welcome back to the channel there's a new paper out now in the journal vaccine and it's about the covid-19 vaccine and some of the harms due to the vaccine it's the largest observational analysis of 99 million people and it's entitled covid-19 vaccines and Adverse Events of special interest a Multinational Global vaccine Data Network cohort study of 99 million individuals they like to put the 99 million in the title so they can try to get accepted in a good journal and they actually did this time and this paper shows very concerning safety signals across a number of domains including myocarditis paric carditis ITP gomar syndrome Bell's paly ADM pulmonary embolism fbal seizures and more I'm going to talk about those concerning safety signals seen in this paper but I want to talk more broadly about what the paper shows and why it is so unnerving because I think it suggests rather strongly that there were safety signals that have been ignored and underexplored and that in many populations particularly young people particularly people who had already had and recovered of covid-19 and for many additional doses Beyond dose 2 plus 3+ 4 plus 5 plus it is quite likely in some cases you can easily show for instance young men between the ages of 16 and 24 but in other cases it's probably quite likely that the harms outweigh the benefits for vaccination in that age group and that means that the mandates in those age groups are deeply morally problematic they're scientifically problematic and they bankrupt trust in public health one more bit of background before I get into this page paper is that just in the last 2 weeks Astra zenica has announced that they're going to Cease the production of their covid-19 vaccine the adenoviral vector vaccine both the Johnson and Johnson and astrazenica vaccine are adenoviral vaccines with a very large DNA payad and one of the problems that these vaccines had was vaccine induced thrombocytopenia and thrombosis or vit which is a lot like Hein induced thomy and thrombosis or hit this isn't just your typical blood cloth this was Runaway activation that cannot be easily turned off leading to catastrophic thrombotic events in places you don't want them to happen including the cerebral Venus Sinus I remember when I heard about vid I think it was in 2021 and I realized that this complication was first reported in women between the ages of 18 and 64 and it was occurring at a rate in the initial reports of 1 in 200,000 I think some subsequent reports have brought it as frequent as 1 in 140,000 and I tweeted very early on you can go check the rec that that was game over for this vaccine that safety signal was so catastrophic basically in some cases leading to the death of the person or brain herniation or neurological Devastation that's so horrific and you're debuting it in a population like an 18-year-old woman that has a very lowrisk of bad covid-19 outcomes that even a modest harm like that is going to be a huge setback for your vaccine particularly when there was another vaccine product that didn't have that complication which is the MRA vaccines so I I called it game over back then it took them a few years but finally Johnson and Johnson has thrown in the towel not only on that vaccine but on the entire process of drug development around the adov vector vaccines and more broadly and Astro zenica is thrown in the towel so that is an admission that perhaps governments were too zealous and didn't Target this intervention in the appropriate cohorts of elderly people who had not previously had covid-19 let's talk about the new paper and vaccine this is done by a large multinational group and this concerning safety signals so maybe let me run through you some of those signals there's at least three tables I need to make a note of this minute three three tables I got to put the slide in later in the postproduction three tables that you need to look at okay one table looks at the odds ratio so so basically what are they doing in this they got 99 million people and they've got the records of their vaccination and they're pretty good about when they were vaccinated they also have electronic health records for what happened to them afterwards and you know whether or not the electronic health record documents one of several I think they looked at about 30 or 40 different Adverse Events of Interest things that they thought might be implicated with the vaccine and they looked at those 30 or 40 events and what they're doing is they're comparing the rate of those events prior to vaccination to the rate immediately after vaccination looking at if there's an increase in these Adverse Events after vaccination in the electronic health record what they find is that for some things there is for the cadx vaccine which is an adro Vector vaccine they find uh guon baret syndrome is increased that's noted in red anything in yellow and red on the screen is going to be something that is statistically significant increase in an Adverse Events uh transverse myelitis which is basically a paralytic syndrome is also increased Bell's paly has increased for a number of these including the fiser and the Mna vaccine uh acute disseminated encom mylitis ADM which is a catastrophic side effect is increased for these vaccines um fbal seizures are increased uh in