The Totally Civil Covid Thread. (Closing 31/05)

    The most recent evidence strongly suggests a non-lab origin for COVID-19. It is great that detective work to discover this - notwithstanding the lamentable (and expected) Chinese secrecy, has been able to continue.


    Do three new studies add up to proof of COVID-19’s origin in a Wuhan animal market?
    Preprints unlikely to end debate over how SARS-CoV-2 began the pandemic, but some scientists say lab-leak hypothesis has taken a “blow”
    www.science.org


    and


    The COVID lab leak theory is dead. Here's how we know the virus came from a Wuhan market
    For the lab leak theory to be true, SARS-CoV-2 must have been present in the Wuhan Institute of Virology before the pandemic started. But there’s not a single…
    theconversation.com


    THH

    FDA Lax on Gene Therapy Products

    FDA Lax on Gene Therapy Products
    As products that contain modified genetic material, mRNA COVID vaccines arguably fall into the category of gene therapies. Why then doesn't the FDA apply its…
    www.trialsitenews.com


    As products that contain modified genetic material, mRNA COVID vaccines arguably fall into the category of gene therapies. Why then doesn't the FDA apply its stringent gene therapy restrictions to these products? This is the question posed by pharmacist Dr. David Wiseman, amongst others, at a Cell Therapy Gene Therapy Advisory Committee (CTGTAC) meeting on June 10, 2022. A TrialSite-affiliated group helped to pass a bill into law in Utah, where vaccines are now legally defined as gene therapy. It is now a punishable offense for an employer to force employees to get an mRNA vaccine. Another story discusses the notion that mRNA COVID vaccines are, in fact, gene therapies according to Moderna.


    The CTGTAC works within the office of tissues and advanced therapies (OTAT) of the FDA. The role of the FDA’s OTAT branch is to provide regulatory oversight to ensure the safety of certain medical products. The CTGTAC is a committee made up of 13 experts in various medical specialties. Both of these entities cover gene therapy but do not consider vaccines a part of their work.


    Gene therapy can be used to modify genes by being inserted into the body (or outside of the body) via a vector, like a deactivated virus. There is much promise in this area of research to hopefully treat conditions like cancer, cystic fibrosis, heart disease, hemophilia, and AIDS.


    What Are mRNA Vaccines?

    A vaccine series is available on TrialSite featuring articles on a few general topics and many with specific information regarding COVID-19 vaccines.


    An article entitled “COVID Vaccines Are Not Gene Therapies” states that mRNA technology uses genetic code, but does not enter the DNA, and doesn’t remain in the body for more than three days. Once injected, an mRNA vaccine teaches our cells to make the spike protein found on the surface of the coronavirus, triggering an immune response. The mRNA never actually enters the cells’ nucleus, which houses our DNA. In August 2021, Reuters did a fact check with the final verdict being that mRNA vaccines can be considered genetic-based therapy but are not technically gene therapy.


    Wiseman’s Case

    David M. Wiseman, Ph.D. MRPharmS, is the owner of Synechion, Inc – an advocacy and research organization. Dr. Wiseman has a Ph.D. in experimental pathology. He is a UK pharmacist and previously headed a research program as a top scientist at Johnson and Johnson. His most recent project regards COVID-19 documents.


    Dr. Wiseman presented via slideshow at the CTGTAC meeting on June 10 this year where he made the argument that mRNA COVID vaccines are, in fact, gene therapies and that the FDA should be treating them as such. In January, TSN alluded to the fact that the FDA has previously disregarded Wiseman’s points. He lists studies referring to ongoing research in this area suggesting that there are other experts who are concerned about this novel technology. He also claims that OTAT currently has six labs researching infectious diseases and COVID vaccines, despite the fact that COVID vaccines are not gene therapies.


    Wiseman and others are concerned about vaccines as gene therapy because 1) people are not consenting to receive gene therapy because the COVID vaccines are not officially regarded as such and 2) this technology comes with a new set of risks. Serious health risks could include toxicity, inflammation, and cancer.


