or one of Merck’s two. We’d be back where we started, but poorer, with less public support, and potentially dealing with widespread immunity to the vector. Solid preclinical candidates go sideways all the time, so it could have been even worse. No argument whatsoever that 2MM deaths is awful and tragic. However, it’s the Slateist of Slate pitches to claim that “testing is the real killer.” We had plenty of easy ways to mitigate this (e.g., masks) but, for a variety of stupid reasons, chose not to use them.
    - tinus_hn 6y ago
      So it would have lead to a PR problem, rumors and fear. Beats 2 million deaths. And please, don’t give me the magical masks excuse. Masks might give additional protection, in no way do they solve the issue. And the ‘if only’ statements of some time ago have clearly been proven false. ‘If only we would have worn the masks corona would have been over’. No it wouldn’t because now it’s ‘if only we had worn three masks on top of each other’, which wouldn’t have been necessary if the first statement was true. It just isn’t. It’s easy blameshifting.
      - mattkrause 6y ago
        Or the status quo. Or worse. You can't skip testing "because it worked" this one time; that's the whole point of testing! As for the rest, two words: New Zealand. Also Vietnam, Taiwan, Singapore, Atlantic Canada, and China (though you may not trust their numbers). A huge proportion of these deaths were avoidable.
DiogenesKynikos 6y ago
Are you really arguing for mass rollout of an untested vaccine? Most of the CoVID-19 deaths around the world have been avoidable, even without a vaccine. Countries that reacted properly (mostly in East Asia and Oceania) have had orders of magnitude fewer deaths per capita. Rather than rushing out a vaccine before doing any safety or efficacy testing, I'd rather that countries had controlled the virus with non-pharmaceutical interventions early on.

maxerickson 6y ago

Moderna began Phase I on March 16, Phase 2 in late May and Phase 3 on July 27. So counting from the design of the vaccine, it took 2 months to start the initial trial, 4 months to start the second phase, 6 months to start the third phase, and 10 or 11 months to get to a preliminary result in the phase 3 trial. I count 4 months of phase 1/2 and 5 months of phase 3 (also note that there is some degree of confidence in the safety from the initial results of the phase 2 study). I would think any challenge trial would be an additional study, not a replacement, a study that overlapped with phase 2 and 3 in information gathering (enrolling a smaller number of people but gathering more efficacy data per enrollee). 1 and 2: https://www.nih.gov/news-events/news-releases/experimental-covid-19-vaccine-safe-generates-immune-response https://www.nih.gov/news-events/news-releases/experimental-c... 3: https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid https://investors.modernatx.com/news-releases/news-release-d...