4 ms·

I don't think "move fast and break things" is a great example for healthcare products. We've used this product under emergency use guidelines, which allowed i

I don't think "move fast and break things" is a great example for healthcare products. We've used this product under emergency use guidelines, which allowed it to skip many steps, we should probably do those steps before we presume much more out of this platform.

kadoban 5y ago
At least one mRNA vaccine now has full approval. No steps were skipped, they were just done in a more parallel manner than usual. The usual way is just cheaper, not more safe.
- tommymachine 5y ago
  So there were long term human trials done like with actual vaccines?
  - pertymcpert 5y ago
    What do you mean actual vaccines? As opposed to fake vaccines?
    - tommymachine 5y ago
      Since you asked, the point could be more accurately stated as referring to vaccines meeting the pre 2020 definition of the term (which “mRNA vaccines” do not).
    - robbedpeter 5y ago
      As opposed to mrna vaccines which are significantly different than traditional vaccines. Which you knew, but for some reason, you want to deflect and prevent discussion of anything potentially negative about mrna vaccines? I'm not sure what the charitable interpretation could be.
    - iratewizard 5y ago
      Machiavellian people co-opted the word vaccine because it has a generally positive connotation. They then retconned the word as if it has always included mRNA and viral vector therapeutics.
  - glogla 5y ago
    Are you talking about the COVID vaccines that now have little over seven and half billion administered doses worldwide? Those are likely the most tested vaccines in history.
    - tommymachine 5y ago
      Then surely the data on safety after 36 months is well studied?
pertymcpert 5y ago
Which steps were skipped?
- robbedpeter 5y ago
  Things like longterm efficacy. Longterm safety. Anything that usually requires years of controlled studies, basically. Which, again, you know, but... why is it important to you that vaccines not be criticized honestly?
  - pertymcpert 5y ago
    > Which, again, you know, but... why is it important to you that vaccines not be criticized honestly? .... what?
    - hnbad 5y ago
      The notion that vaccines normally don't get FDA approval without multi-year long-term follow-up studies is absurd enough. That's not how any of this works. All observed "vaccination damage" has been observed in very close proximity to the injection. The talk about "long-term" effects is almost entirely based on FUD spread about the measles vaccine which is in turn based on a fraudulent pseudoscientific article claiming a link between one specific measles vaccine and autism by a guy who tried to push an alternative vaccine. If you still worry bout vaccination damage as a serious concern in 2021 you're on the tail end of a failed marketing campaign.
halfmatthalfcat 5y ago
I think you should be lauding our society's ability to swarm a problem and massively increase efficiency/remove red tape to fulfill a common purpose rather than resting on how things were done before (when things were "normal") as to what is suppose to happen. We're suppose to be able to do things like this in order to save ourselves. Imagine if COVID was deadlier, had a higher R-naught, etc. Would you still be advocating for "taking it slow"? If hundreds of thousands were dying per day should we still be waiting years for a vaccine?
- chrsig 5y ago
  I don't think anyone is arguing against having removed the red tape for covid. The same risk:reward doesn't exist for herpes though.
- robbedpeter 5y ago
  Applauding their efforts but retaining a critical eye for the usual long term safety considerations are not mutually exclusive. You can also laud the mrna vaccines and be critical of the obscene profits being made. In fact, you can also promote vaccinating as widely as possible, and at the same time harshly condemn the politicization of medicine, the creation of second class citizens, and the nonsense power games being fought that seem to exclusively benefit massive corporations that fund political campaigns.
- glogla 5y ago
  Now if we could do that with climate change.
- sterlind 5y ago
  I wonder how things would have turned out if COVID had different properties. With COVID, some people shrugged it off like a mild cold, while others were in the ICU with multiple organ failure. Risk factors tilt the odds but on the whole, the virus is weirdly random. This leads to people having wildly different personal experiences - someone knows a 60-year old who caught COVID and recovered with chicken soup, while someone else knows a family whose children were orphaned by the loss of their young, healthy parents. That randomness is fuel on the fire for partisan divides. I think even with a 10% CFR, there'd be droves of vaccine skeptics, unless the virus hits people with more or less uniform symptoms. ...or maybe it even has nothing to do with lethality at all, look at the ebola vaccine rollouts in Africa.
radu_floricica 5y ago
Almost pathological aversion to "move fast and break things" has gotten us moving forward at a turtle's pace, instead of already having 20 years longer lifespans, not to mention 20-30 years longer productive years. I'm not talking science-fiction, I'm talking simply having done the things we know are possible. I've gotten downvoted once here for saying this, but bioethicists will be put in history in the "genocide" chapter: we didn't do challenge trial for Covid. Just try to wrap your mind around this concept: we knew since early spring of 2020 that Covid is not particularly dangerous for young healthy people. We had plenty of volunteers - there were sites up I think since February. We had countless questions: how does it spread? is it airborn? do masks help? which masks? how is it acting? what drugs help? DO VACCINES WORK? But no. We chose, and I underline, chose, not to answer any of those questions because nobody had the balls to cross the line already drawn in the sand. Of course medicine has downsides. Of course at times we fuck up. But ... god, Thomas Sowell should be required reading in highschool. Everything is a tradeoff. You can't say "we have to move slow" - you have to say "moving too fast or too slow has the following tradeoffs". If you're not keeping in mind what you're losing by moving in one direction, you'll keep steering in that direction until you get to the point of ignoring such low hanging fruits as challenge trials while watching people die.
detaro 5y ago
How is "researching multiple things in parallel" == "move fast and break things"? It's not like people are calling for emergency use authorization or other accelerated steps for a herpes vaccine, it's merely being considered as thing that can be done.
hnbad 5y ago
The covid vaccines were not granted special "emergency use" anything, at least not in the EU. They just parallelized some of the trials and didn't encounter any setbacks. No steps were "skipped". The mRNA technology had also already been in development for a while, just not applied as a medical product (much like how multi-touch had been around for a long time before the iPhone capitalized on it). They were also handled with an abundance of caution, which is why many countries suspended the Oxford vaccine after initial reports of adverse effects in young women despite the extremely low frequency hinting at sampling bias rather than genuine side-effects.

