COVID Vaccine Update and Vaccination Safety Concerns

As TV programs show clips of FedEx planes taking off from various airports delivering these all-important Covid vaccines to cities in the USA and Canada, many people remain confused regarding the safety and efficacy of receiving these vaccines. In fact, during the whole of last week, I’d say every single patient who left my office would ask, “What do you think about the Covid vaccine?” As I’m an integrative, functional medicine practitioner, many patients assumed that I’d be cautious about advising vaccines in general and possibly this vaccine specifically. Nothing could be farther from the truth. 

However, I do have a rather cautious approach to discussing anything to do with vaccines due to a rather unfortunate experience I had ten years ago. On my website I had a ‘recommended reading’ page. On the subject of autism, I’d included an article written by another doctor concerning his general views on autism causation. I was unaware that he’d included a line describing his experience with mothers of autistic children who could swear that, in their particular case, their child’s autistic features had begun around the time of the MMR vaccine. 

A blogger working for the Huffington Post had come across this other doctor’s article on my website and notified the Alberta College of Physician and Surgeons, based on this other doctor’s article, that I was an anti-vaccine doctor! Well, after many legal letters and at great cost, I eventually achieved a retraction of sorts but I was permanently scarred and extremely reluctant to say anything for or against vaccines. 

Soon after that incident, my nineteen-year-old son was diagnosed with meningococcal meningitis. He hadn’t been vaccinated against this potentially deadly disease. He presented with a mild flu-like illness but twelve hours later was in a coma in ICU, where he stayed for three days on IV antibiotics. The doctors weren’t sure whether he’d survive. Consequently, for these reasons I’m now very cautious about taking an ill-informed stance on the subject of vaccines and always attempt to explore the literature before adopting a position regarding the topic. I always encourage my patients to do the same before they adopt a particular position one way or another.

The Pfizer and Moderna Vaccines

So, what do we currently know about the Pfizer vaccine? We know that approximately 44,000 people were studied in the company’s trial and that the adverse outcomes were low, with the vaccine having approximately 95 percent efficacy. Initially published data on November 8 stated that the vaccine was 90 percent effective, which was upgraded to 95 percent on November 18. Fifty million doses of this vaccine are due to be administered in 2020 and up to 1.3 billion doses will be available in 2021, with two doses per person. This would mean approximately half a billion out of 7.6 billion people.

The second vaccine just authorized by the FDA, developed by Moderna, published their data on November 16, saying that their vaccine was 94.5 percent effective. There were ninety-five cases of infection in the study population of 30,000 patients and of those, only five had received the Moderna vaccine and had only mild symptoms. Many susceptible population groups were excluded, such as pregnant women, the very elderly, the immune compromised, and children.

Vaccine Ingredients

With regards to the medicinal ingredients of the vaccine contents, each dose of the Pfizer-BioNTech Covid-19 vaccine contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.

The non-medicinal ingredients are as follows:

• 0.43 mg of ALC-0315 = (4-hydroxybutyl)azanediyl) bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
• 0.05 mg of ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
• 0.09 mg of 1,2-Distearoyl-sn-glycero-3-phosphocholine
• 0.2 mg of cholesterol
• 0.07 mg of dibasic sodium phosphate dihydrate
• 0.01 mg of monobasic potassium phosphate
• 0.01 mg of potassium chloride
• 0.36 mg of sodium chloride
• 6 mg of sucrose
• Water for injection

The diluent (0.9 percent sodium chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.

The Pfizer-BioNTech Covid-19 vaccine doesn’t contain preservative. The vial stoppers aren’t made with natural rubber latex. We also aren’t aware of the vaccine containing some of the usual adjuvants that are added, such as thimerosal or aluminum.

How These Vaccines Work

Both the Moderna and the Pfizer vaccines are a new type called mRNA vaccines. Previous vaccines, such as the flu vaccine and the Hep B vaccine, are entirely different types of vaccines. They contain neutralized viruses or multiple viruses, as in the case of the flu vaccine. Consequently, we can’t extrapolate the same data concerning their safety and side effects profile onto these new vaccines, although some general principles can be observed (see later). Furthermore, we have no long-term studies related to these new vaccines, only animal studies and short-term human studies.   

