COVID Vaccine Concerns
By: Gladys Onachoeziokwu
Tags: Coronavirus, Covid 19, Vaccine, Vaccine Safety, Pfizer

“The man who asks a question is a fool for a minute, the man who does not ask is a fool for life.” said allegedly Confucius many years ago. A Danish proverb states that “The one who is afraid of asking questions is ashamed of knowledge”. Moreover, there is a Polish proverb that says that “The one who asks does not get lost”.

Thus, in my search for truth about the COVID vaccine safety and efficacy, I decided to ask some questions and look for unbiased answers.

So, without unnecessary beating around the bush, I will share some things that I found.

Disclaimer: The article below is not to be regarded or used as a medical advice, it represents personal opinions of the author. If you need or want a medical advice with regards to anything, you should contact your GP or other suitable healthcare professional.

1. Is it a trustworthy medication?

For years, there has been no coronavirus vaccine, not for lack of trying but because previous studies indicated poor safety profile of such vaccines. COVID-19 belongs to the coronavirus subfamily.

For example, previous studies on coronavirus vaccines — such as SARS coronavirus (SARS CoV) vaccine showed that it had potential to cause harmful immune system effects including increased severity of infection with the natural SARS virus through vaccine-associated disease enhancement (VADE). The genomes of SARS coronavirus and COVID-19 virus share nearly 80% of genome sequence identity, and they use the same receptor to get into the cell so issues raised in studies of vaccines for the former should be carefully checked for in the research of the latter (1).

In just one example of a coronavirus vaccine study done on mice models, unadjuvenated vaccine performed poorly in both young and aged animals, and it caused pathological enhanced immune response causing lung inflammation following re-infection with a different variant of coronavirus. This was more severe for aged animals (2).

Similar harmful enhancement of immune response leading to severe pneumonia when exposed to coronavirus following immunisation was observed with other types of corona vaccines such as a vaccine that used SARS N protein. (3).

The authors of a paper published in Nature scientific journal that studied lessons to be learned from previous vaccine research stated that ‘it usually takes a long time to observe VADE because it appears mainly in subsequent challenge or natural infection, by homologous or heterologous viral strains, and the occurrence is often related to antibody titres that have decreased to suboptimal levels’. They also described four recommendations that should be followed to help ensure the development of a safe COVID-19 vaccine. These include:

The vaccine should be tested in various different animal models When assessing the vaccine, the response to different viral strains should be tested with antibodies cross-reactive to SARS-CoV and SARS-CoV-2 (COVID-19 virus). The vaccine research experiments should be reapplied in the same animal model at various ages Studies should also be performed on subjects with comorbidities (1).

From what I can see, in published data so far, we have some limited evidence of compliance with 4th recommendation only. Pfizer researchers claim that their randomised study participants were either healthy or with ‘stable chronic conditions’. They then specify that 21 % of the participants had 1 or more comorbidities. Unfortunately, they provide very little information on what these comorbidities were and what they mean by ‘stable’. They stated the conditions included but were not limited to ‘human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection’ (4). It is concerning that they decided to list these three conditions, giving the impression that those were main conditions of participants who had any, as this is not what elderly people, who are deemed the primary population who needs a vaccine the most, mainly suffer from.

Some may say that since the studies were already performed on humans, the results of animal studies and recommendations 1 and 3 are irrelevant anyway. But this is incorrect. The lifespans of small animals used in research are much shorter than human life, and long-term adverse effects may be much more readily observed in them than in humans. Recommendation 2 is also vitally important considering issues uncovered in previous studies.

Go on and check for yourself in the papers that Pfizer published whether they have kept to the above paper’s advice or at least took it into account. Or if you will, (as after all we cannnot expect Pfizer to publish data from all the experiments they undertook so quickly, can we?) contact MHRC for them to comment on this, surely, it is not a secret or private information.

