Operation Warp Speed brought to the market a new technology in combating infectious disease such as COVID-19, one based on the use of mRNA (messenger RNA) technology (1). The use of mRNA technology has been in development for other diseases such as cancer and genetic disease as well as infectious disease since the 1990s. (2). Since then no drugs using mRNA technology have been approved or brought to the market until Moderna released their COVID-19 vaccine.
This article is meant to help shed some light on the EUA approval of the available COVID-19 vaccines currently in the U.S. It is not meant to provide treatment recommendations or advice, but as talking points or points to further follow and investigate and we continue to learn more about these vaccines, their efficacy, short and long term safety and use in the future. Please discuss your medical treatment decisions with your physician for individualized medical recommendations based on your own personal risk factors. As a reminder, a medical decision should never be made out of peer or societal pressure, but as an individual decision based on each unique person's needs and comfort level. We encourage all our patients to do their own research and use resources coming from multiple reputable sources including other physicians, the CDC, the FDA, NIH, medical journals and peer reviewed research as well as the VAERS database and groups like the Physicians for Informed Consent.
EUA: Emergency Use Authorization by the FDA, what does it mean?
At time of this writing (June 2021), these vaccines have not been approved or licensed by the FDA, and are still under investigation until about 2023.
Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives...
...(although one could argue this point considering everything we know about Vitamin D, Zinc, NAC and other anti-viral and immune support).
Pfizer-BioNTech clinical trial is currently scheduled to end May 2, 2023. https://clinicaltrials.gov/ct2/show/NCT04368728
Moderna-NIH clinical trial is currently scheduled to end October 27, 2022. https://clinicaltrials.gov/ct2/show/NCT04470427
Johnson & Johnson (Janssen) clinical trial is currently scheduled to end January 2, 2023. https://clinicaltrials.gov/ct2/show/NCT04505722
You can read more about EUA here: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
What do the Studies Say?
A 2018 publication sponsored by the Bill and Melinda Gates Foundation categorized new vaccine technology such as mRNA vaccines as "unprecedented", a category of vaccines against diseases that we have never developed a suitable vaccine for yet. According to their analysis, unprecedented vaccines were expected to take 12.5 years to develop and have only a 5% chance of passing phase II trials, and then a 40% chance of making it through phase III trials which assess population benefit. This can be further calculated as about a 2% chance of success to make it past phase III trials. The authors stated this was a "low probability of success, especially for unprecedented vaccines" (3).
It's interesting to see that only two years later we now have an unprecedented vaccine being given to the general public with a reported 90-95% efficacy (4). This is indeed, unprecedented!
The Pfizer vaccine had approximately 22,000 subjects who received the vaccine with 22,000 subjects who did not receive the vaccine with an observation period of two months (5). The Moderna vaccine used 15,000 subjects who received the vaccine with 15,000 subjects who did not receive the vaccine. Both trials included a median observation period of about 2 months and about half of subjects were followed up with for about two months after the second dose (5, 6). The FDA states that due to the length of both studies clinical trial observation period, “it is not possible to assess sustained efficacy over a period longer than 2 months.” (7)
Pfizer vaccine effectiveness was calculated by observing the vaccination status of 178 COVID-19 cases. The Pfizer vaccine was reported as 89%–98% effective over a two-month observation period. (8) However, since there were only 15 COVID-19 cases observed in subjects 65 to 74 years old and only five cases in subjects 75 years or older, the clinical trial did not have enough statistical power to accurately measure the vaccine’s effectiveness in those age groups. In fact, the Pfizer vaccine may be only 53% effective in subjects 65 to 74 years old and 0% effective in subjects 75 years or older (8). This is our most vulnerable population! For the Moderna vaccine, in subjects 18 to 64 years old the vaccine was 91%–98% effective over a two-month observation period (13). However, since there were only 33 COVID-19 cases observed in subjects 65 years or older, the clinical trial did not have enough statistical power to accurately measure the vaccine’s effectiveness in that age group as well. The Moderna vaccine may be only 61% effective in subjects 65 years or older and 0% effective in subjects 75 years or older (12).
The fact we were able to develop such a successful vaccine in 1 year, when the odds of developing one in 12.5 years was estimated around 2% - this is miraculous to say the least.
Because of this, the analytical methods used by both the Pfizer and Moderna trials have been criticized by several authors and publications due to these reasons:
The exclusion of over 3400 "suspected COVID-19 cases" that were not included in the Pfizer vaccine data reported to the FDA.
