Written on 1/13/2021 (and subject to change)
Dr. Emily Maiella
Should you get the Covid-19 vaccination? To best answer this question, I would need two pieces of information. 1. Is it safe? 2. Is it effective?
I’ve spent some time looking at the models that the different major vaccine manufacturers used that decided whether the vaccine is “effective.” In this article, I’ve combined that information with an inquisitive mind and a naturopathic frame of reference. While my opinions have been inserted, my goal is to accurately portray the scientific process and evidence for vaccine safety and effectiveness. In doing so, I hope to address fear and/or confusion with honest information. Towards the end of the article, my goal is to educate and empower patients about their immunity and what they can do to enhance their vitality.
Please note that there is limited data here in terms of vaccine efficacy and safety, and I am not a vaccine expert. I am neither strongly for or against vaccinations in general. I am strongly for education, transparency, science and ethics.
Is it effective? I think an important place to start is to look at what the vaccine manufacturers and the FDA consider vaccine endpoints, which is how they determine efficacy during the trials. NOTE: there are some big looming issues here as this model does not answer the question, is it effective in preventing transmission? Nor does it have provide any evidence of how long the vaccinated participants have decreased risk of infection.
Primary endpoints for vaccine approval include: SARS-CoV-2 infection, symptomatic infection (COVID-19), severe COVID-19, or some combination of these (1). Basically, did the recipients of the vaccine get sick with symptoms.
The U.S. Food and Drug Administration (FDA) recommends minimal phase 3 success criteria for approval of a vaccine: when there is an estimated reduction in the primary endpoint of at least 50% in the vaccine group versus the placebo group, with the 95% confidence internal. This provides assurance of at least a 30% reduction, which is a benchmark consistent with the World Health Organization’s Solidarity Vaccines Trial design. (1). To simplify, did the vaccine participants get less sick than the placebo (unvaccinated) group?
Because they based endpoints of SARS-CoV-2 on symptom presentation/onset, without measuring antibodies, the model here was measuring if the vaccine prevented symptomatic illness. (Which could be good, as this buys the body some time to make an immune response). However, here’s the rub: It is a real concern that vaccine protection against symptomatic COVID-19 could shift the population towards more SARS-CoV-2 infections that are asymptomatic.
For those of you who love statistics, here’s their end-point model that would account for the possible shift to asymptomatic vaccine recipients. This is from the Annals of Internal Medicine, October 2020.
There’s an assumption of the expected percentage of infections in the placebo group that will be asymptomatic. This has to be known and acknowledged by the manufacturers, as it is needed information to determine vaccine efficacy for asymptomatic infection.
“It was assumed that 40% of the infections in placebo recipients are expected to be asymptomatic. Under this expectation, if a vaccine reduces SARS-CoV-2 infections by a modest amount, say 20%, but reduces symptomatic infections by an impressive 70%, the net result will be a 55% increase in asymptomatic infections. In such a scenario, although the vaccine would likely meet success criteria if COVID-19 symptom presentation were the sole primary endpoint and would provide direct clinical benefit to individual vaccine recipients, it may have different population-level effects on the number of secondary transmissions (1).”
So, what they are saying is this: you could receive the vaccine and it can either reduce your symptom presentation, or you can receive the vaccine, and still get the virus with no symptoms at all (asymptomatic). Again, this could be good, or not good, depending on what the goal is.
“If vaccine recipients acquiring asymptomatic infection have low viral infectivity and are weak transmitters, then the vaccine in the aforementioned scenario would likely confer public health benefit on transmission.
However, viral shedding data and epidemiologic modeling studies suggest that unvaccinated asymptomatic persons can transmit the virus, raising questions about the transmission potential of vaccine recipients who acquire asymptomatic infection.
If this vaccine essentially converts symptomatic to asymptomatic infections, without also decreasing viral shedding and transmission potential, this may paradoxically increase transmissions given that viral testing and isolation are presumably less likely in asymptomatic persons.
