Initially released to paid members. Now available for everyone to watch on Rumble. A vital interview on the corrupt ties between the Biden admin White House and the FDA.
Most people are unaware of the difference between “authorization” and “approval”, and with our government and media shoving the shots down our throats it didn’t matter. Oh yes and the mandates..
I am curious where the data came from for the approval decision. Obviously not from VAERS. Also there is no medical code for vaccine injury. So if people are coming into hospital claiming adverse reaction from the shots unless it is reported to VAERS I’m assuming there’s no reference point. So where’s the data coming from?
Why does the analysis from the initially withheld safety data procured from FDA via lawsuit show little efficacy? And this gentleman feels the shots were the miracle worker? Not talking about the booster.
Was the review team aware of the change in the manufacturing process of the Pfizer shot prior to mass rollout?
Not impressed with his stance about young adults getting the shots and his myocarditis viewpoint.
The CDC knew in March 2021 about breakthrough infections and lack of disease protection.
It’s shocking that a product than offers 30% protection is considered “acceptable”. Yes, they raised the bar to 50% but still. Yet the public was lied to outright. Old news.
No the mandates did not cause people to dig in their heels. Their decision had been made early on. I’m sick of that blame game. And no that’s not what caused Covid to spread. That is a leaky “vaccine” so please stop already.
I actually listened to the whole show. In light of Peter Marks recent resignation or “being forced out” as the media says it, this podcast was enlightening to some degree.
Why is the data on vaccines at FDA proprietary IF the FDA is meant to protect and represent the American people. We don’t care about competition…we care about safety and efficacy. “Worth developing a vaccine” means FDA protects this information so competitors cannot emerge…how many better vaccines could get developed if this data was disclosed? ESPECIALLY in the case of a pandemic emergency! What the FDA is essentially doing is protecting the business interests of those pushing for mRNA approval (that is the promise the agency makes and inadvertently promotes these to enter the market). In all fairness there is really no way around this. This in some cases might be more egregious than recommending who should get it. In a pure scientific sense this will always be a conflict of interest that we might call “commercialized” science.
But from the start the shots were meant as protective not as neutralizing immunization. There was first an emphasis that it was protective for all and then the narrative shifted to protect against severe disease. But its original design was to protect against severe disease, NOT to truly immunize and protect against infection. Was the measurement confused that immunization against infection was the RCT, when in fact it was protection against severe disease. This was not clarified very well in the discussion. It is this detail that destroyed confidence in the system…because the mandate for all had to actually imply it was protective against infection, not severe disease and hospitalization. How efficacy was measured seemed mixed up by the people at the top?Many got shots and were infected…
What actually was the impetus for mandates? Above all it is this question that eroded public confidence in public health the most. Even the inserts that came with the shots said in print that the product should not have been coerced and should be taken from free will.
There was mention of lack of manufacturing data…this would be critical for completely new style of vaccine that requires the full intact mRNA to be stable and encapsulated in LNPs in vials that were stored frozen or cold chain?
Even to this day the biological mechanisms are unclear. New recent Akiko Iwasaki work comes to mind. How hard is it to have transparent info on manufacturing lots, full length in vitro transcription results, presence of remaining template plasmid DNA (how was it decided what level this should be?) and tracking the presence of full or partial spike protein after shots…in the peripheral blood as well as antibodies against it over time. Would love to hear more discussion on safety biology, not on efficacy. There is overemphasis on efficacy, not enough on safety (myocarditis was a minor part of the discussion).
An FDA review would only be as good as the data presented…which in some ways was a conflict of interest during that time: two companies being advocated, rushing data to review, how could the data have been top notch, when literally mRNA and it’s technology en masse had never been evaluated. Even “normal style” vaccines take considerable time and effort for full approval. Many vaccine creators openly were vocal about this and were censored. Including some who had attempted vaccination against sars1.
Why was only spike the main antigenic target…another mystery.
So based on Krause’s statement of having the data in front of them they DID make the best decision at the time, but the outcomes, goals, and pressure from the outside kept morphing. In all fairness it must have been difficult. But an FDA review needs more transparency: what about how data is produced? Absolute versus relative risk evaluation? Were the trial participants a good representation of the general population or just the vulnerable pop considering its true purpose was to prevent severe disease and hospitalization? Even 4y later so many things sound unclear. One thing was clear: the messaging was “commitment to science” but if this were true why was rigorous review overruled by the top down? This is the exact opposite of commitment to good science, debate, and safety.
