On mRNA/Gene Therapy

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Re: On mRNA/Gene Therapy

Postby Harvey » Tue Jun 01, 2021 1:11 pm

Iamwhomiam » Tue Jun 01, 2021 3:36 pm wrote:I have no idea why you cannot read the title at the link given, Harvey, but here's the answer to your question, "Cancer: The Forbidden Cures 2010 Documentary full (subtitles: English, русский)."


From the UK, you can't see any information until you agree with Google's 'privacy policy'. I don't agree, therefore...

Thanks for the info.
And while we spoke of many things, fools and kings
This he said to me
"The greatest thing
You'll ever learn
Is just to love
And be loved
In return"


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Re: On mRNA/Gene Therapy

Postby Belligerent Savant » Wed Jun 02, 2021 11:15 am

.

The comments to this article are much more interesting, to me, than the article itself; a few of the comments are reproduced below:

https://blogs.sciencemag.org/pipeline/a ... eir-lipids



RNA Vaccines And Their Lipids

By Derek Lowe 11 January, 2021


....

168 comments on “RNA Vaccines And Their Lipids”

JW Ulm, MD, PhD says:
11 January, 2021 at 5:38 pm

Derek,
Thank you immensely for this thorough explication on the mRNA vaccines’ lipid nanoparticles (LNP), a subject I’ve been striving to get a handle on, but this also ties into another conundrum with the vaccines that’s been raising great concern for me and lately, most of medical and biomedical colleagues: What exactly is the tissue tropism and cellular localization of these nanoparticles, and could this pose a side effect threat through errant MHC-I-mediated autoimmunity? Are they crossing the blood-brain barrier? Entering the parenchyma of vital organs (that even SARS-CoV-2 can’t access) and expressing the coronavirus spike protein on MHC-1 molecules, making these critical tissues targets of cytotoxic attack?

Briefly, a major safety checkbox for the mRNA vaccine modality in general is the tissue localization of the lipid nanoparticle vehicles, for which you’ve done a wonderful job of explaining the composition of, since they are mechanistically fundamentally different from all other vaccines here. Most vaccines (what I called Type 1, e.g. subunit and inactivated virus) are essentially “MHC-2 only,” get taken up by dendritic cell phagocytosis and presented to CD4 T-cells in lymph nodes, so little to no CD8-mediated cytotoxicity against presenting cells. Attenuated virus vaccines like MMR (“Type 2”) do have some cytotoxicity mediated by CD8 lymphocytes attacking target cells presenting viral epitopes on MHC-1 cell-surface molecules, *but still limited to the tropism of the wild-type virus*. That’s where the lipid nanoparticles make mRNA vaccines elementally different from both, with a much broader tropism as far as I can tell. Even if they’re not omnitropic, it seems that they can enter a much broader tissue range compared to even attenuated virus vaccines, an impression confirmed from what you’ve written here. And since the mRNA vaccines would induce SARS-CoV-2 viral spike protein expression, that seems to mean that people who get the mRNA vaccines are going to have a much greater range of cells and tissues vulnerable to cytotoxic attack, since they’d be expressing the spike protein on MHC-I molecules. While this may prove to be more immunostimulatory, it also seems to indicate that the mRNA vaccines pose a much greater risk of systemic and critical tissue and organ damage than other vaccines, especially if multiple booster shots are needed, with side effects that may not manifest for years (with cumulative damage and chronic inflammation).

This is where the picture gets aggravatingly murky, since it seems that neither Pfizer nor Moderna has posted up much of anything in the peer-reviewed literature about cellular and tissue localization from what many of us can tell, and this doesn’t seem to show up in the regulatory documents either, even though it would seem to be THE critical safety question for any proposed COVID-19 mass vaccination campaign. For the animal studies, it’d be as simple as using the companies’ nanoparticles to package GFP or equivalent indicator proteins, and seeing which tissues they go to and express the gene product. But there seems to be precious little published on this, and again from your descriptions here, it seems those tissue localizations would be quite broad. There have been published studies on LNP formulations in the past with varying tropisms but again, from what I can tell, the specific formulations in the actual vaccines are hard to get a handle on — perhaps because they’re considered trade secrets, and Pfizer and Moderna are worried about the other stealing the formula? — and even more crucially, we don’t know where in the body they’re going (through endocytosis, which leads to an MHC-1 expression pathway for viral antigens). And therefore, which tissues the vaccines’ mRNA payload is thus expressing the SARS-CoV-2 spike protein in, inviting cytotoxic attack.

The nightmare scenario would be if e.g. the mRNA vaccines’ lipid nanoparticles are, indeed, crossing the BBB (blood brain barrier) and getting endocytosed into critical glial cells, like oligodendrocytes, or even worse, into neurons themselves in the brain and spinal cord, putting a bullseye on these critical cells for cytotoxic CD8 lymphocytes. If so, we’d be setting the stage for a rash of multiple sclerosis and ALS-type clinical scenarios down the road with multiple boosters. My old medical colleagues have been getting especially concerned about this possibility, and I think this may be behind the recent sharp plunge in willingness among more and more healthcare workers to take the mRNA vaccines. in the absence of long-term safety or efficacy data, which is an unfortunate shortcoming given the pandemic’s urgency, we can only go with fragmented hints here and there about potential downstream issues, so we need a wealth of information with full transparency to make up for that shortcoming. And I think the recent reports of some severe adverse effects in the VAERS (esp. neurological issues, or the vaccinated Ob-Gyn physician in Miami dying suddenly of ITP that from early reports, seems to have been triggered by the vaccine) are causing cold feet among doctors and healthcare workers, esp. in the absence of tissue localization information. I used to work in gene therapy and recall how we’d obsess on tissue tropism for our vectors before considering clinical trials, so I’m bewildered that this information seems almost absent for an almost entirely new vaccine modality (for mass vaccination of healthy populations) here — it would go a long way toward reassuring fears and increasing uptake of the mRNA vaccines, both among the general public and medical professionals.

As a corollary to your topic and excellent explanations here, do you happen to have information about the tissue tropism of the mRNA vaccines, specifically where the nanoparticles are going? If you’d like to do a Blog post on this, I’ll be enthusiastic to forward it on to my ex-colleagues, as there’s a massive question mark about this very issue that’s halting further vaccine adoption for a huge number of people. With better information about precisely where the mRNA vaccines are going, hopefully the concerns of health professionals especially can be reassured and boost confidence for the vaccine program.

JW Ulm, MD, PhD says:
11 January, 2021 at 5:49 pm

For further reference on these specific concerns in case helpful, here’s the link to my Rapid Response last month in BMJ (clickable from my comment name since looks like we can’t provide links within the comment text body). It lays out the mechanistic considerations regarding the mRNA vaccines’ tissue tropism and cellular localization, and a more detailed rundown of how precisely their cellular uptake, and the immunological processing of the SARS-CoV-2 viral epitopes expressed from the mRNA payload, would differ fundamentally from all previous vaccine modalities. Hopefully this won’t prove to be a factor in provoking toxicity, and would be enthused to hear any detailed rundowns from anyone in the know to shed light on the tissue tropism question!

Cole J. Batty says:
11 January, 2021 at 7:56 pm

The vaccines are injected intramuscularly. Blood brain barrier or organ targeting are a non-issue because this route of administration is not systemic. The vaccine is primarily working in the draining lymphatics of the injection site. When working on gene therapy with e.g. AAV, tropism is very important because the viruses are often administered systemically and rely on the inherent or engineered tropism of the virus to induce expression in desired tissues. Trafficking studies have been done. One that is quite similar to what you describe above is linked in my name. One thing that may help in your search is to use terms like trafficking or localization instead of tropism, as tropism as a term is more used for cell subsets which viruses preferentially infect/replicate in, while those other two terms are more often used for non-viral delivery systems.

Botond Igyarto says:
12 January, 2021 at 1:58 pm

There are a lot of unknowns with this platform. I have been trying for a while to have my comments considered for publication. The furthest I got with it was that one of the top immunology journals helped me edit it to fit their requirements, and after all the efforts of trimming down they decided to drop it because the “climate is not appropriate”. Here it is, uploaded to Preprints: https://www.preprints.org/manuscript/202012.0493/v2 (or by clicking on my name).

Marko says:
12 January, 2021 at 2:33 pm

“…they decided to drop it because the “climate is not appropriate” ”

I wonder if the CDC made a similar calculation. This was on an earlier version of a CDC page describing how mRNA vaccines work :

“COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the muscle cells, the cells use them to make the protein piece.”

This is on the current version :

“COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the immune cells, the cells use them to make the protein piece.”

https://www.cdc.gov/coronavirus/2019-nc ... /mrna.html

Maybe when the climate is appropriate they’ll tell us the whole truth, but with the CDC’s record on flip-flopping on all things coronavirus, how would we ever know?

S says:
11 January, 2021 at 8:38 pm

Good information. Yes, a recent paper has been published in Nature Neuroscience entitled “The S1 protein of SARS-CoV-2 crosses the blood–brain barrier in mice” to uncover its ability to cross Blood Brain Barrier. Which tissues will mRNA vaccine target exactly? A little alarming situation, this. Would be better if more information by vaccine companies are provided rather than getting anxious on trade secrets.

