Posts by Fm1

NIAID/Moderna Agreements Re-Open Questions about COVID-19: Did We Have Foreknowledge of the Pandemic?

NIAID/Moderna Agreements Re-Open Questions about COVID-19: Did We Have Foreknowledge of the Pandemic?

Many aspects of the COVID-19 outbreak, and response have been problematic. For example, why was the lab-originated hypothesis rigidly shut down for the first…

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Many aspects of the COVID-19 outbreak, and response have been problematic. For example, why was the lab-originated hypothesis rigidly shut down for the first couple years of the pandemic? A new set of questions are raised by a set of contracts that can be seen here. The first document, dated November 6, 2015, is between Moderna and the US government’s National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Titled, “Confidential Disclosure Agreement,” the contract states that NIAID’s proprietary information relates to vaccine research for HIV, influenza, Ebola, and MERS, while Moderna’s “proprietary and confidential information [is] related to design and manufacture of a messenger RNA platform…” This agreement was then amended many times to extend its duration. The next relevant document is a contract from August 22, 2016. In the appendix, the agreement posits that, “Moderna's vaccine development efforts have spanned various infectious diseases, and include world-class expertise in mRNA construct production optimization, up to and including cGMP drug product manufacturing in order to bring clinical candidates forward through regulatory processes in the US and EU.” More agreements between NIAID and Moderna were signed in 2017 and 2018. A reminder during 2015, Ralph Baric and colleagues from University of North Carolina and elsewhere including Wuhan Institute of Virology world published in the journal Nature “A SARS-like cluster of circulating coronaviruses shows potential for human emergence.” This risky gain-of-function-esq coronavirus modification methodology made its way to China according to an important piece by Rowan Jacobson titled “Inside the risky bat-virus engineering that links American to Wuhan.”

Is two days to create a COVID-19 vaccine credible?

Next, we fast forward to 2019, a mid-December 2019 Material Transfer Agreement between Ralph Baric and team at the University of North Carolina at Chapel Hill and NIAID as well as Moderna, states that the later parties will transfer to the university, “mRNA coronavirus vaccine candidates developed and jointly owned by NIAID and Moderna.” (Italics added.) Also, according to a New York Magazine article published December 7, 2020, Moderna’s COVID-19 vaccine had been “designed by January 13” 2020. The piece’s author David Wallace-Wells noted that this was only two days after the SARS-CoV-2’s genetic sequence was made public by Chinese researchers. The New York Magazine article reported that “the Moderna vaccine design took all of one weekend. It was completed before China had even acknowledged that the disease could be transmitted from human to human, more than a week before the first confirmed coronavirus case in the United States. By the time the first American death was announced a month later, the vaccine had already been manufactured and shipped to the National Institutes of Health for the beginning of its Phase I clinical trial.” An amazing feat.

A ”few weeks” of vaccine protection?

The story, “How a secretive Pentagon agency seeded the ground for a rapid coronavirus cure” was published by the Washington Post on July 30, 2020. According to the Post, in February 2020, vaccine scientists were hard at work: “Their mission was part of a program under the Pentagon’s secretive technology research agency. The goal: to find a way to produce antibodies for any virus in the world within 60 days of collecting a blood sample from a survivor.” The article continues, “The program was halfway done when the first case of the novel coronavirus arrived in the United States early this year. But everyone involved in the effort by the Defense Advanced Research Projects Agency (DARPA) knew their time had come ahead of schedule.” In an opinion that, due to short effectiveness time, COVID-19 vaccines are limited: “The idea was to take the blood of a virus survivor and quickly identify the best antibody out of thousands in the bloodstream. Then, the genetic code of that antibody could be injected into troops to give them temporary protection against the virus immediately. Protection could range from a few weeks to a few months — enough time for a deployment.”

Full story someday?

TrialSite previously published a look at DARPA’s role and the possibility that the US government created SARS-CoV-2. After all a memo was sent to TrialSite, one seemingly originating from DARPA with the research agency’s formal seal declaring that SARS-CoV-2 was an American-made technology.

We asked DARPA to confirm that the document was a fake. They could not, rather a communications executive informed TrialSite that DARPA could not confirm or deny the authenticity of the memo. Interestingly, this executive in DARPA offered TrialSite interesting information: the spokesperson in an email assured TrialSite that DARPA was not funding EcoHealth Alliance. Of course, they didn’t have to communicate anything other than that they could not confirm nor deny the question in the email.

But EcoHealth alliance—the group that worked with NIAID to potentially bring coronavirus gain-of-function to China during a time when the Obama administration put a halt on such research. Remember the ties established above between Baric and Wuhan scientists. Baric denies that his coronavirus engineering had anything to do with SARS-CoV-2. There is no hard evidence for a connection.

In the meantime, while Fauci and colleagues at the NIH/NIAID tried to position the SARS-CoV-2 origins with a high certainty as a natural, zoonotic event, no one has been able to prove that either. And by the time Biden came into office the World Health Organization sent a mission to China to investigate the pathogen’s origins again. This time representing America was none other than EcoHealth Alliance’s president Peter Daszak, one of the top coronavirus researchers in the world, intimately associated with gain-of-function, Fauci and the Wuhan Institute of Virology. Talk about a potential conflict of interest.

But taken together, all the above facts raise serious questions as to SARS-CoV-2 origins: If the pathogen was created in a lab, and a good number of federal agencies now suspect this is a distinct possibility, who created the virus? It’s popular among American politicians and associated Beltway pundits to point the finger at the Chinese Community Party (CCP) for the main culpability of COVID-19. And the elements in the Chinese government undoubtedly play a serious role in COVID-19 as reported by TrialSite in numerous articles such as in March 2020, titled “China’s Response to COVID-19: The Good, The Bad and The Ugly.” But there is most certainly a lot of highly coincidental, disturbing data points suggesting at least some probability of American involvement if the pathogen (SARS-CoV-2) was in fact developed in a lab.

The reality that Moderna was researching mRNA coronavirus vaccines prior to official recognition of the pandemic raises more questions than answers.

Of course, this could be merely coincidental as it has become clear among other things, apparently Pentagon-funded research into general pandemics occurred around the same time, and the generic coronavirus (based on the experience of SARS-CoV-1) was likely one for consideration.

Then there are other coincidences such as the Event 201, occurring October 2019, featuring a simulated coronavirus pandemic. Robert Kennedy Jr., now running for President of the United States, argued in his book “The Real Anthony Fauci” that this was beyond coincidence, evidencing probable foreknowledge of the imminent pandemic. Yet the fact checkers have made it clear (and from a logical standpoint) that this isn’t proof of any foreknowledge.

It would appear that at least some of the Republican-led House is also curious about all of this given the recent letter sent to the acting director of the National Institutes of Health. The other day the House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Subcommittee on Health Chair Brett Guthrie (R-KY) sent a letter to Dr. Lawrence Tabak, the senior official who is performing the duties of Director of the National Institutes of Health (NIH). Their concern on behalf of the Oversight and Health subcommittee concerns a request for information to bolster the committee’s ongoing investigation into the origins of COVID-19, regarding any early sequences, data from early cases, or other pertinent documents related to the early stages of the pandemic.

We here at TrialSite have some serious questions about all this, including:

How can the foundation of a vaccine be developed in two days?

Is it merely coincidence that Moderna and NIAID agreed to transfer coronavirus-specific mRNA vaccine candidates to Chapel Hill days or weeks before we knew anything about SARS-CoV-2, the virus behind what was to become just several weeks later COVID-19?

What’s the nature of the Pentagon pandemic readiness program occurring during the same time?

Why did leadership in NIH/NIAID scramble to stop any discussion of lab origins? Note, for the first year if a journalist even mentioned the prospect of the lab leak theory they would be labeled as a conspiracy theorist, and likely censored on social media like Facebook.

