“The association of increased risk of COVID-19 with higher numbers of prior vaccine doses in our study, was unexpected.
We still have a lot to learn about protection from COVID-19 vaccination, and in addition to a vaccine’s effectiveness it is important to examine whether multiple vaccine doses given over time may not be having the beneficial effect that is generally assumed.”
Excerpts from medRxiv preprint titled “Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine.” The Cleveland Clinic, December 19, 2022.
The Cleveland Clinic has recently reported that their previously vaccinated and boosted healthcare personnel are three times more likely to test positive for COVID-19 compared to their unvaccinated colleagues. You read that right! Those employees who had vigilantly followed CDC vaccination guidelines (but have not been boosted with the new bivalent mRNA vaccine) now find themselves much more prone to come down with Covid than their fellow workers who have never received a dose of an mRNA Covid vaccine.
Before I delve into the specific results of this timely and consequential study, I wish to provide some background information to help put these startling results in context.
The Cleveland Clinic
The Cleveland Clinic is ranked among the top hospitals in the United States. Over its storied hundred-year history of patient care, it has become the world’s first integrated international health system with more than 65,000 caregivers working at locations in the US, Canada, Britain, and Abu Dhabi, with net assets topping 14 billion dollars in 2022.
medRxiv—Preprint Server for Health Sciences
Cold Spring Harbor Laboratory (a not-for-profit research and educational institution), the British Medical Journal, and Yale established medRxiv (pronounced “med archive”) in 2019. At this internet site, readers are given free access to complete but unpublished, cutting-edge medical research. All human health research published on this site has been “conducted, analyzed, and interpreted according to scientific principles.” Readers should bear in mind that unlike conventional medical journals, articles on medRxiv are not certified by peer review before being posted online.
“medRxiv aims to improve the openness and accessibility of scientific findings, enhance collaboration among researchers, document provenance of ideas, and inform ongoing and planned research through more timely reporting of completed research.”
With the onset of the pandemic, medRxiv has become a major source for disseminating research on COVID-19.
FDA Approval of Bivalent mRNA Vaccines
On August 31, 2022, the FDA approved bivalent mRNA vaccines tailored to combat the BA.4/BA.5 lineages of the Omicron variant of SARS-CoV-2 virus. These bivalent vaccines contain additional genetic information that—upon entering human cells—directs biosynthesis not only of spike proteins present in the original strain of SARS-CoV-2, but the spike proteins of these BA.4/BA.5 Omicron strains as well. It is these spike proteins that are the antigens that induce an immune response in our bodies.
In response to FDA approval and in concordance with CDC guidance, the Cleveland Clinic offered these updated bivalent vaccines to its employees located in Ohio beginning on September 12, 2022.
Purpose of Vaccine Study
FDA approved these bivalent mRNA vaccines without requiring the manufacturers—Pfizer and Moderna—to demonstrate their effectiveness in humans. The Cleveland Clinic decided to address this glaring deficiency by conducting a real-world, evidence-based, in-house study of 51,011 of their employees who work in Ohio. “The purpose of this study was to evaluate whether the bivalent COVID-19 vaccine protects against COVID-19.” By the end of their 3-month study in December 2022, 10,804 employees (21% of their Ohio workforce) were boosted with the bivalent vaccine.
Study Findings
Their findings were published December 19, 2022 in a medRxiv preprint. The authors of the study found a modest 30% protective effect against COVID-19 for those employees who were boosted with the bivalent vaccine.
But this finding came with a caveat. When the study was initiated, the Omicron variants BA.4/BA.5 lineages for which the bivalent boosters were designed to offer protection against were the predominant circulating strains in Ohio. Since the study concluded, more contagious Omicron strains such as XBB.1.5 and BQ.1.1 have supplanted BA.4/BA.5. This calls into question whether this modest level of protection still holds true today or will hold true over the coming months.
Over the course of this study, 79 percent of the Cleveland Clinic Ohio workforce chose not to receive the bivalent booster, including the 13 percent who have remained unvaccinated throughout this pandemic. This variation in vaccination status allowed the Cleveland Clinic to see how well previous vaccination was holding up against the Omicron variants in late 2022, and to compare their level of vaccine protection with the incidence of Covid seen in their unvaccinated employees.
By comparing previously vaccinated to unvaccinated employees, the Cleveland Clinic discovered an association between prior vaccination and an increase risk of catching Covid. What’s worse, the Cleveland Clinic found this diminished immune response observed in the vaccinated becomes more pronounced with each injection.
Below is a bar graph I prepared to help visualize their data. To aid in comparing risk, I normalized the Cleveland Clinic data by setting the risk of unvaccinated employees catching Covid to 1.