The irony of the dialogue that FDA doesn’t recommend who should take shots and then the podcast ends with the former FDA regulator saying “FDA shouldn’t recommend” is then recommending a healthy 20yo college soccer player should take it based on risk benefit. Without any transparency about what this published risk/benefit is. I would wholeheartedly side with Rav on this one. I also think more rigorous study is needed on the claim that shots somehow lessened the myocarditis that would otherwise have happened without it…there is so much more nuance to this including those coerced to take the shot after being infected. Krause rightfully called this nonsense…so again the “blanket coverage” approach Rav mentions was just plain wrong.
One more nuance here is the risk benefit ratio is actually a marketing point for a product. If it was high and compelling (even without long term studies) it seems strange that ultimately it was mandated. There is always this question of who is protecting who with shots…but it always needs to be a decision of “I read the label and I decided yes or no to use this product to protect myself.”
Great discussion…while there was advocacy for more to be employed at FDA…perhaps there should just be more rigorous review to start…how many of these treatments coming in even deserve review to begin with? Generally though it seems like regulation would need to increase if increased confidence in public health and support for FDA will be restored?
..."The FDA's role is crucial for public health and safety."...there is no such thing as public safety. The only role of the FDA is to approve big pharma drugs no matter how deadly they are.
Witness mRNA poisons which no one in the FDA will ever admit that they are murder drugs. So much for stupid public safety. All I have control over is my safety...at least as far as making decisions about taking vaccines and drugs. I couldn't care less about anything the FDA, CDC or HHS says.
Crixcyon so true. It all boils down to your decision. The question was whether we were properly informed. In a clinical trial (including the ones that would have been conducted or EUA), consent is foremost for participation. Why then did consent evaporate if we hold it sacred in the “scientific process” but it no longer matters in the “real world?” In my biomedical ethics training the number one warning for clinical work is coercion without consent. If we are committed to a scientifically-ethically-centered world why would consent no longer matter.
I have not watched the whole interview, and I will not defend most of what the Biden admin did on COVID and vaccine policies.
Most definitely not the various mandates, all of which were indefensible.
But re: the headline here:
I am very glad they pressured the FDA to make the vaccine available sooner rather than later.
That was a GOOD thing, not a bad one.
So that it became available for the very old and those with multiple comorbidities sooner rather than later.
Which not only helped save their lives, but the AVAILABILITY of the vaccines enabled getting rid of so many government-imposed lockdown policies relatively sooner than relatively later.
Even if you are correct that “The Biden admin pressured the FDA to accelerate the review because they wanted to impose mandates for the military.” Their motivations for the speedup are not what I care about most; I care about the policy outcome.
I of course vociferously disagreed with all the mandates, the ones on the military.
Re: you claim that “That is not how science ought to function”, we are talking about public policy during a pandemic. So many of those things were not how society or government should function.
I have no doubt I’d agree with you on most other aspects here. And I’d surely agree known side effects should have been revealed.
But speeding up the availability of vaccines, however, was definitely net a good thing.
He makes it sound like just another day in the office...like this was a "normal" vaccine and not MRNA based gene therapy. Was his department even qualified to review this novel "treatment"?
Thank you for this. We all remain, however, behind the crushing CEPI-Gavi military ball of mRNA countermeasure platforms in the name of driving global innovation in biodefense and now (with actions across the political divides) with massive commitments to ‘AI’ backed vaccination programs in the name of pandemic preparedness.
Little has changed EXCEPT the US State Dept and NSC is now putting the world on an emergency footing without diplomatic or humane guidelines. AI uses the flood of pro-vaccine articles (devoid of science) to automate ignorance at all levels. The programs are neither safe or effective. We can now see that it was a distraction to pull out of the WHO while leaving the public- private-🇺🇸military/intel agencies in charge of an extrajudicial injection program. Bombing Yemen, destroying Gaza and Ukrainian targets are terrible yet only the deadly appetizer. Onerous tariffs on imports is going to starve US while Pandemic profiteers, unelected autocrats and technocrats of all kinds ally in global domination, destroying our middle class and anyone but oligarchs outside our borders.
Your findings are good to know! What do we do to put this in meaningful context. Trump Admin 1 and now 2 are going to hurt us and put us at war against one another, and others in ways many of us will not survive. RFK Jr hasn’t stopped the unelected globalists any more than MAGA Republicans or Democrats. Peace and health be with us.💝
Everything changes with Marty Makary and RFK Jr. Totally different playing field, rules and leaders. New direction, new leadership.
Thank you!
