6 ms·

I'm about far from anti-vaxer stance as its possible to be, so please don't think this is where this is coming from, but isn't this crazy quick compared to how

by LandR 7y ago

I'm about far from anti-vaxer stance as its possible to be, so please don't think this is where this is coming from, but isn't this crazy quick compared to how long vaccines usually take? Is the long time to create vaccines not usually to make sure they are safe? What is different now that it can be done quicker? Is it just the sheer amount of effort and cash being thrown at it?

afarrell 7y ago
A lot of labs were researching MERS and SARS already.
fuckknows 7y ago
So according to In The Pipeline[1] they essentially modified their existing MERS vaccine so that it worked for SARS-COV-2. Their original vaccine had already gone through phase 1 trials and had shown efficacy and no harmful side effects. [1] https://blogs.sciencemag.org/pipeline/archives/2020/04/23/a-close-look-at-the-frontrunning-coronavirus-vaccines-as-of-april-23 https://blogs.sciencemag.org/pipeline/archives/2020/04/23/a-...
- throwaway888abc 7y ago
  Thanks
- mcarmichael 7y ago
  Derek Lowe is terrific in communicating complex ideas in the field to concerned lay observers like me; he's been a great resource for reliable information about the science of this thing. Just to clarify; the ChAdOx1 MERS prospect hasn't proceeded to a trial demonstrating efficacy in human subjects (as yet). That's a particularly important distinction here, given the nature of the novel delivery mechanism[1] and prior observation of complications in SARS-CoV-1 vaccine development[2] [1] https://en.wikipedia.org/wiki/Viral_vector#Adenoviruses https://en.wikipedia.org/wiki/Viral_vector#Adenoviruses [2] https://www.hkmj.org/abstracts/v22n3%20Suppl%204/25.htm https://www.hkmj.org/abstracts/v22n3%20Suppl%204/25.htm
  - ignoramous 6y ago
    > Just to clarify; the ChAdOx1 MERS prospect hasn't proceeded to a trial... Looks like it has (for SARS-CoV-2 instead): https://www.genengnews.com/news/astrazeneca-joins-u-of-oxford-and-spinout-to-develop-covid-19-vaccine/ https://www.genengnews.com/news/astrazeneca-joins-u-of-oxfor...
enaaem 7y ago
Parallel processing. Normally a few labs would work on a particular vaccine. If a potential vaccine fails they have to retry something else and this whole process can take a long time. Now, pretty much all virus labs in the world are rushing to create a vaccine. There are 70 potential candidates last time I've read, so there is a high change one them works.
deleted 7y ago
[deleted]
Mikeb85 7y ago
Coronavirus shares 90ish percent of its genetic material with SARS. So they had a head start.
- Traster 7y ago
  We share 99% of our DNA with chimps, I don't think it's a helpful measure.
  - Ensorceled 7y ago
    We use chimps in biomedical research precisely because of that overlap, why do you think it's not a helpful measure?
    - mattkrause 7y ago
      We...don’t actually. The NIH started phasing chimp research out in 2013 and USFWS declared them endangered (and thus off-limits for anything invasive or distressing) in 2015. Great apes can be used for observational studies (like kids), but I think even drawing blood for non-vet reasons is now pretty regulated. Other primates, especially rhesus monkeys and, increasingly, marmosets, are important model animals for lab experiments but are less closely related to humans. Sources for the down voters: https://www.nih.gov/about-nih/who-we-are/nih-director/statements/timeline-nihs-decision-end-use-chimpanzees-research https://www.nih.gov/about-nih/who-we-are/nih-director/statem...
      - Ensorceled 7y ago
        You’re being downvoted for utterly missing the point.
        mattkrause 7y ago
        Care to explain?
        7y ago
rsynnott 7y ago
Other coronavirus vaccines have been developed before, though not brought through the full process. And this is really pretty early in the process; this is the start of human trials. Even if everything goes wonderfully there won't be mass manufacture of this for a while.
jartelt 7y ago
This is a very early step (phase 1). They are giving the vaccine to small number of healthy people to make sure it is safe in that population. From there they have to go on to larger trials that look at both safety and effectiveness. The phase 2 and phase 3 trials will take much longer.
- mattkrause 7y ago
  Is this really a phase I? 800 people seems absolutely massive if it is—and I don’t think they’d bother with a placebo arm for safety. Edit: Found the registration. It’s a weird combined Phase I and II: https://clinicaltrials.gov/ct2/show/NCT04324606 https://clinicaltrials.gov/ct2/show/NCT04324606
  - tialaramex 7y ago
    Well, it is complicated by the reality that this disease is widespread. I was rejected because I had cancer (years ago but they don't need any extra factors) but this is mostly like a normal Phase I in that the primary question is: Do humans tolerate this vaccine? Roughly half those recruited (at random) get a different vaccine, an irrelevant one, that protects against Meningitus but we've no reason to think would make any difference to a coronavirus - and half get the new one. You can't tell what it was they stuck in your arm, so they can compare the two groups to see if any side effects were significantly more common for the new vaccine. Because this coronavirus is widespread in the community they will also unavoidably get to collect information that would usually be the purpose of Phase II/III trials - did the group who got the "real" vaccine get COVID-19 symptoms less often that the other group? Or if they did, were they less severe? You normally don't do this, and if you tried an ethics committee would stop you - it's unethical to expose patients to a novel risk when you haven't even figured out if the treatment you're trying is safe first. But in this case the risk is already there, for absolutely everyone, so you aren't making anything worse by just measuring if your treatment helped.
    - mattkrause 7y ago
      Right, but for those same reasons, a Phase I trial is usually much smaller and has “safety and tolerability” as an endpoint rather than disease-related outcomes (as this one does). I don’t think those usually have randomized control groups; see the example below. In this case, it looks like the Oxford group had previously used the same ChAdOx platform to make a MERS vaccine, and they’re leveraging that data (here: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30160-2/fulltext# https://www.thelancet.com/journals/laninf/article/PIIS1473-3...) to move more quickly into a combined Phase I and II trial.

