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

    Quote from Shane D.

    Looking back,

    I look back to 1977..

    in my last Tripos paper before farewellling the UK

    I warned of a " plasmid holocaust"

    never imagining that BigPharma would unleash one for profit

    44 years later..

    Dr. Laura Braden | Day 3 Truro Hearing | National Citizens Inquiry
    Listen to Dr. Laura Braden as she examines the scientific and technical aspects of the vaccine delivery. Dr. Braden dives in to the unreliability of dosage…
    rumble.com

    Sequencing of bivalent Moderna and Pfizer mRNA vaccines reveals nanogram to microgram quantities of expression vector dsDNA per dose
    Several methods were deployed to assess the nucleic acid composition of four expired vials of the Moderna and Pfizer bivalent mRNA vaccines. Two vials from…
    osf.io

    Quote from Zephir_AWT

    this thread may lure interest of many visitors about the rest of this forum

    So you just regard the thread as clickbait. Targeted at whom, exactly? Potential LENR researchers?


    And this is just after accusing the moderators of being in the pockets of "big pharma" (despite some of them occasionally contributing to the thread).


    I'm no fan of the multinational pharmaceutical corporations. Like all large corporations, they can abuse their power. But this particular thread was one of the reasons I felt rather wary of signing up to the forum. There is a fine line between intelligent concerned inquiry, and pathological contrarianism - and to a casual visitor this thread can sometimes appear like the latter.


    Important though this subjects is, it isn't core to LENR research.

    "The most misleading assumptions are the ones you don't even know you're making" - Douglas Adams

    Quote from Wyttenbach

    It's all mafia in the west today.

    SV40 simian virus, plasmids for all from La Familia Covidioso.. even for the bambinos.

    Dr. Laura Braden | Day 3 Truro Hearing | National Citizens Inquiry
    Listen to Dr. Laura Braden as she examines the scientific and technical aspects of the vaccine delivery. Dr. Braden dives in to the unreliability of dosage…
    rumble.com

    Meantime Dr Laura Braden was fired for

    discrediting the SPIKEcine.

    probably I'll fire myself from LF..

    after June is a good time to do some exptal stuff anyway

    save the planet and all that

    ;)


    pathological contrarianism, well I'm sure that's aimed at me. You are right that I will not change my position on vitamin d. It is the key to a long healthy life. I also post studies that western media ignores, trying to get all the science out there for people to be more informed. I have made a choice to be well informed and to pass it on and this thread gives me that avenue. Being informed, helps make good choice.

    This is why 1.6 million Americans died during Covid and it's an indictment of or 37th world ranked healthcare system in the world. The richest country in the world ignores its own citizen suffering


    New Research Reveals Poverty as the Fourth Leading Cause of Death in the U.S.

    New Research Reveals Poverty as the Fourth Leading Cause of Death in the U.S.
    Researchers at the University of California, Riverside have identified poverty as the fourth-greatest cause of death in the United States. Poverty was…
    www.trialsitenews.com


    Researchers at the University of California, Riverside have identified poverty as the fourth-greatest cause of death in the United States. Poverty was associated with an estimated 183,000 deaths in the country in 2019 among people 15 years and older. This estimate is considered conservative, the authors said, because the data is from the year prior to the COVID-19 pandemic. The findings are published in JAMA Internal Medicine.


    The analysis estimated the number of poverty deaths by analyzing income data kept by the Institute for Social Research at the University of Michigan and death data from household surveys from the Cross-National Equivalent File. Deaths reported in surveys were validated in the National Death Index, a database kept by the National Center for Health Statistics, which tracks deaths and their causes in the U.S.


    Poverty is identified as people with incomes less than 50% of the U.S. median income.


    According to the analysis, only heart disease, cancer, and smoking were associated with a greater number of deaths than poverty. Other common causes of death, including obesity, diabetes, drug overdoses, suicides, firearms, and homicides, were less lethal than poverty.


    The research also found that people living in poverty have roughly the same survival rates until they hit their 40s, after which they die at significantly higher rates than people with higher incomes and access to resources.


    These findings have major policy implications, said the researchers.


    “Because certain ethnic and racial minority groups are far more likely to be in poverty, our estimates can improve understanding of ethnic and racial inequalities in life expectancy,” the paper reads.


    The study shows that poverty should get more attention from policymakers, said David Brady, the study’s lead author and director of UCR’s Blum Initiative on Global and Regional Poverty.


    “If we had less poverty, there'd be a lot better health and well-being, people could work more, and they could be more productive,” Brady said. “All of those are benefits of investing in people through social policies.”