    Retroposition fears

    Retroposition is defined as a cellular molecular process in which transcribed and spliced mRNAs are fortuitously reverse-transcribed and inserted into new genomic positions to form a retrogene. This study published in April 2022 discusses retroposition and urges further primary research on this topic. The study’s author concludes that the research presently does not establish for certain that mRNA vaccines cannot impact genomes.


    The big debate is whether mRNA can enter the cell’s nucleus to change or damage DNA. This is a huge ethical issue when it comes to human DNA, not least because a plethora of health problems can occur after DNA is unintentionally altered, including cancer. In a substack entry, the author refers to a paper published in October 2021 suggesting that there is evidence the spike protein created by mRNA vaccines can infiltrate the cell nucleus. This paper was later retracted in May 2022 for an unidentified reason.


    Wiseman also discusses the reverse transcription and insertional mutagenesis fears ofDr. Sahin, co-founder of BioNTech, but no records were located regarding this claim. However, this has been explored by other researchers, such as in this study where scientists observed reverse transcription in vitro after introducing the Pfizer mRNA COVID vaccine BNT162b2. Researchers used human liver cells in this case. Using PCR technology, researchers could observe the BNT16b2 vaccine entering the liver cells and the reverse transcription of mRNA to DNA. This research was completed in vitro, so it does not have certain clinical relevance. It shows that the mRNA vaccine has the capability of entering a human cell and being transcribed into DNA, but researchers did not apply these findings to human health.


    Where Does the FDA Stand?

    The FDA maintains its stance that the mRNA vaccine used to protect against SARS-CoV-19 is not gene therapy. As such, it is not subject to review by the OTAT and CTGGAC.


    The OTAT attempts to remain transparent and a platform for education surrounding these complex topics. The next meeting, referred to as “OTAT Town Hall”, is scheduled on Zoom for September 25, 2022, and will address stakeholder questions regarding gene therapy chemistry, manufacturing, and controls.

    Quote from Fm1

    As products that contain modified genetic material, mRNA COVID vaccines arguably fall into the category of gene therapies. Why then doesn't the FDA apply its stringent gene therapy restrictions to these products? This is the question posed by pharmacist Dr. David Wiseman, amongst others, at a Cell Therapy Gene Therapy Advisory Committee (CTGTAC) meeting on June 10, 2022. A TrialSite-affiliated group helped to pass a bill into law in Utah

    Just to answer this question for real (rather than as AV rhetoric).


    gene therapies ought to be things that change the DNA in the nucleus of cells in the body and so alter cell action permanently. That is pretty radical, and pretty dangerous.


    mRNA-based medicines or vaccines (it can be used for both) use mRNA as a delivery vehicle for the drug where the body's own cells generate the drug from the mRNA instructions. Because it is non-nuclear it does not persist and there is nor permanent significant change.


    The EU legislation, for what ever reason, decided to call mRNA-based treatments gene therapy. It suits antivaxxers to do this because it makes mRNA-based vaccines, particularly, sound more scary than they actually are.


    Now there are potential concerns from mRNA technology - as with any new medicine. mRNA can make small changes to the mitochondrial DNA - as by the way can any viral infection! So this is a risk (if it causes harm) that catching COVID gives you more of than an mRNA vaccine. But still it is worth pointing out.


    But they are far far less than the risks of therapies that meddle with nuclear material correcting defects by altering the nuclear genome of cells.


    The antivaxxers, and trialsite is an antivaxxer site, are interested in what things are called because they want vaccines to sound as risky as possible.

    Quote from THHuxleynew

    The EU legislation, for what ever reason, decided to call mRNA-based treatments gene therapy.

    Again let me point out that there are mRNA vaccines used for gene therapy. They do change the DNA in the cell nucleus. Perhaps the EU is meant to address these vaccine types? I don't know, but I suppose if you do a close reading of the legislation you will see. That would be "what ever reason."


