4 ms·

“Only” six people so far have suffered this, but they’re in a younger cohort so it’s worth taking very seriously.

Throwawayaerlei 6y ago
It's relatively cheap for the US to do since we made the catastrophic mistake of depending on Emergent BioSolutions to make the vaccine in the US, so all our raw doses are coming from a Janssen plant in the Netherlands and we've run out of the "banked" doses made before FDA Emergency Use Authorization. What I'm finding interesting is that if this has anything in common with the (AZ/)Oxford vaccine problem as we should suspect, it would not seem to be related to Oxford's unique or nearly so use of an unstabilized version of the spike protein. At this point the only things obviously in common are some version of the spike protein and using adenovirus vectors. Different ones of the latter, a chimpanzee derived one for Oxford and a normal human one that's one of the causes of "the common cold" for Janssen. Derek Lowe has commentary from yesterday on all this here, up to date except it only mentioned Janssen in passing based on his hearing about early cases with the latter: https://blogs.sciencemag.org/pipeline/archives/2021/04/12/az-oxford-calculations https://blogs.sciencemag.org/pipeline/archives/2021/04/12/az... It goes into the cold risk/benefit calculations you should make for various treatments and their diseases.
fortran77 6y ago
All women of childbearing age. Aren't blood-clots a known risk of estrogen-based birth control, too? And if all the people with blood clots were women, why not stop it in women only?
- ulrikrasmussen 6y ago
  I think because it is too early to draw any conclusions from the gender correlation. In my country (Denmark) most people who got AZ (which is suspected of having a similar problem) were front-line personnel in healthcare, which has more women than men.
- thehappypm 6y ago
  It's not just a blood clot. It's a pretty unique blood issue that's really complicated and really dangerous. Why pause it? Several reasons. The USA has tried very hard to keep vaccine confidence high. We didn't follow the UK's lead on prioritizing first doses; we're giving doses on the schedule the doses were designed for. We didn't approve AZ yet, because there's some question marks there. We didn't approve a myriad of other vaccines from other countries we don't trust. A great way to blow that trust away is to continue to let some people get J&J then watch as people continue to die. Second, J&J has had serious supply issues. Pfizer and Moderna have been the workhorse. I haven't been able to find clear data but it looks like J&J is less than 10% of the doses injected. It would be much, much more substantial of a problem if we had to pause Pfizer or Moderna. Third.. and this one is maybe more controversial.. J&J does have lower efficacy. Maybe the USA is better off with a two-dose-vaccinated populace.
  - Throwawayaerlei 6y ago
    US FDA vaccine strength Phase III clinical trials appear to have a minimum of 30,000 participants in the typical 50/50 experiment/control distribution, whereas e.g. Novavax's U.K. based Phase III trial was half that. AZ's US Phase III trial was delayed at least a month because of a possible correlated adverse event and per "reliable rumor" a lack of candor from AZ (in general both AZ and Oxford have done about the worst in the West in testing and communications, not counting Sputnik V). They now have their US efficacy data but have not yet made an application for an Emergency Use Authorization from the FDA no doubt due to not yet having safety data from half their subjects who got the vaccine, which was the gate for the mRNA vaccine applications. None of the other vaccines have had EUA applications, although we should see one from Novavax pretty soon. J&J or rather Janssen's production capabilities are mostly in the EU, we in the US have been getting doses made in the Netherlands with fill and finish (bottling) in the US. Unfortunately Emergency BioSolutions, a company who's competence is all political, not production, got the initial subcontract to make Janssen doses in the US, and predictably has done a horrible job. To make a long story short their Baltimore factory has not received FDA approval and just plain shouldn't without a complete top to bottom housecleaning, everything from firing every person in it to actually keeping the equipment and rooms etc. clean and free of mold and bacteria (yes, it's that bad). Merck though has recently agreed to make doses. So we've run out of "banked" pre-authorization supplies of Janssen doses, and are not getting a whole lot from the Netherlands. Moderna and Pfizer appear to be in much better shape because they're not depending on delicate cell cultures to make their vaccines, production is much simpler except for the microfluidics that mix the lipids and mRNA. Biologically the most complicated thing is making DNA using E. Coli, that's much easier to do correctly than cell cultures, especially in bulk. As for total doses administered in the US, see https://covid.cdc.gov/covid-data-tracker/#vaccinations https://covid.cdc.gov/covid-data-tracker/#vaccinations As of yesterday only 6.9 million of Janssen out of 190 million total. And you're right about the efficacy, Janssen's objective from the beginning was to develop the single most effective one dose vaccine, which they've achieved, although they're trying two doses eight weeks apart in a separate US based Phase III trial.

