FDAがワクチンの重大なリスクを認める
well a warm welcome to this talk now the FDA in the United States has just approved a new vaccine an mRNA madna vaccine with known serious adverse events and known multiple other adverse events this is disappointing to put it mildly i think we have to assume that the American bureaucracy and the uh the FDA is more of an oil tanker which is going to take a while to turn around rather than a sailing yacht which can tack quickly let me immediately give you the evidence for this claim here we are here this is the letter granting biological license application approval uh and really quite a concerning event now this is the uh this is the vaccine here M M N spike now um you probably worked out from this this is a an mRNA vaccine that produces spike protein i know I know the lipid nanop particles will go everywhere i I know serious adverse events of this vaccine from the manufacturer’s own information serious adverse events were reported by 2.7% of participants uh who received this new vaccine the comparator vaccine it was 2.6% so the new vaccine 2.7% serious adverse events the older vaccine that it’s replacing 2.6% and of course the presumably this is a vaccine to combat JN1 variant now let’s just so basically the FDA has just approved um a preparation here with uh 2.7% incidence of serious adverse events i would not dream in clinical practice of giving a treatment that had a 2.7% risk of serious adverse events unless there was a really big risk there was a really big risk benefit analysis so if the patient’s about to die of something of course it’s an acceptable risk but for any benefit you would get from this 2.7% I just find this beusing that this could possibly be uh be authorized um we we already know um we already know from um other studies the high incidence of adverse events so this for example is um all adverse events reported to VAS we see the massive increase when the um mRNA vaccines were rolled out this is the uh domestic data with uh deaths after the roll out of the vaccine again massive increase in the ve reporting and uh this is related to influenza vaccine 118 times more adverse events were reported compared to influenza vaccine so how this can be approved is rather a mystery to me I must say um but it is now fortunately uh we’ve got this information here this is the um this is what you call the packet insert it’s what the nurses and doctors can see when they give this so we’re able to get quite a bit of relevant information here um this is in the public domain i’ve put the link to it off course and it tells us quite a lot of interesting facts which I’m about to sort of try and summarize a little bit because it’s a bit complicated um let’s start off with that now well that’s where we got this information from here to begin with and that’s a medium follow-up of 8.8 months now of course 8.8 months medium follow-up is not enough to tell us about uh other adverse events uh such as potential malignancies for for example so it’s a pretty short follow-up in in terms of that participants received either this uh mRNA 1283 which is the new one or this mRNA 1273 which is the which is the old the old Madna vaccine now the key thing here is obviously you can see that what they’re doing here is comparing their new vaccine with their old vaccine not a placebo not a placebo so they’re compare they’re comparing one one of their vaccines with another one of their vaccines and saying isn’t this good you we’re getting we’re getting uh we’re getting benefit from it this is the clinical trial here um again you can read that for yourself it’s all there that is the clinical trial this is the Madna report which is just the industry report on the vaccine uh here’s this more on the study details here now there’s some interesting things on this that I’m not going to cover in this video we’ll probably cover it later there’s one I’m concerned about related to uh pregnancy but I’m not going to cover that now that’s actually on this one here um but we’ll we’ll we’ll stick to the basics on on this one first of all so I mean this is what they’re claiming that 9.3% higher relative vaccine efficacy compared to but you know protecting against what you know it’s um so you know the claim they’re claiming a slightly higher rate of protection but let’s let’s go on and look at some of the uh side effects and contraindications that this vaccine has admittedly the the manufacturers admitting uh have contraindications Do not use MN spike to individuals with a known history of severe allergic reactions uh this is not concerning at all this is universal it would always be the case you never give something obviously you never give a drug to something that a patient’s allergic to obviously so that’s not concerning this is concerning myocarditis and pericarditis increased risk of myocarditis and pericarditis confirmed risk has been highest in males 20 uh 12 to 24 years of age confirmed but I wouldn’t have it even though I’m old onset of symptoms typically in the first week following vaccination typically in