Here’s a video showing wildlife using a game trail in Voyageurs National Park in northern Minnesota over the course of a year (June 2019 – August 2020):
I lose a sense of time watching these trail cams. I love them. I love watching wildlife that’s truly wild. Wolves have such a bouncy, jazzy gait. Bears look like me searching for the bathroom in the middle of the night.
The Environmental Working Group (EWG) has developed a special category called “EWG Verified.” It comes with its own label or mark that can be associated with a product. The product must meet “health standards independently developed by EWG’s research team.” The mark is sure to benefit sales of products designed for people interested in “clean” living.
The label costs:
Costs for participation vary widely, generally ranging from hundreds of dollars to thousands of dollars per year, based on factors such as company size and stage of development, pricing structure options, number and sales of EWG VERIFIED products, and related considerations. Typical fees include an application fee, evaluation fee and trademark usage royalty or annual flat fee. The EWG VERIFIED license agreements generally are for an initial term of three years and include standard licensing provisions, including with respect to quality control.
“Independently developed” standards? Pay-to-play? Third party certification always seemed a bit scamy to me.
Using MedAlerts, I queried the CDC’s VAERS database for adverse effects from COVID vaccines. From about mid-December 2020 to 6 August 2021, there were
12.791 reports of deaths following the vaccine.
559,040 reports of adverse events not including deaths.
CDC’s own studies of VAERS indicate it only captures about 1% of actual adverse events. Even if that’s low, at 25%, which I think is high for a passive system, that means millions of people have suffered after vaccination.
In 1976, the government abruptly stopped vaccination for swine flu after 53 vaccine-related deaths.
I think the bar for what we consider a safe drug has been lowered over the years.
Everyone who received a COVID vaccine should have been informed that they are at risk of more severe disease should they become infected compared to those who were not vaccinated.
This study found that comprehension of that risk is “unlikely to occur” because “the risk is sufficiently obscured.”
Informed Consent Disclosure To Vaccine Trial Subjects Of Risk Of COVID‐19 Vaccines Worsening Clinical Disease, International Journal of Clinical practice, 4 December 2020
The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.
Results of the study: COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
Conclusions drawn from the study and clinical implications: The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.
Wow. This statement. Strong language: “nontheoretical”:
Thus, a finite, non‐theoretical risk is evident in the medical literature that vaccine candidates composed of the SARS‐CoV‐2 viral spike and eliciting anti‐SARS‐CoV‐2 antibodies, be they neutralising or not, place vaccinees at higher risk for more severe COVID‐19 disease when they encounter circulating viruses.
But:
Both Moderna and Johnson and Johnson term the risk of vaccine‐elicited disease enhancement as “theoretical.”
More strong language:
Based on the published literature, it should have been obvious to any skilled medical practitioner in 2019 that there is a significant risk to vaccine research subjects that they may experience severe disease once vaccinated, while they might only have experienced a mild, self‐limited disease if not vaccinated.
Do you think people know this? And is this what has been going on in Israel?
In Israel:
“95% of the severe patients are vaccinated”.
“85-90% of the hospitalizations are in Fully vaccinated people.”
“We are opening more and more COVID wards.”
“The effectiveness of the vaccine is waning/fading out”
(Dr. Kobi Haviv, earlier today on Chanel 13 @newsisrael13 )
“The vaccine distribution to the sciatic nerves may lead to conditions like sciatica.”
In a recent post I talked about how COVID vaccines can enter platelets where spike protein can then be synthesized, leading to platelets undergoing an immune response – causing internal bleeding and blood clots. The paper below reiterates that:
Recently, vaccine distribution to the vasculature and interaction with circulatory platelets have been proposed as a likely mechanism for thrombosis with thrombocytopenia syndrome.
This paper though focuses on nerve cells instead of blood cells (a platelet is a blood cell). It proposed a similar mechanism: vaccine enters nerve cell, spike protein is synthesized, nerve cells are attacked by immune system. The result here is pain and paralysis.
Rapid Response: Autoimmune Damage To The Nerves Following Covid Vaccines: EMA Issued Warning To Patients And Healthcare Professionals, BMJ, 14 August 2021.
EMA [European Medicines Agency] recently investigated the cases of Guillain-Barre syndrome (GBS) following Covid vaccine AstraZeneca (AZ) and have issued a warning to raise awareness of healthcare professionals and the public about GBS cases following Covid vaccinations and recommended revising the product information for Covid vaccine AZ [1]. MHRA [ Medicines and Healthcare products Regulatory Agency] later also concluded that as a precautionary measure they will also be adding a warning for GBS in the product information [2]. A similar warning has been issued by the United States FDA for the GBS followed by Janssen (J&J) Covid vaccine [3]. GBS is a rare but serious condition in which the immune system starts attacking the body’s healthy nerve cells in the peripheral nervous system that can result in pain, numbness, muscle weakness usually in the feet, hands and limbs) that can also spread to the chest and the face. EMA has advised people to seek immediate medical attention if they develop weakness and paralysis in the extremities progressing to the chest or face following the Covid vaccine.