What’s behind the purported DARPA memo and the research agency’s unwillingness to deny its veracity? Why did a relatively high up executive there point out in an email to TrialSite that they were not funding EcoHealth Alliance?

Why was Peter Daszak, president of EcoHealth Alliance, sent as an American representative to the WHO group looking into the SARS-CoV-2 origins in Wuhan, despite the clear conflict of interest?

Was unprecedented censorship during the pandemic, evidenced by intensive collaboration between elements of government, media and tech, evidence of some broader agenda?

Hopefully, one day we will have the full story of how SARS-CoV-2 and the deadly COVID-19 pandemic came to be, as well as the backstory of how some folks appeared to, perhaps, have foreknowledge, moving with uncanny timing, seemingly anticipating unprecedented events to come.

NIH Clinical Investigator Acknowledges Rare Neurological-Related Injuries Associated with COVID-19 Vaccines: What Are You Going to Do About It?

NIH Clinical Investigator Acknowledges Rare Neurological-Related Injuries Associated with COVID-19 Vaccines: What Are You Going to Do About It?

Avindra Nath, M.D. knows a thing or two about the COVID-19 vaccines and the neurological issues, although rare, that may ensue.  Far earlier in the…

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Avindra Nath, M.D. knows a thing or two about the COVID-19 vaccines and the neurological issues, although rare, that may ensue. Far earlier in the pandemic when the AstraZeneca vaccine was still undergoing testing in clinical trials, a group of patients including React19 co-founder Brianne Dressen engaged with Nath and others at the National Institutes of Health (NIH). Dressen and some others experienced neurological problems associated with the AstraZeneca COVID-19 vaccine. In fact, as myriad issues emerged with that experimental product the decision was made to not consider that particular COVID-19 vaccine for distribution as a countermeasure under the Emergency Use Authorization. Nath and others conducted an observational study that was never peer-reviewed, uploaded to the preprint server medRxiv and essentially forgotten. TrialSite reported on the study where Nath and colleagues emphasized that more time was necessary for scientists and physicians to determine the true nature of any causal relationship between the COVID-19 vaccines and neuropathies. So, lots of time has passed—what more does the NIH Principal Investigator have to say on the topic?

It should be noted that during those early days of the pandemic not only Nath via his National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH but also representatives from other federal agencies such as the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) were aware of these early reports of neurological-related vaccine injuries. Brianne Dressen has explained to TrialSite that numerous upbeat promises were made by the agencies to support the COVID-19 vaccine injured with research and access to care. But particularly after the political winds blew hard as 2020 transitioned to 2021, with the outgoing Trump administration fiasco, the January 6th uprising, plus Biden’s new intensified focus on vaccination, it led to the worst possible political storm impacting the vaccine injured, raising questions about the COVID-19 vaccine or unbelievably just claiming an industry tarnished a person in the eyes of many. Essentially the topic was intensely politicized and remains so. In some societal circles, it’s a taboo topic, one that can divide what were friends, even family.

In Nath’s most recent article in the journal Neurology titled “Neurologic Complications with Vaccines: What We Know, What We Don’t, and What We Should Do” Nath, an NINDS Senior Investigator highlights first the impact of vaccination generally over the last half century, nearly eradicating potentially deadly infections that in days gone by were constantly taking lives. He is correct. Vaccination has played a vital role in individual and collective health despite the trendiness of elements in the medical freedom movement to deny that reality.

However, Nath and most in positions of influence and power in health-related research today treat vaccines as if they were all alike. But they are not. Importantly, not all vaccines are the same, even when the FDA has approved them as safe and effective. But it’s as if this classification immediately delegitimizes any critique of these medicinal-based products. An either-or false dilemma narrative is set up. Either you believe that it's universally good or you don’t. But that’s not how the real world works, especially with medical products with side effects.

The reality is that some vaccines have better safety track records than others, and at least historically, the vaccines that we have that are tried and true have a lengthy development lifecycle and several iterations of advancement.

The number of vaccines on the CDC childhood schedule continues to grow. As of this writing, there are 18 vaccines on the CDC’s Child and Adolescent Immunization Schedule for children from birth to 18 months, and this includes the COVID-19 vaccine. Importantly, the particular version of the vaccine now in circulation remains experimental (investigational) in that only the bivalent Omicron BA.4/BA.5 product became available as recently reported by TrialSite. See a dialogue between this author and Dr. David Wiseman on TrialSite’s YouTube channel on this topic.

There are another 18 vaccines on the CDC’s schedule from the age of 18 months to 18 years. While many of these vaccines remain a bedrock of personal and public health, TrialSite continues to have questions about the placement of the COVID-19 vaccine, again, still investigational (despite the licensure that did occur with the monovalent product), on the childhood vaccination schedule from birth to 18 months.

Nath in his generally cursory piece emphasizes that despite an evolution toward more sophisticated vaccines (mRNA or protein-based) and “well-defined” manufacturing process (see Emergent BioSolutions fiasco for glaring examples of production problems with the COVID-19 vaccines) he acknowledges that well, “despite such measures, vaccines are not without side effects including those that impact the nervous system.”

So, there is an explicit acknowledgment that neurological issues are present, at least on rare occasions. A wealth of information exists in various monitoring systems today, yet as will be noted below Nath calls for a more complex reporting scheme, involving global platforms, with full industry buy-in. A tall order that in all reality is years away. What about people with debilitating conditions today?

Nath points to “numerous case reports and case series” implying “possibilities” of such potential serious adverse events. But the NIH scientist isn’t squaring with the American public. The “React19 Scientific Publications & Case Reports,” database houses a collection of 3,400 peer-reviewed case reports and studies involving post-COVID-19 vaccine reports of serious adverse events. Including 24 therapeutic categories, the repository includes 628 studies associated with neurological issues associated with post-COVID-19 vaccine adverse events. 628 studies, even if only case series, is a lot and should be well studied, reported on and translated to the clinic to educate and empower more doctors and health care professionals to help patients. Isn’t that what it’s all about?

The NIH scientists remind all of the universal immunity the U.S. government grants to bio-pharmaceutical companies developing vaccines during the national public health emergency under the Public Readiness and Emergency Preparedness (PREP) Act. Industry, and in fact, the entire value chain of vaccination from pharma companies to healthcare clinics has absolutely no liability associated with the mass vaccination campaign during the emergency. Any compensation for injury must come from what TrialSite has identified as a dismal failure—the Countermeasures Injury Compensation Program (CICP). To date, despite over 11,000 claims only three have been awarded. This is an outrageous reality. This demonstrates the government’s intention, which is to leave the vaccine injured to fend for themselves.

Importantly, vaccine makers generally don’t have liability for any injuries even before COVID-19. That dismissal of liability emerged with the National Childhood Vaccine Injury Act of 1986 which shifted liability from industry to government under the National Vaccine Injury Compensation Program (VICP)---an alternative to traditional products liability and medical malpractice litigation for people injured by the receipt of one or more standard childhood vaccines. While VICP is far better than CICP, it as well needs to be updated and modernized.

Nath reminds us of all that the government is busy monitoring for COVID-19 vaccine injuries thanks to both the “active and passive surveillance programs” in place by the CDC and FDA (think VAERS). TrialSite has reported on heretofore not conceivable volumes of adverse event reports in the VAERS system. Yet we are constantly reminded that despite the fact that the system was billed as a key to monitor for safety signals, VAERS doesn’t do much to help us because causation isn’t proven. This is true, however, when the incidence is reported in VAERS just one or two days after the administration of the COVID-19 vaccine the probability of some causal connection markedly increases, all things being equal.