    Then again, perhaps the legislators are ignorant.


    It is a little unfortunate that two different mRNA technologies are being developed at the same time, one that modifies DNA, and the other that does not. People will confuse them. That's understandable, but unfortunate. I hope the legislation makes a clear distinction between the two types.


    Again, here is the video from Tal Zaks of Moderna explaining the difference:


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    Quote from Fm1

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    Forgive me for not considering Rand Paul either unbiassed or an accurate reader of the scientific literature (that would apply to any politician, but particularly one with neither 1st nor second higher education degree). I will accept that he is likley (given his background) a persuasive speaker - and therefore take care not to listen to his rhetoric when I want to develop an objective view of any subject. (PS - gaining an MD does not count as this, nor does experience as an opthalmologist!).


    In the Uk Margaret Thatcher would be an example of a well educated politician whose views on science (whatever her politics) were well-informed. She therefore championed various causes not commonly recognised, such as the need to deal with AGW, at a time when the evidence, and need for immediate action, was strong but very much less certain than now. Whereas Rand Paul shows an extraordinary inability to grasp what is now well proven science by refusing to admit the causes of climate change and advocating no action.


    Paul attended Baylor University from fall 1981 to summer 1984 and was enrolled in the honors program. During the time he spent at Baylor, he completed his pre-med requirements in two and a half years,[18] was involved in the swim team and the Young Conservatives of Texas and was a member of a tongue in-cheek secret organization, the NoZe Brotherhood, known for its irreverent humor.[19] He regularly contributed to The Baylor Lariat student newspaper.[16] Paul left Baylor without completing his baccalaureate degree,[18] when he was accepted into his father's alma mater, the Duke University School of Medicine, which, at the time, did not require an undergraduate degree for admission to its graduate school. He earned an M.D. degree in 1988 and completed his residency in 1993.[20]

    Extraordinary that anyone on this site should be quoting Rand Paul youtube clips as an answer to scientific points!


    RP is strongly anti-science - whether from ignorance or deliberate act I do not know. It is sort of worse though if he is lying for reasons of political expediency.


    Paul, who is announcing a presidential run on Tuesday, is an anti-government extremist and a climate change denier. Just last April, he said he is “not sure anybody exactly knows why” the climate is changing. He went on to call the science “not conclusive” and complain about “alarmist stuff.” If you’re wondering what he means by “alarmist stuff,” in 2011, while arguing for a bill that would prevent the EPA from regulating carbon emissions, Paul said, “If you listen to the hysterics, … you would think that the Statue of Liberty will shortly be under water and the polar bears are all drowning, and that we’re dying from pollution. It’s absolutely and utterly untrue.” Paul went on to assert that children are being misled into believing that “pollution” has gotten “a lot worse,” when “It’s actually much better now.” Paul, of course, was conflating conventional air pollution — like sulfur dioxide, which has declined in the U.S. — and climate pollution, which is cumulative and global, and therefore gets worse every year, even if America’s annual emissions drop.


    Indeed, Paul is prone to making ignorant, conspiracist statements about science in general. In October, he suggested to Breitbart News that Ebola may be more easily spread than scientists say and that the White House had been misleading the country on the issue. And in February, Paul told CNBC, “I’ve heard of many tragic cases of walking, talking normal children who wound up with profound mental disorders after vaccines.” This despite the fact that the supposed connection between autism and vaccination has been thoroughly debunked.

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    Quote from Fm1

    Conclusions: The use of COVID-19 vaccines to prevent and control SARS-CoV-2 infections and complications is the most practicable policy worldwide.

    Never did hear greater bullshit. They use the wrong verb "is" instead of was. If you want to get Omicron then vaxx & booster yourself. It will not protect you from a serious outcome and leave some unknown future damage.

    From the horse's mouth, CDC study!


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    Quote from Fm1

    From the horse's mouth, CDC study!