This vaccine works by providing genetic code in terms of computer, laboratory derived mRNA sending information to your own cells on how to temporarily, not permanently, manufacture what’s known as the spike protein, which is found on the outside of the coronavirus. Your cells receive this mRNA genetic code that’s wrapped in polyethylene glycol or PEG, and yes, that is the main ingredient found in anti-freeze, along with phospholipids from the vaccine. They then absorb it and send it to an organelle inside your cell called the ribosome that then manufactures the spike protein. Your cells then release the spike protein for which your own immune cells called T cells and B cells (antibodies) are developed, attacking these spike proteins. 

The first dose, referred to as ‘priming the immune response’, is where your immune system learns to recognise the virus and this process takes from two to three weeks. The second dose is when your immune system does the main work of building your long-term defenses against the virus. 

If you should get the Covid viral infection at a later date, your body will have readily prepared T cells and B cells that will attach to the outer covering spike proteins of the actual virus and thus neutralize it. These manufactured spike proteins won’t be permanently embedded in your DNA, at least as far as we know, and won’t be permanently turning on your immune system. Thus, the effect of the vaccine won’t be long lasting.

Some estimates calculate that the effect will only last for between six and twelve months, with the possibility existing that yearly vaccinations will be necessary. 

Many vaccines, like the measles vaccine, confer lifelong immunity, but respiratory infections like Covid-19 do not and neither will the vaccines. Naturally occurring immunity seems to start to fall off after two to three months, with the possibility of getting a second infection rising after that period, especially as the virus appears to be mutating into more virulent forms. The first known case of reinfection was noted on April 25 and the first known case of a second infection causing death was published in October 9, 2020. (1)

Potential Side Effects and Symptoms

After the first dose you’re likely to feel a little pain and minor swelling around the injection site, with some stiffness in the arm muscle that usually disappears by the next day. 

After the second injection, most of the immune defense building takes place and one may feel a flu-like illness with low-grade fever, fatigue, and chills. This only usually lasts a day and is gone by the morning. 

With the future single dose vaccines, the side effects experienced may be similar to those after the second dose vaccine as mentioned. 

If you don’t develop these side effects, it may mean that your immune system isn’t adequately primed. This has been seen in the elderly, as the competency of their immune response may wane with age, as well as with the immune-compromised. 

It’s important to note that with these symptoms, you’re not getting a mild case of Covid. This is impossible as there’s no actual virus in the vaccine. This is your immune system responding to a foreign antigen as it should by raising your metabolism and mobilizing all your immune cells to the site though a protein called the heat shock protein (HSP90). 

How the Moderna and Pfizer Vaccines Differ

There are differences between the Moderna and the Pfizer vaccines. Moderna’s vaccine encodes for the entire spike protein on the surface of the virus, whereas Pfizer’s vaccine only encodes for a part of the spike protein called the binding domain. The spike protein is what a virus uses to attach to your cells, inject its DNA, and thus turn your cells into a factory for virus replication that spreads throughout your body. As the vaccine is targeted against a small aspect of the virus and isn’t the entire virus, the risk of getting sick from the entire injected or dead vaccine is nil. The Pfizer vaccine appears to elicit a slightly stronger response than the Moderna vaccine.

The Moderna version is given twenty-eight days apart, whereas the Pfizer vaccine is administered twenty-one days apart. 

Moderna uses a different propylene glycol liposomal encapsulation and the Moderna vaccine appears to be almost 100 percent effective against long-haul chronic disease. 

Moderna is authorized for people eighteen years and older, while Pfizer’s vaccine was authorized for people ages sixteen and up.

Pfizer’s vaccine needs to be stored at ninety-four degrees below zero. After it thaws, it can be stored in a normal fridge for five days but must be used with six hours if kept at room temperature. Moderna’s vaccine still needs to be kept cold, but at a standard freezer temperature of negative four degrees. After it thaws, it can be refrigerated for thirty days.