kadoban 5y ago

At least one mRNA vaccine now has full approval. No steps were skipped, they were just done in a more parallel manner than usual. The usual way is just cheaper, not more safe.

tommymachine 5y ago
So there were long term human trials done like with actual vaccines?
- pertymcpert 5y ago
  What do you mean actual vaccines? As opposed to fake vaccines?
  - tommymachine 5y ago
    Since you asked, the point could be more accurately stated as referring to vaccines meeting the pre 2020 definition of the term (which “mRNA vaccines” do not).
  - robbedpeter 5y ago
    As opposed to mrna vaccines which are significantly different than traditional vaccines. Which you knew, but for some reason, you want to deflect and prevent discussion of anything potentially negative about mrna vaccines? I'm not sure what the charitable interpretation could be.
  - iratewizard 5y ago
    Machiavellian people co-opted the word vaccine because it has a generally positive connotation. They then retconned the word as if it has always included mRNA and viral vector therapeutics.
- glogla 5y ago
  Are you talking about the COVID vaccines that now have little over seven and half billion administered doses worldwide? Those are likely the most tested vaccines in history.
  - tommymachine 5y ago
    Then surely the data on safety after 36 months is well studied?

pertymcpert 5y ago

Which steps were skipped?

robbedpeter 5y ago
Things like longterm efficacy. Longterm safety. Anything that usually requires years of controlled studies, basically. Which, again, you know, but... why is it important to you that vaccines not be criticized honestly?
- pertymcpert 5y ago
  > Which, again, you know, but... why is it important to you that vaccines not be criticized honestly? .... what?
  - hnbad 5y ago
    The notion that vaccines normally don't get FDA approval without multi-year long-term follow-up studies is absurd enough. That's not how any of this works. All observed "vaccination damage" has been observed in very close proximity to the injection. The talk about "long-term" effects is almost entirely based on FUD spread about the measles vaccine which is in turn based on a fraudulent pseudoscientific article claiming a link between one specific measles vaccine and autism by a guy who tried to push an alternative vaccine. If you still worry bout vaccination damage as a serious concern in 2021 you're on the tail end of a failed marketing campaign.

