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Aug. 4, 2022 - RFK Jr. The Defender
34:39
Leaked Moderna Files with Sasha Latypova

Sasha Latypova discusses leaked Moderna files showing FDA Colluded With Moderna.  According to Sasha Latypova, an ex-pharmaceutical industry executive, documents obtained from the U.S. Department of Health and Human Services on Moderna’s COVID-19 vaccine suggest the U.S. Food and Drug Administration and Moderna colluded to bypass regulatory and scientific standards used to ensure products are safe.

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Okay, everybody, I have an extraordinary guest today, and she's going to tell you something that's very, very important for people to understand.
Her name's Alexandra or Sasha Latapova, and I want you to...
I want to take care to recite her credentials because it's really important for you to understand the credibility of what she says.
And in order to really appreciate that, we need to understand where she comes from.
Sasha Latapova has spent 25 years in pharmaceutical research and development.
She is a pharmaceutical industry executive.
She has started a number of successful companies.
Mainly focused on creating and reviewing clinical trials.
She has worked with more than 60 companies worldwide, pharmaceutical companies, to submit data to the FDA, so she knows how clinical trials are supposed to function.
And She's written an article for The Defender, which I urge people to read, and we're going to kind of go through that article point by point.
Basically, the article is a charge.
That FDA and NIH know that there were terrible, terrible flaws in Moderna's trial by which it got licensed to sell the Moderna vaccine, the mRNA vaccine, and that the trial does not prove safety.
Far from it.
The studies that they actually use suggest that this is a very, very dangerous vaccine product.
But that they use very deceptive, deliberately deceptive techniques to conceal the flaws and the warning signals in those studies.
Sasha has meticulously analyzed 699 pages of studies and test results that were used supposedly by FDA to clear Moderna's mRNA platform, and she concluded that FDA is now lying to the public.
They accepted fraudulent test designs, substitutions of test articles, glaring omissions, whitewashing of serious signs of health damage by the product.
And they have lied.
The federal regulators have persistently lied to the public on behalf of the manufacturers.
So I want to go through the points and we're going to do it quickly.
And as I said, you're not going to get bored because this is really extraordinary stuff.
And by the way, I want to point out one thing.
Sasha is not only a brilliant pharmaceutical analyst, but she's also a pretty amazing painter, and I appreciate you.
What she told me before we started talking is that she's kind of stopped painting, which is her hobby and her avocation now.
Earning COVID to actually go and do a deep dive into these studies, and she is uniquely qualified to do this, and so her opinion is something that we should listen to, not just her opinion, but the rationale, which is really why we're here.
The first point you make is that Moderna's non-clinical summary contains Mainly irrelevant materials.
It's 699 pages, but I think 400 pages of the material were on a study on rats that was completely unrelated to this vaccine.
Why don't you just talk about that for a second?
Thank you, Mr.
Kennedy, for such a wonderful introduction and very kind.
The package that I reviewed is called non-clinical summaries.
It's everything in animals and cell lines that the manufacturer is supposed to complete and which usually takes many years to complete before the product can be given to human subjects in clinical trials, before it's considered de-risked enough for human clinical trials, which is a tightly controlled setting before it's considered de-risked enough for human clinical trials, which is a And this package was in response to a FOIA requesting specifically these materials and
Now, it comes from what's called Module 2 from NDA or New Drug Application and New Biologics Application.
And Module 2 is only narrative summaries by the manufacturer of their studies.
So we're still missing a large number of results, such as full reports that are supporting these narratives and also the manufacturing section, which is Module 3.
So what I had is these 700 pages of their own summaries of their own studies, and I read them.
And yes, about 400 pages of that was multiple copies with amendments of one study that was conducted in a different test article.
It's mRNA 1647, which is not the spike vax mRNA.
That one is 1273.
And this particular mRNA study that they submitted, as if it supported the spike facts, was for experimental product.
It's a construct of six different other mRNAs, and it was in development in 2017 for cetomegalovirus.
It has nothing to do with COVID illness or virus or anything like that.