Moderna’s vaccine’s side effects were found to be more common after the second dose. Some experts are advising that people may want to consider taking the day off work after getting the second shot.

In September 2020, Pfizer published a study in Nature (2) showing that the two doses elicited a very strong immune T and B cell immune response. Concentrations were above those seen in serum from patients who had been naturally infected with Covid-19 and then recovered. It was therefore noted that those who received the vaccine had a much stronger response than those who acquired the immunity from the infection. 

Moderna also published similar data on November 12 in the New England Journal of Medicine (3) showing that their vaccine induced a robust immune response in all their patients and protected against viral replication in lung and nose cells without evidence of harm. 

Another advantage of these mRNA vaccines is that they can be made very quickly. However, a disadvantage is that they can also break down very quickly. As a result, certain precautions need to be in place. For example, the building blocks of the mRNA have to be modified so that they’re more stable. The building blocks are coated with certain materials, such as polyethylene glycol (4) and phospholipids, so that they’re less likely to be degraded.

Mast Cell Activation and Allergic Reactions

Pfizer’s and Moderna’s Covid vaccines appear to be the only lipid nanoparticle encapsulated vaccine for use in humans. The implication is that there may be a mechanism whereby these nanoparticles can incite allergic or pseudo-allergic reactions, including activation of mast cells. (5) The question then arises whether it’s the covering of the vaccine rather than the vaccine itself that causes the mast cell reaction, hence placing individuals at risk for anaphylactic type reactions. 

Were any tests run on the nanoparticle lipid carrier to secure FDA approval? At this point, we simply aren’t sure. 

However, side effects from this method of delivery have been known for some time. (6) Conjugation of polyethylene glycols (PEGs) to proteins or drug delivery nanosystems is a widely accepted method to increase the therapeutic index of complex nano-biopharmaceuticals. Nevertheless, these drugs and agents are often immunogenic, triggering the rise of anti-drug antibodies (ADAs). 

It may be possible in the future to measure antibodies to PEG and we may be able to predict an individual’s susceptibility to adverse immune reactions to PEGylated drugs and vaccines and thereby increase their efficacy and safety.  

However, Dr. Lawrence Afrin, one of the leading theorists/clinicians in the world of mast cell activation syndrome (MCAS) has the following comment to make about the use of PEG: “Polyethylene glycol (PEG) is such a ubiquitously used excipient in such an extraordinary array of products (medications and otherwise) that I would think one would be hard-pressed to find a first-world (or, probably, second-world or third-world) patient who has not been exposed to it. Perhaps — and I wouldn’t even bet on it, so I’ll just say ‘perhaps’ — one could find members of remote tribes (Amazon, African, New Guinea, etc.) who have never been exposed, but it would be a challenging search.” (7)

The most important step in the manufacture of these vaccines is to freeze the vaccine so that all enzyme activity is stopped. This extreme freezing won’t be available in developing countries and thus the more traditional vaccines such as AstraZeneca vaccine or the Russian vaccine will be used in those areas. (8)

The AstraZeneca vaccine is much cheaper to produce and doesn’t require refrigeration. Early data published on November 23 indicated that the vaccine at full dosage produced 62 percent effectiveness but surprisingly, when only half the recommended dose was accidentally used, there was 90 percent efficacy. (9)(10)

What We Recommend

What we don’t have are any long-term results or any results regarding people with chronic autoimmune disease or those with chronic infections, like many of the patients we see at our clinic with chronic Lyme disease and/or co-infections. Therefore, we can offer some advice. 

If you’ve ever had a severe or anaphylactic allergic reaction to anything or have severely uncontrolled mast cell activation syndrome, you’re discouraged from getting this vaccine.

We do have previous data on people who have had some form of autoimmune disease and had a severe reaction or worsening of their autoimmune disease when exposed to a vaccine of any kind, for example the flu vaccine or hepatitis B vaccine. These people should be cautious before getting this vaccine. 

There’s also a slight risk, perhaps 0.1 percent, that you may trigger an autoimmune reaction or illness from the vaccine. Getting a vaccine of any kind may trigger an autoimmune disease. You have to balance the risk of autoimmune disease against the risk of dying from Covid. 