With 672 million doses of COVID-19 vaccines administered in the United States from December 14, 2020, through March 1, 2023, serious adverse events are indeed rare. But they are occurring. Out of the 19,476 preliminary reports of deaths associated with the vaccines a substantial percentage of these occurred shortly after vaccination. Again, that doesn’t mean the vaccine triggered the death. But deaths are occurring—we have been reporting on them around the world. Some nations such as Taiwan and Singapore seem to have more reasonable and responsible government compensation schemes as compared to the United States, United Kingdom and Canada.

Nath continued in his journal entry, “While most side effects of vaccines are benign and transient, such as headache or fatigue, more serious side effects, including devastating neurological complications may occur.”

So, what does Nath propose to do to help this vulnerable population? Where is the health equity agenda in this case? According to his paper, “future research” is necessary to better understand the neurological complications of the COVID-19 vaccines (which he acknowledges involve other vaccines as well). He proposes the following research trajectory:

Expansion of active surveillance programs

Develop tools for gathering precise information on neurological complications

Genetic susceptibility studies

Immune proofing of individuals with neurological manifestations

Determine association with comorbidities

Develop animal models

Conduct clinical trials for prevention and treatment of adverse events

Nath is also big on working to build influential, global monitoring systems with complete industry buy-in. Does he understand how difficult, how time-consuming the realization of such a vision entails?

What about the patients with vaccine injuries struggling now? Does he care about this vulnerable population? Nowhere therein does Nath really address what to do with the COVID-19 vaccine-injured population today.

The stakes here are bigger, more severe given the intense mandates and societal pressures that emerged during the pandemic, along with what was clearly federal agencies playing fast and loose with the law. True informed consent for example wasn’t really practiced during the pandemic in most cases. Although classified as rare, considerable risks continue to be associated with the COVID-19 vaccines, particularly for certain cohorts (Myocarditis for young men as an example), but during the emergency, the specter of catching COVID terrified the society far more than the rare prospect of an injury, which most likely would be mild.

At TrialSite we continue to carefully monitor the topic, and while we cannot prove our vaccine-injured estimations, we consider them reasonable. The extent to the scope and scale of the vaccine-injured population varies depending on point of view, outrageously, often even political point of view given the overall politicization of the topic.

We’ll simplify and call out two extremes—the so-called medical freedom movement extreme and the mainstream medical establishment, which we believe systematically suppresses accurate insight into the topic.

While the more extreme groups classified as “anti-vax” may declare millions have died from the COVID-19 vaccines in all reality there is no real evidence to make this claim. Any algorithms used to generate such high numbers are quite suspect and not validated anywhere. We are concerned by the growing tendency toward sensationalism to drive attention and eyeballs and in many cases monetization among the anti-vax crowd.

On the other hand, from a mainstream point of view, government estimates may vary but there is no formal, systematic research on the matter, at least that we are aware of. The government has only acknowledged a few deaths associated with the COVID-19 vaccines even though nearly 20,000 were registered in VAERS (again that doesn’t mean they are connected to the vaccine).

At least some of the research Nath proposes in his paper has been suppressed, or even shut down. There isn’t much money in studying COVID-19 vaccine injuries. And this is unlikely to change barring some extreme unforeseeable changes.

TrialSite reminds all that in the United States 270 million people alone received their primary series and based on nearly 2.5 years of ongoing monitoring of data and study sources worldwide, we estimate that a range from anywhere from half a million to 2 million people are struggling with material health issues that persist since the administration of the COVID-19 vaccine. We acknowledge that not all of these are because of the vaccine solely—long COVID and other issues very well could be factors. It’s a complex difficult situation for those that are struggling, ill, in pain and left to fend for themselves in most cases.

The vaccine-injured population along with a much larger long COVID population which too is severely underserved represent the overall demographics of America. Not surprisingly many of them face dire financial consequences. While literally trillions of public dollars were generated and redistributed during the pandemic suffice it to say coming out of the emergency there were economic winners, and a lot of losers, economically and health-wise. All things being equal socio-economic divisions only intensify during such crises. Put another way, during pandemic times while the government does offer programs of one type or another to help the masses, the rich get far richer while the poor become dramatically poorer. The middle class continues to shrink and the working poor grow in numbers. A majority of the vaccine injured based on our estimates fall into the general socio-economic categories meaning many people in this cohort face dangerous economic times.

Given the economics of health care delivery in this country and the fact that the appropriate government agencies have decided to avoid all accountability and responsibility, we must find other means to support vulnerable populations while finding ways to organize across partisan divides to hold elected officials accountable.

It would appear that care navigation and coordination support, vitally needed for complex health matters, must be supported and sustained by the private sector. Nonprofits such as React19 but also myriad other groups, faith-based organizations and firms committee to helping fellow humans in dire health care need to receive more support. Help should be available from corporations of all types, foundations and charities, faith-based groups, and from wealthy households. Big pharma involved such as Pfizer, BioNTech and Moderna must chip in. This would do wonders for their brands (currently in the gutter), and potentially turn around what has become a complete lack of trust in that particularly important industry.

This author personally emailed Albert Bourla suggesting that Pfizer, a great American pharmaceutical company, support programs to help the vaccine injured. No response as of yet, and I’m not holding my breath, but unfortunately, I have little trust in the leadership across the key government agencies. These are institutions I have looked up to over the years with great reverence. Not anymore.

I founded TrialSite to disseminate and democratize information associated with the world of biomedical/health-related research, with a particular focus and emphasis on clinical trials; how they worked, what advanced therapeutics were in the pipeline and importantly, what trial sites and principal investigators were involved with any given study.

Our paradigm at TrialSite necessitates an openness--and commitment to be as objective and unbiased as humanly possible. I was told by someone relatively high placed in the U.S. Department of Health and Human Services of the importance of TrialSite. I asked them why they made that statement to me—what was the basis for that declaration?

This individual, again fairly high up the ladder in government, told me that during the COVID-19 pandemic, TrialSite was the only biomedical media platform consistently reporting a diverse, unbiased array of COVID-19 vaccine study results. TrialSite consistently reported on the positive outcomes (how the vaccines have prevented more severe infections especially earlier in the pandemic for example) as well as the negative outcomes (from their durability and breadth challenges to reports of serious adverse events/injuries, for example).

This official further told me that while media on the right became increasingly unbiased, even radicalized, headed to more universal anti-vaccine positions (never mentioning any of the positives associated with the COVID vaccines), media to the center and left, especially mainstream media only followed very careful scripts, likely influenced by a confluence of government industry, influence, and power.

The topic of health research becomes ever more important with an ongoing revolution in life sciences, from amazing new ways to combat cancer to the latest in vaccine technology, but at the same time, declining health indicators across various American segments portends mounting crises ahead.

With TrialSite we sought to create an independent media platform that could showcase all the good, but also the challenges, and the outright problems, including the ugly ones, involving the science and the business of research. Four years into this still-emerging startup and I believe we have accomplished a lot, but there is so much more to do.

Knowledge in any particular field helps empower individuals and groups, and as we have seen during the pandemic the government along with large media and tech corporations actively collaborated to suppress and censor access to vital biomedical research information, reflecting powerful vested interests in the economy and society. Unfortunately, as committed as Dr. Nath is to the advancement of good science, he’s stuck in an institution that likely needs considerable reform, and definitely new leadership with a different agenda, and mission.

Check out Dr. Nath’s article in the journal Neurology.