JW Ulm, MD, PhD says:
11 January, 2021 at 10:10 pm

S,
Thanks for apprising me of that paper. It helps to illuminate and builds upon many of the concerns I’ve been hearing among colleagues about potential tissue trafficking and localization. If indeed the spike protein components (as translated from the transduced vaccine mRNA) are expressed at high enough levels, this seems to raise additional questions about the potential for the gene product to cross the blood-brain barrier through adsorptive transcytosis even if expressed outside of it. This on top of the still-murky picture about whether the nanoparticles themselves can cross the BBB (or other critical tissue compartments) and enter glial cells or neurons outright, leading to expression of the cytotoxicity-inducing spike protein in complex with MHC-I on the surface of sensitive cells.

Cole J. Batty (sorry can’t respond directly due to comment nesting, the commenting software doesn’t have a “Reply” option by your comment):
Many thanks for providing the link to that paper. I’ve been reading as much as I can about the biochemistry and in vivo behavior of the various lipid nanoparticle formulations, and this does shed a good deal of light. However, I have to raise questions about one of the statements in your post: “The vaccines are injected intramuscularly. Blood brain barrier or organ targeting are a non-issue because this route of administration is not systemic.”

This strikes me as questionable because intramuscular injection very much does lead to systemic circulation of the injected payload. In fact one of the first things we learn in med school is that IM injection is favored precisely because of the substantial vascularization of large muscles, which carries the vaccine material systemically. From the link (with my name): “Intramuscular injection is the method of installing medications into the depth of the bulk of specifically selected muscles. The basis of this process is that the bulky muscles have good vascularity, and therefore the injected drug quickly reaches the systemic circulation.”

Although I agree that the vaccine’s lipid nanoparticles would likely tend to collect extensively in local lymphatics, I’ve never heard of an IM injection that’s restricted exclusively to the injection site or nearby lymphatics alone. Every time I’ve been in the clinic, IM (esp. the deltoid) has been chosen precisely because the injected material inevitably goes systemic, through which it could reach peripheral tissues, vital organs, and the blood-brain barrier. It’s still unclear of course if the vaccine is reaching the BBB, or endocytosing within glial cells or neurons beyond it, and your linked paper does help to illuminate some of the issues with trafficking and cellular localization. Still, the most challenging aspect of following the lipid nanoparticle literature is that the LNPs’ chemistry and in vivo behavior can vary so substantially depending on the specific formulation. And if the vaccine manufacturers are invoking trade secrets as a basis for withholding further details about their LNPs (or allowing independent labs to test tissue localization with reporter genes), this leaves the public with a big doughnut hole in critical knowledge about the vaccines’ in vivo behavior.

Even very recent related literature on trafficking other LNPs can’t answer this question for us, since again the different lipid recipes vary so much in their chemistries and in vivo localization that we won’t know which tissues the vaccines themselves are entering. We need to have precise information regarding where exactly *the vaccine manufacturers’ specific LNPs* are going, and where the SARS-CoV-2 S protein is expressed, since a non-selective tissue localization–especially if traversing the BBB–could lead to marked cytotoxic attack on MHC-I-spike protein complexes, and thus significant cumulative tissue damage, in a range of targets potentially well beyond the localization of the wild-type virus. If anything, the wide population cohort of intended vaccine recipients, coupled with the compressed timeframe and lack of long-term efficacy and safety data, makes it all the more important to acquire such data instead of leaving such questions to chance. Even more so given the rate of adverse events and even deaths that are cropping up lately in the VAERS database logs.

Marko says:
11 January, 2021 at 11:57 pm

JW,

We’re led to believe the LNPs are taken up by the muscle cells around the injection site, and spike expression occurs therein within hours of the injection. While I have no problem believing that’s mostly true, I doubt that it’s 100% true. The question then becomes how much – 20% , 1% , .01% ? – escapes into the systemic circulation.

I believe the number of RNA payloads per dose is on the order several billion, so some unknown fraction of that constitutes the number of potential off-target cells that could be reached and subsequently destroyed. If that number is randomly distributed throughout the body, it’s probably not a big deal, but if there is some significant “tropism” to specific nervous system tissues, for example, it might be.

More transparency on this would indeed be welcome.

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Re: On mRNA/Gene Therapy

Postby Grizzly » Thu Jun 03, 2021 12:17 am

^^^

Indeed. I knew before we got here where we were going, just as clear and soberly as I did the moment I heard and saw the day of 911, that they are lying to us, I knew it then and I know it now.
“The more we do to you, the less you seem to believe we are doing it.”

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Re: On mRNA/Gene Therapy

Postby drstrangelove » Sat Jun 05, 2021 1:29 am

Seems to come down to the unknown long term effects of ALC-0315 and ALC-0159.

PK studies with the two novel LNP-excipients ALC-0315 and ALC-0159: Wistar Han rats were IV bolus injected with LNP formulated luciferase-encoding RNA at 1 mg/kg and ALC-0315 and ALC-0159 concentrations at 15,3 mg/kg and 1,96 mg/kg respectively. ALC-0315 and ALC-0159 levels in plasma, liver, urine and faeces were analysed by LC-MS/MS at different time-points up to 2-weeks.
Assessment reportEMA/707383/2020Page 46/140ALC-0315 and ALC-0159 were rapidly cleared from plasma during the first 24 hours with an initial t½ of 1.62 and 1.72 h, respectively. 24 hours post-dosing, less than 1% of the maximum plasma concentrations remained. A slower clearance rate was observed after 24 hours with ALC-0315 and ALC-0159 terminal elimination t½ of 139 and 72.7 h, respectively.Following plasma clearance, the liver appears to be to major organ to which ALC-0315 and ALC-0159 distribute. The applicant has estimated the percent of dose distributed to the liver to be ~60% for ALC-0315 and ~20% for ALC-0159. The observed liver distribution is consistent with the observations from the biodistribution study and the repeat-dose toxicology, both using IM administration. For ALC-0315 (aminolipid), the maximum detected concentration in the liver (294 μg/g liver) was reached 3 hours after IV injection. ALC-0315 was eliminated slowly from the liver and after 2-weeks the concentration of ALC-0315 was still ~25% of the maximum concentration indicating that ALC-0315 would be eliminated from rat liver in approximately 6-weeks. For ALC-0159 (PEG-lipid), the maximum detected concentration in the liver (15.2 μg/g liver) was reached 30 minutes following IV injection. ALC-0159, was eliminated from the liver faster than ALC-0315 and after 2-weeks the concentration of ALC-0159 was only ~0,04% of the maximum detected concentration. The applicant was asked to discuss the long half-life of ALC-0315 and its effect, discussion on the comparison with patisiran, as well as the impact on the boosts and post treatment contraception duration. The applicant considered that there were no non-clinical safety issues based on the repeat dose toxicity studies at doses (on a mg/kg basis) much greater than administered to humans; this was acceptable to the CHMP. Both patisaran lipids showed an essentially similar PK profile in clinic with a strongly biphasic profile and long terminal half-lives. According to the applicant, it is difficult to further contextualize the pharmacokinetic data and therefore to understand the safety of these molecules, beyond consideration of dose. There is a large dose differential between the human BNT162b2 dose and the dose used in the toxicity studies (300-1000x) which provides an acceptable safety margin.Moreover, according to the Applicant given the large difference in dose between the toxicity studies and the clinically efficacious dose (300-1000x), it is unlikely that the administration of a booster dose will lead to significant accumulation. Finally, the applicant is of the opinion that these results support no requirements for contraception. The CHMP found this position agreeable. While there was no detectable excretion of either lipid in the urine, the percent of dose excreted unchanged in faeces was ~1% for ALC-0315 and ~50% for ALC-0159.

-European Medical Agency - Comirnaty(Pfizer) Assessment Report ,page 45, https://www.ema.europa.eu/en/documents/ ... ort_en.pdf

It would appear the raw data is available here: https://www.pmda.go.jp/drugs/2021/P2021 ... I100_1.pdf

Some phrases of interest:
- "post treatment contraception duration"
- "no non-clinical safety issues"
- "PK profile in clinic with a strongly biphasic profile and long terminal half-lives"
- "results support no requirements for contraception"

Think of every existing thing humans have produced. Think of every instance where the quality of those things were supplemented to increase the quanty.

This is a classic case of quantity over quality to increase the production of safety data via circumvention of the observation period. This is why our clothes fall apart seasonally. Our electronics breakdown annually. And why our medicine regulating agencies modify their advise at higher and higher rates.
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Re: On mRNA/Gene Therapy

Postby Belligerent Savant » Mon Jun 07, 2021 10:24 pm

.

https://www.ijidonline.com/article/S1201-9712(21)00364-7/fulltext
First case of postmortem study in a patient vaccinated against SARS-CoV-2

Highlights

We report on a patient with a single dose of vaccine against SARS-CoV-2.

He developed relevant serum titer levels but died 4 weeks later.

By postmortem molecular mapping, we found viral RNA in nearly all organs examined.

However, we did not observe any characteristic morphological features of COVID-19.

Immunogenicity might be elicited, while sterile immunity was not established.