So far, we know that themRNA COVID-19 vaccine causes serious adverse effects. From the ones covered by media, 2 NHS staff and 2 healthcare workers from Alaska suffered very serious allergic reactions just after the vaccine was started to be given to the public (5,6,7). In Alaska, the two workers who suffered the extreme bad reactions had no previous history of severe allergies and were 2 of 144 people who were given the vaccine on that day (7).

I don’t think anyone (at least definitely not me) expected to see this many such severe adverse reactions to the vaccine just after it was released. The initial numbers are very high, 2 in 144 is 1 in 72. According to WHO, the rate of anaphylaxis for other vaccines is 1 in a million (8). So this occurs at a much higher rate with COVID vaccine than expected. And unfortunately, we are talking only about anaphylactic or severe allergic reactions that are immediately apparent. We can also be sure of many other adverse reactions that are not immediately apparent and/or that are deemed less severe in nature. The manufacturers’ product leaflet and UK governmental website state this much. According to that information, symptoms following this vaccine that would be usually associated with colds and flu are ‘very common’(9). This, we know. However, what is far more concerning is what we do not know. The governmental information leaflet does state that pregnant women should not take it and advises to not get pregnant for at least 2 months after taking it as there is no data available on how it may affect the pregnant women (9). What they failed to mention is that there is no data available on many other important things. We do not know the long-term health effects of the vaccine, and we do not know even relatively short-term effects for people with not so stable chronic conditions as the volunteers used in the study were healthy people or those with ‘stable chronic conditions’.

Further, despite the newness of COVID-19, there are already studies that show that it is likely it could be implicated in development of different autoimmune diseases. It can do so by ‘molecular mimicry’ — ‘The scientific rationale is that, following the infection, the immune responses raised against SARS-CoV-2 may cross-react with human proteins that share peptide sequences with the virus, in this way leading to autoimmune pathologic sequelae.’-as per a study published in Autoimmune Rev. Journal (10).

The problem is, that if a natural virus can cause an autoimmune disease, so can vaccines developed against the virus- this has been implicated with other vaccines in multiple studies. Researchers from a study published in Journal Nature, explain that ‘Molecular mimicry refers to a significant similarity between certain pathogenic elements contained in the vaccine and specific human proteins. This similarity may lead to immune crossreactivity, wherein the reaction of the immune system towards the pathogenic antigens may harm the similar human proteins, essentially causing autoimmune disease.’

One medical doctor in a letter to BMJ editor suggested that since there is a justified rush in getting the COVID-19 vaccine out, that ‘In the understandable socioeconomic rush towards mass vaccination without longer-term safety testing, it would seem that an essential stage in any vaccine licensing process should involve a careful analysis of the human proteome against vaccine peptide sequences. This should minimise the risks both of acute autoimmune reactions to inoculation and future chronic autoimmune pathology’ (11). Has the Pfizer done that? Again, my guess is as good as yours; not from any evidence available to the general public. It is worth mentioning here that the vaccine has not been licensed yet, it has just been given emergency authorisation (in the US) or temporary authorisation (in the UK) to be used.

Another consideration is that due to strict conditions in which the vaccine is to be stored and used (‘requires storage in an ultra-low temperature freezer at -80°C to -60°C or a thermal container at -90°C to -60°C… The undiluted vaccine can be stored for up to 5 days (120 hours) at 2–8°C, or up to 2 hours at temperatures up to 25°C, prior to use’ (12)) and pressure to deliver many vaccines in a short period of time, unintended errors can easily happen. That was the case with the polio vaccine in 1955, where there was public pressure for quick distribution of the new vaccine. One manufacturer distributed a batch of contaminated vaccine that then caused serious harmful effects in 70000 children, 164 of whom suffered permanent injury, and 10 died (13).

One other factor to consider is new strains of the virus. We all have heard that a new strain of COVID-19 has just been found. Not surprisingly as it has been now about a year since it was discovered. We all know that for a flu virus, new vaccine is needed nearly every year as new strains become virulent every year (14). The Pfizer vaccine was developed against the initially found strain of the virus. Are there any studies that prove that in contrast to flu, new strains of the coronavirus do not need a new vaccine?

