So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (Deputy Director for Vaccines Research and Review) and Marion Gruber (Director for Vaccines Research and Review) abruptly resigned from their positions at the end of last month.
Phil Krause is also the lead author on this article published in Lancet along with his boss (with a publish date of two days ago) which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time in the article extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases. But if you read deeply, this is a man confused that no one is listening to what the data says when it goes against what they want.
What I feel is most important is the one line that everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning?", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled?", which will lead to "did I recommend things that only made sense because I assumed the data was valid? Was this all horse shit from the beginning??"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, their frustrations, and argument, revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster ... yet their superiors are pushing hard for that.
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He must have been really confused why these seemigly logical arguments didn't get him anywhere, but it's because he still thinks any of this has anything to do with facts and data.
And I'd love to pick apart those covid vaccine efficacy figures included (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.
So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (deputy Director for Vaccines Research and Review) and Marion Gruber (can't find his position) abruptly resigned from their positions at the end of last month.
Phil Krause is also the lead author on this article published in Lancet, with a publish date of two days ago which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time in the article extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases. But if you read deeply, this is a man confused that no one is listening to what the data says when it goes against what they want.
What I feel is most important is the one line that everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning?", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled?", which will lead to "did I recommend things that only made sense because I assumed the data was valid? Was this all horse shit from the beginning??"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, their frustrations, and argument, revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster ... yet their superiors are pushing hard for that.
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He must have been really confused why these seemigly logical arguments didn't get him anywhere, but it's because he still thinks any of this has anything to do with facts and data.
And I'd love to pick apart those covid vaccine efficacy figures included (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.
So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (deputy Director for Vaccines Research and Review) and Marion Gruber (can't find his position) abruptly resigned from their positions at the end of last month.
Phil Krause is also the lead author on this article published in Lancet, with a publish date of two days ago which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time in the article extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases. But if you read deeply, this is a man confused that no one is listening to what the data says when it goes against what they want.
What I feel is most important is the one line that everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning?", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled?", which will lead to "did I recommend things that only made sense because I assumed the data was valid? Was this all horse shit from the beginning??"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, they're frustrations, and argument revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster?
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He must have been really confused why these seemigly logical arguments didn't get him anywhere, but it's because he still thinks any of this has anything to do with facts and data.
And I'd love to pick apart those covid vaccine efficacy figures included (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.
So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (deputy Director for Vaccines Research and Review) and Marion Gruber (can't find his position) abruptly resigned from their positions at the end of last month.
Phil Krause is also the lead author on this article published in Lancet, with a publish date of two days ago which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time in the article extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases. But if you read deeply, this is a man confused that no one is listening to what the data says when it goes against what they want.
What I feel is most important is the one line that everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning?", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled?", which will lead to "did I recommend things that only made sense because I assumed the data was valid? Was this all horse shit from the beginning??"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, they're frustrations, and argument revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster?
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He must have been really confused why these seemigly logical arguments didn't get him anywhere, but it's because he still thinks any of this has anything to do with facts and data.
And I'd love to pick apart those covid vaccine efficacy figures included (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.
So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (deputy Director for Vaccines Research and Review) and Marion Gruber (can't find his position) abruptly resigned from their positions at the end of last month.
Phil Krause is also the lead author on this article published in Lancet, with a publish date of two days ago which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time in the article extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases. But if you read deeply, this is a man confused that no one is listening to what the data says when it goes against what they want.
What I feel is most important is the one line that everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled", which will lead to "did I recommend things that made sense based on what I thought, but is in fact a load of complete horse shit?"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, they're frustrations, and argument revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster?
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He must have been really confused why these seemigly logical arguments didn't get him anywhere, but it's because he still thinks any of this has anything to do with facts and data.
And I'd love to pick apart those covid vaccine efficacy figures included (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.
So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (deputy Director for Vaccines Research and Review) and Marion Gruber (can't find his position) abruptly resigned from their positions at the end of last month.
Phil Krause is also the lead author on this article published in Lancet, with a publish date of two days ago which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time in the article extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases. But if you read deeply, this is a man confused that no one is listening to what the data says when it goes against what they want.