Abstract

A previously symptomless 86-year-old man received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later from acute renal and respiratory failure. Although he did not present with any COVID-19-specific symptoms, he tested positive for SARS-CoV-2 before he died. Spike protein (S1) antigen-binding showed significant levels for immunoglobulin (Ig) G, while nucleocapsid IgG/IgM was not elicited. Acute bronchopneumonia and tubular failure were assigned as the cause of death at autopsy; however, we did not observe any characteristic morphological features of COVID-19. Postmortem molecular mapping by real-time polymerase chain reaction revealed relevant SARS-CoV-2 cycle threshold values in all organs examined (oropharynx, olfactory mucosa, trachea, lungs, heart, kidney and cerebrum) except for the liver and olfactory bulb. These results might suggest that the first vaccination induces immunogenicity but not sterile immunity.



Immunogenicity
Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted: • Wanted immunogenicity typically relates to vaccines, where the injection of an antigen provokes an immune response against the pathogen, protecting the organism from future exposure.

https://en.wikipedia.org/wiki/Immunogenicity

Sterilizing immunity differs from effective immunity in that the latter can prevent illness but still lead to asymptomatic infection. Sterilizing immunity remains the holy grail of COVID-19 vaccine research, although several candidates in the pipeline show promise.

https://www.verywellhealth.com/covid-19 ... ty-5092148
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Re: On mRNA/Gene Therapy

Postby Belligerent Savant » Tue Jun 08, 2021 8:11 pm

.

https://www.medscape.com/sites/public/c ... -Joo6NN5zs


465 comments

N B
4 hours ago

I had my second Pfizer shot on 4/6. I am 25, have no existing health conditions, not allergic to anything, and never had a reaction from a vaccine before. I felt nothing from the first shot, but after the second one I had arm cramping in the arm I got the shot in. I thought this was normal until 5 days after the vaccine I had muscle cramps in both my legs and arms. I thought still I had done something from working out until a couple days after that I started to experience sharp, electric pains in my arms and legs I had never experienced before. It wasn't constant, but I went probably every 10 minutes with either a cramp or sharp pain. I went to my primary care Dr to rule out vitamin deficiencies, etc. which all came back normal so she referred me to a neurologist. They said immediately it was caused by the vaccine, and informed the FDA. My pain finally started to subside significantly until 1.5 weeks ago I started getting the sharp pains in the sides of my head, followed by headaches/pressure. It feels like I'm being electrocuted. I decided to go to the ER because I had had enough of this, and had a CT scan done, which came back fine. I still have terrible head pain almost 2 weeks later and occasional pain in my legs and arms. I've been prescribed nerve pain medication, but takes a couple weeks to fully work. The neurologist basically said my I'm having a crazy immune/neurological reaction to the vaccine and should go away. It's been almost 2 months now since the first symptoms... I reported with VAERS as well. Nice to see that some other people have been experiencing muscle cramps, twitches, and neurological issues as well. Let me know if anybody else has muscle cramps and nerve pain that I am experiencing!
4Like

Anna K
3 hours ago

This sounds really similar to what I have (posted below). Let me know if you want to talk. Haven’t gotten the headaches yet but have head pressure
2Like

Anna K
4 hours ago

I have been reading these comments and waiting to post. I received my first Pfizer vaccine on 5/15. I had the sore arm and malaise. What followed has been a nightmare. I started experiencing numbness especially on the right side of my body (opposite of the shot arm). At its peak, I would wake up to my body so violently numb/pins & needles and malaise that I would physically throw myself out of the bed. I had some lab tests done. I am waiting on my second round of lab tests. The first round was fine, I’ll post an update if the second is not. Went to a neurologist who suggested an EMG and gave me gabapentin. Currently I am experiencing the malaise, strange sensations through my body, numbness on the right side. And a new feeling of spiraling staticky light headedness. I am trying to control my anxiety best I can and pray for a full recovery. I was a healthy active 33 year old with no known medical conditions.
3Like

Leslie Busichio
9 hours ago

LB Registered Pharmacist

I had my second Pfizer Covid vaccine on March 19th. I have existing autoimmune issues , but mild. After the first week, I went into a hormone storm. I am 55 years old but have been in menopause for over 1 and 1/2 years with no symptoms. I had horrible night sweats, hot flashes, jitteriness , tension headaches with tingling at the back of my head and mouth. I also have developed Functional Dyspepsia. I do have controlled IBS, but never had anything that affected my digestion. I have lost over 12 pounds, and weigh 95, because I have to eat very small meals in order to keep the pain away and nausea. My thyroid medication had to be completely changed, I was having increase blood pressure and pulse, which led me to the ER twice. I have been told by a neurologist that I have anxiety. I am currently working with a psychologist, endocrinologist, GI, Integrative MD, and about to start accupuncture. Stay tuned if I get any relief. I am about to get an MRI to rule out any brain or nerve damage. I pray this will go away as time goes on and I can get back to my wonderful life.
4Like

V B
14 hours ago

I am a Registered Nurse and Paramedic. I have never had COVID. I received my 1st dose of Moderna on January 30, 2021. Received my 2nd Moderna vaccine on March 1, 2021. 13 days later I got “COVID Arm” at injection site. The swelling, redness, warmth, and itchiness lasted for 3-4 days and finally abated after taking Benadryl around the clock.

Then I developed a Severe allergic reaction to unknown substance on 04/28/21. After seeing doctor it was determined I had a new allergy to peanut butter. At the same time I developed Painful swollen spongy Fingers joints. ANA, Rheumatoid factor, Sed rate was negative/normal. C-Reactive protein elevated.

Then On May 4, 2021 I developed Pain, Bloating, Vomiting after Breakfast. It felt like a bowel Obstruction (I have a history of a partial small bowel obstruction due to surgical adhesions. This cleared up after 4 days NPO.

Then on 05/13/21 I developed Pain and severe swelling to both Wrists and Stomach & URQ Soreness. I saw a hand surgeon who said it was a “gout like” inflammation and he treated me with steroids. It cleared up.

Now I’m going back to the hand surgeon today June 8, 2021 for severe pain and swelling in both arms radiating to forearms. I have an appointment for the rheumatologist in July.

I’m an advocate of vaccines, however I believe that the Moderna vaccine has sent my immune system into overdrive and it has triggered a cascade of side effects. I’m allergic to all NSAIDS, so other than ice, I have not been able to take anything for the pain. I just want to be out of pain and get my range of motion back in my arms. I hope these side effects eventually go away. I will be completing a VAERS report.

There needs to be greater transparency of the post clinical trial side effects of the COVID vaccines.
6Like

A B
1 day ago

I received my first Pfizer injection in March 2021. I have been delaying the second as I did have an immune response (low grade temp, headache, fatigue, sore arm) but I also had generalized muscle fasiculations (twitching) of the opposite side of my body (face arms, legs and even abdomen) as well as vivid dreams the night following the vax and myoclonus like jerks that would wake me from sleep with some cramping. I have anxiety at baseline though did have labs and an EMG all unremarkable. Prior to the vaccine I have only ever had muscle twitching following intense exercise with possibly poor hydration. The twitches lasted for about a week- 1.5 wks. My partner had twitching of the injected arm starting 1 week post Pfizer and lasting for total duration of 1 week. My primary physician cannot give much guidance as to the second vaccination. This really isn't something being openly discussed.
7Like

Dr. Liz Liz
2 days ago

It seems the HUSH on this is devastating. May we learn from our past, and avoid prolonging or repeating these kinds of errors.

https://www.lifesitenews.com/news/vacci ... rous-toxin
11Like

A B
2 days ago

I had a first dose of Moderna vaccine in mid-January and after 2 days, my lymph node in the armpit was swollen and painful for 8 days or so. It went away but after 2 days of that, I started feeling some swelling on left side of my chest/breast area. I have been dealing with this since then. 5 months have passed but no solution. So far the diagnosis is that it is some sort of edema/lymphedema because my lymph node got damaged or primary lymphedema triggered. This is pretty weird and some swelling is also visible. I am a male in my forties. I have not found any other person or website where such symptom is discussed. Does anyone has similar symptom and any suggestion for treatment?
2Like

Laura Leffel
22 hours ago

@A B I work in home health. We have a patient who had swelling in the side of her face, neck and upper arm on the side she got the vaccine as well as pain and debilitating weakness which even extended to the leg. She has been getting Physical and Occupational Therapy.
2Like

Jen Dieckhaus
2 days ago

I am so happy to find this website. It is scarey to me that there are so few sites about the aftermath of the vaccine. They only have a few "immediate reaction" (arm swelling) sites. I have an autoimmune disorder and was taking cosentyx (6 mo) when I received my first Pfizer vaccine in Feb. I had no immediate reaction but since then I have debilitating fatigue and the worst brain fog ever. I have stopped the cosentyx because this is so scarey. There is not a day my mind feels sharp or I can make it 8 hrs without exhaustion. I have stopped working at my job of 27 years in the medical field because I cant trust my decision making. I do get numbness in my hands and legs now. I get very cold alot for no reason. I have been to the MD all with all normal blood tests so no one seems concerned. I pray every night to wake up the person I was a year ago.
7Like

Laura Leffel
22 hours ago

@Jen Dieckhaus I have an autoimmune disease and that's why I wouldn't get the vaccine. I pray that you will recover.
3Like

Dr. cassandra balomiri
5 days ago

I'm asking myself when this all have an end? Two weeks after Astra Zeneca i woke up with dizziness...it was rather oscillopsia, permanently as i moved. Then one week later i developed paresthesia...first the right part of my face, then alway a different pattern, i just woke up in the morning with both arms tingling/ 2 arms and a leg/ just a leg or an arm/ just a few fingers...for a short period of time ( like 2 days) i also had visual problems...then just weird feelings in my limbs, like some sort of mild numbness, always alterning the link and right side of the body...i just could not belive it...not to mention that my heart rate was about 120/min like weeks ( i admit it could have been caused by all that anxiety which come after i developed those neurologic issues).