Among those who did not take the bivalent vaccine, the risk of contracting Covid was 1.70 times higher for those employees who previously had a single dose of the original mRNA vaccine compared to unvaccinated employees.
Stating this finding in terms of percentages, compared to the unvaccinated, the risk of contracting Covid rose by 70% in those individuals who had previously received one and only one dose of mRNA vaccine. Moving on to those employees having received two doses, their risk increase by a factor of 163%; three doses by a factor of 215%; and four or more doses by a factor of 238%.
Notwithstanding this adverse evidence regarding vaccination, did injection of the bivalent booster vaccine reduce serious illness, hospitalization, and death from Covid?
Of the 51,011 Cleveland Clinic employees monitored in this study (average age 42 years, 75% of whom were women), 2,452 of them came down with Covid over the course of three months. Thankfully, “there were too few severe illnesses for the study to be able to determine if the vaccine decreased severity of illness.”
My Five Takeaways from this Vaccine Study
First, it is astounding that the Cleveland Clinic would find it necessary to carry out its own, self-funded, in-house study to see if an FDA-approved vaccine actually worked as touted. Remember, the purpose of their study was “to evaluate whether the bivalent COVID-19 vaccine protects against COVID-19.” What does this say about the credibility of the FDA’s booster vaccine approval process?
Second, I deeply appreciate the research efforts of the Cleveland Clinic and their fidelity to transparent science, wherever it may lead, and their openness to critique and correction. I wrote to one of the medical authors of this study to convey this sentiment.
“Kudos to you and your colleagues at the Cleveland Clinic for conceiving and conducting your in-house, retrospective, 3-month-long study to evaluate in what circumstances and to what degree administration of a bivalent COVID-19 vaccine protects working-aged adults against COVID-19.
I also commend you for publishing your findings promptly and in a publicly accessible manner.”
This author kindly and promptly wrote back: “Dear Dr. Nies, Thank you for your interest in our paper and for taking the time to provide feedback.”
Regarding my feedback, the doctor also wrote: “You are absolutely correct that mRNA vaccines don’t contain antigens. I will go over the paper carefully and revise the wording where necessary to correct this oversight.”
Third, what I find most disturbing is the possibility that each dose of mRNA vaccine is dampening the human immune system’s protective response to SARS-CoV-2; and this dampening effect appears longer lasting than the transient benefit offered by vaccination.
At the Cleveland Clinic, “Voluntary vaccination for COVID-19 began on 16 December 2020, and the monovalent vaccine as a booster became available to employees on 5 October 2021.” Immunity afforded by full vaccination back in 2021 had mostly worn off by September 2022. Yet, a year and a half later, the immune system of these previously vaccinated individuals now is less than half as good at fighting off Covid when compared to the unvaccinated.
Fourth, this study focused on relatively healthy, working-age adults, and therefore may not be directly applicable to the young, the elderly, and the infirm.
Fifth, neither I nor the Cleveland Clinic study authors are antivaxxers. I am pro-health. I am not writing to offer individualized medical advice. My desire is to inform the public with pertinent, reliable information to aid the process of informed consent, to encourage the development of effective public health policy, and to promote general wellbeing.
Concluding Reflections
The Cleveland Clinic stated in their medRxiv report: “The arrival of the Omicron variant in December 2021, brought a significant change to the immune protection landscape. Previously infected or vaccinated individuals were no longer protected from COVID-19.” Furthermore, “protection from vaccine-induced immunity decreased within a few months after vaccine boosting.”
This is in line with recent statements made on January 23, 2023 by the global vaccination philanthropist Bill Gates while speaking at the Lowy Institute in Australia. Gates said we need “to fix the three problems with vaccines. The current vaccines are not infection blocking; they are not broad, so when new variants come up, you lose protection; and they have very short duration, particularly in the people who matter, which are old people.”
I believe we are now at a point in the pandemic where we are playing “whack-a-mole” with currently available boosters. Variants of the SARS-CoV-2 virus are popping up faster than we can whack them down with multivalent vaccines whose protection quickly wanes compared to what we should expect from vaccines. Therefore, I recommend we stop shoveling billions of federal tax dollars to makers of these mRNA Covid vaccines.
And while we await others to fix these problems, which typically takes a decade in non-emergency vaccine development, I would like to see a major pivot of our attention and resources away from disease prevention toward vitality promotion.
Let’s encourage ourselves and others to engage in activities that promote wellness and strengthen our amazing immune systems, such as eating well, getting plenty of sunshine, exercise, and sleep, and attending to our mental, emotional, and spiritual needs. Health benefits derived from this approach are long lasting and when practiced appropriately, they come without adverse side effects.
