Alexandra Latapova has spent 25 years in pharmaceutical research and development. She is a pharmaceutical industry executive who has started a number of successful companies. She has worked with more than 60 companies worldwide, and submitted data to the FDA, so she knows how clinical trials are supposed to function. In order to appreciate that, we need to understand where she comes from. Sasha has meticulously analyzed 699 pages of studies and test results that were used supposedly by FDA to clear Moderna's mRNA vaccine, 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 the public on behalf of the manufacturers, and have failed to act on the warning signals in those studies. In this episode, we discuss her findings, and her rationale for why the vaccine should never have been approved at all, and why it should have been given the go-ahead to go into commercialization in the first place. This is a must-listen episode for anyone who wants to understand why the MMR vaccine failed to get the nod from the FDA and why the product should be allowed to go forward with clinical trials. If you're interested in learning more about the MMR product, then this is the episode you need to be sure to check out the article she wrote for The Defender, The Daily Mail, The New York Times, and The Huffington Post, The Guardian, The Washington Post, and many other publications on the topic of MMR. . Thank you for listening to this episode. We really appreciate your support. - we really appreciate you! and we really really appreciate the support you're showing us your support and your support, and we're looking forward to hearing back from you in the next episode. Thank you so much for all of your questions and support us in the coming episodes. We can't wait for you to send us your questions, comments, and comments. We'll see you next week! - Thank you, Alex, next week. xoxo, Sarah, - Emily, Rachel, Jeff, and Kait, Caitie, and Katie, - Tom, Rachel Sarah, and the rest of the team at The New Yorker in the new book, "The Spike Vaccine Project" by Rachel Goodman, The Other Way"
00:00:00.000Okay, everybody, I have an extraordinary guest today, and she's going to tell you something that's very, very important for people to understand.
00:00:07.000Her name's Alexandra or Sasha Latapova, and I want you to...
00:00:12.000I want to take care to recite her credentials because it's really important for you to understand the credibility of what she says.
00:00:24.000And in order to really appreciate that, we need to understand where she comes from.
00:00:30.000Sasha Latapova has spent 25 years in pharmaceutical research and development.
00:00:35.000She is a pharmaceutical industry executive.
00:00:38.000She has started a number of successful companies.
00:00:42.000Mainly focused on creating and reviewing clinical trials.
00:00:48.000She 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.
00:01:00.000And 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.
00:01:16.000That 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.
00:01:35.000The studies that they actually use suggest that this is a very, very dangerous vaccine product.
00:01:41.000But that they use very deceptive, deliberately deceptive techniques to conceal the flaws and the warning signals in those studies.
00:01:56.000Sasha 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.
00:02:15.000They accepted fraudulent test designs, substitutions of test articles, glaring omissions, whitewashing of serious signs of health damage by the product.
00:02:28.000The federal regulators have persistently lied to the public on behalf of the manufacturers.
00:02:34.000So I want to go through the points and we're going to do it quickly.
00:02:38.000And as I said, you're not going to get bored because this is really extraordinary stuff.
00:02:44.000And by the way, I want to point out one thing.
00:02:46.000Sasha is not only a brilliant pharmaceutical analyst, but she's also a pretty amazing painter, and I appreciate you.
00:02:57.000What she told me before we started talking is that she's kind of stopped painting, which is her hobby and her avocation now.
00:03:05.000Earning 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.
00:03:23.000The first point you make is that Moderna's non-clinical summary contains Mainly irrelevant materials.
00:03:32.000It's 699 pages, but I think 400 pages of the material were on a study on rats that was completely unrelated to this vaccine.
00:03:44.000Why don't you just talk about that for a second?
00:03:48.000Kennedy, for such a wonderful introduction and very kind.
00:03:52.000The package that I reviewed is called non-clinical summaries.
00:03:56.000It'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
00:04:21.000Now, it comes from what's called Module 2 from NDA or New Drug Application and New Biologics Application.
00:04:28.000And Module 2 is only narrative summaries by the manufacturer of their studies.
00:04:33.000So 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.
00:04:44.000So what I had is these 700 pages of their own summaries of their own studies, and I read them.
00:04:51.000And yes, about 400 pages of that was multiple copies with amendments of one study that was conducted in a different test article.
00:05:00.000It's mRNA 1647, which is not the spike vax mRNA.
00:05:51.000What 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.
00:06:08.000It 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.
00:06:19.000And then there are three versions of module 2.4 that was supposed to be this module.
00:06:24.000So there are three different versions of it, slightly different, talking about, you know, similar stuff covering same studies.
00:07:25.000Well, so they studied different versions of the product in non-clinical and clinical, and they put it there in their package.
00:07:33.000So this type of formulation was used for non-clinical, and then this type of formulation was used for clinical studies.
00:07:40.000And so to me, that was already glaring.
00:07:43.000Why are you, you know, because the product needs to be studied exactly the same through all these phases.
00:07:49.000And 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.
00:08:40.000But 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.