I have been to ORL, Neurologist, Cardiologist, Eye MD... had a lot of blood samples ( looking for causes for paresthesia), MRI Head and Neck, nerve conduction study ( thought could be MS)...all clear ( just some vit D deficiency)...after a few weeks ( 6-8) it started getting better, now the dizziness is gone, i wake up sometimes with 2-3 fingers tingling....but i started developing muscle twitches...just horribe...i twitch in different parts of the body, mostly back, shoulders and legs...been twitching for 4 weeks now...I took an emg, everything normal. The Paul Ehrlich Institute was informed ( Germany). I'm not against vaccines but this was the most horrible experience of my life...and is not over yet...i hope twitches won't last too much....
9Like

Mark Wilson
4 days ago

I've had some similar symptoms following my 1st AZ vaccine on 13 April. I had the usual side effects the day after then a week or two later I started getting regular Raynauds attacks 2-3 times a day (I have had these previously but only once every week or two.

About 3 weeks after my vaccine, I started getting severe tremor on standing (after being seated at my desk for 2-3 hours), which felt like a full-on panic attack. A couple of days later I had a mild palsy in the left of my face and then started getting continous twitching/fasciculations in all my leg muscles, particularly obvious in the calfs. This spread to my arms but only to a very low degree.

Over the course of the next week, the severe tremors stopped, although I do get a tightness (like a feeling of anticipation) at times, the tremors are still continuing 24/7 although to a lesser degree.

I've had a couple of days of severe sweating of my feet, one day of continuous paresthesia in the soles of both feet, occasional oscillopsia, muscle weakness, high blood pressure

As of today, almost 7 weeks post vaccine, I've still got a continuous low level of muscle twitching, muscle weakness (struggling to run 5k when I'm used to running 90-100k a week) and some very slight oscillopsia - I don't feel dizzy, but I don't feel quite balanced and eyesight focus is a fraction too slow.

Hopefully if AZ gets enough reports, they'll start to look into it, although it took a while and a fair bit of external pressure before the rare clotting was accepted. I've reported my symptoms in the UK and awaiting a referral from my own GP to a neurologist, although given what others are saying, they're unlikely to find anything obviously wrong.

I have seen speculation (and this is not my area of expertise) that the spike protein in the vaccine may on rare occasions cause adverse reactions in the ACE2 receptors in the endolithial cells in the blood vessels. I think it's been established that the actual COVID virus spikes does this which causes the wide range of cardiopulmonary problems. Have to wait and see
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jenn gerrity
5 days ago

i received my first dose of moderna on April 23rd, second on May 21st. The first shot my arm blew up and I had muscle soreness for about three days. My fatigue was very strong to the point where I wasn’t able to physically concentrate for two days following. On day three of the first shot as I was trying to go to bed I started convulsing and having muscle spasms. This went on for about an hour to the point where I couldn’t even get up to walk around or leave my bed in general. When I was finally able to get up and look at myself I had noticed that my face was completely white to the point that I thought I was going to faint or pass out. My anxiety in between the first and second shot was very extreme to the point that I wasn’t able to concentrate and I gave myself multiple panic attacks. My second shot was just about the same as the first. The second shot I also had extreme fatigue to the point where I slept continuously for two days straight. Again on day three I had the muscle spasms but they only lasted about a half an hour compared to one hour like the first one. Following that for another two days I had an excruciating headache that lasted me all day, that not even Tylenol, sleeping long periods of time, resting or drinking water could help. After day five I was fine, so far I am good but still concerned and questioning my long-term side effects
...

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Re: On mRNA/Gene Therapy

Postby Belligerent Savant » Wed Jun 09, 2021 2:06 pm

.

One important point, Re: the above Medscape link, which I should have included in my quoted excerpt:


Commenting is limited to medical professionals.
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Medical professionals. Not anonymous 'cranks'. (unless you're willing to entertain the notion that a number of these are 'spoofed' accounts. Quite a bit of work for minimal gain).

https://www.medscape.com/sites/public/c ... -Joo6NN5zs

A few more recent comments below while I'm here. And keep in mind: these are all near-term reactions. There is no data yet on lingering effects 12+ months in. The hope is adverse effects will be minimal and/or the body can eventually 'flush out' these issues, rather than have them linger and contribute to, or hasten, illness.

473 comments

Dr. Brian Lenzkes
2 hours ago

I have seen very similar cases with neurologic changes. One case of severe ataxia in an elderly male 2 wks post Pfizer vaccination. I know of a 28 year old (not under my care, I take care of his parents) admitted for acute onset seizures 3 hrs post vaccination and severe tachycardia..no risk factors and negative workup. One of my former patients, extremely healthy with normal labs died suddenly 8 days after 2nd vaccination---family decided against autopsy. Most patients have not had these side effects.
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Dr. Deborah Malatesta

11 hours ago

Had AZ no issues.
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Tevin Thompson
12 hours ago

I have been having issues with full body convulsions and twitching accompanied with cognitive impairment. It's also felt like my face has been constantly hot or on fire and I'm not sure how to describe it really. I got the first dose of the vaccine on the 26th of April and things haven't gotten any better since then. I wonder if anybody's experienced something similar?
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Khursheed Kang
5 hours ago

@Tevin Thompson hi Tevin, this tremors is apparently showing up more and more as time goes and there is a reason - do check Prof Bhakdi's explanation(he really explains well) on this in particular and other side effects by searchin in youtube either his name and Perspectives on the Pandemic "Blood Clots and Beyond or his interview by Thinking Slow there too.. i would do more research before getting the second doze if i were u.. seriously dont trust blindly the med. organisations (wont name them but u prob know which are the main ones).. stay safe !
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Dr. Candice Black
17 hours ago

I also have been having lower leg muscle twitching. It is associated with a feeling of anxiety and prevents sleep. I worry about ALS and other serious diseases, but wonder if this could be vaccine related. I had 2 doses of the Pfizer vaccine. The timing is consistent with other posts. Sounds like a diagnosis of elimination. It doesn't seem to be going away. Only getting worse.
3Like

Dr. cassandra balomiri
12 hours ago

Those were my worries, too. That's why I took an emg. But nothing helped me calm down like these posts...i see many people experienced twitching. Mine are finally almost gone after 5 weeks. I don't know if they simply dissapeared or is because I started massaging the muscles like ten times a day :))) ( i was totally desperate) this triggered some weird muscle pain in all muscles and the twitches diminished/ almost disappeared the next days...anyway what really disturbes me is that there are no official datas about those reactions, even so many people officially reported them...it would help many others maybe calm down and stop thinking that they have such diseases like ALS/ MS/etc. For me it was a nightmare like the next 3 months after vaccination, I really felt i was getting crazy having the feeling that i am the only one experiencing such reactions/ i have some grave disease.
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Re: On mRNA/Gene Therapy

Postby Karmamatterz » Wed Jun 09, 2021 5:01 pm

Excellent posts and link BS. Thank you for taking the time to help share information like this.
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Re: On mRNA/Gene Therapy

Postby Belligerent Savant » Thu Jun 10, 2021 1:52 pm

.

Appreciate the sentiment, KM. Perhaps of minimal consequence, at least in this space.

Meanwhile, another despicable act out there in the wild. Read the dishonest language in the comment from the CEO. The purposeful misinterpretation of metrics and misleading commentary:

Houston Methodist suspends 178 unvaccinated employees

CEO Dr. Marc Boom said 27 of the 178 have received the first of a two-dose vaccine and won’t be fired if they get their second. The rest are subject to termination.


Below is the full statement from Dr. Boom:

"Congratulations to all! As of today, we are nearly 100% compliant with our COVID-19 vaccine mandate with 24,947 of us being fully vaccinated. Houston Methodist is officially the first hospital system in the country to achieve this goal for the benefit of its patients.

"Yesterday marked the deadline to be fully compliant, and I want to personally thank you and update you on where we stand now. We had only 178 full-time or part-time employees who did not get fully vaccinated or were not granted an exemption or deferral. Of these employees, 27 have received one dose of vaccine, so I am hopeful they will get their second doses soon. Of our employees, 285 received a medical or religious exemption, and 332 were granted deferrals for pregnancy and other reasons.

"The small percentage of employees who did not comply with the policy are now suspended without pay for the next 14 days. We won’t have the final numbers for two weeks as employees can still get vaccinated with their second dose or with the one-dose Johnson & Johnson vaccine. I wish the number could be zero, but unfortunately, a small number of individuals have decided not to put their patients first.