Oh and ‘Even if you had COVID-19, still get the vaccine as it may ‘top up’ your immune response and provide longer protection’- ‘experts’ say. Where is the research evidence that proves this? Help me out.

2. Is this vaccine efficient at what it’s supposed to be doing?

It’s probably much too early to know. An associate editor of the British Medical Journal made a very interesting comment:

“The topline efficacy results from their experimental covid-19 vaccine trials are astounding at first glance. Pfizer says it recorded 170 covid-19 cases (in 44,000 volunteers), with a remarkable split: 162 in the placebo group versus 8 in the vaccine group. Meanwhile, Moderna says 95 of 30,000 volunteers in its ongoing trial got covid-19: 90 on placebo versus 5 receiving the vaccine, leading both companies to claim around 95% efficacy.

Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown.”

He then also explains possible flaws in the design of the study that could have confounded the efficacy data (15).

In another BMJ article, again it is explained in great detail that the trials of COVID-19 vaccine were not designed to test for what is most important for the public- whether it would help decrease the number of people getting severe COVID illness and whether they would decrease the transmission of the disease. The Pfizer vaccine trial (and others as well) simply have not tested for this (16). They have proven short-term (so far) efficacy in decreasing the relative risk of their primary endpoint they tested for but not in what would be of real use for public health.

3. Is Pfizer a trustworthy company?

Pfizer self-funded their COVID vaccine development research spending millions of dollars, if for any reason they would not sell millions of the vaccines they not only are not going to make a very good profit, but they would also lose all the money invested.

Pfizer is very far off from having a clean record of being an honest pharmaceutical company.

There have been multiple lawsuits for damages made by their drugs, some of which resulted in Pfizer paying very large amounts of money in settlements. The Drugwatch website provides short descriptions of such lawsuits and settlements (17).

And I will expand a bit just on a couple of examples:

Pfizer was proven guilty of unethical research on Northern Nigerian children with an antibiotic called Trovan. It was done without the consent of the children’s parents. Also, children in the ‘non-Trovan’ group were provided with sub-therapeutic doses (lower dose than is known to cure a disease) of normally recommended antibiotic ceftriaxone (used in the study as the so called ‘gold standard’ against which the efficacy of the experimental drug was tested) (18). It is disgusting, not only for the harm they did to those innocent children and their families but also because of the far-reaching consequences it could have on millions of people around the world, were this fraud not caught on time- as their aim was to prove the superiority of their drug in treating bacterial meningitis to help gather evidence that it should be chosen in the future for such cases, which would help secure more money for Pfizer. Despite admitting that they lowered the dose of ceftriaxone by two thirds, Pfizer still refused to admit that they did anything wrong. However, after US judge has granted a lawsuit to happen in the US, Pfizer went for settlement with Nigeria (19).

By the way, Trovan was approved by governmental regulatory bodies and released and used in different countries including US and EU and thousands of people were treated with it before it became apparent that it was toxic to liver cells. It caused liver problems in many patients and was confirmed to cause an acute liver failures in at least 14 patients, 6 of whom died. Trovan was then pulled off the shelves over a year after it was released on the market (20).

According to the Public Citizen’s Health Research Group, the toxic effects of the drug on the liver were clearly evident from both animal and human studies before the drug was approved (21). However, Pfizer maintains that Trovan studies indicated no serious problems with the drug.

As it was stated in one article in the New York Times (22):

“The case showed how a new drug, marketed by an expert like Pfizer, could be swiftly prescribed to thousands of patients before all the side effects were known. Pfizer said its tests of Trovan had not revealed any serious problems.”

The article also included this amazing statement by then Pfizer’s chairman:

“In the clinical trials Pfizer conducted to receive F.D.A. approval, William C. Steere Jr., the chairman of Pfizer, said that there was no evidence that Trovan could cause liver problems. As in all drug trials, the patients involved are carefully screened, he said, and many with complicated health problems are ruled out. That means that some side effects do not show up until after a drug is approved.

“You put the drug in the general population, and then everyone is taking it,” Mr Steere said. “We just hold our breath and wait to see if there is something unique with the drug.”