00:08:52.000You have to do this all at once, and usually this takes years and years and years to accumulate this data.
00:09:01.000And 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.
00:09:15.000Absolutely, because those are experimental products, unapproved, previously failed, and you cannot use unapproved experimental products in support of another unapproved experimental product.
00:09:27.000Yet FDA obviously did not object to any of this.
00:09:31.000That 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.
00:09:42.000The second point is that the mRNA is the vehicle that carries...
00:09:51.000The payload, which is the spike protein to the cells.
00:09:56.000And the spike protein is the active ingredient.
00:09:59.000And what they were studying was simply the vehicle.
00:10:03.000They 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.
00:10:13.000That was not the subject of any of those.
00:10:17.000And 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.
00:11:03.000Also, we're talking about a completely new chemical entity.
00:11:06.000In 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.
00:11:17.000Both the vehicle and the content, which is the mRNA coding for spike protein.
00:11:22.000And they said it's completely novel compound.
00:11:24.000Nothing like this was ever approved before.
00:11:25.000Therefore, this is a new molecular entity.
00:11:28.000And as a new molecular entity, you're required to study that new molecular entity.
00:11:32.000And if it's a two-part, like a payload and vehicle, well, both separately and together in the final assembly.
00:11:41.000And 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.
00:11:53.000And as long as you study the syringe, it doesn't matter what's inside it.
00:12:43.000They 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.
00:12:55.000So they said, we're doing a repeat dose toxicity study in RADS, and it's a small sample size.
00:13:00.000And 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.
00:13:06.000They take a small sample size of animals, they divide it into multiple doses.
00:13:11.000So now you have four animals on one dose.
00:13:13.000You can never make any conclusions out of this.
00:13:38.000And then Moderna says, then they use deceptive language because this is a summary.
00:13:42.000I haven't seen the full report of results.
00:13:44.000They're using deceptive language saying, well, there were no vaccine-related deaths in this study, which means that you had deaths.
00:13:52.000You're just saying that they were not vaccine-related.
00:13:55.000And 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.
00:14:06.000And 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.
00:14:25.000Yeah, so that's another finding I had about the reproductive toxicology.
00:14:29.000By the way, all of these were also what's called non-good laboratory practice compliance studies, which are unacceptable for approval.
00:14:37.000Let'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.
00:15:00.000None of them qualify as good laboratory practices.
00:15:03.000There were 29 unique studies, but only 10 were done with the correct mRNA.
00:15:10.000And 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.
00:15:25.000And that one was not completed at the time the approval was given.
00:15:33.000So the nine are related to efficacy, although theoretical efficacy.
00:15:36.000They're measuring antibodies in the blood.
00:15:39.000And 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.
00:15:52.000They use those studies to get approval.
00:15:56.000When 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.
00:16:07.000They 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.
00:16:19.000Yeah, they're dismissing their own findings and saying it's unvalidated assays.
00:17:38.000So the timeline makes no sense whatsoever.
00:17:40.000Well, first of all, the reason these called non-clinical versus usual name for these things is preclinical because they're done preclinically.
00:17:49.000But in this case, they were done after clinical trials started in humans.
00:17:55.000So these studies, they just collated them to check the box with the FDA. They have no impact on what happened in the clinical trial.
00:18:06.000But in any case, then I reviewed the timeline, which is also available on FDA website, by the way.
00:18:13.000It's called Summary Regulatory Action Document, which they posted.
00:18:17.000And the first section is regulatory timeline.
00:18:19.000And in that regulatory timeline, we find out that they had a pre-IND meeting.
00:18:25.000So Moderna had a pre-IND meeting with FDA. Explain what IND means.
00:18:30.000Yeah, 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.
00:18:43.000And 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.
00:18:54.000However, here we have Pre-IND meeting on February 19th, 2020, and IND formally opened next day.
00:19:02.000Now, we also should remember that global pandemic was declared on March 11th, so a month later.
00:19:09.000Somehow, 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.
00:19:21.000And first of all, they had to get the genomic sequence of the coronavirus-19 in order to formulate the vaccine.
00:19:31.000So they had the vaccine formulated by when?
00:19:38.000So the virus itself was sequenced, I believe, on January 9th.
00:19:42.000And so January 9th virus was sequenced.
00:19:45.000February 19th, they meet with FDA and open IND formally, which means they're starting human clinical trials.
00:19:52.000A very interesting point, also visible in that table, is that the investigational new drug application, there are two of them.
00:20:00.000Apparently, which I've never seen before, because typically you have one molecular entity, one new molecular entity, one product, one investigational new drug application.
00:20:13.000It's a number for the dossier of all the documents that relate to this particular product, this chemical entity.
00:20:19.000And 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.
00:20:28.000So it's both commercial and legal ownership of the product.
00:20:32.000Now we see that there are two of them.
00:20:34.000One belongs to the NIH, to the Division of Microbiology and Infectious Diseases, reporting to Anthony Fauci.
00:20:42.000So that's the one that was used on February 20th to open the IND, that number.