different uh for different products you can look at the table and you can see where it's yellow statistically significant increase and where it's red statistically significant increase and the odds ratio is quite notable I forget the cut off here something like two or three they also look at hematologic conditions and what they find is yes it's linked to thrombocytopenia low platelets idiopathic thrombocytopenia ITP um I think this confirms an observation many people had anecdotally made that our patients with ITP or our patients developed ITP at slightly higher rates after vaccination than they would otherwise have this is sort of confirming that that observation that's been made by many doctors pulmonary embolism appears to be increased Cal Venus sinus thrombosis which is the vit the vaccine induced thrombocytopenia thrombosis syndrome and splenic vein thrombosis also appears increased and then finally across the board the MRNA vaccines are causing heart damage seen in the form of myocarditis you actually see concerning safety signals even for the adenoviral vector vaccines but for things like fizer and Mna they're off the charts bad and this confirms what we had already known all right what are my thoughts on this paper this paper's an underestimate of the problem okay there a number of ways it's a deep underestimate and let me give you a couple examples one is they know very well who got vaccinated but they may be missing people who suffered these complications for a number of reasons for instance a lot of people might have had thrombocytopenia at low platelets but they had no petii no bruising no bleeding they had no symptoms that would prompt them to seek care for those low platelets so they just had low platelets they were lucky they didn't you know get in a car accident or something like that they didn't suffer a a problem from that but they probably had it that's not going to be the electronic Healthcare record cuz they never sought care another way it may not be in the electronic healthc care record is that a young person may come in with abdominal pain and it might be a blood clot in the abdominal uh vessels but for the doctor to think about that and to run a CT with contrast or CT angiogram to catch that the doctor has to have that thought in the back of in mind the doctor's preest probability the doctor's thinking is that this young person with abdominal pain that tends not to be a blood clot in one of these arteries and so they may not be willing to run those scans they may be missing a lot of these events and the last reason it's underestimate is the electronic health record is a piece of I mean I think anyone who's actually done EHR research will acknowledge that this is really an incomplete an incomplete set of what actually exists in the chart would actually happen to people for these reasons I suspect that this is an under estimate of the extent of the problem and that if we were to have complete case ascertainment we would have a higher estimate for a number of these a number of these things now it's also possible that some of these things will are are actually not linked and they would not survive more robust analyses I think that's possible too my intuition my suspicion and the based on my analysis of how biases exist in the data set is that there's probably going to be a bigger problem the other direction where some things are found to be at higher rates than what is depicted in this paper the next thing that's a problem in this paper that I think they're really kind of cheating on is that we know that these Adverse Events don't affect all populations equally if you look at all the people who got the MRNA vaccines and you look at all the people who had myocarditis you'll find the rates are actually quite low myocarditis is not that common well that's because 80y olds and 60y olds don't get myocarditis after the MRNA vaccines it happens to young men typically between the ages of 16 and 24 it happens also at high rate from 12 to 40 but slightly less the core demographic group of men at the end of adolescence and in early adulthood this has also been seen before when it comes to myartis after you know respiratory infections Etc if your denominator is everybody you're not going to see the safety signal in the group of people you want to see it even though they're using an everybody denominator they're still finding odds ratios of 3.48 and 2.78 concerning safety signals imagine if they just focused on young men you might find not only is the problem tfold higher it might be hundredfold higher and I think we know very clearly from the the Israeli study that myocarditis in the first two doses from the fizer product is something about 1 in 3,000 1 in 3500 and we know from Katy Sharp's paper from the Kaiser Permanente experience that from dose 3 is one in 10,000 if you have a one in 10,000 risk of myocarditis from dose three of this vaccine then a young man was harmed by getting dose three end of story they' had already had two doses they may have already had covid-19 their risk of bad Co outcomes after having had two doses was floored and the risk of myocarditis is probably in order of itude greater than the risk of a bad Co outcome after the first two doses so by giving them each additional dose you're subjecting them to net harm