German Study Claims Mask Wearing May Be Harmful

German Study Claims Mask Wearing May Be Harmful

In Britain, there is a call to start wearing face masks in public again because of the spread of the new variant of Covid, Arcturus. Since February,…

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In Britain, there is a call to start wearing face masks in public again because of the spread of the new variant of Covid, Arcturus. Since February, infections from Arcturus have grown to 3.96% worldwide, and there is an estimated 7.2% of cases in the United States. The “variant under monitoring” designation given to XBB.1.16 by the WHO means the variant has “genetic changes” which could affect its characteristics as a virus, including a possible “growth advantage” over other versions of Covid. The variant was first detected in January. Some medical authorities in the United Kingdom are advocating mask-wearing because in the “absence of population-scale mitigations... the focus remains upon individual risk which is, for many, now much lower.” But a recent study out of Germany claims mask-wearing may be harmful.

Exposure to Carbon Dioxide (CO2)

The study claims wearing face masks may raise the risk of stillbirths, testicular dysfunction and cognitive decline in children. According to the study, “Fresh air has around 0.04% CO2, while wearing masks more than 5 min bears a possible chronic exposure to carbon dioxide of 1.41% to 3.2% of the inhaled air. Although the buildup is usually within the short-term exposure limits, long-term exceedances and consequences must be considered due to experimental data. US Navy toxicity experts set the exposure limits for submarines carrying a female crew to 0.8% CO2 based on animal studies which indicated an increased risk for stillbirths. Additionally, mammals who were chronically exposed to 0.3% CO2 demonstrated a teratogenicity with irreversible neuron damage in the offspring, reduced spatial learning caused by brainstem neuron apoptosis and reduced circulating levels of the insulin-like growth factor-1. With significant impact on three readout parameters (morphological, functional, marker) this chronic 0.3% CO2 exposure has to be defined as being toxic.”

The study was done as part of a scoping review where literature was “systematically” reviewed regarding CO2 exposure and facemask use. The study also says, “Circumstantial evidence exists that extended mask use may be related to current observations of stillbirths and to reduced verbal motor and overall cognitive performance in children born during the pandemic. A need exists to reconsider mask mandates.” The research team acquired data from 43 previous studies of mask-wearing and pregnancy. Apparently, mask-wearing creates a “dead space” that traps CO2 leading to more inhaled and rebreathing of the gas.

Conclusions are questioned

The researchers looked at studies focusing primarily on mice and rats, and that appears to be one of the main issues with the research because the data was taken from animals and not humans. Researchers also noted none of the studies they looked at involved mask use, miscarriages or infertility and neurodevelopment disorders. They also said that the exact effects of toxic levels of CO2 on unborn life are not known in great detail.

Additionally, the lead researcher of the analysis, Kai Kisielinski, who describes himself as an “independent researcher” has written other papers claiming mask wearing may cause significant health problems. Kisielinski is also a surgeon in Dusseldorf, Germany. Since the beginning of the Covid pandemic there has been a debate about mask-wearing. Now it seems an argument has been introduced claiming mask-wearing may be unhealthy. There appears to be one constant with the Covid pandemic. It continues to foster divisiveness and debate.

Study Researchers

Kai Kisielinski

Susanne Wagner

Oliver Hirsch

Bernd Klosterhalfen

Andreas Prescher

Effectiveness of Mask Mandates

Effectiveness of Mask Mandates

The COVID-19 pandemic is fading into history but a large-scale review into the effectiveness of mask mandates is sparking renewed interest in this…

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The COVID-19 pandemic is fading into history but a large-scale review into the effectiveness of mask mandates is sparking renewed interest in this controversial topic. The study on the effectiveness of mask mandates comes at a time when most counties, cities, and states have either relaxed or completely ended their mask mandates in the United States. The study’s findings indicate that there was no statistically significant evidence that mask mandates are effective in reducing the spread of respiratory viruses, including COVID-19. However, the study has attracted opposition from prominent figures who have labeled its claims as unfounded as they rely on inconclusive results. TrialSite previously reported on the previous data about face masks.

Whether masks can reduce the risk of exposure to contagious diseases has been a contentious issue throughout the COVID-19 pandemic. Previous studies conducted on the effectiveness of mask mandates have largely remained inconclusive with the largest COVID-19-era study showing the benefits of face masks.

The debate on the mask mandates was settled by an “agree to disagree” model. However, a new study by Cochrane, a non-profit labeled as a gold standard for evaluating health interventions, has released what it terms “strong results” that show the uncertainty of face masks in reducing the spread of contagious infections.

Cochrane organization

Cochrane is a large organization composed of an international network of reviewers. The organization is based in London and is funded by the National Institutes of Health and other countries’ health agencies.

The review by Cochrane has received global attention because the organization has built a trusted reputation by gathering much research on healthcare issues and providing reliable findings. The strict methodology used by the report authors and the peer review process have meant that the released report was well placed to spark an interest in the mask debate once again. However, the key issue with the systematic review as identified by Karla Soares-Weiser, Editor-in-Chief of the Cochrane Library is that the results were inconclusive.

Cochrane evidence on mask mandates

On January 30, the Cochrane organization published its report entitled “Physical interventions to interrupt or reduce the spread of respiratory viruses.”

Cochrane carried out the review using randomized controlled trials (RCTs). 12 of the 78 total included were comparing individuals wearing no facemasks to those with surgical/medical masks on.

The result was that the masks did little to reduce the spread of respiratory diseases. The report itself reviewed at least 78 studies involving at least 610,000 participants. Of all the studies, only six involved the COVID-19 pandemic.

The Cochrane review results also indicate uncertainty about whether wearing P2/N95 respirators reduces the spread of respiratory diseases. The review further indicates that hand hygiene programs slow the spread of respiratory infections.

Limitations

The review includes some studies that examined other respiratory illnesses such as influenza which is less contagious than COVID-19. Another key issue identified by Peter Chin-Hong, MD, is that it is difficult to use randomized control trials to study the effectiveness of masks in reducing the spread of infectious diseases. This is because randomized control studies are limited because they cannot be applied in some institutions, such as hospitals. After all, one cannot ethically randomize an individual in such a setting not to wear a mask.

Responses to the evidence

Tom Jefferson, senior associate at the University of Oxford and the lead author of the Cochrane review summed up its evidence by stating that there is simply no evidence to back up the use of mask mandates in an epidemic. Furthermore, Jefferson slammed some health policies implemented during the three years following the start of the COVID-19 pandemic, labeling them “scientifically baseless policies.”

The release of this Cochrane review has once again stirred debates, especially on social media, regarding the effectiveness of masks Critics of the lockdown measures have used the review to justify their opinions on the government’s needless health policies. Key among these critics has been Bret Stephen whose opinionated article in the New York Times claims that the mask mandates were a bust. Stephen further writes, “Those skeptics who were furiously mocked as cranks and occasionally censored as ‘misinformers’ for opposing mandates were right.”

There has also been a response from Rochelle Walensky, the CDC director, who says, “The Cochrane review is an important study.” However, Walensky proceeds to note that the review’s use of only randomized clinical trials and some trials involving other respiratory illnesses means that the mask guidelines remain the same. This stance by the CDC director is one that identifies the Cochrane review as inconclusive.

The director of the pandemic center at Brown University School of Public Health, Jennifer Nuzzo, indicates that the Cochrane review reveals that very few high-quality studies were carried out to determine the effectiveness of the facemasks during the COVID-19 pandemic. Furthermore, Nuzzo derives from the report that masks have little impact in preventing respiratory diseases at the population level.

Conclusion

The Cochrane report has reignited the debate on the effectiveness of face masks in an epidemic. Although the new review presents results from multiple studies, it fails to settle the debate on the effectiveness of face masks. Thus, this report by the Cochrane organization provides evidence for both camps in the mask effectiveness debate to poke holes into each other’s arguments. Despite this new Cochrane’s review, we have yet to succeed in settling the debates about the mask mandates. The CDC and most public health institutions still hold that the mask guidelines remain unchanged.

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Quote from Zephir_AWT

This and repeated attempts for silence and closure Covid related threads convince me, that at least some moderators of LENR forum have Pharma agenda too.