"I couldn’t be prouder of all of you as I know that for some, this was a very difficult decision. I want to personally thank you for choosing to get vaccinated. You did the right thing. You protected our patients, your colleagues, your families, and our community. The science proves that the vaccines are not only safe, but necessary if we are going to turn the corner against COVID-19. The mRNA technology behind the Pfizer and Moderna vaccines isn’t new or experimental. It’s been around for many years. With more than 300 million doses distributed in the United States alone, the vaccines have proven to be extremely safe. The number of both positive cases and hospitalizations continue to drop around the country, too, proving the vaccines’ efficacy.

"While we celebrate this remarkable accomplishment, I know that today may be difficult for some who are sad about losing a colleague who’s decided to not get vaccinated. We only wish them well and thank them for their past service to our community, and we must respect the decision they made.

"Since I announced this mandate in April, Houston Methodist has been challenged by the media, some outspoken employees and even sued. As the first hospital system to mandate COVID-19 vaccines we were prepared for this. The criticism is sometimes the price we pay for leading medicine. As of today, several other major health care centers have followed our lead and have announced their own vaccine mandates, with many more to follow soon.

"Seven years ago I introduced the “six words” into our culture – unparalleled safety, quality, service and innovation. At that time, we made the commitment to become the number 1 health care system in the world. You can’t say you’re going to be unparalleled and then not be willing to do the things to actually make you unparalleled. Even when those things are difficult.

"This decision was ultimately made for our patients, as they are at the center of everything we do at Houston Methodist. It should bring you great satisfaction to know that your actions will help keep patients as safe as possible when they come to us for care. You have fulfilled your sacred obligation as health care workers, and we couldn’t ask for more dedicated, caring and talented employees. Thank you."


https://www.khou.com/article/news/local ... 9a32fc0875

AND:

...

What happens after the two weeks is unknown, according to the Daily Mail.

Meanwhile, 117 employees are suing the hospital, claiming that they've been pressured into becoming 'human guinea pigs'.

Earlier this month, 117 employees sued Houston Methodist, claiming the hospital 'is forcing its employees to be human 'guinea pigs' as a condition for continued employment,' reported KHOU 11 last month.

They also claim coronavirus vaccines are 'experimental,' because they have only received emergency use authorization and not full U.S. Food and Drug Administration (FDA) approval.

The federal government's Equal Employment Opportunity Commission ruled in December 2020 that employers could legally set vaccine requirements for their workforce. -Daily Mail


Hospital staff were first given until mid-April before the deadline was extended to early June, with $500 bonus payments offered to employees who got vaccinated early. At the time, two employees chose to leave the hospital instead of getting vaccinated. Those with religious or health exemptions had until May 3 to apply for a waiver. According to the Washington Post, 285 employees were given medical exemptions, while 332 received medical deferrals.

"No one should be forced to put something into their body if they're not comfortable with it," nurse Jennifer Bridges told The Texan. Bridges has worked at Houston Methodist for over six years, and is leading the lawsuit.

"People trying to force you to put something into your body that you're not comfortable with, in order to keep your job, is just insane," she told KHOU11 last month, adding "I'm not an anti-vax person. If you want to get it, by all means, get it. I don't take that away from anybody Just let everybody have a choice and the right to make their own decision."

Bridges and the group of employees are being represented by Jared Woodfill from the Houston-based Woodfill Law Firm.

Woodfill told KHOU that his firm filed a declaration action, asking the court to declare the hospital's orders illegal.

He argues that the vaccine is an experimental product, and that it should not be legal to force employees to receive it.

'[The vaccine] that's been on the market for less than a year. And yes, it's being used under EUA, but at the same time, that is experimental by definition,' he said.

'You can't fire someone for refusing to do something illegal, and if you look at federal law, it makes it very clear that it's illegal to force someone to participate in a vaccine trial.' -Daily Mail


https://www.zerohedge.com/covid-19/over ... 19-vaccine
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Re: On mRNA/Gene Therapy

Postby Grizzly » Thu Jun 10, 2021 5:21 pm

On the other hand...

They aren't identifying, investigating, reporting, monitoring, tracking, scrutinizing, or counting any data for vaccinated people in the official numbers unless they are hospitalized or died.
https://www.bloomberg.com/news/articles/2021-05-09/cdc-limits-reviews-of-vaccinated-but-infected-spurring-concerns
“The more we do to you, the less you seem to believe we are doing it.”

― Joseph mengele
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Re: On mRNA/Gene Therapy

Postby stickdog99 » Thu Jun 10, 2021 7:01 pm

https://trialsitenews.com/did-pfizer-fa ... al-trials/

Did Pfizer Fail to Perform industry Standard Animal Testing Prior to Initiation of mRNA Clinical Trials?

TrialSite has learned of material information regarding mRNA vaccine safety revealed by a freedom of information act (FOIA) request filed by a group of Canadian physicians. These doctors have become concerned about COVID-19 mRNA vaccine safety. This new safety information involves the Pfizer mRNA-based vaccine known as BNT162b2 or “Comirnaty.” The FOIA documents reveal animal study results demonstrating that the Pfizer mRNA-based vaccine does not remain at the injection site, but rather appears to spread widely after injection. According to the documents, pre-clinical studies show that the active part of the vaccine (mRNA-lipid nanoparticles), which produce the spike protein, spreads throughout the body and is then concentrated in various organs, including the ovaries and spleen. The FOIA-produced data sets are incomplete, so the full meaning of these data cannot be determined at this time. TrialSite has also learned via regulatory documents that apparently (at least in their European Medicines Agency submission), Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies during vaccines, as key studies did not meet good laboratory practice (GLP). The full panel of industry-standard reproductive toxicity and genotoxicity studies were apparently also not performed. But does this matter in light of the risk-benefit analysis associated with regulatory emergency use authorization (EUA)?

Recently, there has been speculation regarding potential safety signals associated with COVID-19 mRNA vaccines. Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. Women have reported changes in menstruation after taking mRNA vaccines. Problems with blood clotting (coagulation) – which are also common during COVID-19 disease – are also reported.

Among the most critical tests, which must be performed prior to testing any drug or vaccines in a human being, is whether it can cause mutations in the DNA (genotoxicity), or whether it could cause problems with cells or tissues of the reproductive tract – including ovaries (reproductive toxicity). In the case of the Pfizer COVID mRNA vaccine, these newly revealed documents raise additional questions about both the genotoxicity and reproductive toxicity risks of this product. Standard studies designed to assess these risks were not performed in compliance with accepted empirical research standards. Furthermore, in key studies designed to test whether the vaccine remains near the injection site or travels throughout the body, Pfizer did not even use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA producing the luciferase protein.

These new disclosures seem to indicate that the U.S. and other governments are conducting a massive vaccination program with an incompletely characterized experimental vaccine. It is certainly understandable why the vaccine was rushed into use as an experimental product under emergency use authority, but these new findings suggest that routine quality testing issues were overlooked in the rush to authorize use. People are now receiving injections with an mRNA gene therapy-based vaccine, which produces the SARS-CoV-2 spike protein in their cells, and the vaccine may be also delivering the mRNA and producing spike protein in unintended organs and tissues (which may include ovaries). Unfortunately, there is no way to know if this is related to vaccine safety signals or reports of menstrual irregularities; the required studies were either not done or not done properly.

How mRNA Vaccines are Believed to Work

The current mRNA vaccines are theorized to act locally in draining lymphoid tissue. Formulated lipid nanoparticles that contain mRNA able to produce the spike protein are syringe injected into a muscle such as the deltoid (shoulder muscle). Once the injection occurs, the muscle cells near the injection site are impacted by the mRNA-based vaccine (e.g. the lipid nanoparticles), while much of the dose moves into the intracellular fluid surrounding the muscle cells and consequently drains to lymph nodes (see for example here).

According to this theory, a properly functioning mRNA-based vaccine is delivered into and drives production of the SARS-CoV-2 Spike protein in muscle and lymph node cells. The cells then produce the Spike protein, which is then moved to the surface of these cells where it becomes attached. The foreign virus Spike protein then triggers the immune system to recognize and attack any cell in the body that is either infected by SARS-CoV-2 or has Spike protein on its surface. The vaccine was designed so that the Spike protein is affixed via a transmembrane anchor region, so that it cannot circulate around the body via the bloodstream (see here). The same general scenario applies to all mRNA-based vaccines as well as recombinant adenoviral vectored vaccines (such as the J&J vaccine) designed to use gene-therapy technology to express Spike protein in cells and tissues. This general strategy is designed to reduce the risk that any residual vaccine dose that does somehow end up in the bloodstream (or organs and tissues) ends up not being a safety risk due to unintended biologic effects. Spike protein will remain affixed to cell surfaces, and therefore is not released into the blood where circulating Spike might cause problems by binding to its natural target, ACE-2 receptors. However, any cell that has Spike protein (or protein fragments) anchored on its membrane or displayed on MHC antigen-presenting molecules becomes a target for vaccine-activated immune cells and antibodies, which would then attack, damage or kill those cells in the same way that SARS-CoV-2 virus-infected cells would be attacked. In other words, if very active mRNA delivery particles or recombinant adenoviral-vectored vaccines spread throughout the body, the resulting production of the vaccine antigen (Spike, in this case) will both stimulate immunity and also cause those same cells to be attacked by the immune system. If this actually happens, the resulting “vaccine reactogenicity” could resemble clinical symptoms seen with autoimmune syndromes.