The EMA could not find enough evidence to confirm the association of GBS with the vaccine, however, this may be explained by the vaccine biodistribution to the nerves following intramuscular injection. The vaccine transfection* and translation in the nerves may spur an immune response against nerve cells potentially resulting in autoimmune nerve damage. The preclinical evaluation of Covid vaccine AZ (study 514559) evidenced vaccine distribution) to various body tissues beyond injection site including sciatic nerves [4].
Study 514559 showed that the Covid vaccine AZ was distributed to sciatic nerves in almost all animals and the distributed fractions did not clear throughout the study. The last sample was taken on 29 days post-administration and sciatic nerves of 70% of animals were still tested positive at the end of the study. The vaccine distribution to the sciatic nerves may lead to conditions like sciatica that has been previously linked to the viral infection of the sciatic nerve, such as herpes. The MHRA pharmacovigilance database reported ~187 cases of sciatica post-Covid vaccine AZ as of 28th July 2021. There were at least 127 other instances of nerve injury and 301 cases of various forms of neuropathies (including 207 cases of peripheral neuropathy) listed in the MHRA database [2].
The biodistribution of the vaccine to other nerves is not known as the study 514559 checked for sciatic nerves only being anatomically closer to the injection site (hind limb) in mice. The facial (cranial) nerves, on the contrary, are anatomically closer to the vaccine injection site in humans (deltoid muscle). The MHRA database listed ~1031 cases of facial cranial nerve disorders (527 cases of Bell’s palsy and 457 cases of facial paresis/paralysis), 20 cases of Miller Fisher syndrome and additional 372 cases of Guillain-Barre syndrome (2 fatal) following AZ vaccine up until 28th July 2021.
It is worth noting that the Covid vaccine AZ clinical trials were paused twice and, on both occasions, the trial subjects developed a neurological condition, transverse myelitis. One of the subjects was later diagnosed with multiple sclerosis [5], declared unrelated to the vaccine. Surprisingly, as of 28th July 2021, there are 77 cases of transverse myelitis, 16 cases of myelitis and another 13 cases of encephalomyelitis following Covid vaccine AZ in the MHRA database. Moreover, there are additional 56 cases of multiple sclerosis and another 49 cases reporting a relapse of multiple sclerosis within the MHRA database. The vaccine-induced multiple sclerosis (if proven) may also be an autoimmune response to the vaccine distribution and transfection to the nerves.
The biodistribution (study 514559) also evidenced the vaccine distribution via blood circulation to other tissues notably bone marrow, liver, mammary glands and spleen. The vaccine encoded gene transfection to distant tissues is likely to attract an immune response against various body tissues that can manifest into various autoimmune conditions. Recently, vaccine distribution to the vasculature and interaction with circulatory platelets have been proposed as a likely mechanism for thrombosis with thrombocytopenia syndrome (TTS) [6]. These autoimmune responses may well be transient in many healthy subjects, and the immune response is likely to be very selective towards vaccine transfected cells only, however, the possibility of developing a chronic autoimmune condition in some individuals cannot be overruled. The regulatory authorities are, therefore, requested to review the cases of GBS in association with various other neuropathies and vaccine biodistribution data from preclinical trials. This will not only help in explaining a causal link but will also help take necessary precautionary measures in time for public safety. A similar issue has been reported with Janssen (J&J) Covid vaccine [7], and we anticipate other viral-vector Covid vaccines such as CanSinoBIO (China) and Sputnik V (Russia) are likely to pose a similar risk. The detailed tissue-specific distribution of mRNA vaccines encoding SARS-CoV-2 spike proteins (Pfizer or Moderna) is not fully known that could offer invaluable insights into the long-term safety of mRNA vaccines. However, the surrogate studies using similar formulations by Pfizer [8] and Moderna [9] did confirm a biodistribution of mRNA vaccines beyond the injection site. We urge regulatory authorities to mandate manufacturers to perform adequate biodistribution studies on vaccine formulations and request further data to better understand the implications of vaccine transfection in distant tissues before mass vaccine rollout in children or recommending additional adult booster doses.
* Transfection: “is the process of artificially introducing nucleic acids (DNA or RNA) into cells, utilizing means other than viral infection.”
The Biopharmaceutical Industry Provides 75% Of The FDA’s Drug Review Budget. Is This A Problem?, Forbes, 2018
Note the date. Perhaps, with Operation Warp Speed, the FDA is merely repaying industry for the millions industry paid them to “rush risky drugs to market.”
Excerpts:
Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its approval of new drugs. Entitled: “FDA Repays Industry by Rushing Risky Drugs to Market”, Chen contends that the agency is beholden to the biopharmaceutical industry which pays three quarters of the FDA’s budget used for the drug review process. This is an astounding number. Is any other federal agency supported to this extent by the industry it regulates? Given this level of support, one might assume that the FDA would bend over backwards to meet the needs of its financial backers.
How did we ever get to the point where private industry is providing so much support for a federal agency? Actually, this all began about 25 years ago, when the U.S. was facing a “drug lag”.
To solve this problem, Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992–a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues [were] known as “user fees”,
As a concession to agreeing to these “user fees”, the pharmaceutical industry was promised that the FDA would reduce review times of NDAs
“User fees” have gone up over the years, from $208,000 per NDA in 1995 to a whopping $2,421,495 for fiscal year 2018.
Chen’s concern about the rapid approval on drugs on the basis of limited data or based on surrogate endpoints merits discussion. In fact, it’s a worry that I have shared. It is important that a drug maker prove the benefits of its drug before unleashing it on the public.
When you ask anyone involved in drug R&D about pro-industry bias on the part of the FDA, they laugh.
In 2018, drug companies paid the government $2.4 million to expedite the review process for a drug, one drug. Honestly, it’s like sanctioned corruption.
Source: One of the winners in the 14th iPhone Photography Awards
Red blood cell on the left, white blood cell on the right, platelet in the middle. Wikimedia
Anecdotally:
A 65-year-old man died from blood clots following his second Moderna COVID vaccine. The clots were linked to the vaccine:
Thrombosis With Thrombocytopenia After the Messenger RNA–1273 Vaccine, Annals of Internal Medicine, 29 June 2021
There have been thousands of reports of blood disorders in CDC’s adverse events reporting system (VAERS) for all three vaccines: Moderna, Pfizer, Johnson and Johnson. From an article dated 29 June:
A search of VAERS, using search criteria including reports of blood clots associated with blood coagulation disorders, produced a total of 6,787 reports for all three vaccines from Dec. 14, 2020 through June 18, 2021.
Of the 6,787 cases reported, there were 2,893 reports attributed to Pfizer, 2,394 reports with Moderna and 1,459 reports with J&J.
Clotting was suspected early on:
I am a pediatric specialist caring for children with the multisystem inflammatory syndrome (MIS-C). I am concerned about the possibility that the new vaccines aimed at creating immunity against the SARS-CoV-2 spike protein (including the mRNA vaccines of Moderna and Pfizer) have the potential to cause microvascular injury to the brain, heart, liver, and kidneys in a way that does not currently appear to be assessed in safety trials of these potential drugs.
– FDA, Comment from J. Patrick Whelan MD PhD, 20 December 2020
Thousands of clotting cases later, it’s still suspected. The FDA hasn’t reponded:
The U.S. Food and Drug Administration (FDA) has not responded to concerns that mRNA products, through spike proteins, have “the potential to cause microvascular injury [inflammation and small blood clots called microthrombi] to the brain, heart, liver and kidneys in ways that were not assessed in the safety trials.”
– Blood Clotting Needs to Be Watched with All COVID Vaccines, States the Association of American Physicians and Surgeons (AAPS), 5 April 2021
These clots can appear anywhere: brain, heart, liver, kidney. What’s causing them?
CoViD vaccines may also directly infect platelets and megakaryocytes triggering mRNA translation and consequent spike protein synthesis intracellularly. This may lead to autoimmune response against platelets and megakaryocytes resulting in reticuloendothelial phagocytosis and direct CD8+ T cell lysis.
CoViD genetic vaccines may have a direct role in spurring autoimmune response against platelets that may clinically manifest in thrombocytopenia [very low platelets], haemorrhage [internal bleeding], and blood clots.1,2,3
The vaccine enters the platelet. The platelet makes the spike protein. The immune system attacks the infected platelets. Fewer platelets = bleeding, clots.
References
1. Might Post-Injection Distribution Of Covid Vaccines To The Brain Explain The Rare Fatal Events Of Cerebral Venous Sinus Thrombosis (CVST)?, British Medical Journal, 14 April 2021
2. CoViD Vaccines and thrombotic events: Possibility of mRNA translation and spike protein synthesis by platelets?, British Medical Journal, 11 March 2021
3. Re: COVID vaccines and thrombotic events: is mRNA translation and spike protein synthesis by platelets a real possibility?, British Medical Journal, 11 March 2021
Fanatic Cook 