10 ms·

Testing and clinical trials!

by data_dan_ 5y ago

vimy 5y ago
We don’t do clinical trials for the yearly flu vaccine update, do we?
- s1artibartfast 5y ago
  We also have 80 years of experience with the flu vaccine opposed to 8 months
  - SECProto 5y ago
    > We also have 80 years of experience with the flu vaccine opposed to 8 months 8 months is incorrect. Here's[1] an article from 17 months ago about results from Moderna's covid-19 trials for vaccinations dating back to mar16 2020. So it's been 21 months, not 8 (and that's ignoring trials of mRNA vaccines years earlier as they weren't for this specific virus) [1] https://www.cidrap.umn.edu/news-perspective/2020/07/hopeful-results-phase-1-moderna-covid-vaccine-trial https://www.cidrap.umn.edu/news-perspective/2020/07/hopeful-...
    - s1artibartfast 5y ago
      We can split hairs on what constitutes experience, or when it starts. but the point still stands: We have a lot more experience with the flu vaccine. This is the answer for why not all annual flu vaccines need clinical trials.
      - ashildr 5y ago
        „the flu vaccine“? Which one?
        s1artibartfast 5y ago
        The first vaccines in 1933 were against A type influenzas, followed by vaccines against against B type influenzas in 1942. Here is a pretty good summary of the history of vaccine development. https://www.medscape.com/viewarticle/812621_1 https://www.medscape.com/viewarticle/812621_1 While nearly all influenza vaccines generate similar antibodies, Covid and influenza vaccines generate significantly different antibodies Influenza vaccines generate antibodies against influenza Hemagglutinin proteins targeting sialic acid receptors Covid vaccines generate antibodies for (S) glycoproteins targeting ACE-2 receptors. In short, we have 80+ years of experience generating antibodies for hemagglutinin, and much less for (S) glycoproteins. https://en.wikipedia.org/wiki/Coronavirus_spike_protein https://en.wikipedia.org/wiki/Coronavirus_spike_protein https://en.wikipedia.org/wiki/Hemagglutinin_(influenza) https://en.wikipedia.org/wiki/Hemagglutinin_(influenza)
- heavyset_go 5y ago
  > We don’t do clinical trials for the yearly flu vaccine update, do we? Yes, we do[1][2]. [1] https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947948/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947948/
- GeekyBear 5y ago
  Yes, but it's a greatly abbreviated process for each year's new version of the Flu vaccine. Going forward, the FDA has already said that a reformulation of the mRNA Covid vaccine would face a similarly shortened approval process. >FDA says Covid vaccines that target new variants won’t need large clinical trials to win approval https://www.cnbc.com/2021/02/22/covid-vaccine-fda-says-shots-that-target-new-variants-wont-need-large-clinical-trials-to-win-approval.html https://www.cnbc.com/2021/02/22/covid-vaccine-fda-says-shots...
  - spurgu 5y ago
    This reminds me of the 737 MAX.
legutierr 5y ago
It would have been much faster if regulators and ethicists hadn’t been so squeamish about challenge trials. In order to save dozens of lives that might have been lost in challenge trials, we sacrificed hundreds of thousands of lives so that we could wait for more ethically-sound vaccine trials to complete.
- ajsnigrutin 5y ago
  The problem are the vaccine mandates. If you (soft or hard) mandate a vaccine, and you kill someone with it, that's a lot of responsibility to take, if the vaccine didn't go through a full trial. If the vaccines were as optional as eg. flu vaccines are, then a simple waiver would solve most of the issues. (a 20yo girl died in slovenia due to jannsen vaccine not that long ago, and she got vaccinated, becase she was soft-forced by the government mandates (48 hour testing, far away from home, but unable to use the bus without a test, to go to the testing site, 12eur/test,...).
  - ericb 5y ago
    Your reply is totally off-topic for the parent you replied to.
    - dfabulich 5y ago
      I see why you're saying that, but I think you missed their point. Challenge trials might well allow us to make a safe vaccine available sooner to those who want it, but if we mandate a vaccine that has only undergone challenge trials and then that vaccine kills someone, it would certainly be politically disastrous for challenge trials.
      - Wowfunhappy 5y ago
        Challenge trials are dangerous for the people who participate in the trials, but they aren’t any less rigorous.
        5y ago