EMA Pfizer/BioNTech Vaccine Distribution Studies

As standard practice, the European Medicines Agency (EMA) discloses their assessment of investigational new drug (IND) submissions. In the case of the Pfizer-BioNTech “Comirnaty” vaccine, the EMA assessment can be found on the Web here. This document includes a summary of EMAs evaluation of the non-clinical vaccine distribution studies reported to EMA by Pfizer-BioNTech. These studies were carried out using two methods: 1) use of mRNA producing the luciferase protein and 2) use of radioactive label to mark the mRNA (a more sensitive approach). These studies reveal that the majority of radioactivity initially remains near the injection site. However, within hours, a subset of the stabilized mRNA-containing particles become widely distributed throughout the bodies of test animals.

Upon inspection of the EMA summary document, TrialSite found evidence suggesting that the issue of biodistribution and pharmacokinetics of the “Comirnaty” BNT162b2 vaccine was not thoroughly examined in accordance with industry norms prior to the EMA review of the BNT162b2 IND/CTD. The reviewers share an explicit admission that “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” Rapporteur (Filip Josephson) and Co-Rapporteur (Jean-Michael Race) suggest, however, that Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and suggest that “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.” However, the studies that were performed and submitted were non-GLP. Additionally, the EMA document states “Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350, indicate a broader biodistribution pattern.” This EMA observation corresponds with what appears to be a growing number of adverse events and aligns with data TrialSite observed via the FOIA showing concentrations of LNP-formulated RNAs in the spleen, for example.

To obtain independent reviews of these EMA regulatory documents, TrialSite contacted both Dr. Robert W. Malone, MD, MS, and another expert that wished to remain anonymous, and provided them copies of the EMA analysis and the FOIA documents. Dr. Malone was the original inventor of the mRNA vaccine technology back in the late 1980s. He currently advises several companies in regulatory affairs and clinical development. One of TrialSite’s other sources is a senior regulatory specialist who currently serves as the President of a prestigious European association. When asked to review and comment on the EMA assessment, Dr. Malone noted that normal pharmacokinetic and pharmaco-toxicology studies had not been performed before EUA authorization for the product. “I was particularly surprised that the dossier of regulatory documents indicates allowance for use in humans based on non-GLP PK and Tox studies relying on formulations which are significantly different from the final vaccine.“ After completing a review, TrialSite’s other source noted the following:

“A quick review the Toxicology Section (2.3.3) of The European Medicines Agency (EMA) Assessment Report on Comirnaty (COVID-19 mRNA vaccine) issued on 19 February 2021, raises concerns about data applicability of preclinical study findings to clinical use:

To determine the biodistribution of the LNP-formulated modified mRNA (modRNA), the applicant did study distribution of the modRNA in two different non-GLP studies, in mice and rats, and determined the biodistribution of a surrogate luciferase modRNA.

Thus, one might question the validity and applicability of non-GLP studies conducted using a variant of the subject mRNA vaccine.

In addition, no genotoxicity data were provided to EMA.”

Based on the FOIA documents, the biodistribution results (which are not disclosed in the public EMA summary document) suggest that the delivery technology results in mRNA delivery and significant concentration of the delivery lipids in ovaries, spleen, and other tissues and organs.

Urgent Emergency?

The discovery and review of the biodistribution and pharmacokinetics data obtained by the FOIA request underscores the reservations disclosed in the public EMA assessment. Although not performed to industry GLP standards, these results seem to indicate that lipid/mRNA nanoparticles, which code for the Spike protein, circulate throughout the body and then collect in a variety of organs and tissues, including the spleen and ovaries. This means that the vaccine is not remaining localized near the injection site and draining lymph nodes, but rather is also circulating in both blood and lymph and is subsequently concentrating in important organs. If this results in Spike protein being produced in unintended places including the brain, ovaries, and spleen, it may also be causing the immune system to attack these organs and tissues.

What’s the Risk?

According to official government accounts, minimal risk is associated with this vaccine when compared to the risks of COVID-19 infection. That’s why the U.S. FDA approved the Emergency Use Authorization (EUA) based on a risk-benefit analysis. TrialSite, a vaccine proponent, only raises the issue to ensure full disclosure of any material safety implications to our readership, including clinicians, clinical research safety committees, and public health professionals.

While, according to the CDC’s VAERS database, over 4,000 deaths have been entered in association with all the vaccines, the US government argues that none of these deaths are formally linked to the jabs. About 291 million people have been vaccinated to date, hence overall reported adverse event risk is low. While it is true that many people are completely unscathed, the discovery of these documents and associated information may alter the risk-benefit assessment underlying the EUA decision.

TrialSite is aware that one must be particularly cautious about publishing or communicating speculations that might raise skepticism about vaccine use. Should researchers handle findings differently when there is a chance they might frighten the public? Perhaps small, inconclusive, worrying studies should not be published because they could do more harm than good. Dr. Paul Offit, Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, states: “Knowing that you’re going to scare people, I think you have to have far more data.”

One could argue that even an inconclusive paper can be important, as it can spur the larger, more definitive studies that are needed. It should be “put out there for the scientific community, to look at it, see it, know about it, refine study design and go and look again,” says Gregory Poland, a renowned Mayo Clinic vaccinologist and the Editor-in-Chief of Vaccine. It is crucial, though, for researchers to carefully explain such results in their papers and regulatory filings to prevent misinterpretation or misunderstandings.

Other Relevant New Data

A recent study led by researchers at Brigham and Women’s Hospital and the Harvard Medical School measured longitudinal plasma samples collected from 13 recipients of the Moderna vaccine. The manuscript has been accepted for publication by “Clinical Infectious Diseases” and the pre-print is available here. Out of these individuals, 11 revealed detectable levels of SARS-CoV-2 protein as early as day one right after first vaccine injection. The authors considered that to be normal clearance.

Clearance of detectable SARS-CoV-2 protein correlated with production of IgG and IgA. Measured mean S1 peak levels were 68 pg/mL ±21 pg/mL, and mean spike peak level was 62 pg/mL ± 13 pg/mL. Assuming an average adult blood volume of approximately 5 liters, this corresponds to peak levels of approximately 0.3 micrograms of circulating free antigen for a vaccine designed to only express membrane-anchored antigen. For comparison purposes, most influenza vaccines administer a total of about 15 micrograms of HA antigen per influenza strain. Total levels of antigen expressed by the experimental SARS-CoV-2 mRNA vaccines currently administered to patients are not known.

Root Cause Analysis Suggested

A root cause assessment is suggested to better understand if any of this information adjusts or modifies the EUA risk-benefit analysis. TrialSite suggests that regulators and pharma manufacturers at least review and assess the risk that foreign mRNA-based spike protein delivery and expression in tissues and organs distal to the actual injection site may be contributing to the unusual reactogenicity and adverse event profile associated with these products. The uptake in vaccination rates has slowed in the United States in part due to vaccine hesitancy. However, such a phenomenon can be overcome with acknowledgment, transparency, and continuous commitment to risk mitigation.
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Re: On mRNA/Gene Therapy

Postby drstrangelove » Sat Jun 12, 2021 7:40 am

https://vestibular.org/forum/dizziness/ ... e-effects/
Active community support forum for people self reporting longer term headaches and dizziness post vaccination.
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Re: On mRNA/Gene Therapy

Postby Belligerent Savant » Sat Jun 12, 2021 8:04 am

^^^^

Thanks for that link. I'm going to share 2 of the comments here, principally because it includes a statement that i've noticed on numerous self-reports of side-effects on social media, where the individual reaffirms how 'grateful' they are to have taken the shot despite the side effects and that 'everyone should take it too'.

It's deeply disturbing and pathological. There is some serious trauma and mindfuckery being perpetrated on people (years in the making propaganda Re: blind allegiance to the pharma/vaccine gods).

A virus with a ~99% survival rate for most, and in many instances, those who catch the virus have mild flu symptoms, or no symptoms at all. How is it that so many are willing to submit their bodies for an experimental shot with numerous reported near-term side effects, ZERO data on long-term issues, and on top of that continue to believe they were fortunate to have received the shot?

Deeply troubling and disturbing, the extent of the conditioning.


Jeanieb
New Member

Joined: 3 months ago Posts: 2
March 2, 2021 12:59 pm

Me too.

Had first Moderna and no issues other than covid vaccine arm which came up about 9 days later and last about 5 days.

2nd shot was this past Saturday, February 27th ...did not even feel the shot. That was midday. By night I had a headache and felt off. On Sunday am woke up with bad headache and then added 101.9 fever, aches, chills, nausea.

The next day, Monday, woke up extremely dizzy and thought I would fall for sure. I have been dizzy since. And also an upset and painful stomach but I think that may be subsiding. My husband did the Epley Maneuver on me twice yesterday and I put on a neck brace. I can't tell if it helped or I am just getting used to careful maneuvering. It's definitely not gone. My dr said it should go away. I have an appointment anyway with her on March 23rd. I will continue the maneuver until it stops or I see the dr. and get further advice or a rec.

Has anyone's subsided yet? Please please post if so....or even if not. This is literally the only place I found that mentions this in a specific way.

I am still very grateful for the vaccine and would get it again. I am just hoping this passes sooner rather than later.