    Quote from Frogfall

    Well, now you come to mention it...


    BTW, I take regular high dosage vitamin D too. I was told to do so by my doctor, several years ago. It's hardly revolutionary anti-establishment thinking.

    No it's not but if you have been paying attention our medical authorities are advising doctors to stop testing for vitamin d levels. That froggy is insane and boarders on criminal. You should be very happy your doctor ignored this!


    Do Americans have a vitamin D problem? Here’s what health experts say: ‘You have to be really careful’

    Do Americans have a vitamin D problem? Here's what health experts say: ‘You have to be really careful’
    As a supplement, vitamin D's popularity is only growing — but doctors have mixed opinions on whether it's a good idea or not. Here's what you need to know.
    www.cnbc.com


    But Covid concerns aside, doctors have mixed opinions on the supplement. Some say that when taken in moderation, it’s a harmless daily pill that can only help most Americans. Others argue that it’s a largely pointless expenditure — and that in most cases, it’s irresponsible to even test patients for vitamin D deficiencies.

    Quote

    Important though this subjects is, it isn't core to LENR research.

    It was never subject of LENR research, nevertheless it was always succesfull thread and it shows corruption of science, which has lead into dismissal of LENR findings. I guess it belongs here just because of it.


    Quote

    You better not.

    Alan, Curbina: it didn't evade my attention, you're hanging whole hours in this thread - and you still want to terminate it?

    Zephir_AWT and others concerned with the thread phase out:


    We are closing this thread because we are a LENR-forum and the pandemic is becoming a political issue and ultimately a distraction of our goal. I discuss a lot about these issues with people from all over the world, but not here, because there are plenty of other venues for that.

    I certainly Hope to see LENR helping humans to blossom, and I'm here to help it happen.

    Thanks 4 Radioactive 1

    Zephir_AWT


    I always look at this thread, it's a moderator's job. I post sometimes too. But medical science while an important and interesting topic isn't part of our mission, so since it is no longer front page news the forum moderation team collectively decided to close it by majority vote.


    Further to Wyttenbach's suggestion that we had been influenced by google to 'take it down' I can assure you that if they had I would post it here for all to see.

    FDA Scraps Licensed mRNA Vaccines: Now Only Investigational Products Available to Market—Despite End of Public Health Emergency

    FDA Scraps Licensed mRNA Vaccines: Now Only Investigational Products Available to Market—Despite End of Public Health Emergency
    Yesterday the U.S. Food and Drug Administration (FDA) changed the COVID-19 emergency use authorization (EUAs) of both the Pfizer-BioNTech and Moderna COVID-19…
    www.trialsitenews.com


    Yesterday the U.S. Food and Drug Administration (FDA) changed the COVID-19 emergency use authorization (EUAs) of both the Pfizer-BioNTech and Moderna COVID-19 vaccines for simplification purposes according to the agency’s press announcement. The FDA did away with any use of the original licensed COVID-19 vaccines, deciding that the only mRNA vaccines that will be available are the still investigational (experimental) bivalent booster shots targeting both the original strains and BA.4/BA.5 for all individuals aged 6 months and up. This despite the fact that the national public health emergency has ended. This material change includes any use for an additional dose or doses for certain populations (e.g., immunocompromised, etc.). This means that the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. This raises interesting implications because while the previous monovalent vaccines were licensed (albeit in an unorthodox manner as TrialSite has covered) these products are classified as investigational, or experimental. But what are the implications now that the national health emergency is over? Some other controversial elements to this change. For one, the agency long considered the Gold Standard of food and drug regulatory bodies, is now openly accepting natural immunity, something the federal agencies resisted for much of the pandemic. Also, for the unvaccinated they are scrapping the primary series altogether, meaning that cohort, representing 19% of the U.S. population may only receive one mRNA booster dose targeting the original variant plus BA.4/BA.5. Of course, BA.4/BA.5 are now long gone, out of circulation for quite a while now, replaced by new Omicron subvariants. The agency through its actions acknowledges the transition from pandemic to endemic phase of COVID-19 yet scraps the only licensed products opting to embrace only the investigational vaccines—which only makes sense during a national emergency. The FDA is attempting to make a transition now embracing the influenza vaccine model which has a mixed track record at best.


    Importantly, this particular investigational product class (bivalent booster) hasn’t been well accepted in the market. By the new year, under 20% of all Americans eligible to take this vaccine in fact did so. Currently, only about 20% of the eligible population has opted to receive the bivalent booster (again now the only available product of the mRNA class).