by LandR 7y ago

afarrell 7y ago

A lot of labs were researching MERS and SARS already.

fuckknows 7y ago

So according to In The Pipeline[1] they essentially modified their existing MERS vaccine so that it worked for SARS-COV-2. Their original vaccine had already gone through phase 1 trials and had shown efficacy and no harmful side effects. [1] https://blogs.sciencemag.org/pipeline/archives/2020/04/23/a-close-look-at-the-frontrunning-coronavirus-vaccines-as-of-april-23 https://blogs.sciencemag.org/pipeline/archives/2020/04/23/a-...

throwaway888abc 7y ago
Thanks
mcarmichael 7y ago
Derek Lowe is terrific in communicating complex ideas in the field to concerned lay observers like me; he's been a great resource for reliable information about the science of this thing. Just to clarify; the ChAdOx1 MERS prospect hasn't proceeded to a trial demonstrating efficacy in human subjects (as yet). That's a particularly important distinction here, given the nature of the novel delivery mechanism[1] and prior observation of complications in SARS-CoV-1 vaccine development[2] [1] https://en.wikipedia.org/wiki/Viral_vector#Adenoviruses https://en.wikipedia.org/wiki/Viral_vector#Adenoviruses [2] https://www.hkmj.org/abstracts/v22n3%20Suppl%204/25.htm https://www.hkmj.org/abstracts/v22n3%20Suppl%204/25.htm
- ignoramous 6y ago
  > Just to clarify; the ChAdOx1 MERS prospect hasn't proceeded to a trial... Looks like it has (for SARS-CoV-2 instead): https://www.genengnews.com/news/astrazeneca-joins-u-of-oxford-and-spinout-to-develop-covid-19-vaccine/ https://www.genengnews.com/news/astrazeneca-joins-u-of-oxfor...

enaaem 7y ago

Parallel processing. Normally a few labs would work on a particular vaccine. If a potential vaccine fails they have to retry something else and this whole process can take a long time. Now, pretty much all virus labs in the world are rushing to create a vaccine. There are 70 potential candidates last time I've read, so there is a high change one them works.

deleted 7y ago

[deleted]

Mikeb85 7y ago

Coronavirus shares 90ish percent of its genetic material with SARS. So they had a head start.