Most people are unaware of the difference between “authorization” and “approval”, and with our government and media shoving the shots down our throats it didn’t matter. Oh yes and the mandates..
I am curious where the data came from for the approval decision. Obviously not from VAERS. Also there is no medical code for vaccine injury. So if people are coming into hospital claiming adverse reaction from the shots unless it is reported to VAERS I’m assuming there’s no reference point. So where’s the data coming from?
Why does the analysis from the initially withheld safety data procured from FDA via lawsuit show little efficacy? And this gentleman feels the shots were the miracle worker? Not talking about the booster.
Was the review team aware of the change in the manufacturing process of the Pfizer shot prior to mass rollout?
Not impressed with his stance about young adults getting the shots and his myocarditis viewpoint.
The CDC knew in March 2021 about breakthrough infections and lack of disease protection.
It’s shocking that a product than offers 30% protection is considered “acceptable”. Yes, they raised the bar to 50% but still. Yet the public was lied to outright. Old news.
No the mandates did not cause people to dig in their heels. Their decision had been made early on. I’m sick of that blame game. And no that’s not what caused Covid to spread. That is a leaky “vaccine” so please stop already.
Thank goodness Dr. Jay is now head of NIH!!
I actually listened to the whole show. In light of Peter Marks recent resignation or “being forced out” as the media says it, this podcast was enlightening to some degree.
Why is the data on vaccines at FDA proprietary IF the FDA is meant to protect and represent the American people. We don’t care about competition…we care about safety and efficacy. “Worth developing a vaccine” means FDA protects this information so competitors cannot emerge…how many better vaccines could get developed if this data was disclosed? ESPECIALLY in the case of a pandemic emergency! What the FDA is essentially doing is protecting the business interests of those pushing for mRNA approval (that is the promise the agency makes and inadvertently promotes these to enter the market). In all fairness there is really no way around this. This in some cases might be more egregious than recommending who should get it. In a pure scientific sense this will always be a conflict of interest that we might call “commercialized” science.
But from the start the shots were meant as protective not as neutralizing immunization. There was first an emphasis that it was protective for all and then the narrative shifted to protect against severe disease. But its original design was to protect against severe disease, NOT to truly immunize and protect against infection. Was the measurement confused that immunization against infection was the RCT, when in fact it was protection against severe disease. This was not clarified very well in the discussion. It is this detail that destroyed confidence in the system…because the mandate for all had to actually imply it was protective against infection, not severe disease and hospitalization. How efficacy was measured seemed mixed up by the people at the top?Many got shots and were infected…
What actually was the impetus for mandates? Above all it is this question that eroded public confidence in public health the most. Even the inserts that came with the shots said in print that the product should not have been coerced and should be taken from free will.
There was mention of lack of manufacturing data…this would be critical for completely new style of vaccine that requires the full intact mRNA to be stable and encapsulated in LNPs in vials that were stored frozen or cold chain?
Even to this day the biological mechanisms are unclear. New recent Akiko Iwasaki work comes to mind. How hard is it to have transparent info on manufacturing lots, full length in vitro transcription results, presence of remaining template plasmid DNA (how was it decided what level this should be?) and tracking the presence of full or partial spike protein after shots…in the peripheral blood as well as antibodies against it over time. Would love to hear more discussion on safety biology, not on efficacy. There is overemphasis on efficacy, not enough on safety (myocarditis was a minor part of the discussion).
An FDA review would only be as good as the data presented…which in some ways was a conflict of interest during that time: two companies being advocated, rushing data to review, how could the data have been top notch, when literally mRNA and it’s technology en masse had never been evaluated. Even “normal style” vaccines take considerable time and effort for full approval. Many vaccine creators openly were vocal about this and were censored. Including some who had attempted vaccination against sars1.
Why was only spike the main antigenic target…another mystery.
So based on Krause’s statement of having the data in front of them they DID make the best decision at the time, but the outcomes, goals, and pressure from the outside kept morphing. In all fairness it must have been difficult. But an FDA review needs more transparency: what about how data is produced? Absolute versus relative risk evaluation? Were the trial participants a good representation of the general population or just the vulnerable pop considering its true purpose was to prevent severe disease and hospitalization? Even 4y later so many things sound unclear. One thing was clear: the messaging was “commitment to science” but if this were true why was rigorous review overruled by the top down? This is the exact opposite of commitment to good science, debate, and safety.