Once THuxley did leave this forum, Curbina and others want to close it. I don't believe in coincidences.

The huxster left the thread because he didn't have a leg to stand on. The tide was turning and mainstream started asking questions about vaccines, treatment and mandates. I find it ironic now that mainstream is asking these questions and the mods decided to close the thread. I think they bowed to the brainwashed members. But that's just my opinion!

Don’t Let Them Rewrite the Pandemic

Don’t Let Them Rewrite the Pandemic | National Review

Anthony Fauci and Randi Weingarten try to revise the past.

www.nationalreview.com

The Covid-19 pandemic ravaged the elderly and the sick in this country. It inspired or terrified us into huge social, governmental, and economic experiments. “Lockdown” stopped being just prison jargon. We have long since entered an appropriate period of reflection and investigation. Fights about masks, social-distancing, quarantines, and closures of churches, parks, and other amenities disfigured the normal rhythm of human life, marring funerals and delaying weddings. We are now uncovering years of learning loss and missed developmental milestones in children who were deprived of needed socialization, structured play, and face-to-face learning for speech development

These particular maladies and the way America was an outlier in them are at the feet of our institutions and their leaders. Which is why they are lying so much about their records.

iThe React19 Scientific Publications & Case Series Database

The React19 Scientific Publications & Case Series Database

A nonprofit patient advocacy group dedicated to persons injured by COVID-19 vaccines launched what is likely the world’s largest database of studies,…

www.trialsitenews.com

A nonprofit patient advocacy group dedicated to persons injured by COVID-19 vaccines launched what is likely the world’s largest database of studies, primarily case series/case reports, tracking various serious adverse events and associated injuries associated with COVID-19 vaccines. A valuable resource for researchers investigating various serious adverse events potentially linked to the COVID-19 vaccines, TrialSite estimates that between approximately half a million and 2 million persons in the United States alone struggle with health conditions potentially linked to the vaccines. While serious adverse events are rare with the COVID-19 vaccines, an unprecedented mass vaccination at scale occurred over the past couple years. In the United States alone, over 270 million people received primary series alone.

The database came together as part of a collaboration with React19, Aaron Hertz, TrialSite, and CrossTx. See a recent press release that covers some of that collaboration.

The World’s Largest COVID-19 Vax—Serious Adverse Event Repository

The repository consists of a collection of over 3,400 peer-reviewed case reports, case series, and other studies across 24 general health categories citing adverse effects post-COVID-19 vaccination. React19 co-founder Brianne Dressen sponsored the database, as researching COVID-19 vaccine-related adverse events can be daunting, at least in part, due to the broad myriad of factors involved.

Most challenging is the actual search for these studies. They are published and uploaded across multiple publishing platforms around the world. Given the government not only mandated the COVID-19 vaccines but also set up the conditions to pressure various institutions, organizations and companies across American society to include vacation as part of employment, for example, adverse events were to be expected and such an initiative should have been funded and supported by the government itself.

The ever-growing list of peer-reviewed studies specific to COVID-19 vaccine adverse events is curated and maintained by React19 staff, which includes researchers with Ph.D.s who also happen to be COVID-19 vaccine injured.

TrialSite announces the React19 Scientific Publications & Case Reports database for medical/health researchers and other professionals interested in learning more about this growing problem. Of course, not all of the injuries tracked in the case series/case report studies are definitively linked to the vaccines.

What follows are the top five therapeutic area by number of studies/reports listed:

Topic

# of Studies

Neuro

628

Dermatology

539

Cardiac

432

Thrombolytic/Thrombocytopenia

402

Rheum/Endo/Ortho

212

To visit the React19 Scientific Publications & Case Reports database simply follow the link.

If you believe that you have been injured by the COVID-19 vaccine, visit and reach out to React19.

If you are a provider or attorney seeking resources for your patients visit here.

https://covid.crosstx.com/

Exploring the Possible Side Effects of COVID-19 Vaccines: Are Genital Ulcers a Concern?

Exploring the Possible Side Effects of COVID-19 Vaccines: Are Genital Ulcers a Concern?

While millions worldwide have received the COVID-19 vaccine and reported minimal side effects, concerns have been raised about rare and unexpected reactions.…

www.trialsitenews.com

While millions worldwide have received the COVID-19 vaccine and reported minimal side effects, concerns have been raised about rare and unexpected reactions. One of these is genital ulcers which generated significant interest, as genital ulcers can have a significant effect on a person’s quality of life. TrialSite has also reported skin-related side effects that may be related to the COVID-19 vaccine including the reactivation of the varicella-zoster virus, an eczema skin reaction, and skin diseases.

The American Academy of Family Physicians (AAFP) states that genital ulcers are usually seen due to sexually transmitted infections but may also be due to inflammatory diseases, trauma, or a bad reaction to skin care products. Risk factors included unprotected sex, uncircumcised male genitalia, and more than one sex partner. However, it is possible for inflammatory diseases that lead to genital ulcers to have a hereditary component.

One type of genital ulcer, the aphthous ulcer, was recently linked as a possible side effect of the COVID-19 vaccine.

Vulvar Aphthous Ulcer in an Adolescent After Pfizer-BioNTech (BNT162b2) COVID-19 Vaccination

Vulvar aphthous ulcers are a rare type of genital lesion most common in non-sexually active adolescents. Vulvar aphthous ulcers are typically associated with…

www.ncbi.nlm.nih.gov

Most common non-transmissible ulcer

Aphthous ulcers are lesions on the vulva, similar to “canker sores” you can get in your mouth but they are deeper and larger. Unlike other genital ulcers, this type of ulcer is acquired and is an uncommon, non-sexually transmissible genital ulcer.

While this type of ulcer is typically not considered an infection, with its etiology still unknown, certain viral illnesses such as influenza or Epstein-Barr virus may trigger their development. In these cases, the ulcers are thought to result from the stress that the infection places on the immune system, ultimately leading to the formation of ulcers.

Case studies: Adolescent girls develop genital ulcers after COVID-19 vaccination

TrialSite reported on adverse endocrine events (AEE) following COVID-19 vaccination. AEE areconsidered rare and with a benign outcome. thyroid alterations are the most common. In the report from March 17, 2023, a summary of entries for AEEs in the Vaccine Adverse Event Reporting System (VAERS) was included. The VAERS database was initially accessed on Dec. 20, 2022 for reports including all COVID vaccine manufacturers in the USA. The database was accessed for the second time on Feb. 23, 2023 to get the number of AEEs reported seven and fourteen days post-vaccination. The data shows several genital lesions including

Genital herpes reported 139 times

Genital rash reported 78 times

Genital ulceration reported 59 times

Genital lesion reported 21 times

Genital blister reported 18 times

Genital abscess reported 4 times

Genital ulcer syndrome reported 3 times

In comparison to the commonly reported adverse events (AE), these numbers might seem small. Some more common AEs are anaphylaxis (a severe allergic reaction), thrombosis (blood clotting), and myocarditis (inflammation of the heart).

The genital lesion most frequently reported after the COVID-19 vaccine was herpes, but herpes is also the most common misdiagnosis for aphthous ulcers. Because of this, the cases of vulvar aphthous ulcers post-COVID-19 vaccination may be unrecorded.

The report did not include an age bracket, but several case studies have been found on adolescent girls who presented with genital ulcers post-COVID-19 vaccination.

16-year-old female

The case was of a non-sexually active adolescent girl who developed genital ulcers within 24 hours of receiving her second dose of the Pfizer BioNTech COVID-19 vaccine. She was hospitalized two days post-vaccination and was diagnosed with vulvar aphthous ulcer six days post-vaccination.

