Women and Covid vaccine

vision blue

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Ths was part of a story on why women are getting more side effects than men from the vaccine. They also get Covid Arm more often (95 percent of which are from Moderna apparently) . One unexplained thing tho is why women account for 65 percent of brewkthrough infection Greater immune response should predict less breakthru than nen, not more: women are also more likely to get long haulers syndrome as I believe weve already discussed.

“Whereas dosing for pediatric patients is usually determined by weight, an adult man and woman receive the same dose of vaccine regardless of size
That means women may be getting a stronger dose than is necessary to trigger an adequate immune response. Studies show that may be true for flu vaccines. One 2008 study found women had a similar immune response to half a dose of flu vaccine as men who received a full dose.“
 

Booble

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I've wondered a lot about this. My first thought was "why in the heck would small women be getting the same dosage as large men?" My second thought was "well, when a woman catch a cold from someone, they probably take in the same amount of virus as men do." My third thought was "we don't take in that much virus it replicates when it is inside of us." So then I was back to "why do small women get the same dosage as large men?"
 

Gingergrrl

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Whereas dosing for pediatric patients is usually determined by weight, an adult man and woman receive the same dose of vaccine regardless of size
So then I was back to "why do small women get the same dosage as large men?"
@vision blue and @Booble I had this same thought and have discussed it w/a few friends but none of us were sure if the thought was valid. Historically, are there other vaccines (for adults) in which different doses are given based on height & weight or are all vaccines a "one size fits all" approach? When I did IVIG, my dose was determined by my weight and later when I did Rituximab, my dose was determined using a BSA (body surface area) formula. But maybe vaccines are totally different?
 

Booble

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On the face of giving people of different body mass the same dose does seem odd. But as far as i know the dose given is the lowest one that can provoke an immune response. So it might be that giving say half a dose would produce anti-bodies but only provide limited protection.
I think it might be more of a function of so far they have only done trials with that one dosage. Now that they are seeing greater side effects (and greater immune response) in women there is talk of them looking at differentiating dosage. I have a feeling they simply didn't have time to do that for the initial trials.
 

vision blue

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Could also be side effects greater women have stronger immune responses than men (tho then we are back to why are women getting more breakthru than men if they have stronger immune responses to vax

But i did not find the “explanation” in that web link very satisfying - seemed like a whitewash. If they have different vaccines for adults and children this shows that different populations can have different reactions to vaccines- so one cant know if its body size thats playing a role vs just age

@Booble - do you have any links or no more on how theyre talking about that change for women? Charitable of you to say they just didnt have enough time. I m more cynical and think its because theres probably no money incentive for them to tto spend effort and money to see if extremes of human adult size makes a vaccine less effective or less safe. Theres more profit in one size size fits all and public health doesnt help since they see that as “good enough” - public health is not in the business of saving every last person, just enuf people so society doesnt break down or revolt. And of course big pharma in business of money. So if your not an average person of average size and average race you can be out of luck.

Plenty of examples for oral meds too where they dont adjust dosage for size in adults (eg many antibiotics, and often plaquenil) when it makes no sense so its not like its happening here because vaccibes are different.
 

vision blue

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@Gingergrrl But if vaccines are totally different, then why that dinding that half dose of flu vaccine in women gave sane level of immune response as full dose in men?
Might be due to immune systens not size but still suggests a difference either way

And thats not counting issues of wrong size needle and issues with small arms.
 

Gingergrrl

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I think it might be more of a function of so far they have only done trials with that one dosage. Now that they are seeing greater side effects (and greater immune response) in women there is talk of them looking at differentiating dosage. I have a feeling they simply didn't have time to do that for the initial trials.
I agree that they didn't have time and this was the quickest vaccine production in history. Although long-term, I really hope that they will analyze all of the factors and create a safer COVID vaccine for all populations.

But i did not find the “explanation” in that web link very satisfying - seemed like a whitewash. If they have different vaccines for adults and children this shows that different populations can have different reactions to vaccines- so one cant know if its body size thats playing a role vs just age
I agree that it is not a one-size-fits-all with vaccines (just from this blood clot/platelet issue alone let alone other factors).