The irony of the dialogue that FDA doesn’t recommend who should take shots and then the podcast ends with the former FDA regulator saying “FDA shouldn’t recommend” is then recommending a healthy 20yo college soccer player should take it based on risk benefit. Without any transparency about what this published risk/benefit is. I would wholeheartedly side with Rav on this one. I also think more rigorous study is needed on the claim that shots somehow lessened the myocarditis that would otherwise have happened without it…there is so much more nuance to this including those coerced to take the shot after being infected. Krause rightfully called this nonsense…so again the “blanket coverage” approach Rav mentions was just plain wrong.
One more nuance here is the risk benefit ratio is actually a marketing point for a product. If it was high and compelling (even without long term studies) it seems strange that ultimately it was mandated. There is always this question of who is protecting who with shots…but it always needs to be a decision of “I read the label and I decided yes or no to use this product to protect myself.”
Great discussion…while there was advocacy for more to be employed at FDA…perhaps there should just be more rigorous review to start…how many of these treatments coming in even deserve review to begin with? Generally though it seems like regulation would need to increase if increased confidence in public health and support for FDA will be restored?
..."The FDA's role is crucial for public health and safety."...there is no such thing as public safety. The only role of the FDA is to approve big pharma drugs no matter how deadly they are.
Witness mRNA poisons which no one in the FDA will ever admit that they are murder drugs. So much for stupid public safety. All I have control over is my safety...at least as far as making decisions about taking vaccines and drugs. I couldn't care less about anything the FDA, CDC or HHS says.
Crixcyon so true. It all boils down to your decision. The question was whether we were properly informed. In a clinical trial (including the ones that would have been conducted or EUA), consent is foremost for participation. Why then did consent evaporate if we hold it sacred in the “scientific process” but it no longer matters in the “real world?” In my biomedical ethics training the number one warning for clinical work is coercion without consent. If we are committed to a scientifically-ethically-centered world why would consent no longer matter.
I listened for the first 30-45 minutes. I heard nothing new except—the role of the CDC vs the role of the FDA were differentiated. Thanks.
But please understand that this sounds like finger pointing instead of real information.
To Americans this doesn’t address the loss of confidence in our public health “system/s”.
Where’s the meat?
I have not watched the whole interview, and I will not defend most of what the Biden admin did on COVID and vaccine policies.
Most definitely not the various mandates, all of which were indefensible.
But re: the headline here:
I am very glad they pressured the FDA to make the vaccine available sooner rather than later.
That was a GOOD thing, not a bad one.
So that it became available for the very old and those with multiple comorbidities sooner rather than later.
Which not only helped save their lives, but the AVAILABILITY of the vaccines enabled getting rid of so many government-imposed lockdown policies relatively sooner than relatively later.
Even if you are correct that “The Biden admin pressured the FDA to accelerate the review because they wanted to impose mandates for the military.” Their motivations for the speedup are not what I care about most; I care about the policy outcome.
I of course vociferously disagreed with all the mandates, the ones on the military.
Re: you claim that “That is not how science ought to function”, we are talking about public policy during a pandemic. So many of those things were not how society or government should function.
I have no doubt I’d agree with you on most other aspects here. And I’d surely agree known side effects should have been revealed.
But speeding up the availability of vaccines, however, was definitely net a good thing.
He makes it sound like just another day in the office...like this was a "normal" vaccine and not MRNA based gene therapy. Was his department even qualified to review this novel "treatment"?
Thank you for this. We all remain, however, behind the crushing CEPI-Gavi military ball of mRNA countermeasure platforms in the name of driving global innovation in biodefense and now (with actions across the political divides) with massive commitments to ‘AI’ backed vaccination programs in the name of pandemic preparedness.
Little has changed EXCEPT the US State Dept and NSC is now putting the world on an emergency footing without diplomatic or humane guidelines. AI uses the flood of pro-vaccine articles (devoid of science) to automate ignorance at all levels. The programs are neither safe or effective. We can now see that it was a distraction to pull out of the WHO while leaving the public- private-🇺🇸military/intel agencies in charge of an extrajudicial injection program. Bombing Yemen, destroying Gaza and Ukrainian targets are terrible yet only the deadly appetizer. Onerous tariffs on imports is going to starve US while Pandemic profiteers, unelected autocrats and technocrats of all kinds ally in global domination, destroying our middle class and anyone but oligarchs outside our borders.
Your findings are good to know! What do we do to put this in meaningful context. Trump Admin 1 and now 2 are going to hurt us and put us at war against one another, and others in ways many of us will not survive. RFK Jr hasn’t stopped the unelected globalists any more than MAGA Republicans or Democrats. Peace and health be with us.💝