Jeanieb




Gunny
New Member
Joined: 4 months ago Posts: 1

February 23, 2021 11:37 am

So happy and lucky to get the vaccine!! Everyone should get it!

I received the 1st shot an hour ago and am feeling more and more dizzy for sure. Two years ago, I was diagnosed with Ocular Vestibular Dysfunction due to a complicated TBI that turned into Post-Concussion Syndrome. I moved to Phoenix shortly after the diagnosis because Dr. Javier Cardenas, founder of the Barrow Concussion and Brain Injury Center, accepted me as a patient. It is fascinating what they are doing down there! Holistic stuff. His guidance and the continual rehab helped me immensely and I am still working with Vision Therapy and the like. In any case, I am glad to have found this site and look forward to learning more about the community when I have some time. I am a former athlete and can no longer live at 8000 feet elevation. I will be posting a question soon that involves oxygen saturation and labile hypertension.

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Re: On mRNA/Gene Therapy

Postby streeb » Sat Jun 12, 2021 1:46 pm

Yes, what a depressing ritual: tribute paid to the infallibility of The Narrative and all its untouchable players is the hard requirement before expressing even measured skepticism, doubt, or concern. Anything else and people think you need to be sectioned.

Anyway, has this been posted yet?

Urgent Preliminary Yellow Card Report on Data up to 26 May 2021

Dear Dr Raine,

RE: Urgent preliminary report of Yellow Card data up to 26th May 2021

As the Director of the Evidence-based Medicine Consultancy Ltd and EbMC Squared CiC, I am writing to share with you this urgent preliminary report on the Yellow Card data up to 26th May 2021. Please note that EbMC Squared CiC is a Community Interest Company that conducts research mandated by the public and funded by public donations. We have no conflicts of interest and do not engage in industry-funded work.

The MHRA describes the purpose of its Yellow Card system as providing “an early warning that the safety of a medicine or a medical device may require further investigation. It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about.”

Furthermore, the MHRA recognises that the conditions under which medicines are studied in clinical trials do not reflect how the medicines will be used in hospitals or clinical practice once they are rolled out. This Means that some adverse drug reactions “may not be seen until a very large number of people have received the medicine.”

The Covid-19 vaccines were rolled out in the UK on the 8th of December 2020. As of the 6th May 2021 nearly 39 million people have received their first dose of the Covid-19 vaccine, and 24 million both doses. Sufficient data have now accumulated to get a good overview of adverse drug reactions (ADRs). I would, therefore, like to draw your attention to the high number of covid-19 vaccine-attributed deaths and ADRs that have been reported via the Yellow Card system between the 4th January 2021 and the 26th May 2021. In total, 1,253 deaths and 888,196 ADRs (256,224 individual reports) were reported during this period.

To facilitate a better clinical understanding of the nature of the adverse events occurring, primarily to inform doctors at the frontline, we have searched the Yellow Card reports using pathology-specific key words to group the data according to the following five broad, clinically relevant categories:

A. Bleeding, Clotting and Ischaemic ADRs

B. Immune System ADRs

C. ‘Pain’ ADRs

D. Neurological ADRs

E. ADRs involving loss of Sight, Hearing, Speech or Smell

F. Pregnancy ADRs

After running each search, we entered the results into an Excel spreadsheet, excluding ADRs that were clearly irrelevant or appeared in duplicate. These spreadsheets will be used going forward to facilitate the weekly monitoring of Yellow Card data. We recognise that keywords may need expanding to capture category relevant ADRs that may have been missed in this preliminary ADR scope and analysis.

A. Bleeding, Clotting and Ischaemic Adverse Drug Reactions

We used the following SEARCH TERMS to identify bleeding, clotting and ischaemic ADRs: bleed, haemo*, thrombo*, emboli*, coag*, death, ischaem*, infarct*, angina, stroke, cerebrovascular, CVA.

We included the term ‘death’ in this search group, as this term accounted for many reported fatalities (438) without specific details. Given the large number of fatalities without a specific cause of death, we considered that ADRs reported in this way, in particular as ‘sudden death’, would be most likely to occur from haemorrhagic, thrombo-embolic or ischaemic events. Given the seriousness of this ADR, we considered it justifiable to do this pending a Freedom of Information (FOI) request to clarify the cause of death in these 438 people.

Using these search terms, 13,766 bleeding, clotting and ischaemic ADRs were identified – 856 of which were fatal. Government reports have highlighted the occurrence of cerebral venous sinus thrombosis, apparently accounting for 24 fatalities and 226 ADRs up to the 26th May 2021.However, our analysis indicates that thromboembolic ADRs have been reported in almost every vein and artery, including large vessels like the aorta, and in every organ including other parts of the brain, lungs, heart, spleen, kidneys, ovaries and liver, with life-threatening and life-changing consequences. The most common Yellow Card categories affected by these sorts of ADRs were the nervous system (152 fatalities, mainly from brain bleeds and clots), respiratory (with 103 fatalities, mainly from pulmonary thromboembolism) and cardiac categories (81 fatalities).

B. Immune System Adverse Drug Reactions (Infection, Inflammation,Autoimmune, Allergic)

We used the following SEARCH TERMS to identify immune system ADRs: INFECTION (category), IMMUNE DISORDERS (category), -itis; immun, multiple sclerosis, lupus, myasthenia, pernicious, diabetes, Addison, Crohn’s, Coeliac, Graves, alopecia, amyloidosis, antiphospholipid, angioedema, Behcet’s, pemphigoid, psoriasis, aplasia, sarcoidosis, scleroderma, thrombocytopenia, vitiligo, Miller Fisher, Guillain-Barre; allerg*, urticaria, rash, eczema, asthma.

To the 26th May, a total of 54,870 ADRs and 171 fatalities fell into this category, which comprised the second most common cause of post-vaccination fatalities after ‘Bleeding, Clotting and Ischaemic ADRs’. However, only 4 associated fatalities were reported under the Yellow card ‘IMMUNE DISORDERS’ category, with the majority (141 fatalities associated with 19,474 ADRs) reported under the ‘INFECTIONS’ category. Among 1,187 people for whom post-vaccination COVID infection was reported, there were 72 fatalities (6% of reported COVID infection ADRs).

Many ‘INFECTION’ category ADRs indicated the occurrence of re-activation of latent viruses, including Herpes Zoster or shingles (1,827 ADRs), Herpes Simplex (943 ADRs, 1 fatal), and Rabies (1 fatal ADR) infections. This is strongly suggestive of vaccine-induced immune-compromise.Bell’s palsy, also associated with latent virus reactivation, is reported in the Neurological ADRs section of this report (D). Also suggestive of vaccine-induced immunocompromise was the high number of immune-mediated conditions reported, including Guillain-Barré Syndrome (280 ADRs, 6 deaths), Crohn’s and non-infective colitis (231 ADRs, 2 deaths) and Multiple Sclerosis (113 ADRs).

Allergic responses to the vaccines comprised 25,270 reported ADRs, with 4 fatalities occurring among 1,001 people experiencing anaphylactic reactions.

C. ‘Pain’ Adverse Drug Reactions

We used the following SEARCH TERMS to identify pain ADRs: pain, -algia.

Pain ADRs accounted for at least 157,579 ADRs (18%) in total. A large number of these were arthralgias (joint pains – 24,902 ADRs) and myalgias (muscle pains – 31,168 ADRs), including fibromyalgia (270 ADRs), a long-term condition that causes pain all over the body. Among Congenital Disorders (usually conditions present from birth) there were 11 reports of Paroxysmal Extreme Pain Disorder (PEPD), which is an extremely rare inherited disease caused by a genetic mutation leading to dysfunction of voltage-gated sodium channels. The head was the most common location for pain, but abdominal pain, eye pain, chest pain, pain in extremities, and anywhere else that pain can be imagined was reported. Headaches were reported more than 90,000 times and were associated with death in four people (excluding deaths reported to be from other causes, that may also have involved headache).

D. Neurological Adverse Drug Reactions

In addition to examining ADRs in the NERVOUS SYSTEM DISORDERS (category), we used the following SEARCH TERMS to identify neurological ADRS specifically involving paralysis,neurological degeneration, and convulsive ADRs as follows: (paralysis), palsy, paresis,neuropathy, incontinence, Guillain-Barre, Miller Fisher, multiple sclerosis; (neurodegeneration)encephalopathy, dementia, ataxia, spinal muscular atrophy, delirium, Parkinson; (seizure),convuls, seizure, fit, -lepsy

Twenty-one percent (185,474) of ADRs were categorized as Nervous System Disorders in theYellow Card system. A wide variety of neurological ADRs were noted, including 1,992 ADS involving seizures and 2,357 ADRs involving some form of paralysis, including Bell’s palsy (626ADRs). Other ADRs involving encephalopathy (18), dementia (33), ataxia (34), spinal muscular atrophy (1), Parkinson’s (18) and delirium (504) may reflect post-vaccination neurodegenerative pathology.

The majority of fatalities associated with Nervous System ADRs occurred as a result of central nervous system haemorrhages – 127 fatalities out of the 186 fatalities reported as Nervous System fatalities. These 127 have been counted in group A (Bleeding, clotting and IschaemicADRs).More information is needed to determine the extent of the morbidity associated with this alarmingly large category of ADRs. Access to the full Yellow Card database and consultation with clinical specialists, along with follow up of these reports, is urgently needed.