However, it is also worth noting that the patient in the study had an extensive medical history that involved corrective surgeries for several congenital conditions. She also had a history of recurrent oral ulcerations. Even her family had a history of canker sores so severe they needed medical intervention.

Laboratory tests showed:

Negative evaluation of SARS-CoV-2 RNA

Negative swab and blood test of the lesion for herpes simplex virus 1 and 2

Other STI tests were returned negative

An Epstein-Barr nuclear antigen antibody was found - an indication of previous infection with the virus.

The result shows a typical presentation of ulceration resulting from an inflammatory disease that can be triggered by an influenza-like illness.

12-year-old and 14-year-old female

The case report included the case of two adolescents who had received the Pfizer-BioNTech COVID-19 vaccine.

Acute Genital Ulceration After Severe Acute Respiratory Syndrome Coronavirus 2 Vaccination and Infection

Reactive, nonsexually related acute genital ulceration, also known as Lipschütz ulcer, is a nonsexually related ulceration involving the vulva, most commonly…

www.ncbi.nlm.nih.gov

A 12-year-old. This patient presented with genital ulcers two days after receiving the second dose of the COVID-19 vaccine. Shewas otherwise healthy with no history of oral or genital ulcers, no sexual activity, and no autoimmune disease. All laboratory workups turned up negative. Findings were deemed to have been triggered by the COVID-19 vaccine.

A 14-year-old. This patient presented with genital ulcers three days after receiving the second dose of the COVID-19 vaccine. She’d had a prior episode of genital ulcers several months before this presentation. All laboratory workups, including COVID-19 testing, were negative for both occurrences.

This patient’s genital ulcer recurred approximately 6 months later, 24 hours after testing positive for COVID-19.

13-year-old to 17-year-old female

The Journal of Pediatric and Adolescent Gynecology reported three cases of genital ulcers following Pfizer-BioNTech COVID-19 vaccination without COVID-19 infection.

https://www.jpagonline.org/article/S1083-3188(22)00153-X/fulltext

A 13-year-old female. This patient presented with genital ulcers one day after receiving the second dose of the COVID-19 vaccine. She’d had one episode of genital ulceration in the past. The genital ulcer was positive for corynebacterium–bacteria that can cause respiratory and non-respiratory disease (diphtheria)–and negative for the rest of the laboratory workup.

A 14-year-old female. This patient presented with genital ulcers after the first dose of the COVID-19 vaccine. She’d had one episode of herpes simplex virus (HSV)-negative genital ulcer in the past. The genital ulcer was biopsied and showed signs of chronic inflammation. The ulcer was negative for the rest of the laboratory workup.

A 17-year-old female. This patient presented with genital ulcers one day after receiving the second dose of the COVID-19 vaccine. The genital ulcer was positive for Staphylococcus aureus–bacteria that often cause skin infections–and negative for the rest of the laboratory work-up. EBV workup was not obtained by this patient.

14-year-old female

The case was of a non-sexually active adolescent girl who presented with genital ulcers two days after receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine.

The patient’s medical history included heavy menstrual bleeding and Type I von Willebrand disease that required an extended cycle combination of oral contraceptives. The patient had no history and family history of genital or oral lesions. She tested negative for EBV and any other laboratory workup.

COVID-19 infection and vulvar aphthous ulcer

Aphthous ulcers have also been linked to COVID-19 itself. There were two case studies of COVID-19-positive patients who presented with vulvar aphthous ulcers who had no familial predisposition, no previous infection with EBV, and claimed not to have been exposed to sexual risk factors.

A 41-year-old woman presented with a 10-day history of dry cough and rhinorrhea, with a coinciding 5-day history of a genital ulcer at the time of consult. The patient tested negative for the rest of the laboratory work-up done. She came back one week later with a resolving genital ulcer but progressive respiratory symptoms and tested positive for COVID-19.

COVID‐19‐related acute genital ulcers

www.ncbi.nlm.nih.gov

A 19-year-old adolescent girl presented with a vulvar aphthous ulcer two days after testing positive for COVID-19.

Vulvar Aphthous Ulcer in an Adolescent With COVID-19

Vulvar aphthous ulcers have been associated with various prodromal viral illnesses. We describe the case of an adolescent girl who developed vulvar aphthous…

www.ncbi.nlm.nih.gov

Worth looking into

COVID-19 vaccines have been reported to have several side effects that have raised safety concerns about the vaccines. More than the other vaccines, the Pfizer-BioNTech COVID-19 vaccine has been linked to a number of side effects ranging from common to rare adverse reactions post-vaccination, now including genital ulcers on the list.

Although many national organizations have endorsed vaccination and have encouraged 12-year-olds to 16-year-olds to receive the Pfizer-BioNTech COVID-19 vaccine, these case studies emphasize the need for more data and research into the adverse immune reactions after a COVID-19 mRNA-based vaccine.

Present reports and studies are aiming to look into the causal relationship between the COVID-19 vaccines and genital ulcers by conducting more studies and research. TrialSite will continue to monitor emerging cases of adverse events following a COVID-19 vaccination.

Kitasato University Preclinical Animal Models—Orally Administered Ivermectin Exhibits Robust Potential Against SARS-CoV-2

Kitasato University Preclinical Animal Models—Orally Administered Ivermectin Exhibits Robust Potential Against SARS-CoV-2

A prominent academic research center in Japan investigated the potential of the anti-parasitic, Nobel Prize associated drug Ivermectin with antiviral COVID-19…

www.trialsitenews.com

A prominent academic research center in Japan investigated the potential of the anti-parasitic, Nobel Prize associated drug Ivermectin with antiviral COVID-19 treatment options. Reported on by TrialSite earlier on during the pandemic, medical researchers at Kitasato University found at least some compelling evidence for ivermectin’s use against SARS-CoV-2, the virus behind COVID-19. Now the university’s Medical Center in Saitama Japan reports on the findings of a preclinical animal study published in the prominent journal Nature. This recent investigation evaluated the effects of the in vitro effects of ivermectin in a hamster model of SARS-CoV-2 infection. The results were quite promising.

Preclinical Lab Findings

The team represented by corresponding author Takayuki Uematsu Deputy Head of Laboratory, Kitasato Institute Medical Center Hospital reports that the oral administration of ivermectin before SARS-CoV-2 infection in the animal subjects linked to decreased weight loss and pulmonary inflammation. Moreover, Uematsu and team report:

“ …the administration of ivermectin reduced pulmonary viral titers and mRNA expression level of pro-inflammatory cytokines associated with severe COVID-19 disease. The administration of ivermectin rapidly induced the production of virus-specific neutralizing antibodies in the late stage of viral infection. Zinc concentrations leading to immune quiescence were also significantly higher in the lungs of ivermectin-treated hamsters compared to controls.”

Of course, this was only an animal study but TrialSite notes that the FDA justifies female rat studies as a basis for administration of COVID-19 mRNA vaccines in pregnant women along with observational data associated with the Centers for Disease Control and Prevention. See the FDA package insert for Pfizer’s Comirnaty section 8.1.

Lots of Data during the Pandemic

One site that tracks ivermectin studies reveals 203 ivermectin-based studies targeting COVID-19 since the onset of the pandemic. Of these C19IVM.ORG reports 96 of the studies involving 1,030 scientists and 135,554 patients across 27 countries demonstrate a statistically significant improvement for mortality, ventilation, ICU hospitalization, record, cases and vial clearance. Other studies listed evidence of prophylactic benefit.

TrialSite has reported on compelling real-world data involving use of ivermectin in combination with doxycycline for example in Uttar Pradesh India. An aggressive public health outreach campaign during the height of the Delta surge in India appeared temporally associated with phenomenal results. Sending pairs of health care workers villages and towns across India’s most populated state, they distributed home medicine kits which included ivermectin doses and doxycycline.