It's relatively cheap for the US to do since we made the catastrophic mistake of depending on Emergent BioSolutions to make the vaccine in the US, so all our raw doses are coming from a Janssen plant in the Netherlands and we've run out of the "banked" doses made before FDA Emergency Use Authorization. What I'm finding interesting is that if this has anything in common with the (AZ/)Oxford vaccine problem as we should suspect, it would not seem to be related to Oxford's unique or nearly so use of an unstabilized version of the spike protein. At this point the only things obviously in common are some version of the spike protein and using adenovirus vectors. Different ones of the latter, a chimpanzee derived one for Oxford and a normal human one that's one of the causes of "the common cold" for Janssen. Derek Lowe has commentary from yesterday on all this here, up to date except it only mentioned Janssen in passing based on his hearing about early cases with the latter: https://blogs.sciencemag.org/pipeline/archives/2021/04/12/az-oxford-calculations https://blogs.sciencemag.org/pipeline/archives/2021/04/12/az... It goes into the cold risk/benefit calculations you should make for various treatments and their diseases.

fortran77 6y ago

All women of childbearing age. Aren't blood-clots a known risk of estrogen-based birth control, too? And if all the people with blood clots were women, why not stop it in women only?

ulrikrasmussen 6y ago
I think because it is too early to draw any conclusions from the gender correlation. In my country (Denmark) most people who got AZ (which is suspected of having a similar problem) were front-line personnel in healthcare, which has more women than men.
thehappypm 6y ago
It's not just a blood clot. It's a pretty unique blood issue that's really complicated and really dangerous. Why pause it? Several reasons. The USA has tried very hard to keep vaccine confidence high. We didn't follow the UK's lead on prioritizing first doses; we're giving doses on the schedule the doses were designed for. We didn't approve AZ yet, because there's some question marks there. We didn't approve a myriad of other vaccines from other countries we don't trust. A great way to blow that trust away is to continue to let some people get J&J then watch as people continue to die. Second, J&J has had serious supply issues. Pfizer and Moderna have been the workhorse. I haven't been able to find clear data but it looks like J&J is less than 10% of the doses injected. It would be much, much more substantial of a problem if we had to pause Pfizer or Moderna. Third.. and this one is maybe more controversial.. J&J does have lower efficacy. Maybe the USA is better off with a two-dose-vaccinated populace.
- Throwawayaerlei 6y ago
  US FDA vaccine strength Phase III clinical trials appear to have a minimum of 30,000 participants in the typical 50/50 experiment/control distribution, whereas e.g. Novavax's U.K. based Phase III trial was half that. AZ's US Phase III trial was delayed at least a month because of a possible correlated adverse event and per "reliable rumor" a lack of candor from AZ (in general both AZ and Oxford have done about the worst in the West in testing and communications, not counting Sputnik V). They now have their US efficacy data but have not yet made an application for an Emergency Use Authorization from the FDA no doubt due to not yet having safety data from half their subjects who got the vaccine, which was the gate for the mRNA vaccine applications. None of the other vaccines have had EUA applications, although we should see one from Novavax pretty soon. J&J or rather Janssen's production capabilities are mostly in the EU, we in the US have been getting doses made in the Netherlands with fill and finish (bottling) in the US. Unfortunately Emergency BioSolutions, a company who's competence is all political, not production, got the initial subcontract to make Janssen doses in the US, and predictably has done a horrible job. To make a long story short their Baltimore factory has not received FDA approval and just plain shouldn't without a complete top to bottom housecleaning, everything from firing every person in it to actually keeping the equipment and rooms etc. clean and free of mold and bacteria (yes, it's that bad). Merck though has recently agreed to make doses. So we've run out of "banked" pre-authorization supplies of Janssen doses, and are not getting a whole lot from the Netherlands. Moderna and Pfizer appear to be in much better shape because they're not depending on delicate cell cultures to make their vaccines, production is much simpler except for the microfluidics that mix the lipids and mRNA. Biologically the most complicated thing is making DNA using E. Coli, that's much easier to do correctly than cell cultures, especially in bulk. As for total doses administered in the US, see https://covid.cdc.gov/covid-data-tracker/#vaccinations https://covid.cdc.gov/covid-data-tracker/#vaccinations As of yesterday only 6.9 million of Janssen out of 190 million total. And you're right about the efficacy, Janssen's objective from the beginning was to develop the single most effective one dose vaccine, which they've achieved, although they're trying two doses eight weeks apart in a separate US based Phase III trial.