From TrialSite Staff October 2, 2021
Recently, community members sent TrialSite a presentation sponsored by Humetrix, a real-time analytics data platform used to monitor and analyze health care outcomes associated with 5.6 million Medicare beneficiaries (65+). Part of a U.S. Department of Defense study called “Project Salus,” or “Effectiveness of mRNA COVID-19 vaccines against the Delta variant among 5.6M Medicare beneficiaries 65 years and older,” was recently presented Sept 28, 2021. Consisting of 17, the Project Salus study represented an AI-based project sponsored by the Department of Defense (DoD) and the Joint artificial Intelligence Center (JAIC) to understand better the data associated with the vaccinations. The findings should concern everyone interested in COVID-19 mRNA-based vaccine performance and seriously raise questions about POTUS declarations that the current pandemic is one of the “unvaccinated.” If the Project Salus findings are correct—and there are some limitations the authors acknowledge—a majority of those now infected by COVID-19 are vaccinated. This means that transmission may be primarily occurring by vaccinated individuals. A disturbing trend appears starting 3 to 4 months post-vaccination with growing SARS-CoV-2 infections, which becomes quite prominent by month 5 to 6 post-vaccination with either Moderna or Pfizer-BioNTech. Although Project Salus reveals Moderna to be a superior vaccine in terms of length of protection, both vaccines are associated with significant waning effectiveness. Death rates have declined thanks to the vaccine, so not all the news is negative, but this data again raises several substantial questions that must be addressed. Those previously infected with SARS-CoV-2 have greater protection once vaccinated, according to the data. Does the number of infections possibly imply ADE? Moreover, the claims that the present pandemic is one of the “unvaccinated” have shown to be a falsity based on this data, mindful of the limitations listed. Kudos to the team at DoD, JAIC, and Humetrix for taking the time to run this vital study covering the Medicare population age 65 and above across America.
Led by JAIC, the study looked into a total Medicare cohort of 20 million beneficiaries nationwide, with 16 million of the subjects aged 65 years and up. The study data covered 5.6 million vaccinated Medicare beneficiaries (2.7 million with Pfizer and 2.9 million with Moderna) from January to Aug 21, 2021. With a total of 161,000 breakthrough infections, the investigators discovered 33,000 breakthrough hospitalizations and 10,400 breakthrough ICU admissions.
The study team used the Humetrix cloud-based analytics platform to crunch data from HHS Centers for Medicare and Medicaid Services (CMS) and the CDC’s “SVI” data. Other platforms will be employed for mapping and analysis purposes.
The findings suggest that the bulk of COVID-19 infections occur among those fully vaccinated, and outcomes for this purportedly projected cohort worsens over time. Moreover, the study authors find the actual rise of breakthrough hospitalization (fully vaccinated people with severe SARS-CoV-2 infection) grows with time after mRNA vaccination—meaning the effectiveness of the Pfizer-BioNTech and Moderna vaccine products wanes considerably by month 6. In addition, the increase for risk such as breakthrough infection rises by 2.5X, according to the study.
The study authors point out that based on this mass analysis, those who have previous COVID-19 infection (natural immunity) fare better than those that don’t when measuring risk for COVID-19-based breakthrough hospitalization, which means that those who have been infected and then vaccinated are safer than those that have just been vaccinated. Moreover, the analysis points out that the older the Medicare beneficiary, the weaker the mRNA vaccine is in protecting the person against breakthrough hospitalization.
Generally, the hospitalization rates and death rates associated with breakthrough infections are lower than the rates observed in COVID-19 cases in the pandemic pre-vaccination phase in 2020. The hospitalization rate previously was 32% and now, in the vaccination stage is 23% for breakthrough infections. Moreover, the death rate in the pre-vaccine stage for Medicare beneficiaries was 12%, and now has plummeted to 4% in the post-vaccine stage.
The study authors listed several possible breakthrough limitations, including the following:
- Possible overestimation of breakthrough rates due to definitions associated with COVID19 diagnosis but not confirmed by PCR or antigen test
- Possible overestimation of breakthrough cases due to assuming identical breakthrough rates between people with claim-based vaccination data and those lacking vaccination data in their claims
- Overestimation of breakthrough rates would lead to underestimation of vaccine effectiveness breakthrough infections and breakthrough hospitalization
Other Findings of the Study
Additionally, in the slides depicting the study data “Total & Breakthrough Cases in the 65 Years and Older Salus Cohort,” the study depicts a graph showing the number of COVID-19 cases from Feb 6, 2021, to Aug 21, 2021, showing how, with the advent of Delta cases dramatically increased again. The data reveals that 71% of all COVID-19 cases by August were of vaccinated people, indicating that while the vaccine reduces hospitalization and death, it most certainly doesn’t stop the transmission of the disease.
Moreover, in slide eight titled “Is mRNA Vaccine Effectiveness Against Delta Breakthrough Infection Waning over Time in 65 Year Older Salus Cohort?,” the study team demonstrates a dramatic decline in vaccine effectiveness within just a matter of 3 to 4 months. That is, “Breakthrough infection rates 5-6 months post-vaccination are twice as high as 3-4 months post-vaccination.” This data, if accurate, suggests, at best, a suboptimal vaccine product. Any vaccine product that only provides strong protection for a few months cannot be described as compelling. Moreover, it doesn’t make sense to have boosters every three to four months.
In Slide #10 titled “Does Age Affect Vaccine Effectiveness Against Breakthrough Infections in the 65 Years and Older Cohort,” the study authors come to a conclusion that “Age has a minor contribution to the reduced vaccine protection seen in the group vaccinated 5-6 months ago.”
By Slide #11, the study team identifies clear waning vaccine immunity and that Moderna affords greater protection than Pfizer. For both vaccines, Slide #13 establishes that vaccine effectiveness against breakthrough hospitalization wanes considerably by months 5-6 as compared to months 3-4. Slide #16 depicts data revealing that mRNA vaccine effectiveness falls short of what was predicted in studies. And of course, they conclude on this slide with data that the vaccine does a better job of preventing hospitalization than an actual infection—hence the virus still spreads and offers, TrialSite suggests, a potential viral reservoir for variant evolution?
The last slide, “Risk for Model Breakthrough Hospitalization,” suggests considerable more risk for vaccinated individuals as they approach age 75, 84, and then again above 85.
This study called Project Salus, sponsored by the DoD in conjunction with the JAIC, analyzed 5.6 million Medicare beneficiary records. Using Humetrix, they uncover disturbing data that a majority of COVID infections are now vaccinated people and that a growing number of hospitalization are also among the fully vaccinated in the 65 years and up cohort.
The data herein suggest that President Joe Biden’s claim that this pandemic is one of the “unvaccinated” is an outright falsity.
TrialSite’s founder Daniel O’Connor suggested, “Assuming the identified study limitations don’t materially impact the findings, the implications of the Project Salus study results are notable, identifying significant risk in vulnerable vaccinated populations.” He continued, “A substantial proportion of infections during the Delta surge are among the vaccinated, indicating that the ‘pandemic of the unvaccinated’ thesis may need to be revisited.” O’Connor also emphasized that “assuming vaccine effectively significantly wanes starting at the third or fourth month—markedly worsening by month five and six after the vaccination, what are the implications for ongoing protection for COVID-19? We don’t know these answers now but hopefully, a diverse panel of experts can pick apart this data for more insight.”
Back in January 2021, Humetrix touted the “now configured for COVID-19 vaccine safety and efficacy monitoring in the Medicare population targeted to be vaccinated in priority.” The group posted initial work in the preprint server medRxiv and also published in JAMA.