Testing and clinical trials!

vimy 5y ago

We don’t do clinical trials for the yearly flu vaccine update, do we?

s1artibartfast 5y ago
We also have 80 years of experience with the flu vaccine opposed to 8 months
- SECProto 5y ago
  > We also have 80 years of experience with the flu vaccine opposed to 8 months 8 months is incorrect. Here's[1] an article from 17 months ago about results from Moderna's covid-19 trials for vaccinations dating back to mar16 2020. So it's been 21 months, not 8 (and that's ignoring trials of mRNA vaccines years earlier as they weren't for this specific virus) [1] https://www.cidrap.umn.edu/news-perspective/2020/07/hopeful-results-phase-1-moderna-covid-vaccine-trial https://www.cidrap.umn.edu/news-perspective/2020/07/hopeful-...
  - s1artibartfast 5y ago
    We can split hairs on what constitutes experience, or when it starts. but the point still stands: We have a lot more experience with the flu vaccine. This is the answer for why not all annual flu vaccines need clinical trials.
    - ashildr 5y ago
      „the flu vaccine“? Which one?
      - s1artibartfast 5y ago
        The first vaccines in 1933 were against A type influenzas, followed by vaccines against against B type influenzas in 1942. Here is a pretty good summary of the history of vaccine development. https://www.medscape.com/viewarticle/812621_1 https://www.medscape.com/viewarticle/812621_1 While nearly all influenza vaccines generate similar antibodies, Covid and influenza vaccines generate significantly different antibodies Influenza vaccines generate antibodies against influenza Hemagglutinin proteins targeting sialic acid receptors Covid vaccines generate antibodies for (S) glycoproteins targeting ACE-2 receptors. In short, we have 80+ years of experience generating antibodies for hemagglutinin, and much less for (S) glycoproteins. https://en.wikipedia.org/wiki/Coronavirus_spike_protein https://en.wikipedia.org/wiki/Coronavirus_spike_protein https://en.wikipedia.org/wiki/Hemagglutinin_(influenza) https://en.wikipedia.org/wiki/Hemagglutinin_(influenza)
heavyset_go 5y ago
> We don’t do clinical trials for the yearly flu vaccine update, do we? Yes, we do[1][2]. [1] https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947948/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947948/
GeekyBear 5y ago
Yes, but it's a greatly abbreviated process for each year's new version of the Flu vaccine. Going forward, the FDA has already said that a reformulation of the mRNA Covid vaccine would face a similarly shortened approval process. >FDA says Covid vaccines that target new variants won’t need large clinical trials to win approval https://www.cnbc.com/2021/02/22/covid-vaccine-fda-says-shots-that-target-new-variants-wont-need-large-clinical-trials-to-win-approval.html https://www.cnbc.com/2021/02/22/covid-vaccine-fda-says-shots...
- spurgu 5y ago
  This reminds me of the 737 MAX.

legutierr 5y ago

It would have been much faster if regulators and ethicists hadn’t been so squeamish about challenge trials. In order to save dozens of lives that might have been lost in challenge trials, we sacrificed hundreds of thousands of lives so that we could wait for more ethically-sound vaccine trials to complete.

ajsnigrutin 5y ago
The problem are the vaccine mandates. If you (soft or hard) mandate a vaccine, and you kill someone with it, that's a lot of responsibility to take, if the vaccine didn't go through a full trial. If the vaccines were as optional as eg. flu vaccines are, then a simple waiver would solve most of the issues. (a 20yo girl died in slovenia due to jannsen vaccine not that long ago, and she got vaccinated, becase she was soft-forced by the government mandates (48 hour testing, far away from home, but unable to use the bus without a test, to go to the testing site, 12eur/test,...).
- ericb 5y ago
  Your reply is totally off-topic for the parent you replied to.
  - dfabulich 5y ago
    I see why you're saying that, but I think you missed their point. Challenge trials might well allow us to make a safe vaccine available sooner to those who want it, but if we mandate a vaccine that has only undergone challenge trials and then that vaccine kills someone, it would certainly be politically disastrous for challenge trials.
    - Wowfunhappy 5y ago
      Challenge trials are dangerous for the people who participate in the trials, but they aren’t any less rigorous.
      - 5y ago