    With spring around the corner, it’s not clear if this change will make an impact on the hesitancy or if in fact contributes to more hesitancy. We must remember that there is limited clinical trials data associated with the currently available product (bivalent original plus BA.4/BA.5 strains)—the experimental product was released onto the market less any clinical trials data which is one of the reasons why so few opted to receive).


    The FDA uses risk-based methods to assess risk with patient safety at the top of the list. Although during this pandemic and ensuing emergency this media has observed agency behavior that raises critical questions about both competencies and intentions. We must remember that the agency’s top vaccine scientists (Dr. Philip Krause and Marion Gruber) resigned from the agency, not pleased with its direction during the pandemic.


    But the FDA touts its rigorous risk-based methods to power decisions involving the vaccines. The agency’s scientists and regulatory analysts will review levels of risk to people, the likelihood of occurrence, severity of occurrence and the like. They authorized the bivalent booster dose however with no clinical trials data at the time but among other things analyzed the deltas in the new product as minimal. For example, they make declarations that mRNA manufacturers use the same process for manufacturing but numerous quality problems have been exposed during the pandemic.


    Regardless, given their knowledge of the monovalent platform, they extend much of the same understanding, assumptions and the like to the bivalent product—although there is an old saying: “The devil is in the details.”


    What’s the rationale for scrapping the licensed product for an investigational one?

    As emphasized by the agency, simplifying the process in an attempt to bolster vaccine rates undoubtedly is a driving factor in what at least some critics may call out as a troubling decision. But in doing so, the FDA has arguably opened up new avenues for challenge.


    In the table below are listed key factors identified by the FDA and a brief summary:


    Vaccination Category


    FDA Summary


    Persons previously vaccinated but have not opted to yet receive the bivalent booster dose.


    This cohort may opt to receive a single dose of the bivalent booster dose.


    Persons that have received their bivalent booster dose


    This cohort may not receive another booster at this time. They must await FDA decision as to future vaccination after the agency receives recommendations on the fall strain (much like they do with influenza) composition at an FDA advisory committee in June.


    Persons aged 65 and up who have received their bivalent booster dose


    This cohort deemed high risk can access one additional dose at least four months following their initial bivalent dose.


    Most immunocompromised persons who have received the bivalent COVID-19 vaccine


    Like the elderly cohort, this high-risk group can receive an additional single dose of one of the bivalent booster doses at least two months following a dose of a bivalent COVID-19 vaccine. Important additional doses may be administered based on intervals determined by the healthcare provider. But there is an exception. For the cohort of age 6 months through 4 years of age eligibility for additional doses depend on the vaccine previously received.


    Most unvaccinated individuals


    Persons falling under this category At least 81% have received one dose in U.S. meaning 19% are completely unvaccinated and can receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines—meaning they are doing away with the primary series of mRNA vaccine moving forward for this category.


    Children 6 months through 5 years of age who are unvaccinated


    This category considered vulnerable may receive a two-dose series of the Moderna bivalent vaccine (6 months through 5 years of age) or a three-dose series of the Pfizer-BioNTech bivalent (6 months to 4 years of age). Children who are 5 years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.


    Children 6 months through 5 years of age who received one, two or three doses of a monovalent COVID-19 vaccine


    Children in this age bracket may receive a bivalent vaccine, but the number of doses that they will receive will depend on the vaccine and their vaccination history.


    Does the FDA now openly embrace Natural Immunity?

    Yes. Ironically, the FDA has now come out discussing the benefits of natural immunity via previous infection. Although beyond the scope of this article, they avoid discussions of immunity science in the context of SARS-CoV-2 and vaccination.


    Many scientists and doctors as well as critical press such as this one was dumbfounded by the lack of study into natural immunity during the first stages of the pandemic.


    While health systems in other nations were conducting natural immunity-focused COVID-19 research as were some independent groups in America during earlier parts of the pandemic, the federal agencies seemed intensely focused on only vaccination during the first year after the vaccines were released.


    By the spring of 2021, as it became apparent that the Delta variant could evade vaccine-induced antibodies (breakthrough infection) more critical questioning commenced. Before that, much of the mass media with armies of staff generally reported on what the government told them to account, however.


    With the recent change the FDA’s director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. went on the record:


    “At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination.”


    Acknowledging the protective powers of previous infection Marks continued:


    “Evidence is now available that most of the U.S. population 5 years of age and older have antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”


    Has the FDA fully embraced natural immunity, long accounted for with infectious diseases such as influenza in its assessment of risk with COVID-19?