A low-but-non-trivial percent of individuals in both studies were deemed to be COVID-19 positive at baseline, despite this being a criteria for exclusion from the study (so they were likely already immune).
The use of relative risk reduction vs. absolute risk reduction. Relative risk reduction is much less specific and is how the Pfizer and Moderna studies came to the 90-95% efficacy conclusion. Had they looked at absolute risk reduction, the Moderna vaccine would be calculated at 1.1% and the Pfizer vaccine would be calculated at 0.7% for absolute risk reduction (9, 10).
What about the Johnson & Johnson vaccine?
The J&J vaccine is different from Moderna and Pfizer in that it uses “old-school” technology. J&J requires 1 shot whereas Moderna and Pfizer require 2 shots, spaced apart 4 weeks, and 3 weeks, respectively. Moderna and Pfizer use mRNA technology discussed above.
The J&J vaccine uses an adenovirus vector, meaning it uses a common virus that isn’t normally dangerous to carry the SARS-CoV-2 gene that codes for the spike protein. This gene is inserted into this adenovirus’ genome and the adenovirus is modified to prevent replication. This gene is like the instruction pamphlet for the adenovirus. Now the adenovirus knows how to make the SARS-CoV-2 spike protein. Once the virus is injected into a person, the virus infects our cells, our cells use the information to make the spike protein, and then our body begins making antibodies to the spike protein tagging the spikes as an invader.
In other words, what’s injected into someone who opts for the J&J is a virus with an altered genome that will make the SARS-CoV-2 spike protein, somewhat like a Trojan horse. Then, the body will react to both the virus and the spike protein, alerting our immune system of danger, making antibodies that are specific to the spike protein and also remembering this for later, just in case this person will come into contact with the spike protein again. The antibodies only last for up to a couple months, but the memory is what we hope will last much longer. This is called “adaptive” or “acquired” immunity.
It can take the body 7-14 days to mount a full immune response as it takes a while for all the cells to find the antigen. It can take 3-4 days to mount a second response, meaning that when our body encounters this foreign protein called an antigen the second time, our body will react much faster.
Side effects, Adverse Events and Potential Problems
You might have heard recently that Johnson & Johnson was taken off the shelves briefly on April 13, 2021 because 15 cases out of 7.5 million doses reported a rare blood clot, specifically, cerebral venous sinus thrombosis. The CDC and FDA have since recommended “People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.” As of April 23rd, 2021, the CDC and FDA have resumed administration of this vaccine, arguing benefit over risk.
Side effects happen with any vaccine and COVID-19 vaccinations are no exception.
Common side effects after vaccination include:
Pain, swelling, or redness where the shot was given
Mild fever
Chills
Feeling tired
Headache
Muscle and joint aches
Serious side effects include an allergic reaction also known as anaphylaxis, fainting also called vasovagal syncope, and shoulder injury among the mentioned blood clots above and others. Adverse effects are reported to VAERS, Vaccine Adverse Effects Reporting System and are freely available to review.
Please notify your healthcare provider of any severe side effects of vaccination.
According to the Physicians for Informed Consent, the Pfizer COVID-19 vaccine clinical trial found the overall incidence of severe adverse events during the two-month observation period to be 1.1%, or 1 in 91, in the vaccinated group and 0.6% in the unvaccinated group, resulting in a vaccine risk of 0.5% or 1 in 200 vaccinated subjects (5) Consequently, subjects who received the vaccine had nearly double the risk of a severe adverse event occurring in the two-month observation period compared to subjects who did not receive the vaccine. A severe adverse event was defined as one that “interferes significantly with a participant’s usual function (11).
The Moderna COVID-19 vaccine clinical trial found the overall incidence of severe adverse events during the two month observation period to be 2% or 1 in 50 in vaccinated subjects between 18 and 64 years old and 1.2% in the unvaccinated group, resulting in a vaccine risk of 0.8% or 1 in 125 vaccinated subjects. The incidence of severe adverse events was 1.7% or 1 in 59 in vaccinated subjects 65 years or older and 0.8% in the unvaccinated group, resulting in a vaccine risk of 0.9% or 1 in 111 vaccinated subjects (12). Consequently, subjects who received the vaccine had nearly double the risk of a severe adverse event occurring in the two-month observation period compared to subjects who did not receive the vaccine, similar to Pfizer. A severe adverse event was one that persisted for longer than a week and either prevented the ability to perform daily activities and required medical intervention, or required hospitalization (12, 13)
Per the FDA, “There is currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 18 years of age, pregnant and lactating individuals, and immunocompromised individuals.” And, because all subjects were observed for only two months, the long-term safety of the vaccine for any age group is not known. The FDA states, “Long-term safety and long-term effectiveness are areas the Sponsor [Moderna] identified as missing information.” (12)
Read More on the Physicians for Informed Consent Informational Handouts on the Pfizer and Moderna vaccines.
