8 ms·

My impression is that this was done to specifically counter Donald Trump rushing a vaccine prior to the election. I don't think it was really made to give any s

My impression is that this was done to specifically counter Donald Trump rushing a vaccine prior to the election. I don't think it was really made to give any security beyond that

saiya-jin 6y ago
Any increase in testing time will give some, albeit hard to measure, improvement in safety of the vaccine. Or am I missing something?
- marcosdumay 6y ago
  Trump has made some very worrisome statements intended on either rushing a vaccine or placing the blame for the lack of it into whoever refuses to rush it. Then the FDA answered with a non-statement that said basically "there's no conspiracy, we are fully invested into doing our job". And, of course, that gave a clear signal that the FDA felt pressured and was reported worldwide with that bias. So, I read the GP saying that the manufacturers are telling the FDA "we know better than you" in an attempt to conserve their own credibility. Notice that this is a very bad message to pass into their own regulator, and worrisome for different reasons. But as long as it's only PR, it's not a real problem.
calvinmorrison 6y ago
How about "rushing" the vaccine to you know... end the pandemic? Or would you rather more people die "from covid" to hurt Trumps chances of winning?
- RHSeeger 6y ago
  I'd rather more people die to Covid than find out 20 million people have failing livers and 5 million were born with birth defects because they rushed a vaccine without enough testing.
  - garmaine 6y ago
    COVID has already caused at least that many people to have measurable levels of internal organ damage.
    - umanwizard 6y ago
      Source?
- MacsHeadroom 6y ago
  Vaccines shouldn't be rushed because that's how you kill people with vaccines. Phase 3 vaccine trials take 18-24 months for very good reasons.
- apocalyptic0n3 6y ago
  The bigger issue is if they rush a drug that does long term harm to people, it could destroy the company. This is a drug that they will be giving out to 300+ million people in the US along. Screwing it up would result in a massive amounts of lawsuits that they may not recover from. They don't want to risk that just for some political capital with a person who may not be in power in a few months.
  - garmaine 6y ago
    The fix for that is easy: have the FDA authorization grant them immunity from vaccine safety or efficacy liability.
    - ethanbond 6y ago
      Man that is a good solution. That way we get a vaccine immediately! Who cares if it’s saline. Or arsenic.
      - garmaine 6y ago
        The way these things are worded only protect from unintentional damage.
    - rsynnott 6y ago
      Reputational damage would be a greater risk; this could quite easily turn into the greatest pharmaceutical scandal in history.
- Dylan16807 6y ago
  I feel like ending the pandemic is not a motivation that is likely to make a researcher (an expert) rush things and end up hurting more people. Greed or glory is much more likely to be a motivator for that kind of mistake.
- unethical_ban 6y ago
  Let me clarify what I think the parent meant. This announcement was made very shortly after Trump started making claims that a vaccine could be ready "late October/early November". Trump is a known fool, and even were he not, his losing prospects at re-election, combined with the criticism of his administration's response to the pandemic make it seem like he could be pushing vaccine makers to rush a treatment to pump up voter support. I believe vaccine makers are diplomatically responding to the Trump headline by saying "We aren't going to rush this for the wrong reasons."
  - dmarchand90 6y ago
    Thanks for clarifying! This is exactly what I meant
rsynnott 6y ago
I wouldn't have thought the companies involved are primarily thinking of that. The risk to the companies is that Trump going on about skipping trials will hurt public confidence in any vaccine that is finally released, even if such skipping never happens. This announcement may serve to reassure some people that the manufacturers are going to behave themselves even if the government is negligent. Also, probably, reassure some shareholders. The reputational risks involved in this trial-skipping stuff are horrific.

My impression is that this was done to specifically counter Donald Trump rushing a vaccine prior to the election. I don't think it was really made to give any security beyond that

saiya-jin 6y ago

Any increase in testing time will give some, albeit hard to measure, improvement in safety of the vaccine. Or am I missing something?

marcosdumay 6y ago
Trump has made some very worrisome statements intended on either rushing a vaccine or placing the blame for the lack of it into whoever refuses to rush it. Then the FDA answered with a non-statement that said basically "there's no conspiracy, we are fully invested into doing our job". And, of course, that gave a clear signal that the FDA felt pressured and was reported worldwide with that bias. So, I read the GP saying that the manufacturers are telling the FDA "we know better than you" in an attempt to conserve their own credibility. Notice that this is a very bad message to pass into their own regulator, and worrisome for different reasons. But as long as it's only PR, it's not a real problem.

calvinmorrison 6y ago

How about "rushing" the vaccine to you know... end the pandemic? Or would you rather more people die "from covid" to hurt Trumps chances of winning?

RHSeeger 6y ago
I'd rather more people die to Covid than find out 20 million people have failing livers and 5 million were born with birth defects because they rushed a vaccine without enough testing.
- garmaine 6y ago
  COVID has already caused at least that many people to have measurable levels of internal organ damage.
  - umanwizard 6y ago
    Source?
MacsHeadroom 6y ago
Vaccines shouldn't be rushed because that's how you kill people with vaccines. Phase 3 vaccine trials take 18-24 months for very good reasons.
apocalyptic0n3 6y ago
The bigger issue is if they rush a drug that does long term harm to people, it could destroy the company. This is a drug that they will be giving out to 300+ million people in the US along. Screwing it up would result in a massive amounts of lawsuits that they may not recover from. They don't want to risk that just for some political capital with a person who may not be in power in a few months.
- garmaine 6y ago
  The fix for that is easy: have the FDA authorization grant them immunity from vaccine safety or efficacy liability.
  - ethanbond 6y ago
    Man that is a good solution. That way we get a vaccine immediately! Who cares if it’s saline. Or arsenic.
    - garmaine 6y ago
      The way these things are worded only protect from unintentional damage.
  - rsynnott 6y ago
    Reputational damage would be a greater risk; this could quite easily turn into the greatest pharmaceutical scandal in history.
Dylan16807 6y ago
I feel like ending the pandemic is not a motivation that is likely to make a researcher (an expert) rush things and end up hurting more people. Greed or glory is much more likely to be a motivator for that kind of mistake.
unethical_ban 6y ago
Let me clarify what I think the parent meant. This announcement was made very shortly after Trump started making claims that a vaccine could be ready "late October/early November". Trump is a known fool, and even were he not, his losing prospects at re-election, combined with the criticism of his administration's response to the pandemic make it seem like he could be pushing vaccine makers to rush a treatment to pump up voter support. I believe vaccine makers are diplomatically responding to the Trump headline by saying "We aren't going to rush this for the wrong reasons."
- dmarchand90 6y ago
  Thanks for clarifying! This is exactly what I meant

rsynnott 6y ago

I wouldn't have thought the companies involved are primarily thinking of that. The risk to the companies is that Trump going on about skipping trials will hurt public confidence in any vaccine that is finally released, even if such skipping never happens. This announcement may serve to reassure some people that the manufacturers are going to behave themselves even if the government is negligent. Also, probably, reassure some shareholders. The reputational risks involved in this trial-skipping stuff are horrific.