And the product was never approved, so it was a failed product.
Yes.
Moderna based its approval on an irrelevant study of a completely different product, and that product itself never got approval.
Exactly.
What you write in here that's really interesting is that they keep repeating, they keep reprinting parts of these studies that they've already reprinted and showed you, and you make the conclusion that they seem to be trying to achieve a minimum word count.
It did seem that way because while the package, you know, appears huge, 700 pages, so 400 is this irrelevant study that they copied multiple times.
And then there are three versions of module 2.4 that was supposed to be this module.
So there are three different versions of it, slightly different, talking about, you know, similar stuff covering same studies.
But why do you have three versions?
And which one was the one that FDA used?
Because you understand, it's a matter of law.
All of this we're discussing is a matter of law.
In fact, it's in code of federal regulation of what is supposed to be in these studies, what is the table of contents, what modules.
And now we have three versions and then a bunch of relevant stuff.
Now, by modules, what do you mean?
Do you mean...
Is that they were studying different versions of the vaccine.
Very, very different versions.
One of them had, I think, five milligrams of the spike protein or the active ingredient was the spike protein.
And the other have 20 milligrams and they're in completely different formulas.
Yeah.
Is that what you mean when you talk about it?
And they don't really ever disclose which one they're talking about.
That's exactly right.
Well, so they studied different versions of the product in non-clinical and clinical, and they put it there in their package.
So this type of formulation was used for non-clinical, and then this type of formulation was used for clinical studies.
And so to me, that was already glaring.
Why are you, you know, because the product needs to be studied exactly the same through all these phases.
And if you change the product somewhere in the middle, well, you have to go back and redo and you have to do some bridging study because you have to prove that that's the same result you're going to get in safety and efficacy that you're claiming later on.
So they're studying multiple versions.
They're also including different versions of the summary.
So the summary document that the FDA is supposed to receive, review, and make a decision on, well, there are three versions of it, too.
And they're a bit different.
And to remind the audience, what they're studying here is not human beings.
This is before any of these products were ever given to humans.
These are the studies.
They're mainly animal studies.
And maybe there are some cultural studies, some PhD studies, I don't know.
A little bit of those as well, yeah.
But there's studies that you need to do in order to reach the threshold where, yeah, now you can start trying them on small numbers of human beings in the phase one trial.
You have to do this all at once, and usually this takes years and years and years to accumulate this data.
And what they did is instead of studying their product, they simply took studies of other mRNA vaccines and submitted that to FDA. It should have been laughed out of the room.
Absolutely, because those are experimental products, unapproved, previously failed, and you cannot use unapproved experimental products in support of another unapproved experimental product.
That's a complete no-no.
Yet FDA obviously did not object to any of this.
That was a huge red flag for me because I was shocked that the regulators did not question this, and that's an evidence of collusion to me with the manufacturer.
And now we come to the second part.
The second point is that the mRNA is the vehicle that carries...
The payload, which is the spike protein to the cells.
And the spike protein is the active ingredient.
And what they were studying was simply the vehicle.
They did not do the active ingredient, the thing that is likely to make you sick, that is reactive to human tissue, reactive to the immune system.
That was not the subject of any of those.
And then what you also say is that there have literally been no toxicity studies on the actual spike protein, which is extraordinary because that is what is likely to be hurting people.
Absolutely.
So this claim is key to all of the mRNA DNA products, both Pfizer, Moderna and other so-called vaccines.
They want you to believe that you can have a truck filled with food or you can have a truck filled with explosives.
They're saying it doesn't matter.
Focus on the truck.
It's the same truck.
It doesn't matter what's inside.
So, obviously, that's preposterous.
Also, we're talking about a completely new chemical entity.
In fact, I included in my article a review from European Medicines Agency reviewers who wrote a large summary describing how novel All of this is.
Both the vehicle and the content, which is the mRNA coding for spike protein.
And they said it's completely novel compound.
Nothing like this was ever approved before.
Therefore, this is a new molecular entity.