In the case of Trovan, he said, “it turned out there was.””

Wow, just wow, please, give me a break! I am speechless.

So, after they release a new drug to the general population, they ‘hold their breath and wait to see if there is something unique with the drug’. Maybe, apart from them, there should be a whole bunch of simple people who also just hold their breath, wait and see what happens before jumping into taking a novel drug or vaccine. From his own words, one can conclude that indeed, the first population to get a new drug after its release to general public serve as guinea pigs to see if any effects not seen in controlled studies happen.

Though, after a second thought, he was at least being honest there.

Let us also remember that Trovan was just another, new drug in a well-known class of fluoroquinolone antibiotics that have been used for decades with well-established reasonable safety profile. This is in big contrast to COVID-19 vaccine, which is a whole new type of drug, using novel approach that has never been used before in other vaccines released for public use.

I believe that at least for several years after releasing such a novel pharmaceutical agent, patients should be required to sign a written consent similar to a consent that one signs before participation in a clinical trial that explains the clinical trial results, potential benefits and potential risks, including that the full effects of it, especially long-term ones are not known yet. Whoever then is comfortable with that should sign it and get it. No government should embrace or encourage a drug before its safety is proven, that is, following release to the general population. Until then, they should take a neutral stand. Ideally, no government should ever promote any drug, in order to maintain their impartiality since most drugs are produced by very big influential pharmaceutical companies with a lot of lobbying powers. They should leave it to healthcare professionals to prescribe pharmaceuticals for treatment and prevention according to evidence-based medicine. If a drug does not need prescription, it can also be promoted to the general public directly by the manufacturer.

But I digress.

The governmental regulatory bodies of European Union (including the UK) and the US did approve of the market release of Trovan as well as other medications that were released and then caused enough harm for Pfizer to be forced to withdraw a drug and/or pay hefty settlements (not to mention many other medical drugs and surgical equipment from different other companies that had to be withdrawn after release due to unacceptable and sometimes horrifying harmful effects) so governmental approval does not seem to be fail-proof safeguard to be relied on without questions either.

Probably the most concerning is that, in 2009, Pfizer infamously set a record for the largest health care fraud settlement — whopping 2.3 billion US dollars for fraudulent marketing of a number of drugs that caused harm to people. That included a huge criminal fine.

They had to pay this amount of money for deliberate fraud for which they pleaded guilty.

Excerpt from US department of justice website: ““The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer’s crimes,” said Mike Loucks, acting U.S. Attorney for the District of Massachusetts. “Pfizer violated the law over an extensive time period” (23).

I wonder how anyone can trust Pfizer after that.

I am sure it must have been very expensive for the poor Pfizer to manage all those lawsuits. Luckily for Pfizer’s management though, they do not have to worry about any lawsuits from potential bad effects of COVID-19 vaccine, no matter what, there will not be any. Governments of different countries, including UK and US granted it protection from legal liability for any harmful effects of the vaccine on individuals (24), (25). Can anyone be blamed for not wanting to take something that even its developers and manufacturers don’t want to take responsibility for? Is it surprising that at least some people out there are very concerned about this?

By the way, I see a striking resemblance between the situation in Northern Nigeria in 1996 and the world situation in 2020. In Nigeria, they had meningitis outbreak and obviously where in a dire emergency situation, yet before the full extent of Pfizer’s failings in that Trovan study was exposed, many would defend the Pfizer for taking action and ‘trying to help’ despite them not adhering to expected standards. Similarly, in 2020 when the world suffers from COVID crisis, Pfizer is released from upholding to the expected standard that they would accept legal accountability if things go wrong (as they did go wrong many times in the past) and lots of people are fine with that, after all, what matters is that they are ‘trying to help’ and that they produced a vaccine that so many waited for.

Well, that’s all folks from me, at least for now. I encourage you to do your own research.

Choose you today whether you take the COVID vaccine or not. Personally, I would be happy with whatever choice you make as long as it is a fully informed one.

As for me, I have already made my mind up.

References