the first week following vaccination this is for myocarditis specifically although some individuals with myocarditis and or pericarditis following administration of mRNA covid vaccines have required intensive care support see the way they put this almost as a throwaway way although some individuals with myocarditis or pericarditis following administration of mRNA co vaccines have required intensive care support and they go on available data suggests individuals typically have resolution of symptoms within a few days with conservative management so yes some people have been admitted to um some people have been admitted to uh although some individuals of my perod following administration have required intensive care support some have required intensive care support but but hey don’t worry about it most have most haven’t now let me give you the choice um would you like mild pericarditis for a week or not available data suggests that individuals typically have resolution of symptoms within a few days with conservative management in hospitalized patients so clearly admitting here if you read between the lines in hospitalized patients so there are hospitalized patients who’ve been diagnosed with COVID 19 vaccine associated myocarditis so clearly admission here that this vaccine associated myocarditis exists they’re just trying it just appears to me that they’re trying to sort of minimize it with the way this is written most of these patients had received two primary uh series of an mRNA COVID vaccine prior to their diagnosis so So yes mo mo most of them have this um as a um most of them have this as a an effect after the second vaccine but I wouldn’t have one at all now uh they do quote this paper here cardiac manifestations and outcomes of covid-19 vaci vaccine associated mocarditis in the young in the USA so let’s have a quick look at what that is saying uh at a medium follow-up of approximately 5 months post vaccination persistence of abnormal cardiac magnetic resonance imaging findings that are markers for myioardial injury was common so basically this is saying using MRI scanning which is is very accurate uh cardiac magnetic resonance imaging scanning uh findings are a marker for myocarditis injury was common so they’re saying on the MRI they can see myioardial damage and then they say the clinical and prognostic significance of these CMR cardiac magnetic resonance imaging findings is not known information is yet to be available about long term now basically what they’re saying is they’re seeing lesions in these patients in the mocardium um now when there’s damage to myocardial cells they don’t regenerate so those cells are lost for life um they’re lost for life and it can be seen on MRI scanning that they’re not going to grow back now over time well first of all that could reduce myioardial overall contractility reducing fitness over time that could potentially lead to heart failure and it could also lead to uh things like heart block and abnormal cardiac rhythms so it concerns me that on MRI you’re finding uh markers for mocardial injury and and they’re clearly admitting that they are finding these markers for myioardial injury uh they don’t know about the clinical effects but I’ve just expressed my concerns and information about potential long-term harm is not there actually I’ve just finished that sentence long-term squeli of myocarditis or pericarditis following administration of mRNA coid9 vaccine so they don’t know so um we we don’t know all these things that are risks um we don’t know if these mocardial lesions are going to cause illness in the future but hey myocardial lesions are an acceptable risk is what it seems to be saying to me i just don’t get how they can be taking such risks to be quite honest um I don’t get it but they’re saying they don’t know but hey ho carry on anyway uh never mind the torpedoes full steam ahead never mind the icebergs let’s get to New York on time right syncopy okay that doesn’t concern me fainting is a known adverse effect of course with anything um altered immuno competence including individuals receiving imunosportive therapy may have diminished immune response so it might not work very well in imunompromised persons limitations of the vaccine may not protect all vaccine part recipients so here they’re admitting that uh um next spike is going to run the risk of these adverse events and it might not work in some people anyway adverse reactions less common less severe adverse reactions uh most common so this is greater than 10% reported adverse reactions now this is in the uh 12 to 17 year old age group and I’ve put the older age group 18 to 65 in brackets so um pain at the sight of injection older people 74.8% younger people 68.8% pretty high headache about half of people are going to get headache fatigue nearly half are going to get fatigue or over half if you’re in the older age group myalgia painful muscles again getting on for half these are common i mean if you had a bit of you know if you had all these things at the same time you’d feel pretty