Basically, this is your individual risk and you’re the one that has to make the decision. 

Not everyone with chronic infections like Lyme disease also has autoimmune disease. In fact, the majority don’t have autoimmune features. If you have active infections or Lyme disease, and you’ve had severe worsening of your Lyme disease or co-infections from any kind of previous vaccination, you may not want to get the vaccine.

Safety and Side Effects: What We Know from Flu Vaccinations

Some people succumb to anaphylaxis and Guillain-Barre Syndrome (GBS) as a result of flu vaccinations.

Anaphylaxis is a severe life-threatening reaction to any antigen, which usually responds to an epi-pen injection, but if left untreated can lead to death. Guillain-Barre is an ascending paralysis from your legs and up your torso that can affect the respiratory centres in the brain, leading to death if left untreated. Usually, patients with this severe form are intubated for prolonged periods. 

The reported incidences by the CDC for anaphylaxis are 1.31 cases per million and one to two people will develop Guillain-Barre. 161 million Americans get the flu shot each year, thus around 210 cases of anaphylaxis are reported with a fatality of between 0.25 and 0.33 percent, the death rate being approximately one death every two to three years.(11) Around three to five percent of people with GB will die and a small number of people are permanently affected. 

Consequently, between four and fifteen people die every year and between three and four hundred suffer severe injury from the flu vaccine. However, approximately 55,000 people die every year from the flu itself, with most of the deaths occurring amongst the unvaccinated. 

It appears that Covid-19 vaccinations may have fewer side effects than flu vaccinations for the following two reasons.

1. With the flu vaccination, more flu viruses are included as opposed to the one in Covid-19, thus having fewer potentially harmful antigens. 
2. Although mRNA viruses haven’t been used in humans before, they contain even fewer proteins that the virus found on flu vaccines and so have less propensity to trigger an immune response altogether.

However, it’s worth noting that the total compensation paid out over the life of the USA government’s National Vaccine Injury Compensation Program (NVICP) is about $3.6 billion. The flu vaccine tops the list of the most common list of claims paid out by the NVIC for vaccine side effects. (12)

So, is the vaccine as injurious to your health as is often proclaimed? Or is it as safe as medical statistics proclaim? The subject is extremely difficult to unravel. 

We’re constantly making trade-offs between one set of statistics and the other. Many deaths occur every year from motor vehicle accidents. Approximately 39,000 deaths occur as a result of accidents in the USA every year and many more people are maimed permanently, but we all make the choice of driving to get us from A to B, knowing full well what the risks can be. 

Furthermore, we’re also aware of how diet and lifestyle play a huge role in the advent of cardiovascular disease but many choose to make no changes to their toxic food choices or lobby against the business practices of fast-food companies in order to mitigate their risks of dying of a heart attack. 

We’re therefore faced with a choice. Are we willing to make the trade-off of a few hundred people suffering long-term injury and a dozen or so dying every year from Covid-19 vaccinations in exchange for preventing a projected 500,000 or more deaths and possibly returning to normal life? Around 40 percent of the population of the United States believe it’s a bad trade-off at present, with the numbers increasing daily as radicalized right-wing and left-wing media channels and public personalities jump into the fray.

For Further Consideration

There are some further issues for consideration for those of you who wish to explore aspects of this controversial fray.

Many people are hesitant to have the vaccine as the long-term effects of these synthetic mRNA vaccines haven’t been studied in the humans. 

Animal studies using mRNA over the past twenty years have shown significant side effects, especially autoimmune disease. Hence mRNA vaccines weren’t implemented years ago because of these potential safety concerns. 

It’s important to note that all liabilities for vaccine damage have been waived for the companies producing them. 

PCR testing also has a high number of false positives.

Many people are vehemently opposed to all vaccines, not just this one, and no amount of medical reassurance and statistics will convince them otherwise. Other individuals believe that the entire Covid-19 pandemic is a hoax. Many patients are known to have denied that Covid-19 was real even as they were dying from the virus. Others have cursed the doctors who have diagnosed them and left hospitals in order to die at home. 