@Gingergrrl But if vaccines are totally different, then why that dinding that half dose of flu vaccine in women gave sane level of immune response as full dose in men? Might be due to immune systens not size but still suggests a difference either way
It might not have made sense what I said earlier and I completely agree with you. I was asking if anyone knew of examples of vaccines (in adults) in which people were given different doses based on gender, body-weight, or other factors (and I'm not sure of the answer myself).

Females aren't used in many types of research, due to the view we are complicating things wiht our troubling hormones. its not right. Maybe that has gotten better.
I think most of these studies have white males as the majority of the subjects in the study. I don't know about the COVID vaccine trials but historically this is the case.
 
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I think most of these studies have white males as the majority of the subjects in the study. I don't know about the COVID vaccine trials but historically this is the case
In the phase 3 trial of the astrazen/oxford jab there were 32,000 subjects. About half were female. 79% white, 22% Hispanic, 8% Black, 4% Native American, 4% Asian. 20% were over 65 and included some with diabetes, obesity and CV disease. In looking at this data (for the clinical trials) I noticed that the fact that no subjects got clots was mentioned. As this was long before there subject of clots came up it suggests to me they were looking out for this and suspected it might be an issue. Dont think there is anything sinister here but worth a mention.
 

vision blue

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@Victronix Wow thatv was some article on vaccines and periods. I chuckled with the person - must be a guy - who was quoted saying there is no mechanism by which this could happen- to my read that seemed like he was dismissing it all. Cant happen, end pf story, no discussion or research neded. Maybe im just projecting from too many experiences.
 

vision blue

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I I was asking if anyone knew of examples of vaccines (in adults) in which people were given different doses based on gender, body-weight, or other factors (and I'm not sure of the answer myself.
only factor i can think of off hand is age. Pediatric vs adult vs older adult. Assuming there is mot besides this, im not sure what the takeaway is. Probably shows they can get away with Ignoring everything except age whichbis too glaring (or profitable) to sweep under the rug. Been reading sone of the old Materia Medica from early 20th century and its amqzing they devote plenty of space to discussing how you experiment ti figure out the reappropriate dose for eqch person. Bothers me flow chart nedicine cant be bothered to do this.
 
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In the phase 3 trial of the astrazen/oxford jab there were 32,000 subjects. About half were female.
It still may be a problem, it all depends how data and results were calculated. There is a study on finding optimal office temperature, but it is based on men research only. This temperature is too low for most women and it is still used worldwide. Even if they would have statistically set the temperature in the middle between men and women tolerance, it would still be a bit too cold for women and a bit too warm for men. Vaccine happy medium may be too high for women to the point where it starts to be detrimental. It's doubtful that minimum dose was based on women studies only.
 

pamojja

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..it all depends how data and results were calculated.
If what the investigation of German lawyer with a cell-biologist found is true, the actuality isn't differntly hair-raising for man or women. Below the transcript and translation shortened to 10% pertaining only to the effective minimal dose of BioNTech: http://enformtk.u-aizu.ac.jp/howard/gcep_dr_vanessa_schmidt_krueger/

This is Hearing No. 37 of the German Corona Extra-Parliamentary Inquiry Committee with \ Dr. Vanessa Schmidt-Krueger, beginning at minute 3.56.38 of the hearing to the end.\ The transcript was first produced in German and then translated (by Gilian Crowther, member of the BDÜ, the Federal Association of Interpreters and Translators)

For the original, please see Hearing 37 here

The German Corona Extra-Parliamentary Inquiry Committee was launched by Dr. Reiner Fuellmich on July 10, 2020. Dr. Fuellmich LL.M. (UCLA) is an attorney at law, authorized to represent at all courts in the US federal state of California. He has been a consumer protection trial lawyer in California and Germany for 26 years.

The Corona Investigative Committee has been listening to a large number of international scientists and expert testimony since its inception. Class-action lawsuits are being prepared in the US and Canada. Lawsuits are also being prepared in Germany. Germany does not permit class-actions so the process is being prepared differently there. The committee is also working on the creation of legal guidelines and data caches that attorneys around the world will be able to use to file their own lawsuits.

On 30^th^ January 2021 the German Corona Extra-Parliamentary Inquiry Committee interviewed Dr. Vanessa Schmidt-Kruger, a Cell Biologist with over 20 years’ experience in molecular medicine working at the Max Delbrück Center for Molecular Medicine (https://www.mdc-berlin.de/person/dr-vanessa-schmidt-kruger).