which was in fact sanctioned by public health and implemented and forced in the form of mandates so what I think is this is a deeply problematic look at the safety literature because it doesn't take much harm to realize that the public health apparatus actually coerced and forced people under penalty of being fired or thrown out of school to receive dose after dose even if that dose was at net harm to them I think the same thing is true for ITP I'd love to see that broken up by age I'd love to see um you know Ser venosus thrombosis obviously broken up by age because if an 18-year-old is getting cereal Venus sinus thrombosis even at a rate of 1 in 200,000 that's enough to tank any potential benefit of the vaccine in that age group because their risk of hospitalization or death was already very very low particularly if they're a healthy 18-year-old you know so these papers in my mind are always dishonest because they don't break apart the risk benefit calculus in each age group one more Point sometimes people say that no matter what Adverse Events you find from vaccination the covid-19 is always worse that's a pretty stupid thing to say and here's why it's a stupid thing to say if you look at the papers that make that claim here's what they look at they look at among people who went to the doctor and had a covid-19 positive test how many of them had myocarditis how many of them had severe disease how many of them got sick so the rate of myartis is among those people we've documented covid-19 in X number of people had myocarditis and you compare that among the people who got the shot X number of people had myocarditis but the problem is the denominator for the shot is the real denominator you know who got it but the denominator of people who came to you and tested positive for covid-19 is not the real denominator the real denominators all the people who had covid-19 the vast majority of which one didn't even know they had it two they felt a little tickle in their throat they didn't even test themselves three they felt sick at home with a cold and they did nothing about it four they tested themselves at home but they didn't tell you the test result and then five got so sick so concerned that they sought medical care and that's the denominator you're focusing on you're looking at Adverse Events in a subgroup of people probably the sickest and probably those at most at risk of these Adverse Events and then you're comparing that against vaccination absolutely brain dead epidemiology you need to do a Sero prevalence study to actually survey the population see how many people actually had Co and use that as your real denominator if you actually cared about doing honest science which I have not yet seen we're doing an empirical analysis on this that's a spoiler don't steal my idea anyone listening to this we're going to publish a paper on this I've not seen anyone do it right yet I'm going to look at every single paper and I'll tell you how many did it right but I don't think many of them are going to do it right they're not doing it right the next problem with that argument is that the vaccine doesn't stop you from getting covid-19 anyway so if there is a harm of myocarditis from getting covid-19 you don't avoid getting covid-19 even if you get nine doses you're still going to get co9 it might be less of a harm of getting covid-19 if you've had two doses than no doses at all so we could Quant ify that but it's certainly not vaccine or infection it's as many vaccines as you want and then infection okay so infection always comes always comes those are two of the big reasons why I think that there's some dishonesty in this literature and then the other reason when we talk about young populations we talk about six-month-old babies 2-year-olds 5-year olds 11 year olds we have to acknowledge there's no evidence of efficacy that's worth its salt we've got very flawed case control studies where the controls are fundamentally sampled from a different population than the cases and That's a classic problem in case control literature we also have observational studies that are plagued with numerous biases that on my substack I'm going to cover more in in the next few weeks because I think it's really good to teach epidemiology with I read a really great article by Peter Doshi he talks about some of those biases I'm going to talk about that more in my substack that's what you should go subscribe to because that's where I talked about this initially so putting it all together we see concerning safety signals for ITP and thrombocytopenia meaning that this vaccine can lower your platelet so that establish that I think as a biological fact I think that goes hand inand with a lot of evidence we see febal seizures that's a problem myartis pericarditis racing heart super ventricular teoc cardia Bell's paly PE ADM and more does it mean that every age group derive net harm I think that's that's not the case I I don't believe that's the case I think there's a lot of reasons why that's probably not the case elderly 2021 or in the Delta wave of 2020 were so bad that they probably still derived net benefit for instance a nursing home resident but does it mean that a young man derived net harm absolutely I think that's been shown over and over we first showed that in an article