    Yes. This is the case and represents a gradual embrace over time. The agency will state that they are just following the science but this isn’t totally true. They avoided science when it was convenient earlier in the pandemic. The agency, however, doesn’t go into emerging science suggesting at least according to some studies that immunity from previous infection may be superior to vaccine-induced immunity. Some studies suggest so-called hybrid immunity represents the most protection.


    What’s the basis for the FDA’s scientific confidence in the bivalent booster (now the primary vaccine)?

    The agency touts that their decision for the cohort age 5 years and up is based on unfolding data they cite in their recent press entry plus post-marketing data.


    Why has the market been so resistant to accept the bivalent booster (now the only class of mRNA product available)?

    TrialSite suggests that this particular vaccine booster has not been well accepted in the market due to a confluence of factors and market forces. For example, the bivalent investigational vaccine was released on the market A) during a time that while more transmissible, Omicron strains generally led to less severe symptoms—meaning less overall fear in the market; B) the investigational product was released with no clinical trials data; C) immunity from previous infection was becoming commonplace (although highly infectious Omicron strains can more easily evade both vaccine and previous infection-induced antibodies); and D) a growing disease with the agency became palpable across various demographic segments (trust in regulators issue).


    A recent CNN piece pegs the number at 20% of the total eligible population.


    Does the FDA’s announcement mention the rates of serious adverse events? Vaccine injured?

    No. TrialSite reminds us that these vaccine products are novel—in fact, the only mRNA product now available in America is by definition investigational or experimental. It’s only because of the national public health emergency that the risk-benefit analyses were conducted and that overall, the risk of COVID-19 was deemed in excess of the risk with the vaccines.


    But with over 270 million people across America receiving a primary series a TrialSite estimate of 0.02 to 0.08 serious adverse incident rate means that potentially over 2 million people could be classified as vaccine injured. This rate could be as low as half a million persons. Nonetheless TrialSite, an independent media and network solely focused on biomedical/health research suggests consumer confidence in the nation’s vaccines becomes a serious agenda moving forward. This is in part, due to the way the government handled the COVID-19 response.


    When it comes to COVID-19 vaccine injuries the government can start to rebuild a positive brand by A) accepting that there are injured while communicating to providers that it’s safe to care for this vulnerable population; B) modernizing the vaccination compensation programs and working to incent payers (public and private) to cover such costs and C) following its support for “Health Equity” across this diverse patient class.


    Why does the agency consider both Moderna’s monovalent primary series and bivalent booster vaccine safe and effective?

    For one, the agency’s previous analyses of clinical trials data of the monovalent vaccines (both Moderna and Pfizer-BioNTech) in persons aged 6 months of age and up as well as the investigational bivalent Moderna COVID-19 vaccine (original and Omicron BA.1) in individuals aged 18 and above.


    The FDA also points out the effectiveness of a single dose of the mRNA vaccine based on an analysis of immune response data from clinical studies in which 145 persons 6 years of age and up had evidence of prior SARS-CoV-2 infection and 1,376 individuals 6 years of age and older without evidence of prior SARS-CoV-2 infection had received two doses of monovalent Moderna COVID-19 Vaccine. The immune response after one dose of vaccine among participants with evidence of prior infection was comparable to the immune response after two doses among participants without evidence of prior infection.


    The agency excludes any mention that the bivalent product (original and BA.4/BA.5 strains) were released with no clinical trials data for that specific product. One justification for not segmenting and providing further analysis of quality and safety—the same manufacturing processes were used for previous (monovalent and B.1) and existing bivalent vaccines.


    What about Pfizer?

    Much like Moderna the agency points to their previous analyses of clinical trials data of the monovalent vaccine for use in persons age 6 months and up as well as for the investigational bivalent vaccine (original plus BA.1) in persons aged 55 and up and safety data with the Bivalent dose that went to market (original plus BA.4/BA.5) in persons age 6 months and older and immune response data in persons age 6 years to 4 years of age.


    Just like Moderna, the agency excludes any mention that the bivalent product (original and BA.4/BA.5 strains) were released with no clinical trials data for that specific product. One justification for not segmenting and providing further analysis of quality and safety—the same manufacturing processes were used for previous (monovalent and B.1) and existing bivalent vaccines.