Conversely, if the vaccine decreases both symptomatic infections and transmission potential, then the population benefits may be magnified. Results from nonhuman primate studies to humans, challenge studies of rhesus macaques vaccinated against SARS-CoV-2 (vs. unvaccinated controls) offer evidence that either possibility may occur, respectively. (1)”
More and more information will be obtained, as the vaccine roll-out happens. I do pray that it goes smoothly, though I do acknowledge the need for us all to have alternatives on hand, if the roll-out is not as successful as anticipated, if this is not the “safe and effective light at the end of the tunnel.” While the CDC’s number’s for effectiveness seem very promising, up to 95%, I will encourage you to continue to think critically.
Let us all challenge the paradigm of “vaccines are good” or “vaccines are bad.” Can we have some real conversations about if this is a safe and effective vaccine for one subset of the population, but not for others? Your health history and risk factors (Are you pregnant? Do you (male or female) plan on becoming pregnant in the next year or so? What’s your immune-status? Do you have an auto-immune predisposition? Prior vaccine reactions? Allergy to polyethylene glycol? Which medications do you take?) need to be evaluated. Are you planning a surgical or medical procedure before or after your immunization? Let’s take a moment and think through the unknowns first, in order in maximize vaccine potential and minimize risk.
Vaccines can have side effects. They just do. This is not denied by anyone, not even the manufacturers or the government. I will be on the look out for the more long term side effects that have not had sufficient time to be reported. The original vaccine participants will be monitored for 2 years.
The differences between the Pfizer and Moderna vaccine ingredients and reported side effects are subtle. If interested, here is a list of ingredients, with milligram dosages. Neither vaccine contains preservatives, heavy metals, egg products or animal/human fetuses. Or microchips. The vial stoppers are natural latex. Each vaccine contains 100 mcg of nucleosidemodified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.
It is difficult to determined which manufacturer has a lower amount of Polyethelene glycol, (PEG), which is the likely culprit in the serious anaphylactic reactions that have been reported thus far.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose.
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.
Each dose of the Moderna COVID-19 Vaccine contains the following ingredients: a total lipid content of 1.93 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride, 0.043 mg acetic acid, 0.12 mg sodium acetate, and 43.5 mg sucrose.
In clinical studies, the adverse reactions in participants 18 years of age and older were pain at the injection site (92.0%), fatigue (70.0%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23.0%), axillary swelling/tenderness (19.8%), fever (15.5%), swelling at the injection site (14.7%), and erythema at the injection site (10.0%).
Putting this all together:
Until we have a greater understanding of the long term efficacy, safety, long term immunity (or not) and transmission rates, I advocate for continued social distancing, hygiene and mask wearing, even if you are a vaccine recipient.
For me personally, I will need to having a solid understanding of 1). Is the vaccine going to afford me long term immune/antibody protection; 2). Will I be effectively helping to stop the transmission to others if I receive it? 3). Is it safe for me/others?
The CDC and the FDA will monitor for vaccine reactions, though if it is anything like their protocols for other vaccinations, it may be short sited. There are no adjuvants in this vaccine, and aside from the polyethylene glycol coating (which is a real risk for anaphylactic reactions that are widely reported in other vaccines), most ingredients seem inert. I am going to red-flag the new Messenger RNA type of vaccination. A rushed, and completely new (and at this point only approved for emergency use, as it not approved or licensed by the FDA) type of vaccine doesn’t sit well with me. I typically try not to eat genetically modified foods, so…. I still have reservations. I plan to wait another 6-12 months before I reconsider whether to vaccinate myself or my family. This recommendation is what feels right for me and my family. However, I may think differently about that if I lived with an elderly or immune-compromised person, if I was elderly myself, or had risk factors that would put me at an increased risk of severe disease or death. It seems like, at this point, the vaccine is proving efficacious for preventing these severe situations. But for now, I am a young-ish vital person with no risk-factors who is willing to build an immune library (AKA antibodies) if I need to. I will hold off until there is more information to be had, and until then I will act responsibility with the intention to decrease transmission to others and to myself.
