Insights for Flourishing: Are mRNA Bivalent Vaccines Helpful?

“Recognition that the original COVID-19 vaccines provided much less protection after the emergence of the Omicron variant spurred efforts to produce new vaccines that were more effective. … Given the demonstrated safety of the earlier mRNA vaccines and the perceived urgency of need of a more effective preventive tool, these vaccines were approved without demonstration of effectiveness in clinical studies.”

–Excerpt from the Cleveland Clinic peer-reviewed article Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine, published online in the journal Open Forum Infectious Diseases, April 19, 2023.

Preamble

On a brisk day in December 2022, a family member, who had been fully vaccinated, boosted, and had had Covid three times, called to ask my opinion whether to take the new bivalent vaccine. I said before I offered any suggestions I wished to see if studies demonstrating their effectiveness against Covid had been published.

Fortuitously, after we hung up, I immediately came across a relevant YouTube video which had been posted only a few hours earlier by a medical source I trust. It described a brand-new study conducted by the Cleveland Clinic on the effectiveness of the bivalent vaccine. A few minutes into the video, my wife came back from shopping. I turned off YouTube to bring in the groceries.

The next day, I discovered this YouTube video had been taken down for violating misinformation policies. And not only that, my watch history stored on my laptop had been purged to remove any record that I had ever viewed this verboten video!

These events served to pique my interest to find out for myself what the Cleveland Clinic had reported.

In summary, we now know that by the end of their full six-month study, the Cleveland Clinic discovered the Pfizer and Moderna bivalent mRNA vaccines offer no discernible protection against Covid.

Furthermore, so few of the 51,017 employees (including 5,953 unvaccinated employees) in their study became severely ill with COVID that they could not determine if the bivalent vaccine reduced severity of illness.

Finally, the Cleveland Clinic showed prior vaccination(s) of their employees with the original Pfizer or Moderna mRNA vaccines are strongly correlated with increased susceptibility to catching Covid compared to their unvaccinated employees. This association holds true whether the Human Resources Department classified their job description as Clinical or non-Clinical (e.g., frontline nurses and doctors versus administrative clerks).

The Cleveland Clinic

The Cleveland Clinic, one of America’s premier hospitals, is ideally suited to conduct this study because their “very early recognition of the critical importance of maintaining an effective workforce during the pandemic led to devotion of resources to have an accurate accounting of who had COVID-19, when COVID-19 was diagnosed, who received a COVID-19 vaccine, and when.” In-house data on the more than 50,000 employees who work in Ohio, coupled with continued and extensive monitoring of their employees, permitted the Clinic to determine and to follow changes in the bivalent vaccine’s effectiveness on a biweekly basis.

Specifically, for 26 weeks beginning in September 2022, when the Pfizer and Moderna bivalent vaccines first became available and began to be administered to employees, the Clinic tracked the vaccination status and the incidence and severity of COVID-19 in their workforce.

Open Forum Infectious Diseases Journal

The authors of this Cleveland Clinic study published their results in the journal Open Forum Infectious Diseases.

The Open Forum Infectious Diseases (OFID) is an open access, online journal published by Oxford Academic, the research platform of Oxford University Press. OFID focuses on the intersection of biomedical science and clinical practice, with an emphasis on knowledge that could improve patient care globally. Peer review by the medical experts comprising the OFID Editorial Board ensures the journal publishes articles of high-quality content.

The journal labeled the Cleveland Clinic study a “MAJOR ARTICLE.”  As of June 24, 2023, it was still trending as the “Most Read” of all the articles published by OFID.

Key Findings of the Cleveland Clinic Study

Bivalent Vaccination Affords Little to No Protection Against Contracting COVID

The first key finding is bivalent vaccine effectiveness dropped from a modest 29% to near zero as new strains of more infectious, vaccine-resistant SARS-CoV-2 viruses supplanted prior strains (see Table 1).

By the time the study concluded, “A protective effect of bivalent vaccination could not be demonstrated while the XBB strains were dominant.”

Over the course of this 6-month study, Covid occurred in 4,424 employees (8.7% of the workforce).  “There were too few severe illnesses for the study to be able to determine if the vaccine decreased severity of illness.”

The combination of vaccine ineffectiveness in preventing Covid, no demonstrable benefit in reduce severity of illness, along with the reality that most Americans have had Covid and recovered, led the Cleveland Clinic study authors to conclude that “there could be some concern that a substantial proportion of individuals may be unlikely to derive any meaningful benefit from a bivalent vaccine.”

Prior Vaccination is Strongly Associated with Increased Risk of Contracting Covid

The second key finding I wish to share is “The higher the number of vaccines previously received, the higher the risk of contracting COVID-19.”

Over the course of this study, most Cleveland Clinic employees (74%) chose not to receive the bivalent vaccines.

For those employees who declined the bivalent vaccines, the Cleveland Clinic looked to see how well their prior vaccination(s) were holding up, and how well these previously vaccinated employees fared compared to their co-workers who had never been vaccinated against COVID-19. 

As shown in Table 2, prior vaccination was associated with a significant increased risk of contracting COVID-19. The risk of Covid increased as the number of vaccinations previously received increased. As an aid for showing the added risk of catching Covid amongst the various groups of vaccinated employees, the relative risk of catching Covid by unvaccinated employees was set to 1.

Stated in terms of percentages, compared to the never-vaccinated employees, the risk of contracting Covid rose from being 107% higher in those individuals who had previously received only one dose of the original mRNA vaccine to being 253% higher for those individuals who had received four or more doses.

While the study authors characterized this association as “unexpected,” nevertheless, they did go on to say theirs “is not the only study to find a possible association with more prior vaccine doses and higher risk of COVID-19.”

Physiological mechanisms that could account for this increase in susceptibility to COVID-19 centered around longer-term changes to our immune systems triggered by mRNA vaccination. Two immune system changes deemed relevant and cited by the study authors are “immune imprinting” and “antibody class switching.”

Immune imprinting is a phenomenon where the body repeats its original immune response—established when it first encountered the SARS-CoV-2 spike protein generated by vaccination— instead of updating its response to new variants. In other words, the body’s immune memory is stuck in the past and does not respond as effectively in warding off this ever-evolving virus.

Antibody class switching occurs when the immune system moves “toward making non-inflammatory spike-specific IgG4 antibodies after repeated SARS-CoV-2 mRNA vaccination.” In other words, mRNA vaccination induces the body to make a highly unusual class of antibodies that recognize the specific virus spike protein but do not signal the inflammatory components of the immune system to destroy the virus.

Final Thoughts

The Cleveland Clinic performed this study using only in-house resources. They voluntarily published their proprietary findings in the peer-reviewed medical literature. Their purpose was to provide real-world, clinical data on the efficacy of the bivalent vaccines that could improve patient care.

When I wrote about this groundbreaking study in the February 2023 issue of the Crozet Gazette, it had not yet been peer reviewed. Now it is a peer-reviewed publication in a prestigious medical journal. Furthermore, the authors extended the study period from 13 to 26 weeks making their data even more rock-solid, statistically significant, informative, and compelling. 

Guided by the Hippocratic Oath to “first, do no harm,” we are now at a tipping point. For most people, given the strains of SARS-Cov-2 virus in circulation today, current mRNA vaccine technology not only is not providing a meaningful benefit, it is strongly associated with making vaccinated people more susceptible to contracting Covid.

Of course, everyone’s medical history and circumstances are unique, including my family member who had asked for my opinion. My goal in writing is to help my family and my readers make informed choices regarding whether bivalent vaccination is appropriate for them; as always, in consultation with their physician and other medical health practitioners.