    Some Commentary

    For both Moderna and Pfizer-BioNTech numerous studies raised questions about the effectiveness of the bivalent booster dose against new Omicron variants, yet the FDA avoids any mention of those. The agency selects certain studies over others to bolster its claims. For example, in the case of Pfizer pointing to observational data from England on the effectiveness of one dose of monovalent Pfizer-BioNTech vaccine.


    Generally, TrialSite review of the evolving body of scientific data (from randomized controlled trials, observational etc.) confirms that the vaccines confer some level of additional protection against severe COVID-19 yet that overall protection wanes as compared to earlier use cases and phases during the pandemic, and the duration of effectiveness continues to condense-- as fast as in 90 days.


    Observational data becomes ever more complicated and intertwined with so many vaccinated persons also infected with a growing hybrid immunity including both antibodies from previous infection and vaccine-augmented immunity. The overall risk-benefit calculus changes given the overall lessening of symptomatic responses, accumulating immunity and potential for safety incidence. The FDA implicitly recognizes this by incrementally moving toward a more risk-based approach targeting vaccination to those higher at risk (e.g., elderly, etc.).


    The Authorizations

    The FDAs recent move to make these changes was driven by discussions that occurred during a meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Jan. 26. Then the VRBPAC by unanimous vote recommended harmonizing the strain composition of COVID-19 vaccines used in the U.S. There was also support for simplifying the vaccine dosing schedule.


    Following the Influenza Pattern

    In June, the FDA will hold a meeting of its VRBPAC to discuss the strain composition of the COVID-19 vaccines for the fall of 2023. Much like the FDA does yearly with the influenza vaccines, the agency will seek input from the committee on which SARS-CoV-2 variants and lineages are most likely to circulate in the upcoming year. Once the specific strains are selected for the COVID-19 vaccines, the FDA expects manufacturers to make updated formulations of the vaccines for availability this fall.


    Does the FDA acknowledge that the existing available vaccines are investigational (which also means experimental)?

    Yes. They explicitly call out that “The amendments to the EUAs were issued to ModernaTx and Pfizer Inc.” Interestingly what this means is that they have scrapped the use of a licensed product, embracing an investigational product during a time when there is no more emergency.


    What about safety?

    While there is a constant messaging in the mainstream media that the data and science point to the vaccine products being both safe and effective (and in fact, they are for most people, although there is absolutely no data on long-term effects of the mRNA vaccines) rare to somewhat rare incidence of adverse events raise concern. The FDA press entry mentions nothing about rare serious adverse events and associated vaccine injuries.


    Are the fact sheets updated?

    Yes. The FDA reports that the fact sheets for both Pfizer-BioNTech and Moderna were updated so what does the fine print in these documents say about vulnerable categories from young children to pregnant lactating women? What follows are some key highlights—


    Pregnant women? Is the investigational bivalent vaccine safe and effective per the FDA’s fact sheet?


    The agency doesn’t know. What follows is the exact language:


    “No data are available regarding the use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent during pregnancy. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.”


    Generally, it’s not a good practice to in part base a decision for a medical product authorization on a study of 40+ rats. For those interested TrialSite has developed a detailed timeline of milestones and recommendations for use of the COVID-19 mRNA vaccines and pregnant persons.


    What about lactation?


    The agency insert again speaks a very different language than what is promulgated throughout the media and in doctors’ offices and clinics for example:


    “Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent on the breastfed infant or on milk production/excretion.”


    What about children?

    Under pediatric use the FDA does point to studies:


    “Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 months through 17 years of age. This authorization is based on safety and effectiveness data with Pfizer-BioNTech COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and the bivalent vaccine (Original and Omicron BA.1). Pfizer-BioNTech COVID-19 Vaccine, Bivalent is not authorized for use in individuals younger than 6 months of age.” Note that the agency doesn’t clearly explain that the current investigational product in circulation is based on original and BA.4/BA.5 and that there is no clinical data used as a basis.


    See the links to Pfizer for healthcare providers and recipients and caregivers.


    Follow the link to review Moderna’s FDA fact sheets.


    Call to Action: TrialSite reminds all in the U.S. that the FDA’s mandate is to “protect the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” An incredibly important agency also serving to protect the food supply, cosmetics, dietary supplements, products that emit radiation and for tobacco products the FDA regulates at least a quarter of the entire U.S. economy. It’s important to ensure that this vital agency in the executive branch of government (under Department of Health and Human Services) is working for the good of the American people and not heavily capitalized special interests. And importantly a diversity of scientific perspectives is accepted and embraced by the agency for vigorous dialogue and debate—that powers good science.


    Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
    The FDA amended the EUAs of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals.
    www.fda.gov

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