And as a new molecular entity, you're required to study that new molecular entity.
And if it's a two-part, like a payload and vehicle, well, both separately and together in the final assembly.
And they've never done that.
And this is almost like saying, if you study a polio vaccine, it comes in the same syringe as the flu vaccine or as, you know, an insulin shot or whatever.
And as long as you study the syringe, it doesn't matter what's inside it.
And normally...
The first thing that FDA needs to do when it approves any new product is to do toxicity studies.
Does it kill rats?
Does it cause cancer?
Does it have long-term impacts?
Is it tertogenic?
Is it mutagenic?
Does it hurt the fetus?
Does it cause any impacts when you give just the payload?
Do a group of rats and then have a control group that doesn't get it, what happens?
What is the all-cause mortality, injury, et cetera?
None of those studies were ever done.
So we have no idea about the toxicity of this product.
Absolutely.
They did one very short study, only one, of repeat dose toxicity, which wasn't completed at the time of this document that I have, of the time of the summary that they submitted for approval.
So they said, we're doing a repeat dose toxicity study in RADS, and it's a small sample size.
And then when you do, and both Pfizer and Moderna actually did it the same way, which to me says FDA told them to do it this way.
They take a small sample size of animals, they divide it into multiple doses.
So now you have four animals on one dose.
You can never make any conclusions out of this.
And then they don't complete it.
Even when they do complete it, they terminate it early.
So all of these studies were done before major safety signals cleared.
So they had huge increases in inflammatory markers, markers of what immunity decrease in red blood cells, which is horrific.
The weight loss, fur loss, lymph nodes enlarged.
And then Moderna says, then they use deceptive language because this is a summary.
I haven't seen the full report of results.
They're using deceptive language saying, well, there were no vaccine-related deaths in this study, which means that you had deaths.
You're just saying that they were not vaccine-related.
And then they're saying, oh, and the lymph nodes were recovering at the end of the study, which means that you have a major safety signal still ongoing and you terminate the study just not to find out what happens.
And is that the same study where the rat babies, the second generation, also had very, very serious bone damages, like ribbon-like ribs and nodules on their ribs, high, high percentages of them.
Yeah, so that's another finding I had about the reproductive toxicology.
By the way, all of these were also what's called non-good laboratory practice compliance studies, which are unacceptable for approval.
Let's just go back, because there were 29 studies offered, okay, and only 10 of those, all of them were non- None of them would be approved in any other legitimate study, because they all use flawed laboratory practices.
None of them qualify as good laboratory practices.
There were 29 unique studies, but only 10 were done with the correct mRNA.
And of those, nine of them were Pharmacology studies, the only one which looked at efficacy as the vaccine event disease, only one looked at toxicology.
And that one was not completed at the time the approval was given.
Yeah, exactly.
So the nine are related to efficacy, although theoretical efficacy.
They're measuring antibodies in the blood.
And then they also dismiss their own results by saying they're unvalidated assays, we didn't have positive controls, you know, all sorts of language like that.
And this is the irony, because...
They use those studies to get approval.
When the studies come back and said, oh, uh-oh, there were these horrendous problems, then they said, oh, those studies are not legitimate because they're not controlled.
They first used them to get approval, and then when the studies give these horrendous safety signals, they said, don't pay any attention to those studies, they're illegitimate.
Yeah, they're dismissing their own findings and saying it's unvalidated assays.
We don't have positive controls.
Oh, the virus is so novel that there are no animal models for it.
Then they're referring to SARS and MERS animal models.
I'm like, well, then you have those models, right?
And then they're also saying, well, Ralph Baric gave us a mouse-adapted SARS-CoV-2 virus.
I'm like, oh, wait a second.
So it's not that novel.
He has a mouse-adapted virus.
I mean, literally one sentence.
One paragraph, they say, there are no mouse-adopted SARS viruses that we can study in mice.
And then in the very next paragraph, they quote Ralph Baric, saying, we have mouse-adopted viruses.
I got plenty of them for anybody who wants them, essentially.