The effort was so successful that even the World Health Organization (WHO) touted the results in a press release. See “Uttar Pradesh: Going the Last Mile to Stop COVID-19.”

Not surprisingly the WHO in this important admission omitted the ingredients of the home medicinal kits. Health officials from Uttar Pradesh went on the record defending the use of ivermectin as a key ingredient for the successful program. Mainstream media at MSN showcased the positive results. A prominent physician also verified the results of the ivermectin use.

A similar effort was led in Mexico City by the public health apparatus in one of the world’s most populated cities. They reported positive results with use of ivermectin. These real-world programs didn’t collect extensive data so it cannot be claimed conclusively that these programs in fact helped reduce not only the severity of SARS-CoV-2 but also its transmission. Interestingly, however, in Uttar Pradesh the turnaround was dramatic. The Western press censored this news.

In the U.S. early on during the pandemic, the ICON real-world observational study showed positive results led by a husband and wife physician team at a health center in Florida. The results were peer-reviewed and published in the journal Chest.

Recently the French biotech MedinCell reported statistically significant benefits associated with their version of the drug targeting COVID-19. See "Ivermectin delivers statistically significant results against COVID-19, including Omicron in SAIVE trial.”

Importantly a handful of prominent studies sponsored by nonprofits and academic research centers however are used by regulators and public health agencies in the West to declare ivermectin’s lack of efficacy. Studies such as Together and COVID-OUT didn’t find compelling evidence for the benefits of ivermectin, but critics questioned some of the study design elements.

The general consensus among developed world medical establishments, regulators and apex research institutes is that ivermectin isn’t’ effective against COVID-19. The National Institutes of Health only recommends use of ivermectin targeting COVID-19 in clinical trials.

Japanese Interest but in Animal Models

These most recent results out of the Japanese university suggest that ivermectin may have efficacy in reducing the development and severity of COVID-19 by affecting host immunity in a hamster model of SARS-CoV-2 infection.

Prophylactic administration of ivermectin attenuates SARS-CoV-2 induced disease in a Syrian Hamster Model - The Journal of Antibiotics

www.nature.com

FDA: Licensed Vaccines Do Not Need to Prevent Infections or Transmission

FDA: Licensed Vaccines Do Not Need to Prevent Infections or Transmission

Recently, during the Food and Drug Administration (FDA) contemplated changes to the COVID-19 vaccine status, they elicited a commenting period. An organization…

www.trialsitenews.com

Recently, during the Food and Drug Administration (FDA) contemplated changes to the COVID-19 vaccine status, they elicited a commenting period. An organization called the Coalition Advocating for Adequately Labeled Medicines (CAALM) tracked by TrialSite filed a petition requesting that the agency update the COVID-19 vaccine product labeling –for both Pfizer and Moderna products—to reflect their actual safety and efficacy more accurately. The third entry was titled “Requests that the FDA require that the sponsors of Comirnaty, Spikevax, Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccines (collectively, ‘Pfizer and Moderna COVID-19 vaccines’) amend current product labeling.” While the principals behind CAALM are experts and offer the FDA valid points in their comments, the FDA flatly rejects the organizations requests, declaring that a licensed vaccine doesn’t need to demonstrate that they prevent infection or transmission nor does a vaccine authorized under provisional emergency use authorization need to demonstrate infection prevention or transmission.

Before delving into the FDA’s response, a brief reminder on the importance of CAALM. Led Linda Wastila, BSPharm, MSPH, Ph.D., a Professor and Parke-Davis Chair in Geriatric Pharmacotherapy, Department of Practice Sciences, and Health Outcome Research; Director of Research, also with Peter Lamy Center on Therapy and Aging, University of Maryland, TrialSite reported on the group’s first notable effort to pressure the FDA to modify the COVID-19 vaccine labels. See “University of Maryland Pharma Professor Introduces ‘CAALM’---for FDA Updates of COVID-19 Vax Labels for Transparency.”

Linda Wastila and others at CAALM are at it again. This time they are using their expertise in pharmaceutical product labeling to request that the regulatory agency modify the mRNA—based COVID-19 vaccine product labels more accurately to reflect the actual nature of the still investigational vaccine products.

A note here, the FDA in an unorthodox manner approved the vaccines—first, Pfizer by approving Comirnaty, yet keeping BNT162b2 (investigational) as the only vaccine in distribution.

TrialSite hypothesized on that move that the Biden administration sought to kill the proverbial birds with one stone—the action would generate more confidence in the market, thereby reducing any vaccine hesitancy while also providing the legal grounds for imminent forthcoming mandates at the federal and local levels (of course much of the federal mandate announced by Biden was tossed by the courts).

The FDA response

In a telling letter to the organization (CAALM), the FDA declared, “FDA authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission…Similarly, a vaccine can meet the EUA standard without any evidence that the vaccine prevents infection or transmission.

Call to Action: Check out the link for the entire FDA docket.

Regulations.gov

End the COVID-19 Emergency and Forget About Long COVID--The Vaccine Injured, They Don’t Even Exist

End the COVID-19 Emergency and Forget About Long COVID--The Vaccine Injured, They Don’t Even Exist

TrialSite reported on how a major American health system essentially did a bait and switch, marketing a comprehensive long COVID program, with care navigators…

www.trialsitenews.com

TrialSite reported on how a major American health system essentially did a bait and switch, marketing a comprehensive long COVID program, with care navigators and the like, only to downgrade to a voice mail service with a handful of specialist options. Long COVID and vaccine injuries represent a growing problem outcome of the COVID-19 pandemic needing more investments in research and direct care which must include comprehensive chronic care management and care navigation services. With an estimated 16 million persons experiencing long COVID, and anywhere from 500,000 to 2 million persons struggling with COVID-19 vaccine-related injuries according to TrialSite estimates, one recent media suggested that these patients feel “swept under the rug.”

Multi-billion Intermountain Health Drops Long COVID Virtual Navigation Line—All But Disbands Care for Hundreds of Thousands of Utahns with Long COVID

Now is not the time to shut down dedicated long COVID centers and clinics, but that is exactly what Utah’s Intermountain Healthcare (IHC) has recently…

www.trialsitenews.com

Recently, the Lund Report done in conjunction with LAist, NPR, reported on the mounting crisis associated with long COVID patients being left to fend for themselves. This, despite over $1billion spent on COVID-19 research, driven by taxpayer sources, as reported recently by industry media STAT News.

The recent piece authored by Jackie Fortier is well intentioned and describes the pain and suffering three different long COVID patients must endure, leading to lost careers, broken marriages where they are dismissed and disbelieved by family and friends.

Going through the templatized process of deferring to an authority—the U.S. Centers for Disease Control and Prevention (CDC), the author cites the latest estimate that 6% of U.S. adults or 16 million or so likely struggle with long COVID symptoms. This is a group, however, so impacted that they struggle to carry out day-to-day activities, work and the like.

The author cites another 675-patient study by the University of Southern California’s COVID-19 Pandemic Research Center, finding that in Los Angeles County 46% of adults who contracted COVID fully recovered; the remaining 54% continued to struggle with issues, from brain fog to persistent cough, all adversely affecting daily life.

But there is no critical directive in this article—no scanning of how health systems are dropping the accountability of coverage—they did get paid lots of money from the federal government for COVID-19 cases after all, which was a redistribution of taxpayer and public-derived capital; or the billions in the aggregate that agencies from the National Institutes of Health to the Biomedical Advanced Research and Development Authority to the Department of Defense spent on exotic therapeutic approaches targeting COVID-19.