Now for a naturopathic approach. Let’s start with a brief discussion of Germs and Terrain.
The germ theory is attributed to Louis Pasteur and Robert Koch. This has been the prevailing paradigm of conventional thinking and infectious disease practices. The basic premise is that the germ is gifted with virulence factors that allow the pathogen to cause disease. To some extent, this is true as evidenced by what can be observed from infection causing tissue damage, cell destruction or even death.
The problem is that theory gives all the power to the pathogen, and I think that this paradigm is far too simple. The germ theory seemed quite scientific especially at the turn of the 20th century, when it was discovered that bacteria and viruses could be identified and isolated, and that finally, diseases could be explained, and blamed on a particular pathogen. Pharmaceutical companies jumped on this opportunity, and started promoting antibiotics, antivirals and vaccines as solutions. Slay the germ and extinguish it from the planet!
Please note, that I am not terribly dogmatic in my thinking about science and medicine, so my brief explanation of the the germ theory might sound harsh. However, I do believe that this paradigm took away the human need to pay attention to their diet, to their hygiene and to the extremely important environmental influences. That is what I want to focus on. What do we have control over in this lifetime.
We are the sickest country in the world, with extraordinary chronic illness rates. Much of which is preventable. When will we start talking about the epidemic of cancer and heart disease, which are still taking more lives everyday compared to COVID-19.
Naturopathic physicians have continued to successfully treat viruses, respecting nature, the planet and our own vital force. This paradigm respects the indisputable healing potential of the vital force within us and the natural environment.
There are countless natural antivirals, from herbal medicine to nutritional-supplement types of treatments. From high dose Intravenous Vitamin C (Yes I did, like many other physicians, websites and natural products manufacturers get censured by the FDA when I posted that study on my website in the spring, for those who are interested: https://www.nutraingredients.com/Article/2020/03/25/Hospital-turns-to-high-dose-vitamin-C-to-fight-coronavirus) to the use of homeopathic nosodes. That said, this is not the platform for addressing all the natural medicines that are potentials for immune enhancement or anti-virals. More so, I’d like to emphasize the role of self-responsibility, self education and empowerment. We need to take charge of our health, and minimize risk factors that are in our control. Lock-Down? NO, Walk-down (as my husband likes to put it.). By maintaining a healthy weight, normal blood pressure and blood glucose, you are going to dramatically decrease your risk factors. You can do this before you are even offered the vaccine (for most people). By eating healthy foods, with low to no sugar, (even if you have lead a life of relatively unhealthy eating up to now), you will be doing your immune system a huge service. I promise, it will help decrease infection, this is scientifically proven by immune cell studies. Walk in nature. Cook foods and healthy meals that come from vegetables, grains, legumes and meats. Challenge yourself to read labels for sugar and added ingredients. Heck, challenge yourself to not cook from a package at all! Do an elimination diet for suspected food allergies and see if you can identify that pesky culprit that is contributing to your chronic skin, joint or digestive symptoms. Find sources of inflammation, and get them out of of your life! Spend time laughing and loving, and finding peace. Acknowledge and respect the power of neuro-psycho-immunology and the immune enhancing power of happiness. You can do all of this and cut your risk factors down. This is you, your life, your health. Whether to take the vaccine is up to you. But, I would not count on the vaccine, at least at this point, to be our ultimate saving grace. It’s a group effort, I encourage you do the hard, meaningful and lasting work on your end.
(1). Research and Reporting Methods22 October 2020 Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials Devan V. Mehrotra, PhD*, Holly E. Janes, PhD, Thomas R. Fleming, PhD, https://doi.org/10.7326/M20-6169
The Windhorse Naturopathic Clinic
We are not anti-vaccine. We Are pro-child. Pro-family . Pro-community. We are pro-research. We are Pro health, Pro wellbeing, Pro-safety. We are pro-Governmental transparency. We are Pro-pharmaceutical company accountability. We are pro-honesty. We are pro-critical thinking. We are pro-freedom.
Adapted from “yourfamilychoice.com“