Well, for Moderna special, I don't know.
Yeah.
With his friends at Moderna.
He has one.
Yeah.
All right.
Let's talk about the conflicts of interest.
So what happened?
I mean, first of all, the rapidity with which they got this talk about that and how it doesn't say there's something just screwing.
Oh, absolutely.
So the timeline makes no sense whatsoever.
Well, first of all, the reason these called non-clinical versus usual name for these things is preclinical because they're done preclinically.
But in this case, they were done after clinical trials started in humans.
So these studies, they just collated them to check the box with the FDA. They have no impact on what happened in the clinical trial.
Which is a major safety violation.
But in any case, then I reviewed the timeline, which is also available on FDA website, by the way.
It's called Summary Regulatory Action Document, which they posted.
And the first section is regulatory timeline.
And in that regulatory timeline, we find out that they had a pre-IND meeting.
So Moderna had a pre-IND meeting with FDA. Explain what IND means.
Yeah, sorry, IND is Investigational New Drug Application, and as a manufacturer, as a sponsor of the product, you're supposed to formally open it with FDA when you initiate human clinical trials.
And there's a pre-IND meeting, and usually months after, after you've discussed your strategy with the regulators, you come back with your package for that IND meeting.
However, here we have Pre-IND meeting on February 19th, 2020, and IND formally opened next day.
Now, we also should remember that global pandemic was declared on March 11th, so a month later.
Somehow, these visionaries could predict the future with such certainty that they opened a clinical trial for the vaccine for which pandemic was announced a month later.
And first of all, they had to get the genomic sequence of the coronavirus-19 in order to formulate the vaccine.
So they had the vaccine formulated by when?
Obviously, by that date.
So the virus itself was sequenced, I believe, on January 9th.
And so January 9th virus was sequenced.
February 19th, they meet with FDA and open IND formally, which means they're starting human clinical trials.
A very interesting point, also visible in that table, is that the investigational new drug application, there are two of them.
Apparently, which I've never seen before, because typically you have one molecular entity, one new molecular entity, one product, one investigational new drug application.
It's a very important number.
It's a number for the dossier of all the documents that relate to this particular product, this chemical entity.
And then if you, as a manufacturer, you own that number, that gives you the right to market the product to get the revenues and profits for it.
So it's both commercial and legal ownership of the product.
Now we see that there are two of them.
One belongs to the NIH, to the Division of Microbiology and Infectious Diseases, reporting to Anthony Fauci.
So that's the one that was used on February 20th to open the IND, that number.
And then there is a second number that's owned by Moderna, and that was submitted later in April, at the end of April.
My question was then, what is the commercial relationship between Moderna and NIH? And why is it not disclosed?
And we would like to know because this is above and beyond a patent type of a deal.
So as a manufacturer, I myself have licensed IP from universities funded by federal grants.
And what happens is when you start selling the product, you pay them small royalties of which half goes to the inventors and half goes to the university.
In this case, we have obviously a commercial relationship by which NIH can not just have some sort of a licensing for IP royalty, but they actually can...
And it's undisclosed who gets those revenues because there's actually, I think, four or six of Anthony Fauci's deputies who also have royalty rights, margin rights for this product that are derived from this margin rights for this product that are derived from this IND number.
So there are people who are part of the approval process and development process of this vaccine who are paid for by the United States taxpayer, who work for an agency that owns half the royalty rights, apparently, for the vaccine, who are part of the apparently, for the vaccine, who are part of the group that is actively lying to the public about the safety of the vaccine.
And they stand to make, the agency stands to make billions.
And these individuals, perhaps millions, well, $150,000 a year.
They're legally for the rest of their lives.
And they're children.
So millions and millions of dollars that they stand to make, that individuals stand to make, who are part of the process of approving this vaccine and now lie, as you show, actively lying to the public about the safety of the vaccine.
They're lying, not only lying, they're also part of this whole machine that's forcing people to get the product.
So they're forcing the mandates, they're forcing these perverse financial incentives onto the public, onto universities, employers, military, and they're deriving revenues and profits from the product that they force and they lie about.