Many medical doctors have also adopted controversial stances. They claim that Covid-19 isn’t a real epidemic or that the Covid-19 vaccine will negatively alter your DNA. They state that the real epidemic is fear and hysteria, accelerated by corporations who gain from flawed testing, dangerous antiviral drugs, and flawed vaccines; therefore, this whole epidemic is driven by profit and hysteria. 

Others believe that the vaccine will be used as a method of population control. They think that Bill Gates is behind this epidemic so that he can make more profits from the vaccination program and that tracking chips will be embedded in people to enact some kind of population control as the world’s population increases. 

The problem that arises if between forty and fifty percent of the population are skeptical about getting the vaccine is that vaccines, no matter how effective, may not be able to turn this epidemic around. Those who get vaccinated will be temporarily protected, but approximately 128 million people who don’t get vaccinated still represent a huge part of the population that’s still susceptible to the virus. And we have no way of knowing who they are. 

Another concern is that pro-life individuals worry that the vaccine was made from the cells of aborted babies.

It’s true that traditional vaccinations use dead or altered viruses, which have to be grown in cell lines and those cell lines originated with aborted fetal cell lines. The cell lines in question did indeed originate from embryonic kidney tissue acquired from a handful of human abortions performed in the 1960, 1970, and 1980s. These cells were then grown in the laboratory multiple times for decades. 

However, no cell lines on which the viruses were grown make their way into the vaccines. The two vaccinations grown from synthetic genetic material called mRNA don’t use cell lines at all. They’re developed using genetic sequencing on computers. These mRNA vaccines are thus considered ‘ethically uncontroversial’. 

However, AstraZeneca’s vaccine is produced from a modified virus grown on cellular material that was derived from this original fetal cell line. Purists may want to consider their options with this knowledge in mind. 

Vitamin D, Vitamin C, zinc, ivermectin, and famotidine confer some immunity. I’ve previously written on this subject and will revisit it in my next blog post.  

Please make up your own mind regarding whether or not you’re going to choose to get this vaccine. 

While as a licensed physician with the Alberta College of Physicians and Surgeons I must strongly encourage you to obtain the vaccine, I’m aware and sensitive to many of the dissenting points of view.

Health Canada and the American College of Asthma, Allergy, and Immunology (ACAAI) Guidelines

The following guidelines are published by Health Canada and the ACAAI.

What’s known and reported by Health Canada is as follows: 

Health Canada has conducted a rigorous scientific review of the available scientific evidence to assess the safety, efficacy and quality of the Pfizer-BioNTech COVID-19 vaccine. No major safety concerns have been identified. Based on the current information, Health Canada has assessed that this vaccine’s benefits outweigh its risks. The side effects observed during clinical trials of Pfizer-BioNTech’s COVID-19 vaccine are similar to those experienced with other vaccines, including pain at the site of injection, body chills, feeling tired and feeling feverish. These side effects will resolve on their own and do not pose a risk to health. According to Health

Canada,(13) they have followed up on the two reports of anaphylactoid reactions to Pfizer BioNTech’s COVID-19 vaccine in the U.K. These reactions occurred on December 8, 2020.

Both individuals in the U.K. had a history of severe allergic reactions and carried adrenaline auto injectors. They both were treated and have recovered.

As vaccine roll-out begins in Canada, Canadians may be wondering about the risks of allergic reactions. In Canada, all vaccines carry a warning about the risk of serious allergic reactions, including anaphylaxis, and immunization clinics are equipped to manage these rare events.

People with allergies to any of the ingredients of the vaccine are currently cautioned against receiving it. This caution is already noted in the Canadian Product Monograph (prescribing information) for the Pfizer-BioNTech COVID-19 vaccine. (14) Health Canada has reviewed the available evidence and has concluded that the current Product Monograph and available public health guidance are appropriate, and is not recommending any changes to the product’s use at this time.

If you know you have allergies to any of the ingredients in the Pfizer-BioNTech COVID-19 vaccine, you should not receive it.

If you have experienced a serious allergic reaction to another vaccine, drug or food, you should talk to your health professional before you receive the vaccine.