Potential problems:
Other theoretical but very real concerns are cited in Seneff and Nigh's well researched paper "Worse than the Disease? Reviewing some possible unintended consequences of the mRNA vaccines against COVID-19", and include (14):
The use of PEG (polyethelyne glycol and its variants) to help stabilize the mRNA from degradation. Studies have shown that low dose injections of these compounds can create "dramatic pathological immune activation" which in animal studies has presented as anaphylaxsis and cardiovascular collapse with the second injection exposure more likely to cause these reactions.
Antibody Dependent Enhancement (ADE) is a special case of reaction which can happen after infection or vaccination when insufficient numbers of antibodies try to neutralize or bind to the virus but instead facilitate viral entry into our cells and thus, infection. This phenomenon has been seen in macaque studies resulting in severe pulmonary damage and appears to be more likely in older adults with previous exposure to COVID spike proteins. All 3 manufacturers are reportedly working to develop booster shots, so there exists the very real possibility of triggering ADE to a future COVID infection or booster injection.
Pathogenic Priming is another potential concern which is similar to ADE. In this case, the proteins associated with SARS-CoV-2 proteins may be autoreactogenic and create more severe disease upon second exposure, especially in the elderly population. The pre-existing antibodies seem to suppress the adaptive immune system.
There is also speculation that the Spike protein could trigger a range of autoimmune diseases due to protein similarities between the Spike protein and human cells. It seems antibodies which bind well with the Spike protein also bind well with human tTG (Celiac Disease), TPO (Hashimoto's) and myelin basic protein (Multiple Sclerosis) as well as several other endogenous human proteins. This has been confirmed in a 2021 study and may also be a contributor to MIS (Multisystem Inflammatory Syndrome) in children. It is also becoming more widely accepted that autoimmune disease can be a risk of COVID-19 infection in general. But, those with strong innate immune systems rapidly clear the virus with little to no antibody production (i.e. asymptomatic or mild cases) whereas the vaccine completely bypasses that adaptive immune system by injection past the mucosal barriers with the sole purpose of antibody production.
There have been several cases of development of ITP (Idiopathic Thombocytopenic Purpura) after COVID-19 vaccination, which is an autoimmune disorder where the platelets are attacked and destroyed by the immune system stopping the ability to normally clot blood and can cause death by hemorrhage or blood loss. This may be due to concentration of the vaccine in the spleen and liver.
A study out of Israel showed a significant increase in incidence of Shingles in recently vaccinated individuals. This implicated that the COVID-19 vaccines may be impairing the innate immune system and it's memory of the chicken pox virus from prior infection or vaccination.
Spike Protein Toxicity is a potential concern as the Spike protein in general, but especially without the rest of the viral particles, may exacerbate injury in certain tissues such as the blood vessels of the brain, heart and lungs, as well as certain cells of the intestine, kidneys, gallbladder and testes in men. Several studies have now shown that the coronavirus spike protein is able to gain access to cells in the testes via the ACE2 receptor and disrupt male reproduction.
The SARS-CoV-2 spike protein has a similar protein structure to known prion diseases, such as MAD COW. There is speculation it could behave like a prion disease which are typically neurodegenerative and implicated in conditions such as Alzheimer's, Parkinson's disease and ALS.
Fragmented proteins are a particular problem with the Pfizer vaccine and due to the manufacturing process. These fragments of the RNA material may generate incomplete spike proteins by our cells, an altered protein structure and possible change in cellular function. There is no data yet on what these fragments may or may not do, so there is a lot of uncertainty here.
Read about these concerns in more detail: Worse than the Disease? Reviewing some possible unintended consequences of the mRNA vaccines against COVID-19, published by the International Journal of Vaccine Theory, Practice and Research.
Other Factors to Consider:
Mutations and Variants: All viruses and bacteria mutate and change over time. We are still not certain if the vaccine will protect against these strains. There is thought that as more people are vaccinated this will limit the circulation of the virus and prevent mutation, but there is also thought that vaccination itself may fuel mutation, similar to how bacterial resistance to antibiotics develops over time. Variants may also be making breakthrough cases more common (21).