So this is just a perfect cartel arrangement in my mind.
This is, they're colluding, the regulators using their positions of power to force the product from which they financially benefit.
Now, one of the things that you pointed out in your report, one of the vaccines that they used, one of the studies that they used to get approval was the Zika vaccine.
They cited a study of the mRNA that was used in the Zika vaccine, but it was also financed by Tony Fauci.
Mm-hmm.
And you show that FDA, NIH, and Moderna knew ahead of time that this vaccine is likely to cause that impact.
Because in the studies they cited of other vaccines, those vaccines, those mRNA vaccines caused that impact.
That's correct.
So, by the way, people often say, well, it's such a novel virus and it was such a pandemic and disaster and a rush.
And so they couldn't have anticipated all these problems and technical issues.
That's not true because the FDA has been publishing guidances for mRNA gene therapies since 1998.
And there was extensive regulatory knowledge and scientific knowledge documented about these particular issues.
So there are guidances from the FDA published.
The most recent one related to these types of studies is 2015.
And that one specifically says that this is one of the major risks, vaccine-induced antibody enhancement.
In addition to that, there's risk of death, risk of uncontrolled expression of these proteins, and there's all kinds of risks cited by the guidance.
And it says that the Manufacturers must assess these risks and characterize and exclude them.
And so they knew about it well ahead of time.
And yes, Moderna in general has a history of well-funded failure.
They've never had a product on the market, but they got many, many dollars to do the research.
And so some of these studies, such as Zika vaccine, What happened is they would vaccinate the animals, they never got to human trials, but they would vaccinate the animals and then when exposed to a wild type virus, they would all die.
Eventually they reformulated that particular one, but the best they could get is 20% of them would die.
This is what we're seeing right now.
We see just gigantic numbers of COVID illness after vaccination in vaccinated people over and over and over again.
And some of these lead to hospitalizations and deaths.
All right, let's just talk about, I think this is the final big topic, is reproductive toxicity.
Because, you know, Moderna's vaccine has been approved for use in pregnant women.
It leaves the emergency use authorization.
And on what basis did they do that?
And what did the test really show?
That's a very important topic, and many people have talked about it.
By the way, I do want to add one thing.
The New York Times even acknowledged that Women who get this vaccine report major changes in their menstrual cycles.
Excess bleeding, etc., which is customarily, that is a fertility issue.
That's what we call a fertility issue.
But they said, oh, but there's no fertility issue.
Again, it's kind of this Orwellian doublespeak.
But talk about what the preclinical trial showed.
Yes, exactly.
So the study that they included in the rats was also non-GLP. So the assurance that there's no reproductive problems was based upon one study in rats?
Yeah, one study in rats and non-good laboratory practice compliant.
And it's important to point out that The fertility issue needs to be studied for both women and men.
There are two genders involved in the process.
And that's a requirement from any new compound, new drug that's given to people of reproductive potential.
However, neither Pfizer nor Moderna ever studied it for male fertility issues.
So what they did is they designed these non-GLP studies in rats that were pregnant.
Only females were vaccinated, not the males.
So we have no idea what it does to young men who want to have children in the future.
So that's one issue.
Now, what they did in a female study, they examined both fetuses and when they delivered the pups, and they found, well, first of all, during the pregnancy, mothers experienced toxicity, and Moderna, in their summary, Associated the toxicity with the highest expression of antigen, meaning that it is vaccine related.
So the pregnant rats were losing weight.
They were losing fur, which you can imagine rats eat all the time.
If they're losing weight, especially pregnant rats losing weight, it's a major, major issue.
Obviously, it's a huge toxicity.
And then they found skeletal malformations in the babies and also associated with the time of when the mothers were experiencing highest toxicity, which means it's also vaccine-related.
The skeletal malformations is a standard test in reproductive toxicology studies in animals, and that shows that during that time, the skeleton is not developing well.
The ribs are wavy, malformed.
There are different depositions They call them nodules.