Health professionals should follow guidance and recommendations related to identifying and managing serious allergic reactions following immunization. This includes ensuring that appropriate medical treatment and supervision are in place at all vaccination sites, as indicated in the Product Monograph.

The ACAAI published their guidelines on the risk of allergic reactions to the Pfizer-BioNTech Covid-19 vaccine on December 14, 2020 (15):

Allergic reactions to vaccines, in general, are rare with the incidence of anaphylaxis estimated at 1.31 in 1 million doses given. With the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine by the FDA on December 11, 2020, the ACAAI COVID-19 Vaccine Task Force recommends the following guidance for physicians and other providers related to risk of an allergic reaction on vaccination. These recommendations are based on best knowledge to date but could change at any time, pending new information and further guidance from the FDA or CDC.

1. The Pfizer-BioNTech COVID-19 vaccine should be administered in a health care setting where anaphylaxis can be treated. All individuals must be observed for at least 20-30 minutes after injection to monitor for any adverse reaction. All anaphylactic reactions should be managed immediately with IM epinephrine as the first line treatment. 
2. The Pfizer-BioNTech COVID-19 vaccine should not be administered to individuals with a known history of asevere allergic reaction to polyethylene glycol as it is a component of this vaccine known to cause anaphylaxis. 
3. Data related to risk in individuals with a history of allergic reactions to previous vaccinations and/or mast cell activation syndrome/idiopathic anaphylaxis is very limited and evolving. A clinical decision to administer the Pfizer-BioNTech COVID-19 vaccine should be undertaken by the physician or other provider administering the vaccine using their professional judgment and in consultation with the patient, balancing the benefits and risks associated with taking the vaccine.
4. Individuals with common allergies to medications, foods, inhalants, insects and latex are no more likely than the general public to have an allergic reaction to the Pfizer-BioNTech COVID-19 vaccine. Those patients should be informed of the benefits of the vaccine versus its risks.
5. The Pfizer-BioNTech COVID-19 vaccine is not a live vaccine and can be administered to immunocompromised patients. Physicians and other providers should inform such immunocompromised patients of the possibility of a diminished immune response to the vaccine.
6. Anyone with questions related to the risk of an allergic reaction to the Pfizer-BioNTech COVID-19 vaccine should contact their local board-certified allergist/immunologist.

References

1. Mulder M. et al., Reinfection of Severe Acute Respiratory Syndrome Coronavirus 2 in an immunocompromised patient: A Case Report. Clinical Infectious Diseases https://doi.org/10.1093/cid/ciaa1538
2. Sahin U, et al., Covid-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses, Nature 2020 Oct; 586 (780): 594-599.
3. Jackson LA., An mRNA Vaccine against SARS-COV-2- Preliminary Report N Engl J Med 2020 Nov 12; 383(20): 1920-1931.
4. Polyethylene glycol (PEG) is a petroleum-derivative compound that is made from ethylene glycol (ethane-1,2-diol), the main ingredient in antifreeze. PEG can be found in a number of other products, including skin creams and personal lubricants, and as a food additive for anti-foaming purposes. *THIS IS NOT A REFERENCE
5. Pseudo-anaphylaxis to Polyethylene Glycol (PEG)-Coated Liposomes: Roles of Anti-PEG IgM and Complement Activation in a Porcine Model of Human Infusion Reactions – PubMed (nih.gov)
6. https://www.sciencedirect.com/science/article/pii/S0169409X20301083
7. Personal email correspondence
8. Voysey M, Clemens SAC Madhi SA et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2020; (published online Dec 8.) https://doi.org/10.1016/S0140-6736(20)32661-1
9. Nanoparticles Vaccine against Infectious Diseases. Pathi R, Frontiers in Immunology 4^th October 2028
10. Vaccine Injury Table National Vaccine Injury Compensation Program. www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/vaccine-injury-table.pdf 
11. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74543a-eng.php
12. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74543a-eng.php
13. American College of Allergy, Asthma, and Immunology (ACAAI) Guidance on Risk of Allergic Reactions to the Pfizer-BioNTech COVID-19 Vaccine December 14, 2020

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