Federal agencies indirectly targeted front-line physicians via medical societies and colleges for seeking to care for COVID-19 patients at the earliest signs of infection. One example this media routinely brings up is the ICAM protocol. A pharmacist at a Florida-based health system early on in the pandemic found a combination regimen using repurposed blood thinners, steroids and other medicine that made a material impact, saving lives early in the pandemic. What was the result? After TrialSite published an article gaining wide global circulation, the CEO of that health system shut the program down. Why? Because according to insiders, the health system has a contract with Pfizer to test the vaccine and that contract precluded.

It’s not clear what the impact had on the top-down controls of the pandemic and the federal national emergency, but there is a high probability that many lives were lost because of this response.

Also, while the Lund Report claims that it to be an “independent, nonpartisan, nonprofit” online news source, it, like most media outlets in the mainstream, lack the will and true independence to report on a gross injustice currently unfolding across America: the systematic avoidance of a material number of vaccine-related injuries as a result of the mass vaccination program. Over 270 million primary series vaccinations means that only a safety incidence rate of 0.005 leads to 1.3 million injured. This is a real problem that must be recognized, discussed and dealt with. Journalists for media outlets that systematically ignore such humanistic issues because it's not “safe” have lost their way.

So yes, long COVID patients are getting swept under the proverbial carpet while the COVID-19 vaccine injured as far as our government is concerned don’t even exist.

In the latest document dump from Pfizer comes this report of pregnant and lactating woman.

This is not good

Quote from Shane D.

No doubt, but some people like myself are sensitive to TOO much Vit D pills, and get heart palpitations if going over a certain IU. After 3 years of trial and error, I found my limit is 7,000 IUs/day. Maybe that is because I am outdoors so much? Who knows, but main thing is if you experience this, just take a few days off, then resume at a lower dose.

I would suggest that you ask your primary care doctor to run tests on your cyp2 enzymes. palpitations happen often when rasing vitamin d levels and is not necessarily bad. It's atrial fibrillation that should be a concern, but check with your doctor and have those enzymes checked for alteration or mutation.

Quote from Frogfall

It seems quite clear that Curbina was referring to Twitter (where policies have changed since the Musk takeover).

As far as I can see, the majority of LF members have never posted on this thread. But its prominence can, and will, be used as a stick to bash the forum, by people writing about it in other places.

To give an example; last year I wanted to find out a bit more about the MFMP, but a quick search turned up a post somewhere from someone who criticised it by saying the organisation was being run by a crazy antivaxxer.

This person had actually been favourable owards the concept of LENR, but having come across some of BG's posts about his refusals to accept vaccination, never bothered to look any further - and simply dismissed the entire MFMP as a crank outfit.

Now regardless of anyone's opinions on the various covid vaccines, or their views on government policies around the pandemic, or the people who have refused to comply with them, all these issues have nothing to do with LENR. It is a war that will continue to be fought elsewhere, and importing it into this forum serves no positive purpose.

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People involved in Lenr have also avoided MFMP because of Bobs views. Just narrow minded people

Quote from Alan Smith

We do not censor posts, we have removed a few persistent troublemakers however and sometimes remove insulting, or doxxing comments or invitations of a sexually promiscuous nature, and this is a better place for it.

When you consider the slow crash and burn of many other forums which have attempted to focus on LENR I am sure that we have made a reasonably good job of balancing people's ideas about totally free speech with the need to moderate, relocate or sometimes just delete such posts from a place that many less well informed scientists consider to be a tin-foil hat dominated field of inquiry.

Of course there are divisive (politics, religion, GW) or 'fringe interest' topics (UFO's, Ikebana,) we actively discourage since there are better places for them than a forum which has the goal of being a sensible scientific forum.

We aim to manage things so that all those contributing to or keen to follow the ongoing work can post without fear of ridicule or dismissal. You may have noticed that we do allow for a certain amount of eccentricity by one or two members, but since they are in general confined to particular threads and are encouraged to stay there we don't consider them to be problematic.

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UFO,s are frontpage news over the last couple of days, I didn't notice an articles on Lenr. Sorry just trying a little morning humor. I appreciate the forum giving me and others a place to argue against the narrative and post studies to help prove our points. Just remember VITAMIN D IS THE KEY!!! Thanks again for giving me a place to help people make good choices.

Quote from Alan Smith

We decided some time ago that iit wasn't front page news. It would be like the New Yourk Post running continual front page stories from Timbuctou.

I don't think Lenr is making the front pages either. The media covers what they are told to cover. In years past the possibility of the of the Former NIAID Director lyng to Congress would be front page news. People suspected of dying from vaccines would be front page news but not in today's world so let's just ignore what's going on and talk the same Lenr talk we have hashed out for over 30 years. BRILLIANT!

Vaccines Alone Cannot Slow the Evolution of SARS-CoV-2

Mass Indiscriminate Non-Sterilizing Vaccination is Hopeless

Vaccines Alone Cannot Slow the Evolution of SARS-CoV-2

Mass Indiscriminate Non-Sterilizing Vaccination is Hopeless

petermcculloughmd.substack.com

By Peter A. McCullough, MD, MPH

So many people around the world have witnessed first hand the obvious failure of COVID-19 vaccines. Put simply, they took all the shots and still got COVID-19. Sadly some were hospitalized and died despite being “fully protected” from one of the COVID-19 vaccines.

Because SARS-CoV-2 makes mistakes in replication, there is always a flora of mutants and when a new ecological pressure is exerted, for example, antibodies raised by the next COVID-19 vaccine, the variants that can most successfully thrive in the nasopharynx of the vaccinated will predominate.

Van Egeren and colleagues have performed meticulous calculations of spread and virulence according to ecological pressures and continued propagation of the outbreak. They have concluded that is is impossible for frequent injections of either the same or modified boosters to be successful. In other words, even with perfect compliance the vaccine campaign is destined for failure. The nail in the coffin for COVID-19 vaccination is that even if they worked, only 16% of adults are risking any more booster shots.

Vaccines Alone Cannot Slow the Evolution of SARS-CoV-2

The rapid emergence of immune-evading viral variants of SARS-CoV-2 calls into question the practicality of a vaccine-only public-health strategy for managing…

www.mdpi.com

Vaccines | Free Full-Text | Vaccines Alone Cannot Slow the Evolution of SARS-CoV-2

Hemorrhage After Pfizer-BioNTech (BNT162b2) mRNA COVID-19 Vaccination: A Case Report

Intracranial Hemorrhage After Pfizer-BioNTech (BNT162b2) mRNA COVID-19 Vaccination: A Case Report

The Coronavirus 2019 (COVID-19) pandemic has affected over 700 million people worldwide and caused nearly 7 million deaths. Vaccines currently developed or in…

www.cureus.com

Abstract

The Coronavirus 2019 (COVID-19) pandemic has affected over 700 million people worldwide and caused nearly 7 million deaths. Vaccines currently developed or in development are the most effective tools for curbing the pandemic and mitigating its impacts. In Turkey, inoculation with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2, also known as tozinameran) has been approved.

We report a 56-year-old female patient with underlying essential hypertension who experienced intracranial hemorrhage after receiving her first dose of tozinameran. The patient underwent immediate surgical evacuation of the hematoma, during which a left middle cerebral artery bifurcation aneurysm was macroscopically identified and clipped. The patient was pronounced deceased on the second postoperative day. This is the second case of intracranial hemorrhage following tozinameran administration caused by a ruptured middle cerebral artery bifurcation aneurysm. Upon analyzing the case, there might be a connection between the vaccine's potential immune-triggering effect on hemodynamic patterns and the rupture of the previously unknown cerebral aneurysm. However, these severe complications do not justify avoiding vaccines; further studies are needed. This study emphasizes the need for increased vigilance in patients with underlying systemic comorbidities who have recently been vaccinated and to share our insights into the potential relationship between tozinameran and intracranial hemorrhage.