Traster 7y ago
We share 99% of our DNA with chimps, I don't think it's a helpful measure.
- Ensorceled 7y ago
  We use chimps in biomedical research precisely because of that overlap, why do you think it's not a helpful measure?
  - mattkrause 7y ago
    We...don’t actually. The NIH started phasing chimp research out in 2013 and USFWS declared them endangered (and thus off-limits for anything invasive or distressing) in 2015. Great apes can be used for observational studies (like kids), but I think even drawing blood for non-vet reasons is now pretty regulated. Other primates, especially rhesus monkeys and, increasingly, marmosets, are important model animals for lab experiments but are less closely related to humans. Sources for the down voters: https://www.nih.gov/about-nih/who-we-are/nih-director/statements/timeline-nihs-decision-end-use-chimpanzees-research https://www.nih.gov/about-nih/who-we-are/nih-director/statem...
    - Ensorceled 7y ago
      You’re being downvoted for utterly missing the point.
      - mattkrause 7y ago
        Care to explain?
        7y ago

rsynnott 7y ago

Other coronavirus vaccines have been developed before, though not brought through the full process. And this is really pretty early in the process; this is the start of human trials. Even if everything goes wonderfully there won't be mass manufacture of this for a while.

jartelt 7y ago

This is a very early step (phase 1). They are giving the vaccine to small number of healthy people to make sure it is safe in that population. From there they have to go on to larger trials that look at both safety and effectiveness. The phase 2 and phase 3 trials will take much longer.

mattkrause 7y ago
Is this really a phase I? 800 people seems absolutely massive if it is—and I don’t think they’d bother with a placebo arm for safety. Edit: Found the registration. It’s a weird combined Phase I and II: https://clinicaltrials.gov/ct2/show/NCT04324606 https://clinicaltrials.gov/ct2/show/NCT04324606
- tialaramex 7y ago
  Well, it is complicated by the reality that this disease is widespread. I was rejected because I had cancer (years ago but they don't need any extra factors) but this is mostly like a normal Phase I in that the primary question is: Do humans tolerate this vaccine? Roughly half those recruited (at random) get a different vaccine, an irrelevant one, that protects against Meningitus but we've no reason to think would make any difference to a coronavirus - and half get the new one. You can't tell what it was they stuck in your arm, so they can compare the two groups to see if any side effects were significantly more common for the new vaccine. Because this coronavirus is widespread in the community they will also unavoidably get to collect information that would usually be the purpose of Phase II/III trials - did the group who got the "real" vaccine get COVID-19 symptoms less often that the other group? Or if they did, were they less severe? You normally don't do this, and if you tried an ethics committee would stop you - it's unethical to expose patients to a novel risk when you haven't even figured out if the treatment you're trying is safe first. But in this case the risk is already there, for absolutely everyone, so you aren't making anything worse by just measuring if your treatment helped.
  - mattkrause 7y ago
    Right, but for those same reasons, a Phase I trial is usually much smaller and has “safety and tolerability” as an endpoint rather than disease-related outcomes (as this one does). I don’t think those usually have randomized control groups; see the example below. In this case, it looks like the Oxford group had previously used the same ChAdOx platform to make a MERS vaccine, and they’re leveraging that data (here: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30160-2/fulltext# https://www.thelancet.com/journals/laninf/article/PIIS1473-3...) to move more quickly into a combined Phase I and II trial.