that I wrote in Med page we urge the CDC to do something about it we later published that a paper by Kevin bardos where we show that for boosters Public Health has to be careful it's not good enough to sometimes do good and then sometimes harm people using the Brute Force Power of mandates you have to never harm people using the Brute Force Power of mandates you can never make that error that's an unforgivable error and it's unforgivable to use the Brute Force Power of mandates when you don't and you haven't proven benefit to third parties that's Contra that's contrary to I think traditional medical ethics and that's contrary to basic principles of of Medical Science and so I think that that's a big problem putting this all together I think this is concerning safety signals this is a big population study if anything I think for many of them there's an underestimate for the reasons I've described I think comparing it V virus vers vaccine is a flawed comparison because they're doing a dishonest job they're not doing Sero prevalence denominator for the virus it is almost certainly it is 100% the case that young men were harmed in that age group from dose two and Beyond easily that's easy to show uh it's very likely the case that many other demographics particularly young healthy people were harmed and suffered net harm from aggressive vaccination campaigns the lesson of the story is they could have done a much better job if you want to know how you should listen to my forthcoming interview on econ talk with Russ Roberts uh where I get into the sorts of randomized control trials that they ought to have done instead that would have risk stratified by age and had more appropriate and harder end points and longer followup in younger age groups those are some strategies I'll describe there they could have done a better job Public Health getting this wrong is a catastrophic error I think that people in public health are unwilling to admit they did it they did wrong they're unwilling to admit that they used propaganda and other bruteforce tactics including pressuring places like YouTube and Twitter and Facebook to remove content they're unwilling to admit they did all this and they got it wrong and until they admit a full admission of the errors that they have made I think that the loss of trust is just going to continue to grow we already see signs of it I mean we absolutely plummeting um trust ratings and experts and we actually see plummeting routine childhood immunization rates as a CDC uh gets even more bold and Reckless adding and I told him not to you can read my article in the Free Press run by Barry Weiss I told told them not to add the covid-19 vaccine to routine childhood immunization that's going to result in all of the childhood vaccines being uh pushed aside and that's in fact what we're seeing right now so those are my thoughts it's a very interesting paper in vaccine I think it underestimates the the problem here one more point the author of this paper turned to Twitter to say that my substack post had one inaccuracy and this person or a couple inaccuracies she thinks one of the inaccuracies she said was that it has been well shown that covid-19 vaccines have an improvement in outcomes for children that's been well shown and then she cites a metanalysis of a pile of garbage which is a bunch of case control studies and observational studies and zero randomized control trials that are powered for severe end points that to me is a problem when the authors of the safety signal Studies have their own bias that they're unwilling to concede that the evidence is quite poor for AE low age groups and that there is very little risk in low age groups if they're unwilling to concede that I worry that they're easily able to lump age group groups and do other things to distort safety signals and minimize these clear and concerning problems and then the last thing I'd say is there's a strong political pressure in the scientific Community not to investigate these safety signals I think many people think it's career suicide or taboo and that is also stifling to science and so I think if anything the problem is worse than what's Stone in this paper which appears in the journal vaccine a good journal and is an interesting paper well done in many respects despite the limitations all right if you like this video you know what to do I like to talk about all sorts of evidence-based medicine across all domains from Cardiology I did a couple of randomized Trials there including um for the impella oncology which is of course my favorite thing to look into the evidence of of course the the most randomized control trials the most interesting design features and observational studies which mostly are garbage and occasionally can be useful but mostly are garbage and hyped here there are some kernels of usefulness here despite the the biases here so if you like this video you know what to do if you like this kind of analysis you know what to do subscribe to this Channel follow me at V prasad's observations and thoughts which is drveni pad.com uh on substack I also am a writer for sensible medicine I have my podcast called plenary session and we're back the vpz show we're putting those episodes out and I hope to put out some more and um that's it for now until next time