halfmatthalfcat 5y ago

I think you should be lauding our society's ability to swarm a problem and massively increase efficiency/remove red tape to fulfill a common purpose rather than resting on how things were done before (when things were "normal") as to what is suppose to happen. We're suppose to be able to do things like this in order to save ourselves. Imagine if COVID was deadlier, had a higher R-naught, etc. Would you still be advocating for "taking it slow"? If hundreds of thousands were dying per day should we still be waiting years for a vaccine?

chrsig 5y ago
I don't think anyone is arguing against having removed the red tape for covid. The same risk:reward doesn't exist for herpes though.
robbedpeter 5y ago
Applauding their efforts but retaining a critical eye for the usual long term safety considerations are not mutually exclusive. You can also laud the mrna vaccines and be critical of the obscene profits being made. In fact, you can also promote vaccinating as widely as possible, and at the same time harshly condemn the politicization of medicine, the creation of second class citizens, and the nonsense power games being fought that seem to exclusively benefit massive corporations that fund political campaigns.
glogla 5y ago
Now if we could do that with climate change.
sterlind 5y ago
I wonder how things would have turned out if COVID had different properties. With COVID, some people shrugged it off like a mild cold, while others were in the ICU with multiple organ failure. Risk factors tilt the odds but on the whole, the virus is weirdly random. This leads to people having wildly different personal experiences - someone knows a 60-year old who caught COVID and recovered with chicken soup, while someone else knows a family whose children were orphaned by the loss of their young, healthy parents. That randomness is fuel on the fire for partisan divides. I think even with a 10% CFR, there'd be droves of vaccine skeptics, unless the virus hits people with more or less uniform symptoms. ...or maybe it even has nothing to do with lethality at all, look at the ebola vaccine rollouts in Africa.

radu_floricica 5y ago

Almost pathological aversion to "move fast and break things" has gotten us moving forward at a turtle's pace, instead of already having 20 years longer lifespans, not to mention 20-30 years longer productive years. I'm not talking science-fiction, I'm talking simply having done the things we know are possible. I've gotten downvoted once here for saying this, but bioethicists will be put in history in the "genocide" chapter: we didn't do challenge trial for Covid. Just try to wrap your mind around this concept: we knew since early spring of 2020 that Covid is not particularly dangerous for young healthy people. We had plenty of volunteers - there were sites up I think since February. We had countless questions: how does it spread? is it airborn? do masks help? which masks? how is it acting? what drugs help? DO VACCINES WORK? But no. We chose, and I underline, chose, not to answer any of those questions because nobody had the balls to cross the line already drawn in the sand. Of course medicine has downsides. Of course at times we fuck up. But ... god, Thomas Sowell should be required reading in highschool. Everything is a tradeoff. You can't say "we have to move slow" - you have to say "moving too fast or too slow has the following tradeoffs". If you're not keeping in mind what you're losing by moving in one direction, you'll keep steering in that direction until you get to the point of ignoring such low hanging fruits as challenge trials while watching people die.

detaro 5y ago

How is "researching multiple things in parallel" == "move fast and break things"? It's not like people are calling for emergency use authorization or other accelerated steps for a herpes vaccine, it's merely being considered as thing that can be done.

hnbad 5y ago

The covid vaccines were not granted special "emergency use" anything, at least not in the EU. They just parallelized some of the trials and didn't encounter any setbacks. No steps were "skipped". The mRNA technology had also already been in development for a while, just not applied as a medical product (much like how multi-touch had been around for a long time before the iPhone capitalized on it). They were also handled with an abundance of caution, which is why many countries suspended the Oxford vaccine after initial reports of adverse effects in young women despite the extremely low frequency hinting at sampling bias rather than genuine side-effects.