There are extra ribs sometimes where they're not supposed to be.
And so that all means that there is developmental abnormality in the baby.
And so Moderna wrote it up and they said, well, we had statistically significant increase in the vaccinated arm of these types of skeletal malformations.
And what FDA did, and you can read it on their website, Again, summary regulatory action document.
They wrote it up and they said the reproductive toxicology study was done and there were no vaccine-related skeletal abnormalities.
So they went and directly lied on behalf of the manufacturer.
So you had a situation where the manufacturer is actually pointing to alarming birth defects in the fetuses, the pups, pregnant rats that are given this vaccine.
Alarming, horrendous stuff.
And that would kill any other product.
It's like thalidomide.
These are the kind of things that we saw from thalidomide.
And FDA sees that, clearly understands it cannot acknowledge that fact and still give the drug approval.
So it simply declares there were no birth defects.
And that's what it told the public.
It just lied to us.
They just lied to the public.
Not only they just lied, you know, you remember there was a whole campaign of coercion and forcing pregnant women to vaccinate.
All my honest colleagues in the pharmaceutical industry, we were appalled.
You never, ever, ever do this.
You never give experimental drugs to pregnant women.
Even with studies that are properly designed, we still are cautious and we want to wait and see what the outcomes data shows.
No, this was right out of the gate.
Even before the emergency use authorization, I saw on Twitter, CDC putting advertisements pushing this on pregnant women.
I have no words for this.
But yes, FDA went and directly lied.
And then they sat on this data for a year and we only got it under court order.
So I'm only telling it now because this was ordered by the court to be released and we know it.
Otherwise, we would have never known.
I want to show you a video of Tony Fauci talking in 1999 and then I want to get your take on this.
Many scientists are beginning to believe that a vaccine against AIDS may be impossible to make and too dangerous to test.
If you take it and then a year goes by and everybody's fine, then you say, okay, that's good.
Now let's give it to 500 people.
And then a year goes by and everything's fine.
I say, well, now let's give it to thousands of people.
And then you find out that it takes 12 years for all hell to break loose.
And then what have you done?
So he's got to give it this time.
Something he knows is clearly wrong.
Oh, it's an untested vaccine.
And here's what they did.
Even with the human clinical trials, they said, we're going to do this for five years.
We're going to have a trial, we're going to have a placebo group, and we're going to have a study group that gets the vaccine, 22,000 in each, and we're going to keep the placebo group from getting the vaccine for five years so we can look at all-cause mortality, so we can look at the health differences and outcomes.
As he admits there, there are many impacts that have long incubation periods, that have long diagnostic horizons that could take.
And he himself just said, you need 12 years before you actually can make a judgment about whether the risks of this product are worth the benefits.
And yet, what they did in this study, after promising five years, They cut it off after two months and they gave the vaccine, they vaccinated the placebo group.
So we will never be able to accurately judge the cause, the long-term cause of this vaccine.
Yes, absolutely.
That was horrific when I saw that.
And also what Tony Fauci was saying in 1999, that's the truth.
That's what everybody in the pharmaceutical industry knows.
That's what happens.
Even when you designed everything properly and tested and you spent years and years in preclinical and clinical and everything was by the book.
And you got the results.
You still don't know.
For many years afterwards, there are so many drugs that have been withdrawn from the market after years of marketing because those effects come out later on.
You couldn't prospectively exclude those risks because it just takes a humongous amount of studies.
And so, yes, you find out 12 years later that it causes birth defects or it causes cardiovascular problems or some other problems or cancer.
And now we're seeing all of these things explode in outcomes data.
And they're being ignored by the regulators too.
And they're desperate to eliminate the control group.
They're desperate to vaccinate every single person on the planet because they don't want you to know what's going to happen.
They don't want you to compare.
Sasha Latipova, thank you very much for your courage and for your insight and for taking the time to tell the public about what's really happening at Moderna and at FDA. Thank you.
Well, thank you very much for inviting me.
It's an honor.
It's a pleasure.
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