E. Adverse Drug Reactions involving loss of sight, hearing, speech or smell

We used the following SEARCH TERMS: speech, taste, smell, olfactory, blind, sight, visual,vision, deaf, hearing.

There were 4,771 reports of visual impairment including blindness, 130 reports of speech impairment, 4,108 reports of taste impairment, 354 reports of olfactory impairment, and 704 reports of hearing impairment.

F. Pregnancy Adverse Drug Reactions

Given that vaccinated pregnant women comprise a small proportion of the vaccinatedpopulation in the UK up to 26th May 2021, there appear to be a high number of Pregnancy ADRs(307 ADRs), including one maternal death, 12 stillbirths (reported as 6 stillbirths and 6 foetaldeaths, but only 3 listed as fatal(?)), one newborn death following preterm birth, and 150spontaneous abortions. We have submitted a FOI request as to the cause of the maternal death and will look into pregnancy and congenital ADRs in more detail in our next report.

Limitations of this rapid reportThis report is not comprehensive, and analysis of Yellow Card data is ongoing. The process of defining the search terms was iterative and we trust that it provides a basis for discussion among clinicians and scientists. We have not compared the frequencies of ADRs between different vaccines; however, our impression is that ADRs were not limited to any particular vaccine brand(AstraZenenca, Pfizer and Moderna) or type (mRNA and DNA) currently used in the UK. UK ADRdata mirror data reported on the World Health Organization’s pharmacovigilance database (http://www.Vigiaccess.org). On the latter, most reported ADRs to date (941,774 ADRs and 5,474deaths) have occurred among individuals in the 18 to 44 years and 45 to 64 years of age categories (38% and 35%, respectively); the vast majority (72%) of reported ADRs have occurred among women. Unfortunately, we have been unable to examine the UK Yellow Card data according to age and gender due to lack of data availability.

We are aware of the limitations of pharmacovigilance data and understand that information on reported Adverse Drug Reactions should not be interpreted as meaning that the medicine in question generally causes the observed effect or is unsafe to use. We are sharing this preliminary report due to the urgent need to communicate information that should lead to cessation of the vaccination roll out while a full investigation is conducted. According to the recent paper bySeneff and Nigh (1), potential acute and long-term pathologies include:

• Pathogenic priming, multisystem inflammatory disease and autoimmunity

• Allergic reactions and anaphylaxis

• Antibody dependent enhancement

• Activation of latent viral infections

• Neurodegeneration and prion diseases

• Emergence of novel variants of SARSCoV2

• Integration of the spike protein gene into the human DNA

The nature and variety of ADRs reported to the Yellow Card System are consistent with the potential pathologies described in this paper and supported by other recent scientific papers on vaccine-induced harms, which are mediated through the vaccine spike protein product (2,3). It is now apparent that these products in the blood stream are toxic to humans. An immediate halt to the vaccination programme is required whilst a full and independent safety analysis is undertaken to investigate the full extent of the harms, which the UK Yellow Card data suggest include thromboembolism, multisystem inflammatory disease, immune suppression,autoimmunity and anaphylaxis, as well as Antibody Dependent Enhancement (ADE).

Due to the need for expedience, we have not detailed all ADRs in this preliminary report. The Existing Yellow Card data covering just under a five-month period indicate that the extent of morbidity and mortality associated with the COVID-19 vaccines is unprecedented.Age and gender specific data, as well as the time from vaccination, are required to further our analysis of these data and we have sent Freedom of Information Requests (FOIRs) to the MHRAin this regard.


In addition, urgent independent expert evaluation and discussion is required to assess whether the novel vaccines may be causing gene mutations among recipients, as suggested by the occurrence of usually extremely rare genetic disorders, such as Paroxysmal Extreme PainDisorder (PEPD). In addition to the 11 cases of PEPD on the Yellow Card system, there are currently 12 reports of this extremely rare condition on the WHO’s Vigiaccess.org database and10 on the European Medicines Agency’s (EUDRA) pharmacovigilance database. Are these ADRs occurring in babies of vaccinated pregnant women, or spuriously among vaccinated adults? This question needs urgent attention.

As pharmacovigilance data are known to be substantially under-reported, we recommend that the MHRA urgently publicises these ADR data and assists people with their ADR reporting, to facilitate full elucidation and clarification of the extent of the problem.The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans. Preparation should be made to scale up humanitarian efforts to assist those harmed by the COVID-19 vaccines and to anticipate and ameliorate medium to longer term effects. As the mechanism for harms from the vaccine appears to be similar to COVID-19 itself, this includes engaging with numerous international doctors and scientists with expertise in successfully treating COVID-19.

There are at least 3 urgent questions that need to be answered by the MHRA:

1 How many people have died within 28 days of vaccination?

2 How many people have been hospitalised within 28 days of vaccination?

3 How many people have been disabled by the vaccination?

EbMC Squared CiC remains at your service to assist with further analysis. We kindly request full access to the Yellow Card database with immediate effect to enable a comprehensive,independent and accurate evaluation of the Yellow Card data, which will be undertaken in collaboration with clinical experts.

Yours sincerely,

Dr. Tess Lawrie (MBBCh, PhD)

Director, Evidence-based Medicine Consultancy Ltd and EbMC Squared CiC

Bath, UK


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Re: On mRNA/Gene Therapy

Postby Belligerent Savant » Sun Jun 13, 2021 4:07 pm

.

streeb:
what a depressing ritual: tribute paid to the infallibility of The Narrative and all its untouchable players is the hard requirement before expressing even measured skepticism, doubt, or concern. Anything else and people think you need to be sectioned.

Astutely summarized.


Yes, I encountered the letter from Dr. Tess Lawrie. Worthwhile addition here. It's becoming clear with each passing month -- while there is always the potential for a sudden 'about-face', however slim -- there will be little change to M.O. (Re: large-scale vaccine rollout and related measures) in the near-term. Each of us must simply proceed, for ourselves and our families, however we deem necessary. Those of us that continue to resist will likely face mounting obstacles for whatever semblance of the 'prior normal' we may aim to retain. A postmortem will eventually be written, perhaps 5 or 10 years from now (or is that too optimistic? 20 yrs, perhaps?), decrying the 'tragedy' of our current era, lamenting the passive acceptance by the majority.


A couple links for consideration (both found on LinkedIn):

https://phys.org/news/2021-06-discovery ... ences.html

New discovery shows human cells can write RNA sequences into DNA

Cells contain machinery that duplicates DNA into a new set that goes into a newly formed cell. That same class of machines, called polymerases, also build RNA messages, which are like notes copied from the central DNA repository of recipes, so they can be read more efficiently into proteins. But polymerases were thought to only work in one direction DNA into DNA or RNA. This prevents RNA messages from being rewritten back into the master recipe book of genomic DNA. Now, Thomas Jefferson University researchers provide the first evidence that RNA segments can be written back into DNA, which potentially challenges the central dogma in biology and could have wide implications affecting many fields of biology.

"This work opens the door to many other studies that will help us understand the significance of having a mechanism for converting RNA messages into DNA in our own cells," says Richard Pomerantz, Ph.D., associate professor of biochemistry and molecular biology at Thomas Jefferson University. "The reality that a human polymerase can do this with high efficiency, raises many questions." For example, this finding suggests that RNA messages can be used as templates for repairing or re-writing genomic DNA.

The work was published June 11th in the journal Science Advances.


One of the comments to the above article:
mikael kofod-hansen

senior chemist hos QC Raw materials

The events are becoming still more concerning as time passes in my opinion. From a multidisciplinary standpoint there's a lot to study, and there's has been a very poor flow of information exchange of scientific findings. One could certainly expect that publications have been "filtered" to fit a narrative. From a regulatory standpoint the general, harmonised guidelines seem not followed for clinical studies (it has for instance emerged that Moderna has allowed the placebo group to be vaccinated(!)).
One can hope that the quality guidelines have been followed - but what about the guidelines for biotechnological products, the ICH M6. I haven't seen any, by manufacturer, published results on e.g. viral shedding, and all the vaccines are by definition gene-therapy products and must undergo such evaluation. In fact recent publications would indicate that both shedding and reverse incorporation into DNA are not unlikely. After all, the M6 guidelines were written because such products hold potential to threaten general population, and findings in such studies therefore must be "blank".



https://www.ted.com/talks/christine_sta ... e_expected

Christine Stabell Benn

Professor, Global Health @SDU. Studying the overall health effects of vaccines in Guinea-Bissau and Denmark, discovering that they have important non-specific effects #NSEvac

While we are contemplating COVID-19-vaccines to children, it is worth reiterating that there is still a lot about vaccines that we do not know, including how they may affect the susceptibility to other infections - vaccines have what we have called "non-specific effects".

Since my TEDx, more data has accumulated, and in 2020, Nature named the discovery of non-specific effects one of the milestones in vaccines (https://lnkd.in/dx4MqPy; milestone 13).

Yet, new vaccines are still not being investigated for their non-specific effects. We have little idea whether the new COVID-19 vaccines will affect the susceptibility to other infections, positively or negatively. Among others for that reason I do think we should cautiously reserve the COVID-19 vaccines for those who are certain to gain from the specific protection - and that does not include children.


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