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    Those reading this thread who are not full-blooded antivaxxers will actually have been interested in the way all these statistics get used and abused. This is a particularly meaningless one that therefore gets used a lot by the antivaxxers.


    In this case the headline - 44% of hospitalisations boosted - what does it mean?


    Of course - we'd need to know the percentage of the population who has been booster vaccinated.


    Would that help?


    Nope! (you all have the references in detail for why such comparisons are grossly in error).


    You would think that John Campbell - as a retired Nurse Educator with a PhD in education would know better?


    Or maybe this is one of the perils of modern pedagogical theory - it discourages analytic thought in favour of anecdote and storytelling.

    Quote from Fm1

    IT means that the vaccines and boosters don't keep you out of the hospital. You can continue to pretend this is normal for a vaccine but we all know you are full of crap!

    It is normal for a vaccine.


    For example flu vaccine - very normal - reduces deaths and hospital admission. It does not however prevent it.


    Cohort Study of the Effectiveness of Influenza Vaccine in Older People, Performed Using the United Kingdom General Practice Research Database
    Abstract. Background. The effectiveness of influenza vaccination against hospitalization and death can only ethically be assessed in observational studies. A co
    academic.oup.com


    Background. The effectiveness of influenza vaccination against hospitalization and death can only ethically be assessed in observational studies. A concern is that individuals who are vaccinated are healthier than individuals who are not vaccinated, potentially biasing estimates of effectiveness upward.

    Methods. We conducted a historical cohort study of individuals >64 years of age, for whom there were data available in the General Practice Research Database for 1989 to 1999 in England and Wales. Rates of admissions for acute respiratory diseases and rates of death due to respiratory disease were compared over 692,819 person-years in vaccine recipients and 1,534,280 person-years in vaccine nonrecipients.

    Results. The pooled effectiveness of vaccine against hospitalizations for acute respiratory disease was 21% (95% confidence interval [CI], 17%–26%). The rate reduction attributable to vaccination was 4.15 hospitalizations/100,000 person-weeks in the influenza season. Among vaccine recipients, no important reduction in the number of admissions to the hospital was seen outside influenza seasons. The pooled effectiveness of vaccine against deaths due to respiratory disease was 12% (95% CI, 8%–16%). A greater proportionate reduction was seen among people without medical disorders, but absolute rate reduction was higher in individuals with medical disorders, compared with individuals without such disorders (6.14 deaths due to respiratory disease/100,000 person-weeks vs. 3.12 deaths due to respiratory disease/100,000 person-weeks). Clear protection against death due to all causes was not seen.

    Conclusions. Influenza vaccination reduces the number of hospitalizations and deaths due to respiratory disease, after correction for confounding in individuals > years of age who had a high risk or a low risk for influenza. For elderly people, untargeted influenza vaccination is of confirmed benefit against serious outcomes.



    May I suggest you check facts and details before making insults?

    Quote from Fm1

    Nope! (you all have the references in detail for why such comparisons are grossly in error).


    Ya it's called propaganda, shall I post the definition so you understand?

    FM1 - you well know that you have not done this. You have posted youtube talks, and non-science trialsite propaganda, and studies that do not even attempt the necessary data analysis to work these things out.


    The question was ; what meaning can we attach to 44% hospitalisations from COVID being boosted?

    If you post your single best link explaining this and attaching meaning, I will comment (if it contradicts what is correct, which i will also post in reply)


    Whereas on the link i showed you there are about 4 sublinks (not difficult to find) addressing the popular misuses of statsitics in the context of COVID.


    Well worth reading just so that you understand the statistical issues which apply to many other subjects.

    I don't take the flu vaccine as I've only had flu once in my life. I have built a good immune system response through good nutrition and supplements. I had omicrom in January so my natural immunity to Covid crosses to cover flu as has been shown in recent studies. And for someone so bothered by insults, you provide plenty yourself cowboy

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