What I feel is most important is the one line that reall everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled", which will lead to "did I recommend things that made sense based on what I thought, but is in fact a load of complete horse shit?"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, they're frustrations, and argument revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster?
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He must have been really confused why these seemigly logical arguments didn't get him anywhere, but it's because he still thinks any of this has anything to do with facts and data.
And I'd love to pick apart those covid vaccine efficacy figures included (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.
So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (deputy Director for Vaccines Research and Review) and Marion Gruber (can't find his position) abruptly resigned from their positions at the end of last month.
Phil Krause is also the lead author on this article published in Lancet, with a publish date of two days ago which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases.
What I feel is most important is the one line that reall everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled", which will lead to "did I recommend things that made sense based on what I thought, but is in fact a load of complete horse shit?"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, they're frustrations, and argument revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster?
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He must have been really confused why these seemigly logical arguments didn't get him anywhere, but it's because he still thinks any of this has anything to do with facts and data.
And I'd love to pick apart those covid vaccine efficacy figures included (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.
So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (deputy Director for Vaccines Research and Review) and Marion Gruber (can't find his position) have abruptly resigned from their positions.
Phil Krause is also the lead author on this article published in Lancet, which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases.
What I feel is most important is the one line that reall everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled", which will lead to "did I recommend things that made sense based on what I thought, but is in fact a load of complete horse shit?"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, they're frustrations, and argument revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster?
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He must have been really confused why these seemigly logical arguments didn't get him anywhere, but it's because he still thinks any of this has anything to do with facts and data.
And I'd love to pick apart those covid vaccine efficacy figures included (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.
So I've looked into this and according to the NYT and Yahoo News, yes, Phil Krause (deputy Director for Vaccines Research and Review) and Marion Gruber (can't find his position) have abruptly resigned from their positions.
Phil Krause is also the lead author on this article published in Lancet, which I'll devote the rest of this comment to the discussion of
First and foremost, Phil isn't anti covid vax, and spends most of his time extoling the virues of the current vaccination program to earn the requisite credibility necessary when you're about to say something heretical. However at face value the only criticism is a staunch position against additional boosters.
I could pick some positive out of context reasonings, such as his expression of concern over serious side effects, but he pre-empts that by stating that "the positives of vaccination far outweigh the risks". His primary argument is that limited doses would be better served in vaccinating those who remain unvaccinated, rather than persuing unsupported supposition that boosters will provide much if any additional benefit except perhaps in select cases.
What I feel is most important is the one line that reall everyone here needs to know was uttered:
Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.
I mean, that's the eye into the workings and the reasonings for their resignation more than anything else in the article. The FDA is making decisions entirely based on politics rather than data, these two drew their line, and resigned over it.
Basically they just received their first red pill suppository. That haven't quite woken up to ask,"wait, was it political from the beginning", which will then lead to, "wait, all that data I reviewed, how much of it was fraudulently compiled", which will lead to "did I recommend things that made sense based on what I thought, but is in fact a load of complete horse shit?"
They may not be quite there yet, but the fact that they aknowledge this, is telling:
Estimates may be confounded both by patient characteristics at the start of vaccine roll-out and by time-varying factors that are missed by electronic health records. *For example, those classified as unvaccinated might include some who were in fact vaccinated, some who are already protected because of previous infection, or some whose vaccination was deferred because of COVID-19 symptoms.
Sound familiar? We aren't the only ones tht saw that and went, "wait, that's bullshit, you can't categorize like that"
Basically, they're frustrations, and argument revolve around a lack of evidence suggesting the vaccine loses efficacy against severe disease, which is all that matters, and so there is absolutely no data supporting a push for booster?
To date, none of these studies has provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease.
Doesn't yet get that the vaccine, and the boosters, has nothing to do with covid, and everything to do with control. He closes by conceding that hey, if we're doing boosters we should first be developing and tailoring new versions for variant the variants, like with the flu, not just doing another round.
He doesn't get it.
And I'd love to pick apart those covid vaccine efficacy figures (they are missing the control! Where's the 'unvaccinated' efficacy by which to compare the vaccinated results against?) but I won't. Because that's not the take away here.
TLDR: Top vaccine regulatory research decison makers resigned because the FDA decided that politics, not data, should guide their approval process.