This is her evidence presented at the 37^th^ Hearing of the German Corona Extra-Parliamentary Inquiry Committee on 30^th^ January 2021.


RF = Dr. Reiner Fuellmich\ VSK = Dr. Vanessa Schmidt-Krueger\ VF = Viviane Fischer\ MT = Marcel Templin\ Dr. H. = Dr. Holzeisen (Italy)\ \ *RF: [Dr. Schmidt-Krueger] conducts research on cardiovascular disease and will explain the mechanism and risks of the vaccine.
VSK: I can confirm that. This is the large topic that I would like to cover at the end. Could we come back to that later? I will explain that in detail, that really is the case...


Ok – I’ll now come to my second point, which is determining the vaccine dose, which they were supposed to analyse in the Clinical Phase 1. There’s a Clinical Phase 1, and BioNTech has the task of not just detecting side effects, i.e. spontaneous adverse effects, but also of determining the vaccine dose. They tested three or four different vaccine dosages – 10 micrograms of RNA, 20 µg, and 20 µg respectively in two doses, and [hundertenprogramm? Inaudible] of just one injection. And then they conducted their test 34.56 and the patients were supposed to make notes in the seven-day digital diary. Basically what they found was the higher the vaccine dose – the stronger and higher the concentration of RNA – the more frequent were the side effects. Generally one can say that there were always more and stronger side effects with the second dose than with the first. Older trial participants had fewer because their immune system is already aged and is not so reactive. They naturally analysed the side effects that have been published – fever, fatigue, headaches, joint pain, myalgia, shivering, vomiting, diahorrea. Nothing more is covered in the the publication – we don’t know whether they did more. They also looked at how many antibodies were produced and then bind the spike protein: they did a binding assay and investigated the antibodies when they encounter a virus. They generated an artificial SARS-CoV-2 virus that contains a GFB [NB: “green fluorescent protein”, I think this was mNeonGreen – a fluorescent marker], i.e., cells that are infected with the virus light up green, then one can count how many green cells there are at the end. And if one then isolates the antibodies from the vaccinated trial participants and mixes them with the viruses, then they partially neutralise the viruses, and then one has fewer green cells, you can see that. So to summarise, the vaccine has a positive effect, but the criticism is that there is no positive correlation between the different vaccine doses, i.e., we see the same effect at 10, 20 and 30 micrograms. Despite this they want to use 30 micrograms as the vaccine dose. Although 30 micrograms has many more side effects than 10 micrograms. The benefits are the same, but the risk is different. This is not scientifically justifiable. If I were writing an application for an animal trial and I wanted to vaccinate the animals with 30 micrograms and I had to justify why 30 micrograms, why not 10, then I would never get past the door with my animal trial application if I got the same effect with 10 micrograms. There is simply no additional benefit if I increase the RNA volume in these assays.

WW: I have a question: do these microgram values include the additives (37.51), are the LNPs included, or do these dosages only refer to the mRNA?

VSK: The dose only refers to the mRNA. But they are of course wrapped in the LNPs, and the higher the microgram dosage mRNA, the more LNPs you need.

WW: Ok

VF: Is that a question of costs?

WW: If the side effects come from the nanoparticles, then the dose dependency could be explained by that, and not by the effect of the mRNA.

VSK: The side effects?

WW: Yes

Dr. VSK: Yes of course. Because these are primarily due to the LNPs. But I’ll get onto these at the end.

