07-02-2020, 04:07 PM
(This post was last modified: 09-05-2020, 07:13 PM by BostonCard.
Edit Reason: Fixed the typo
)
https://www.fda.gov/regulatory-informati...t-covid-19
I have downloaded and read the document. Others that have done the same have said that this is one of the best set of guidelines they have ever seen come out of the FDA. These are people who read a lot of them, so I accept their opinion. They did look pretty good to me as well, FWTW. There has to be something going right in this mess.
I posted this basically when it was released. If the FDA follow this document, I think we can be pretty sure that safety is being adequately considered. This document can, I believe, be considered an objective attempt to balance the competing concerns. It was issued somewhat preemptively IMHO in order to ensure political pressure wouldn't work well.
The problem may arise that an EUA is issued due to political pressure and/or the belief that it is necessary to facilitate "reopening". The following link is in many ways interesting.
https://www.nytimes.com/2020/09/02/opini...e=Homepage
This link makes the argument that distributing the vaccine was hasty and ill advised. It ostensibly bases it's argument on the fact that 450 people contracted Guillain-Barré syndrome and 30 people died from the vaccine. The reality is that the argument makes sense only because swine flu turned out to be a nothing burger. Had it truly been as deadly as many "experts" predicted, it could indeed have been another 1918 flu epidemic, in which case only 30 deaths would have been a big "win". I think the article illustrates the difficulty of taking action against a threat that may emerge but hasn't yet done so. You may just be wrong, and are now a fool, who the author hopes Trump doesn't emulate. The concept of "good decision, bad outcome" is unknown to the media with 20-20 hindsight.
With COVID-19, we know a lot about what the downside in the US has been. What we can't know immediately is what the down side of a vaccine is. It takes time for all the ill effects to emerge. We also may not know much about it's long term efficacy either. That also takes time. It is that lack of certainty about the reliability of immunity that will dissuade people from taking the vaccine IMHO. If you know it works, taking it and accepting some (probably very small) risk makes much more sense than if you have no such assurance.
I have downloaded and read the document. Others that have done the same have said that this is one of the best set of guidelines they have ever seen come out of the FDA. These are people who read a lot of them, so I accept their opinion. They did look pretty good to me as well, FWTW. There has to be something going right in this mess.
I posted this basically when it was released. If the FDA follow this document, I think we can be pretty sure that safety is being adequately considered. This document can, I believe, be considered an objective attempt to balance the competing concerns. It was issued somewhat preemptively IMHO in order to ensure political pressure wouldn't work well.
The problem may arise that an EUA is issued due to political pressure and/or the belief that it is necessary to facilitate "reopening". The following link is in many ways interesting.
https://www.nytimes.com/2020/09/02/opini...e=Homepage
This link makes the argument that distributing the vaccine was hasty and ill advised. It ostensibly bases it's argument on the fact that 450 people contracted Guillain-Barré syndrome and 30 people died from the vaccine. The reality is that the argument makes sense only because swine flu turned out to be a nothing burger. Had it truly been as deadly as many "experts" predicted, it could indeed have been another 1918 flu epidemic, in which case only 30 deaths would have been a big "win". I think the article illustrates the difficulty of taking action against a threat that may emerge but hasn't yet done so. You may just be wrong, and are now a fool, who the author hopes Trump doesn't emulate. The concept of "good decision, bad outcome" is unknown to the media with 20-20 hindsight.
With COVID-19, we know a lot about what the downside in the US has been. What we can't know immediately is what the down side of a vaccine is. It takes time for all the ill effects to emerge. We also may not know much about it's long term efficacy either. That also takes time. It is that lack of certainty about the reliability of immunity that will dissuade people from taking the vaccine IMHO. If you know it works, taking it and accepting some (probably very small) risk makes much more sense than if you have no such assurance.