Tuesday, May 09, 2023

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 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.

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

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.


Climate misinformation from "The Guardian"

Leftist organ quick to misallocate blame

The Guardian Australia has made multiple corrections to content it published about misinformation and Sky News Australia.

The online news outlet published a podcast titled, “Fox News and the consequences of lies with Lenore Taylor”, only to later amend it after making false claims relating to Sky News.

A note published on the Guardian’s website underneath the podcast by Taylor, the editor of the Guardian Australia, read: “An earlier version referred to adverse findings by the Australian Communications and Media Authority against Sky News Australia in respect of programs containing misinformation ​about C​ovid-19,” the correction states.

“This was incorrect.

“The programs were broadcast by Foxtel Cable Television Pty Limited on the Daystar channel.”

The embarrassing correction comes just one week after the Guardian also made false claims in relation to complaints lodged with the media regulator, the Australian Communications and Media Authority.

The complaints were made about content relating to commentary by Sky News Australia host Rowan Dean on climate science, however the article incorrectly said the complaints were made by “Australians for a Murdoch Royal Commission”.

In a statement on its website it later corrected the record to state the complaints were made by former prime minister Kevin Rudd.

“This article was amended on 28 April 2023 to clarify that the initial complaints to ACMA were made by Kevin Rudd personally, not by Australians for a Murdoch Royal Commission,” the correction said.

A Sky News Australia spokeswoman said in a statement: “This latest factual error is particularly ironic given the purported expertise of the presenters on the podcast, discussing misinformation.”


Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs


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