The fact is that the clinical study Phase 1 is normally there to find out what quantity of vaccine you need; it is important to prove what the vaccine dose should be. What vaccine dose you need to get the effect you want to have, ultimately. To do that you need to conduct a statistical test across all the different vaccine doses: in science that is a clear case of [Wanneranzapf mengen test – inaudible – a volume test with a name], that is a particular test that one has to use, it tells you whether there is a positive correlation, i.e., that the effect increases with a rising vaccine dose or not, whether it falls, or whether it remains the same. They didn’t do this test, giving the excuse that there were too few data points per group, i.e., that they only had 12 trial participants per group. I wonder whether they knew from the outset why they weren’t consigning more trial participants. And second, it is an absolutely stupid excuse because any scientist would be happy to have 12 datapoints per group, i.e. 12 trial participants per group. It is entirely possible to draw a statistical conclusion – you can do it with 5 or 6 people, it won’t deliver such robust results, but with 12 per group you can draw a fairly good conclusion as to whether there is a correlation or not. If I look at the image – and I’ve got a trained eye – and compare the median values and the scatter of the data, I can already say that there is no correlation. Whatever test I do, it fluctuates, they all have more or less the same effect. I.e. the excuse that they didn’t want to do this test … or let’s say if they had done this test, they would have produced the evidence that 30 micrograms would be too much, they should have used 10 µg vaccine doses.

RF: But that is a particularly egregious error. If that is part of the Phase 1 trial to test out the dose that will be effective, if at the same time as you are telling us Dr. Schmidt-Krueger it doesn’t increase the efficacy: the efficacy remains the same regardless of whether 10 µg or 30 µg are used but the side effects increase, that is severe medical malpractice.

VSK: You have completely understood. That’s exactly how it is. In my opinion they intentionally didn’t use the test because they would have had the evidence and no justification any longer for\ 30 µg. And then they give the stupid excuse that they can’t do the test because they don’t have enough samples.

41.22

MT: First of all I’m wondering how expensive this vaccine is. If I need more of this strange fluid, then it will be more expensive, and for me as a layperson that doesn’t really have an impact on the issue of whether - I mean, if one assumes that it is this miracle treatment, how much do I get from a dose if I increase the dose, or am I getting this wrong? Wouldn’t I get more out of the vaccine if I said right from the outset that I need to use less? Or am I misunderstanding something?

VSK: We know that the vaccine vial is for 5 people, but you get enough out for 6. You give a little less, but you have previous knowledge that that will also work.

RF: The point you are explaining here will have further consequences. We are seeing that it has adverse effects through to death, this point and what’s happening here will play an extremely big role because the doctors have to take responsibility, they are participating in this – this is serious medical malpractice.

This also involves a reversal of the burden of proof. (42.56) Those who have been damaged no longer have to provide evidence that the cause of what has happened is the vaccine: the doctor has to prove that it was not the vaccine and that he/she is not guilty. This is going to be a really strong argument.

VF: Sorry, another question about the costs. Normally one would think – after all, it’s a commercial enterprise – I wouldn’t put ingredients into it that are three times the quantity of what I really need: the RNA surely has a cost.

VSK: It’s costing US more!

RF: That was the simple question. The more of the stuff is pumped into people, the more expensive it is, that’s logical. It would be a remarkable result and difficult to explain – to the taxpayer particularly –

VF: Let’s say the price people are willing to pay for a product of this kind, where they don’t really know what’s in it, is EUR 50, it wouldn’t really be the case that this price would increase if I said I’m putting three times the quantity in. So if it achieved the same effect, they could say this effect costs EUR 50. They won’t have negotiated a price that revolves around how many DNA particles it contains or whatever?

RF: The contracts are secret. Do you know anything about it, is it calculated according to vaccine quantity? I can’t imagine anything else really.

VSK: I don’t know how reliable the data are, but I have heard that normally there 5 vaccines in one vial, but they charge 6 vaccines per vial. Although the company doesn’t have any extra costs for this. That’s a piece of information I have, but I don’t know if it is true, I’ve just heard it.

Dr. H: And something else. The vaccine is mixed by hand: you take the vial, take the unit of measure that you need for one person, and add saline to it, and then it’s injected - ?

VSK: Yes, it arrives dehydrated, i.e. all the water is removed. It contains a small amount of white powder. This is then dissoves in the saline solution and then you have to take the respective amount out of that. The people who received five times the dose probably got all of it.

Dr. H: Exactly, that was the point I wanted to get at: first of all, why do they do that? That seems to me to be a clear vulnerability in the system. That’s the source of error really. Is it because of transport volumes, or what is it?

VSK: Yes, transportation is much better when it is dehydrated. It can be stored better that way.