Breakthrough Cases (Primary Vaccine Failure): The Oregon Health Authority recently recognized 1,009 "breakthrough" cases of COVID-19. A breakthrough case is defined as a positive case of COVID-19 at least 14 days since the final vaccine injection (18). A recent outbreak among the NY Yankees is another case in point that no vaccine is 100% effective (19). These breakthrough cases may be more mild or asymptomatic in presentation, but the OHA reports up to 10% of these cases have still required hospitalization and are more commonly seen in the elderly (20). Whether or not these breakthrough cases can still be transmitted to others is not clear. The CDC is also no longer requiring those who have been vaccinated to have routine COVID-19 testing, so we do not have a full picture of vaccine effectiveness over time.
Who Should Consider It?
To say the least, it is difficult to recommend a product which has not yet been approved, was minimally studied, rushed to the market, is based on a new biotechnology and is missing key safety data.
With that being said, there are individuals who are at extreme risk from a viral infection. These would be people over age 70 with significant co-morbidities, such as lung disease, obesity, and/or diabetes - especially uncontrolled diabetes. The risk of severe complications from COVID-19 in these individuals may outweigh any unknown risks of an experimental preventative treatment. The Infection Fatality Ratio (IFR) for this age group (not including comorbidities) is estimated at 4.6% - 18% (22).
In phase 1a of Oregon's vaccine distribution, priority was given to those individuals most likely to have serious or fatal outcomes as a result of COVID-19 infection. This included:
"Group 1: Hospitals; urgent care; skilled nursing and memory care facility health care providers and residents; tribal health programs; emergency medical services providers and other first responders.
Group 2: Other long-term care facilities and congregate care sites, including health care providers and residents; hospice programs; mobile crisis care and related services; individuals working in a correctional setting; personnel of group homes for children or adults with intellectual and developmental disabilities.
Group 3: Outpatient settings serving specific high-risk groups; in home care; day treatment services; non-emergency medical transportation.
Group 4: Health care personnel working in other outpatient and public health settings.
Quest spike protein antibody testing, how can it be helpful."
At this time, individuals over the age of 16 are eligible to receive one of the COVID-19 vaccines. If you have already had COVID-19 and recovered, you are still eligible to get the vaccine. This is because we do not know how long you are protected after you have been sick with COVID-19, although we are seeing durable antibodies in those who have recovered up to 8 months post infection (15).
In regards to children and adolescents:
Safety and efficacy data was either not tested or insufficient in children younger than 16 years old. In addition, since there was only one case of COVID-19 in subjects 16 to 17 years old in the Pfizer study, the study did not have enough statistical power to measure effectiveness in that age group (8). The Moderna study did not collect safety or efficacy data in those under 18 years old (6).
The estimated age-specific IFR is very low for children and younger adults (e.g., 0.002% at age 10 and 0.01% at age 25) (22)
The Pfizer clinical trial also saw 1 in 9 adolescents experience a severe adverse event, including fever >102.1, vomiting that required IV hydration, diarrhea of 6 or more loose stools in 24 hrs, severe fatigue, headache, muscle pain or joint pain that prevented daily activity (8).
We still do not have long term safety data in any age group.
For those not in the highest risk categories (i.e. most healthy children and adults), it is up to the individual to discuss their unique health needs with their medical providers. Other factors to take into account include:
Vitamin D serum levels (16)
Dedication to a healthy diet and exercise regimen to provide needed nutrients, antioxidants, fresh air and sunlight to support general immune system health
Substance Use Disorders (17)
Willingness to stay home when ill and practice good hand washing hygiene
Ability to take supportive supplements, herbal medicines and homeopathics should you become ill
Willingness to do home hydrotherapy treatments to support recovery
This is not an easy decision to make, and your choice is just that - your choice. It is even more difficult when:
We have infection rates and death rates that could be wildly inaccurate as the definition of an infection and death from that infection has not been clear from the beginning.
Testing guidelines vary and have changed considerably since the beginning of the pandemic, including PCR cycle thresholds, rapid testing vs. PCR testing, various antibody testing and now vaccinated individuals don't even need to get tested, per the CDC.
VAERS data may be wildly under-reported as possible vaccine side effects are often brushed off by medical providers. It is estimated that fewer than 1% of all vaccine reactions are reported (23).
Quest Spike Protein Antibody Testing:
Quest Diagnostics offers antibody testing for the Spike Protein and Nucleocapsid.
These testing options can help determine if your vaccine was effective at producing an antibody response, and if the antibodies present are from vaccination or from natural infection. If you are considering a COVID-19 vaccine, discuss antibody testing with your provider as the presence of antibodies may mean you have some protection from previous infection.