rough auxiliary swelling in the armpit presumably due to the lymph nodes about a quarter but more in the younger age group chills presumably meaning the body’s getting a fever again around about 31% in the younger age group 24% in the older age group achy joints and nausea and vomiting i mean these these um these are described as the minor ones but they’re common um and some of them could be symptomatic of things going on in the immune system um I really don’t know why they would uh want to run these risks um now here’s their comparisons basically 12 to 17 year olds the new vaccine is here this is the new vaccine in this group here and this is the old vaccine in this group here and the the range of adverse effects are comparable so um such high incidence of adverse events appears to be acceptable with the risk of myocarditis with the 2.7% chance of severe severe adverse reactions i mean that’s just quite incredible serious adverse events 2.7% that’s okay mate we’ll pass that for you i really don’t get this i really don’t get it um lots of other information there this is the side effects in the 18 to 64 year olds and again comparable in in the new vaccine to the old one and that’s quite a nice substat article from Mary and uh uh Deacy that read this morning as well so um really quite I don’t know i mean to to me I would call this um I don’t know is it hubus is is it um what is it 2.7% risk of serious adverse events for essentially or very very limited benefit in the age groups and the risk profile that this vaccine is recommended for um anyway there we go that’s that’s that paper just as an aside so I know there’s a bit of echo on that but it just shows that YouTube videos are now available in a multiplicity of languages so if English isn’t your first language uh click on the buttons and you can get me talking in various different languages which is quite amusing of course um so there we go new vaccines passed despite knowing the risks i am disappointed in the FDA I must say um maybe this reflects the massive financial interest in this i don’t know um but if you were my patient and there was completely minimal risk completely minimal benefit from a procedure there’s no way I’d give you a 2.7% risk of uh serious adverse events and and and risk of myocarditis or pericarditis not to mention all the other ones fatigue headache achy muscles achy joints chills nausea vomiting fever nah I’m not going to have it let me know what you think if you’re going to take it let me know but for now with disappointment in the FDA thank you for watching
Serious Adverse Events
https://www.fda.gov/media/186738/download?attachment
MNEXSPIKE group
Serious adverse events were reported by 2.7% of participants (n=156)
Comparator vaccine
Serious adverse events were reported by and 2.6% of participants (n=151)
(median follow-up of 8.8 months).
https://cardiovascular-research-and-innovation.reseaprojournals.com/archive_files/Myocarditis%20after%20SARS-CoV-2%20infection%20and%20COVID-19%20vaccination%20Epidemiology,%20outcomes,%20and%20new%20perspectives.pdf
https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S–FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx
https://www.fda.gov/vaccines-blood-biologics/mnexspike
Targeted approach against the JN.1 variant
Participants received either mRNA-1283 or mRNA-1273.
mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older,
a 13.5% higher rVE in adults aged 65 and older.
https://clinicaltrials.gov/study/NCT05815498
https://ctv.veeva.com/study/a-study-of-mrna-1283222-injection-compared-with-mrna-1273222-injection-in-participants-12-years-o
https://ctv.veeva.com
CONTRAINDICATIONS
Do not administer MNEXSPIKE to individuals with a known history of severe allergic reaction
Myocarditis and Pericarditis,
increased risks of myocarditis and pericarditis,
risk has been highest in males 12 years through 24 years of age.
Onset of symptoms typically in the first week following vaccination
Although some individuals with myocarditis and/or pericarditis following administration of mRNA COVID-19 vaccines have required intensive care support,
available data suggest that individuals typically have resolution of symptoms within a few days with conservative management.
In hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis,
Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis.
In this study,
https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00388-2/fulltext
at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common.
The clinical and prognostic significance of these CMR findings is not known
Information is not yet available about potential long-term sequelae of myocarditis or pericarditis following administration of mRNA COVID-19 vaccines.
5.3 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines.
5.4 Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to MNEXSPIKE
5.5 Limitations of Vaccine Effectiveness
MNEXSPIKE may not protect all vaccine recipients.
6 ADVERSE REACTIONS
Most commonly (≥10%) reported adverse reactions following administration of MNEXSPIKE: