A Toxicologist Has Something To Say About COVID Vaccine

Translator: Lish
Proofreader:Yue Ying Wan Chuan

The last few days of the end of the year, there is no joy in welcoming the new year. There are a few words that have been held in for a year, which consider as not fit to the current environment. I feel the fish thorns get stuck in the back of my throat if I was not speaking out before the year.

It has been two years since the outbreak of the Pandemic began. Epidemics are natural disasters, like earthquakes and floods, and humans must be reactive to them, but of course, the resilience of countries is related to their governments and social environment. I have been in Melbourne to see this is unfolded, the most extended lockdown city in the world (six times in two years for a total of 267 days). As a retired senior citizen, this epidemic had little impact on my safety and livelihood. However, many things have happened over the year that has shaken my beliefs about every aspect of the world.

At the height of the 2020 epidemic, when many people were looking forward to the rapid development of a vaccine, many of my peers and I were not optimistic. This is because, historically, the development of a safe and effective vaccine requires repeated testing and refinement, often over eight or ten years.

In addition to a part of my career in basic medical research laboratories, I spent the last two decades working in the government regulatory body equivalent of the FDA, conducting toxicological assessments of chemicals. Our pre-market risk assessment of a drug or chemical is based on two considerations: the toxicity of the substance itself in animals and humans and the degree of public exposure to it. For example, a cancer chemotherapy drug requires less concern because it is only used for a small number of life-threatening cancer patients, even though it may have teratogenic mutagenic and other toxic severe side effects. On the other hand, the requirements for toxicity are much more stringent for common drugs widely used by the public, such as antipyretics and analgesics.

For some chemicals used in agriculture and animal husbandry, in addition to occupational exposure, the pre-market toxicological evaluation is also very demanding due to the possibility of universal exposure by entering food chain. We generally require pharmaceutical companies to provide animal test data, including acute toxicity, subacute toxicity, chronic toxicity and carcinogenicity, genotoxicity, reproductive toxicity, embryonic teratogenicity, prenatal and postnatal growth and developmental effects. The effects of the toxins on developmental toxicity and developmental toxicity have been studied. The chronic toxicity and carcinogenicity studies require the observation of the entire life cycle (24 or 18 months, respectively) in rats or mice. In contrast, the developmental toxicity studies require the observation of three consecutive generations in rats, with no specific variation spared. Finally, a comprehensive assessment is made to conclude the risk assessment, approval or disapproval for marketing, the scope of use and restrictions, etc.

Although the specific requirements for animal testing and clinical trials of vaccines are different from other drugs, the goal is the same – to be safe and effective. As a result, it is often time-consuming and expensive for a pharmaceutical company to successfully trial a new drug, including a vaccine. Why is this necessary? For one thing, despite the so-called “theoretical pharmacology” (meaningful in the directed design of new drugs), the efficiency and toxicity of a drug fundamentally need to be determined by extensive animal and clinical testing; for another, widely used drugs, including prophylactic vaccines, are a matter of national health and must be tested repeatedly and carefully. This is why, under normal circumstances, it takes up to ten years or more before a safe and effective vaccine can be developed.

The Pfizer vaccine, for example, is one of the first Covid related vaccine to hit the market. Unfortunately, mRNA for vaccines is not a mature technology. Although scientists have studied mRNA technology for three decades, covering tumor vaccines, cellular therapies, local regenerative therapies, mRNA drugs and antibody drugs, it is still in the experimental stage. The use of mRNA technology to develop preventive vaccines for infectious diseases, such as influenza, rabies, Ebola, and Zika virus, is still limited to preclinical research and has never entered clinical trials or applications with no successful examples. If it were not for the onslaught of the COVID-19 and the helplessness of human beings, the mRNA COVID vaccine could not have been pushed to clinical application on a large scale in such a hasty manner. Nevertheless, it is the responsibility of the manufacturers developing the vaccine to fill in the data gaps as much as possible before and after the market launch to ensure the safety and effectiveness of the vaccine (in my opinion, safety always comes first) and the safety and peace of mind of the people. It is also the responsibility of the relevant government authorities to supervise its implementation.

I would like to give an example regarding to toxic Effects. The report presents 4 cases of Bell’s palsy in the test group, which occurred on days 3, 9, 37 or 48 after vaccination and lasted 3, 10, 15 or 21 days each before recovery. and 0 cases were in the control group. The manufacturer contends that the incidence of facial palsy in the test group was consistent with its chance of occurrence in the general population and therefore was not considered a toxic side effect. The FDA simply asked the manufacturer to continue to observe the vaccine in a larger sample. However, a pharmacologist on the FDA’s independent panel pointed out that the probability of this occurring over the lifetime of the general population was not comparable to the same probability of occurring within two months of administration in the trial group (the average observation period was only two months). In contrast, the incidence in the control group was zero for the same duration and under the same conditions. This is clearly a toxic side effect from the vaccine. (The experts could see the foul play at a glance.) In fact, the studies on the safety and efficacy of the mRNA New Crown vaccine are far from adequate. In particular, there is a complete lack of data on its long-term toxicity. Relying only on theoretical grounds to speculate, or even simply believe, is tantamount to gambling on the health and safety of the entire population.

When vaccines such as Pfizer were launched in the US in early 2021, I carefully read the FDA’s fifty-plus page evaluation reports for each Pfizer, Modena vaccines, and all of the UK MHRA’s evaluations of the AstraZeneca vaccine that were available online. In the case of Pfizer, for example, it was developed less than a year ago, even from the beginning of the epidemic in early 2020, and clearly did not have sufficient animal studies and clinical data. In fact, according to the FDA’s evaluation report, safety data from Phase III clinical trials averaged only two months, with side effects including multiple severe acute reactions requiring hospitalization and many unknowns. The anti-infective efficiency (95%!) was calculated by comparing the first 100+ infections in the trial and control groups. The FDA originally required the manufacturer to continue observing and collecting data for 30 months. In fact, no updated data have been seen since then, and even when the vaccine was officially approved for marketing as a product (no longer a EUA), it was still based on the initial data alone.

If anything, the rapid launch of the vaccine was understandable on the balance of pros and cons, based on the dire epidemic in the US and Europe at the time. Whereas the launch in Australia at the time was disturbing, the now ludicrous phenomenon is that the epidemic here has increased in direct proportion to the extent of universal vaccination. The fact is that the vaccine has been far less effective in the real world than expected from the start. Over the year, I have wondered whether the manufacturers’ initial calculations of the vaccine’s efficiency were untrue or whether it was indeed made less effective by the emergence of new mutant strains. Did the epidemic itself ebb and flow with the cycle (as in India and African countries with very low vaccination rates, the epidemic ebbed as usual), or did the vaccination effectively control the outbreak? How does the mutation of the virus relate to the use of the vaccine? Manufacturers, governments, and the media have long blamed the small number of unvaccinated people for the epidemic that the vaccine could not control, and blamed the mutation of the virus. And the ebbing of the epidemic, with fewer deaths and serious illnesses, has been attributed to the vaccine. Imagine that the epidemic has been developing for two years, with more than 800,000 deaths in the United States alone. Can it be said that the most sensitive and vulnerable people have died or become seriously ill during the two years of the virus, and that the relative ebb of the epidemic or the milder cases today may be the result of natural elimination?

A glaringly unjust, unscientific, and crude phenomenon is that before the advent of the vaccine, all postmortem deaths of those who tested positive for the COVID were counted as COVID deaths, with no mention of the fact that most of those in their 80s and 90s had the underlying conditions. Most of the later deaths associated with vaccination or breakthrough infections after vaccination were concluded to be “pre-existing underlying disease”. Suppose an unvaccinated person dies with a COVID. In that case, the media report must only emphasize that he or she was “unvaccinated” and not mention whether he or she had an underlying disease. In short, all the good things are attributed to the vaccine, all the bad things are attributed to the non-vaccination (or if not, to the mutation of the virus), and all the anger and punishment is placed on those who refuse the vaccine. Unfortunately, one year after vaccination, studies in 68 countries, including the United States, found no correlation between the level of outbreaks and the level of vaccination. 

(“Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States”  Eur J Epidemiology 36, 1237-1240 (2021))。

Severe unanticipated side effects have appeared one after another after the vaccine was introduced, such as thrombosis with thrombocytopenia syndrome, myocarditis, and pericarditis. These side effects have been deliberately denied or ignored by the manufacturers and even the government. Yet, some severe side effects and even death after vaccination are so glibly but firmly denied that “there is no obvious/direct evidence that this side effect (or death) is vaccine-related.” This statement is the opposite of the cautionary approach to drug toxicity in our toxicology training: no profound toxic side effect following administration can be ruled out as drug-related unless there is evidence that other factors contributed to such poisonous side effects.

Moreover, vaccine-induced side effects are much higher than the official data collected or reported. A 26-year-old girl I know who works in a nursing home had two doses of the Pfizer vaccine. Two or three months later, she was admitted to the emergency room with a “heart attack” (chest pain) diagnosed as pericarditis and treated with hormones. I asked her, “Did you tell the doctor when you got the vaccine? She came to her senses and said, “You reminded me that I did start feeling sick to my heart after I got the vaccine, and it got worse. But I didn’t think to tell the doctor.” My niece family (nearly forty years old) and multiple of her friends all rushed to chest discomfort and significantly reduced exercise capacity in the weeks following the vaccine. Although they have since gradually recovered, there is concern about possible organic damage to the heart and long-term effects. These individual cases were not reported and are excluded from the more extensive data.

Severe unanticipated side effects have appeared one after another after the vaccine was introduced, such as thrombosis with thrombocytopenia syndrome, myocarditis, and pericarditis. These side effects have been deliberately denied or ignored by the manufacturers and even the government. Yet, some severe side effects and even death after vaccination are so glibly but firmly denied that “there is no obvious/direct evidence that this side effect (or death) is vaccine-related.” This statement is the opposite of the cautionary approach to drug toxicity in our toxicology training: no profound toxic side effect following administration can be ruled out as drug-related unless there is evidence that other factors contributed to such poisonous side effects.

Moreover, vaccine-induced side effects are much higher than the official data collected or reported. A 26-year-old girl I know who works in a nursing home had two doses of the Pfizer vaccine. Two or three months later, she was admitted to the emergency room with a “heart attack” (chest pain) diagnosed as pericarditis and treated with hormones. I asked her, “Did you tell the doctor when you got the vaccine? She came to her senses and said, “You reminded me that I did start feeling sick to my heart after I got the vaccine, and it got worse. But I didn’t think to tell the doctor.” My niece family (nearly forty years old) and multiple of her friends all rushed to chest discomfort and significantly reduced exercise capacity in the weeks following the vaccine. Although they have since gradually recovered, there is concern about possible organic damage to the heart and long-term effects. These individual cases were not reported and are excluded from the more extensive data.

Furthermore, recent data suggest that the coronavirus spike glycoprotein (SARS-CoV-2 spike glycoprotein) induced in vivo by the mRNA vaccine does not have a function other than binding to human immune cells to induce antibodies initially understood. The coronavirus spike protein itself is toxic to human cells in various ways, including causing micro thrombosis and vascular inflammation, both of which are directly related to the severe side effects of thrombosis and myocarditis pericarditis that have been clinically demonstrated. What’s more, new research has found that stinger proteins can enter the cell nucleus and interfere with DNA repair functions. A few are listed here:

Intravenous injection of COVID-19 mRNA vaccine can induce acute myopericarditis in mouse model (Clin Infect Dis 2021 https://pubmed.ncbi.nih.gov/34406358)

The S1 protein of SARS-CoV-2 crosses the blood-brain barrier in mice (Nature Neuroscience 24, 368-378.)

SARS-CoV-2 spike impairs DNA damage repair and inhibits V(D)J recombination in vitro (Viruses 2021, 13 (10), 2056;  https://doi.org/10.3390/v13102056)

Be aware of SARS-CoV-2 spike protein: There is more than meets the eyes (J Biol Regul Homeost Agents May-Jun 2021)

These studies and their results should have been conducted before the vaccine was introduced. And once any of these indications were found, it must have been a matter of increasing the multifaceted research efforts and getting more positive or negative evidence. However, hundreds of millions of people have been vaccinated with these vaccines. Whether they believe it or not, those pushing them must use different rhetoric and reasoning to downplay and mitigate the shock and panic they may have caused among the general public.

It is a pity that instead of alerting the authorities involved, these studies are being obfuscated with “false news” and “misinformation” by people (believed to be the manufacturers’ spokesmen). They either argue that animal tests are not representative of what happens in humans or that the vaccine produces a different spike protein than COVID-19’s spike protein. Why not suspend the use of a vaccine that is ineffective and immediately invest in extensive research to prove or clarify with data? Instead, the drug companies and the government are not doing one thing or the other. They are still bent on further promoting the vaccine, completely ignoring those alarming warnings and the safety of the people.

The potential toxicities that cannot be demonstrated or anticipated at the moment are really my concern. The efficiency of vaccines and the magnitude of acute and short-term toxicity are at least becoming apparent by their use in the real world today. My biggest concern as a toxicologist is the potential long-term carcinogenic and teratogenic effects on fertility and growth and development, at least given the uncertainty of the lack of data. From the very beginning of the COVID-19 vaccine, the developers so stated, and people believed, that is, because the mRNA vaccine is designed for specific mRNA to enter the immune cells and metabolize rapidly once the synthesis of the viral stinger protein is completed, theoretically, the mRNA would not enter the nucleus and alter the body’s genes or produce the associated side effects. In fact, the toxic effects of a drug are difficult to speculate from theory alone; in other words, the vast majority of toxic effects cannot be inferred or anticipated, which is the necessity and importance of systematic animal and clinical trials.

I don’t have a big concern about myself or my generation receiving the COVID vaccine, including the mRNA vaccine. Even with potential mutagenic carcinogenic effects, it’s not that scary for develop fatal cancer five or ten years later. However, for young people, especially children and adolescents, any carcinogenic mutagenic teratogenic potential, any effect on fertility and growth, would be a disaster for the entire nation and humanity. The blood lesson that many people know is the “Thalidomide incident” in the middle of the last century, when in the 1950s, the German company Grandtay developed a new drug Thalidomide, to reduce the early pregnancy reactions of pregnant women. It was marketed in Europe, Australia, Canada and Japan (until its mandatory withdrawal in November 1961), resulting in a total of about 12,000 mutilated babies. A similar catastrophe was prevented in the U.S. when Dr. Frances Kelsey of the FDA prevented the drug from being marketed.

The epidemiological data to date indicate that COVID infections are extremely low in infectivity, pathogenicity and lethality in children. As the ridiculous title of the same article states, “Pfizer claims vaccine will reduce average daily child COVID deaths from almost zero to almost zero”. In such a situation, I cannot understand how those in power in their positions of power can do risk assessment by allowing children to be fully vaccinated with an immature vaccine that has no certainty of effectiveness or safety. I can’t stand it if it is only to increase the rate of universal vaccination that the politicians want, or if this rate of universal vaccination can protect old people like me. For this reason, I have written to all levels of government, asking them to think twice about having mercy on children. However, my words were too small to be helpful.

And the opposite is true. The poor anti-epidemic effect of the vaccine was accompanied by even more relentless marketing by vaccine manufacturers, endless drumming in the media, anti-epidemic policies followed by governments led by the U.S. government, and a high degree of suppression of opposition from experts and the public. If two shots (or one) are not enough, get a third booster shot and a fourth shot every six months or even every four months, with a constant supply from the drug companies anyway? Not enough for adults (already as low as 16 years old), then expand to 12 years old, and then to 5 years old. It is said that Modena is already developing vaccines for infants and children from 6 months to 5 years of age due to competition from Pfizer, which was found to have a head start on pediatric vaccines. This push has been so successful that Austria is said to have started universal vaccination, with no one left behind.

What’s wrong with the world? Natural disasters are rampant, humans are helpless and even have their own agenda (look at all the wars in the world again). Although many of my classmates and friends work for many pharmaceutical companies in the U.S., and one college friend even works for Pfizer, in today’s America political and social environment, I am not even comfortable discussing with them to solve my doubts.

Frankly, in the past two years, Pfizer and some pharmaceutical manufacturers have become as much of an arms dealer as USFDA and the CDC. Here is another example, in June 2021, Biogen filed a new anti-Alzheimer’s drug Aduhelm (Aducanumab). The Independent Expert Committee (Advisory Committee) hired by the FDA was unanimously opposed (10 votes out of 11, 1 unsure), arguing that there was not enough evidence to prove the drug’s effectiveness and that there were serious side effects that could not be ignored. The FDA, despite this opposition, granted its unusual approval. This caused surprise and even anger among many researchers and led to at least three of the experts resigned in the committee so far as silence protest for the decision. People like me rather cannot help but surprise the influence of this drug company in the United States, just as arms dealers influence American politics and the world landscape. It should be noted that the annual cost of this drug is $5,6000 for those who use it. If 5% of the 6 million elderly people with dementia in the United States choose to use this drug, it is expected to generate $17 billion in annual revenue for the drug companies.

Where is the FDA that I knew so well? And where is the once-renowned CDC? Watching coldly along the way, I could see the FDA’s embarrassment and helplessness. The Pfizer vaccine was first marketed in London in December 2020, while the White House announced to the nation that the FDA was reviewing the vaccine (the hesitation was evident as to why the FDA was one step slower than it should be) and would approve the Pfizer vaccine for marketing the following week. What kind of pressure is the administration putting on the FDA by announcing its launch first, before the vaccine experts and authorities have concluded their approval? Every subsequent promotion, booster shots, pediatric vaccines, vaccines for young children, etc., have been announced first by the government before the FDA has reached a review conclusion, creating pressure that the FDA cannot resist. This is why Marion Gruber, director of the FDA’s Office of Vaccine Research and Review (OVRR), and Philip Krause, deputy director, resigned in October and November, respectively. One of the alleged reasons was dissatisfaction with the U.S. government’s announcement that adults should receive a booster shot eight months after receiving two doses. I guess it was unbearable the repeated pressure from the president and the government to the FDA and perhaps the people’s scorn. And, of course, there should be the conscience of the scientists themselves.

It was a year that brought down my faith in many authorities and all I seemed to see was the power of money. And of course, the associated political wrangling, possible wars and disasters.

Where will the world go next year?

Source: https://t.me/MoshangUS

Published by: tianzhihuan

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