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I read that the precursor was using an animal and there is a way to make it artificially (which was not approved by the FDA so far). I just wish governments we

I read that the precursor was using an animal and there is a way to make it artificially (which was not approved by the FDA so far). I just wish governments were focusing on helping in ramping up manufacturing instead of using the current crisis for stealing as much money as possible (which is happening in my country).

mlyle 6y ago
The critical path is microfluidics and machines to make lipid nanoparticles. It's likely these paths are ramping as quickly as possible. There's no use of intact animals to make these vaccines. I don't think there are any use of animal cell cultures in any of the mainline vaccine paths (though there are some human cell lines used in the adenovirus, etc, vaccines that many people consider problematic).
- maxerickson 6y ago
  I imagine they are referring to endotoxin testing. (and then horseshoe crabs and recombinant factor C) The FDA should figure out if fFC works and then mandate use of it if it works.
  - mlyle 6y ago
    Oh, well, sure. But the COVID vaccines even at peak production will likely only be using a single digit percentage of the endotoxin tests done in the US in a typical year. In no way can this be considered limiting. About 60k doses/lot, figure 30 endotoxin tests per lot, that's 1 test per 2k doses =~ 300k endotoxin tests to vaccinate the US.
    - maxerickson 6y ago
      I guess I can't say I've read them closely, but I don't recall any of the recent articles about the crabs having figures like that (which it is good that it isn't a problem, I'm referring to the articles not getting to the important bit about it not being an issue).
      - mlyle 6y ago
        https://www.baltimoresun.com/coronavirus/bs-md-coronavirus-horseshoe-crab-blood-vaccine-20201231-gijaccmxf5dabh4l36nzve6jre-story.html https://www.baltimoresun.com/coronavirus/bs-md-coronavirus-h... "For now, the industry says it has plenty of horseshoe crab blood to screen coronavirus vaccines. Pharmaceutical companies test a sample from a batch of vaccines, not every dose. And that sample size, say three vials, doesn’t change whether the batch contains 100,000 doses or 1 million, says Allen Burgenson of Lonza. In fact, Burgenson says, the industry produces enough tests in one day to screen 5 billion doses of coronavirus vaccine." (I think this is unduly optimistic, because mfrs are likely to screen at multiple steps during production, since the latency of batches is ~100 days, and because lot sizes aren't so large yet. So divide 5 billion by a small integer).

mlyle 6y ago

The critical path is microfluidics and machines to make lipid nanoparticles. It's likely these paths are ramping as quickly as possible. There's no use of intact animals to make these vaccines. I don't think there are any use of animal cell cultures in any of the mainline vaccine paths (though there are some human cell lines used in the adenovirus, etc, vaccines that many people consider problematic).

maxerickson 6y ago
I imagine they are referring to endotoxin testing. (and then horseshoe crabs and recombinant factor C) The FDA should figure out if fFC works and then mandate use of it if it works.
- mlyle 6y ago
  Oh, well, sure. But the COVID vaccines even at peak production will likely only be using a single digit percentage of the endotoxin tests done in the US in a typical year. In no way can this be considered limiting. About 60k doses/lot, figure 30 endotoxin tests per lot, that's 1 test per 2k doses =~ 300k endotoxin tests to vaccinate the US.
  - maxerickson 6y ago
    I guess I can't say I've read them closely, but I don't recall any of the recent articles about the crabs having figures like that (which it is good that it isn't a problem, I'm referring to the articles not getting to the important bit about it not being an issue).
    - mlyle 6y ago
      https://www.baltimoresun.com/coronavirus/bs-md-coronavirus-horseshoe-crab-blood-vaccine-20201231-gijaccmxf5dabh4l36nzve6jre-story.html https://www.baltimoresun.com/coronavirus/bs-md-coronavirus-h... "For now, the industry says it has plenty of horseshoe crab blood to screen coronavirus vaccines. Pharmaceutical companies test a sample from a batch of vaccines, not every dose. And that sample size, say three vials, doesn’t change whether the batch contains 100,000 doses or 1 million, says Allen Burgenson of Lonza. In fact, Burgenson says, the industry produces enough tests in one day to screen 5 billion doses of coronavirus vaccine." (I think this is unduly optimistic, because mfrs are likely to screen at multiple steps during production, since the latency of batches is ~100 days, and because lot sizes aren't so large yet. So divide 5 billion by a small integer).