00:20:48.000And then there is a second number that's owned by Moderna, and that was submitted later in April, at the end of April.
00:20:55.000My question was then, what is the commercial relationship between Moderna and NIH? And why is it not disclosed?
00:21:06.000And we would like to know because this is above and beyond a patent type of a deal.
00:21:12.000So as a manufacturer, I myself have licensed IP from universities funded by federal grants.
00:21:18.000And 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.
00:21:25.000In 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...
00:21:41.000And 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.
00:22:00.000So 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.
00:22:27.000And they stand to make, the agency stands to make billions.
00:22:31.000And these individuals, perhaps millions, well, $150,000 a year.
00:22:38.000They're legally for the rest of their lives.
00:22:42.000So 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.
00:23:00.000They're lying, not only lying, they're also part of this whole machine that's forcing people to get the product.
00:23:06.000So 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.
00:23:22.000So this is just a perfect cartel arrangement in my mind.
00:23:27.000This is, they're colluding, the regulators using their positions of power to force the product from which they financially benefit.
00:23:35.000Now, 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.
00:23:46.000They cited a study of the mRNA that was used in the Zika vaccine, but it was also financed by Tony Fauci.
00:24:18.000So, by the way, people often say, well, it's such a novel virus and it was such a pandemic and disaster and a rush.
00:24:24.000And so they couldn't have anticipated all these problems and technical issues.
00:24:28.000That's not true because the FDA has been publishing guidances for mRNA gene therapies since 1998.
00:24:37.000And there was extensive regulatory knowledge and scientific knowledge documented about these particular issues.
00:24:42.000So there are guidances from the FDA published.
00:24:46.000The most recent one related to these types of studies is 2015.
00:24:50.000And that one specifically says that this is one of the major risks, vaccine-induced antibody enhancement.
00:24:58.000In 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.
00:25:05.000And it says that the Manufacturers must assess these risks and characterize and exclude them.
00:25:11.000And so they knew about it well ahead of time.
00:25:14.000And yes, Moderna in general has a history of well-funded failure.
00:25:19.000They've never had a product on the market, but they got many, many dollars to do the research.
00:25:25.000And 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.
00:25:40.000Eventually they reformulated that particular one, but the best they could get is 20% of them would die.
00:27:07.000So 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?
00:27:22.000Yeah, one study in rats and non-good laboratory practice compliant.
00:27:28.000And it's important to point out that The fertility issue needs to be studied for both women and men.
00:27:34.000There are two genders involved in the process.
00:27:37.000And that's a requirement from any new compound, new drug that's given to people of reproductive potential.
00:27:43.000However, neither Pfizer nor Moderna ever studied it for male fertility issues.
00:27:49.000So what they did is they designed these non-GLP studies in rats that were pregnant.
00:27:55.000Only females were vaccinated, not the males.
00:27:58.000So we have no idea what it does to young men who want to have children in the future.
00:28:06.000Now, 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.
00:28:26.000So the pregnant rats were losing weight.
00:28:29.000They were losing fur, which you can imagine rats eat all the time.
00:28:33.000If they're losing weight, especially pregnant rats losing weight, it's a major, major issue.
00:28:40.000And 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.
00:28:52.000The 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.
00:29:04.000There are different depositions They call them nodules.
00:29:08.000There are extra ribs sometimes where they're not supposed to be.
00:29:11.000And so that all means that there is developmental abnormality in the baby.
00:29:17.000And so Moderna wrote it up and they said, well, we had statistically significant increase in the vaccinated arm of these types of skeletal malformations.
00:29:26.000And what FDA did, and you can read it on their website, Again, summary regulatory action document.
00:29:32.000They wrote it up and they said the reproductive toxicology study was done and there were no vaccine-related skeletal abnormalities.
00:29:39.000So they went and directly lied on behalf of the manufacturer.
00:29:44.000So 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.
00:32:14.000Even with the human clinical trials, they said, we're going to do this for five years.
00:32:18.000We'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.
00:32:39.000As he admits there, there are many impacts that have long incubation periods, that have long diagnostic horizons that could take.
00:32:47.000And 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.
00:32:57.000And 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.
00:33:09.000So we will never be able to accurately judge the cause, the long-term cause of this vaccine.
00:33:29.000Even when you designed everything properly and tested and you spent years and years in preclinical and clinical and everything was by the book.
00:33:40.000For 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.
00:33:51.000You couldn't prospectively exclude those risks because it just takes a humongous amount of studies.
00:33:57.000And so, yes, you find out 12 years later that it causes birth defects or it causes cardiovascular problems or some other problems or cancer.
00:34:05.000And now we're seeing all of these things explode in outcomes data.
00:34:09.000And they're being ignored by the regulators too.
00:34:12.000And they're desperate to eliminate the control group.
00:34:15.000They're desperate to vaccinate every single person on the planet because they don't want you to know what's going to happen.
00:34:23.000Sasha 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.
00:34:36.000Well, thank you very much for inviting me.