For those who are especially vulnerable, it may be worthwhile assessing for an immune response to the vaccine or primary vaccine failure. Testing for antibodies to the spike protein can help ascertain if the vaccine was effective at producing the desired antibodies.
Should you choose to get any of the COVID-19 vaccines:
Talk to your healthcare provider so we can help support your immune function and hopefully help reduce the risk of primary or secondary vaccine failure, as well as adverse side effects.
Primary vaccine failure is an inadequate response of the immune system which results in no immune memory and thus no immunity.
Secondary vaccine failure is loss of antibody memory over time, making the individual susceptible to the illness again after a period of time.
We are generally recommending immune supportive nutrients such as vitamin D, vitamin C, zinc and vitamin A as well supportive homeopathic medicines and immune stimulating herbs like echinacea. Hydrotherapy treatments are a great way to increase white blood cell counts and move blood and lymphatics around the body through the circulation.
Should you choose not to get it, what else you can do to protect yourself and your family.
One of the best things you can do to protect yourself from any viral illness is see your naturopathic physician and get off as many medications as possible, get to an optimal weight and have your diet and nutrition assessed including serum D3 levels, essential fatty acids, correct iron deficiency, adrenal dysfunction and get in the habit of a good exercise routine, fresh air and sunshine!
Check out other ideas for support in these articles:
Want to discuss it more? Current patients are encouraged to schedule a consultation with their providers and new or prospective patients can schedule a complimentary consultation to see if our office is the right fit for your health needs. Visits can be in-person or virtual!
FYI: Oregon Constitution Article 1 Section 20 Stating Vaccine Passports Are Illegal
“Equality of privileges and immunities of citizens. No law shall be passed granting to any citizen or class of citizens privileges, or immunities, which, upon the same terms, shall not equally belong to all citizens.”
#health, #coronavirus, #vaccines, #controversy, #naturopathic, #pacificnatmed, #naturopathic, #immunesupport, #vitaminD
Resources:
National Institutes of Health, 2020
Young et all, 2018
Baden, et all, 2020
Pfizer. Pfizer-BioNTech COVID-19 vaccine (BNT162, PF-07302048): Vaccines and Related Biological Products Advisory Committee briefing document. Meeting date: 10 December 2020. 2020 Nov 30: 38,46. https://www.fda.gov/media/144246/download
U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee. FDA briefing document: Moderna COVID-19 vaccine. Vaccines and Related Biological Products Advisory Committee Meeting: December 17, 2020: 5, 13, 17, 21, 24, 29, 30, 36-38, 46-49. https://www.fda.gov/media/144434/download
U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee. FDA briefing document: Pfizer-BioNTech COVID-19 vaccine. Vaccines and Related Biological Products Advisory Committee Meeting: December 10, 2020:14,16,17,20,24,30,31,40,46,48. https://www.fda.gov/media/144245/download
U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee. FDA briefing document: Pfizer-BioNTech COVID-19 vaccine. Vaccines and Related Biological Products Advisory Committee Meeting: December 10, 2020. Table 8: subgroup analyses of second primary endpoint: first COVID-19 occurrence from 7 days after dose 2, by subgroup, participants with and without evidence of infection prior to 7 days after dose 2, evaluable efficacy (7 days) population; 26. https://www.fda.gov/media/144245/download
Doshi 2020
Brown, R. B. (2021) “Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials”.Medicina (Kaunas) 57(3): 199. https://www.doi.org/10.3390/medicina57030199.)
Pfizer. A phase 1/2/3 study to evaluate the safety, tolerability, immunogenicity, and efficacy of RNA vaccine candidates against COVID-19 in healthy individuals. https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
U.S. Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee. FDA briefing document: Moderna COVID-19 vaccine. Vaccines and Related Biological Products Advisory Committee Meeting: December 17, 2020: 5, 13, 17, 21, 24, 29, 30, 36-38, 46-49. https://www.fda.gov/ media/144434/download
ModernaTX, Inc. A phase 3, randomized, stratified, observer-blind, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine in adults aged 18 years and older; protocol mRNA-1273-P301, amendment 6. 2020 Dec 23. https://www.modernatx.com/sites/default/files/content_documents/Final%20mRNA-1273-P301%20Protocol%20Amendment%206%20-%2023Dec2020.pdf
Seneff, S., & Nigh, G. (2021). Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19. International Journal of Vaccine Theory, Practice, and Research, 2(1), 38–79. Retrieved from https://ijvtpr.com/index.php/IJVTPR/article/view/23 (Original work published May 10, 2021)
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