Dr. H: That explains it. I find that risky. From what I have heard, it has gone wrong. Someone actually forgot to divide off the right quantity, and the patient was given five times the dose. What would the risks of that be in your opinion? (46.49)

VSK: [Inaudible, think must be “The damage”] is much higher. But I will come to that.\ We are still talking about the volume: what I’ve covered is not the only point of criticism while we’re on this subject. In the same study they have also – well, they claim that it is important to give two doses. That may well be true, but they haven’t proved it; they haven’t tested it scientifically. What they did in this study was they gave two doses of all the quantities: 10 µg, 20 µg and 30 µg. Normally to make the assertion [translator: that it is necessary to use 2 doses], you need to have a group where you give just one dose. Normally it’s like this: you get an injection, then the body forms antibodies, it takes a while until it starts, the antibody titre rises and then it forms a saturation curve. So at some point it doesn’t go any higher: then you have reached saturation. And this goes up over time. But to find out whether the second dose has an effect you have to give the injection and find out how high the titre is after 35 days. And then do the same with the other group; after the same time, 35 days, look at how high the titre is. (47.59). And if the titre is higher, then the second dose has had an effect. If it is not higher, then the second dose has not had an effect. I assume it did have an effect because in another vaccine similar to this [Which? Would be useful to know] it did have an effect, but in that case the scientific data were generated a little shoddily – the time is sometimes missing in the data, they simply left it out so that one can’t prove whether it has had an effect or not …. But from experience I think that a second dose is likely to have an effect … but I’m sure it’s like that in a court of law: belief is not evidence or knowledge – i.e., they would have had to prove it in this clinical study with this vaccine. They didn’t do that: they are simply making the claim.

RF: There isn’t a study on it?

VSK: No, I haven’t found one. There is the Clinical Study No. 1 on human beings, that is where they should have tested it.

RF: They should have tested it within the aegis of the Phase 1 study.

VSK: In the study on mice/rats. I don’t know, but this small study on human beings: that would have been the moment where they should have tested it. That’s my opinion.

RF: No, that is correct. Legally that’s the case. They have simply made the claim. Somewhere along the line they made the assertion: better twice than once – perhaps even three times wouldn’t be a bad idea, would have been just as good from all one can tell. That is really ghastly. Professor Hockertz told us that it is usual in the development of new medications – also in the case of vaccines: no preclinical phase was done, no animal trials: Phases 1, 2 and 3 took place in a completely telescoped fashion, and now you are telling us after having … you have just pointed out that the EMA has made various demands that haven’t yet been fulfilled in some cases because they only have to be met by July – but they’re already going ahead and vaccinating. What’s going on here? The study is basically taking place now, right before our eyes, live on stage – on patients who have no idea what we are discussing here just now! We’ll have to tell our Israeli colleagues this, they won’t be happy at all ….

Dr. H: And just to mention Reiner: without the vaccinated being tracked like the trial participants that they are (50.47) If I were a trial participant in a vaccine test series then I would have to be medically tracked, i.e., assessed. People are simply being vaccinated, and if they die it’s counted as a Covid death. That’s the reality. Or more frequently it’s said they died of their underlying conditions. Anything to prevent it being seen as a result of the vaccine.

RF: We just heard that at the start Renate: The fact that three times the quantity that is really necessary is being administered, and at the same time the risk is increased by three times: we definitely have medical malpractice, we definitely have the reversal of the burden of proof, and we can’t say any longer that was Covid, instead we can say we want to hear from you: is the causality … you have to prove that as you have made huge blunders. Is the causality different to the severe medical malpractice that we have to accuse you of. That is what I said from the beginning: this is definitely bodily harm. At the very least because there isn’t any proper up-front clarification/information provided, [as there would be if you were taking part in a study]. But what I’m hearing now in addition to that – my goodness …
 

Booble

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I think this was all based on urgency and the devastation of the pandemic.
From a public health perspective they needed the quickest way to make sure they could eradicate the virus.
Collateral damage was/is less important on the large scale.

I think they didn't feel they could risk going the lower quantity and risk that it did not create enough antibodies when out in the wider population which could lead to not only continued pandemic but also spurring more variants of concern.

This has been a rush job but for a reason.

Sucks on an individual basis but stopping the virus in its tracks as much as possible was the goal.

Note I'm not necessarily condoning this but putting in my two cents on what may have been discussed in the meetings when they made the decision for the larger dose.