8 ms·

This is why you don't skip the animal trials.

arrrg 5y ago
Why do you say that? As far as I know the vector vaccines were tested on animals. Nothing was skipped. The issue is more that this side effect is so rare that it didn’t register even during the quite large phase 3 trials. This is to be expected. If side effects are rare enough you just won’t find them during trials. That’s why it’s important to monitor the vaccine rollout for all vaccines.
- linuxftw 5y ago
  We don't know the side effects are rare because the reporting mechanism for side effects is nearly non existent. If you want to use the VAERS data, the side effects, include death, are not really that rare, in fact, these are the most dangerous vaccines ever produced based on that data. If that data isn't good enough, you'll have to provide data that is.
  - hedora 5y ago
    Link?
- Izkata 5y ago
  If I've found the right ones, they're not due for Phase 3 completion until 2023: https://clinicaltrials.gov/ct2/show/NCT04516746 https://clinicaltrials.gov/ct2/show/NCT04516746 https://clinicaltrials.gov/ct2/show/NCT04505722 https://clinicaltrials.gov/ct2/show/NCT04505722
- officialjunk 5y ago
  usually a new drug takes about 10 years to fully be tested as safe and FDA approved. these vaccines were given emergency temporary approval, because of the pandemic.
  - arrrg 5y ago
    Nothing to do with animal testing. Also, your statement is highly misleading at best. No idea what the US did but the EMA in Europe didn’t relax any of its standards and often drug testing is mostly slow because it’s costly. Here cost wasn’t really an issue and things that are usually done sequentially were done in parallel. That saves time.
    - officialjunk 5y ago
      https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use https://www.fda.gov/news-events/press-announcements/coronavi... https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...
zarzavat 5y ago
How would that help when this rare syndrome only affects a very small proportion of people vaccinated. You would have to test it on hundreds of thousands of animals and that's assuming that the animals are a perfect model for humans.
- usrusr 5y ago
  And even if you injected millions of animals, they might happen to be species that deal perfectly fine with the proteins resulting from erroneous transcription.

Why do you say that? As far as I know the vector vaccines were tested on animals. Nothing was skipped. The issue is more that this side effect is so rare that it didn’t register even during the quite large phase 3 trials. This is to be expected. If side effects are rare enough you just won’t find them during trials. That’s why it’s important to monitor the vaccine rollout for all vaccines.

linuxftw 5y ago
We don't know the side effects are rare because the reporting mechanism for side effects is nearly non existent. If you want to use the VAERS data, the side effects, include death, are not really that rare, in fact, these are the most dangerous vaccines ever produced based on that data. If that data isn't good enough, you'll have to provide data that is.
- hedora 5y ago
  Link?
Izkata 5y ago
If I've found the right ones, they're not due for Phase 3 completion until 2023: https://clinicaltrials.gov/ct2/show/NCT04516746 https://clinicaltrials.gov/ct2/show/NCT04516746 https://clinicaltrials.gov/ct2/show/NCT04505722 https://clinicaltrials.gov/ct2/show/NCT04505722
officialjunk 5y ago
usually a new drug takes about 10 years to fully be tested as safe and FDA approved. these vaccines were given emergency temporary approval, because of the pandemic.
- arrrg 5y ago
  Nothing to do with animal testing. Also, your statement is highly misleading at best. No idea what the US did but the EMA in Europe didn’t relax any of its standards and often drug testing is mostly slow because it’s costly. Here cost wasn’t really an issue and things that are usually done sequentially were done in parallel. That saves time.
  - officialjunk 5y ago
    https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use https://www.fda.gov/news-events/press-announcements/coronavi... https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...

zarzavat 5y ago

How would that help when this rare syndrome only affects a very small proportion of people vaccinated. You would have to test it on hundreds of thousands of animals and that's assuming that the animals are a perfect model for humans.

usrusr 5y ago
And even if you injected millions of animals, they might happen to be species that deal perfectly fine with the proteins resulting from erroneous transcription.