Reprinted from Trial Site News - Large Israeli Real-World Evidence Investigation: Pfizer mRNA Vaccine Linked to Surge in Psoriasis Colitis and Polymyalgia Rheumatica

The national Israeli health system’s data served as a fundamental source of information about how the COVID-19 vaccines were working. It was in Israel that TrialSite started to track significant breakthrough infections as well as myocarditis incidence, for example. A key player in Israeli health is Clalit Health Services (CHS), the largest of Israel's four state-mandated health service organizations, charged with administering health care services and funding for its members. The primary COVID-19 vaccine used in Israel was the Pfizer-BioNTech BNT162b2 (Comirnaty). In this latest retrospective cohort study, Israeli medical researchers tapped into a comprehensive database comparing the rates of immune-mediated diagnoses among persons vaccinated with Pfizer-BioNTech versus unvaccinated persons. First author Michal Shani with both Tel Aviv University and Clalit Health Service, and colleagues established a second cohort as a reference, to compare persons infected with COVID-19 versus persons not infected. With a minimum monitoring period of four months, the researchers divided the cohorts into four age groups including A) 12-17, B) 18-44, C) 45-64 and D 65 years and up. Applying multivariate cox proportional hazard regression models, the team also adjusted with corrections using what’s known as the False Discovery Rate (FDR) method so as to account for the investigation of multiple clinical outcomes. What were the outcomes? The Pfizer mRNA vaccine in fact, was associated with greater risk, but the authors qualify as rare, for psoriasis colitis and polymyalgia  rheumatica. The key moving forward is ensuring that risk-benefit assessments for vaccination programs in Israel are updated to reflect enhanced risk.

Psoriasis and ulcerative colitis (UC) are linked conditions that share chronic inflammation and immune system malfunctions. People with psoriasis are more likely to develop UC, with a risk that's 1.6 times higher than the general population. A 2018 review of studies found that people with psoriasis are also 2.5 times more likely to develop Crohn's disease, another type of inflammatory bowel disease (IBD). Interestingly, Dr. Sabine Hazan has argued based on preliminary research that the COVID-19 mRNA vaccine depletes certain healthy gut bacteria that could lead to some of these conditions if the hypothesis is correct.

Polymyalgia rheumatica (PMR) is an inflammatory rheumatic disorder that causes pain and stiffness in the body, most often in the neck, shoulders, upper arms, and hips. The pain can be sudden or gradual and is usually worse in the morning or after a period of inactivity. PMR can be debilitating, but symptoms often improve with activity.

Findings

The Israel-based team of researchers output was published in the journal Vaccine.

Shani, a medical doctor, and colleagues report their findings from the real world data of the “increased risk for immune-mediated diagnoses following vaccination with BNT162b2” involving psoriasis in all age groups (HR 1.41–1.69), colitis among patients younger than 65 years (HR 1.38–1.93), vitiligo (chronic autoimmune disorder that causes skin to lose color or pigment in patches) in patients aged 45–64 (HR 2.82, 95 %CI: 1.57–5.08) and for polymyalgia-rheumatica in patients aged 65 years or older (HR 2.12, 95 % CI: 1.3–3.47).

In the reference cohort, patients who were infected by COVID-19 were at increased risk for fibromyalgia (widespread musculoskeletal pain) (HR 1.72, 95 % CI: 1.36–2.19 in individuals aged 18–44; HR 1.71, 95 % CI: 1.31–2.22 in individuals aged 45–64), and hypothyroidism (hormone issue with thyroid gland)  (HR 1.54, 95 % CI: 1.15–2.07 in individuals aged 65 years or older.

Vaccine Injury Directory

TrialSite collaborated with React19 and Aaron Hertz to develop the Scientific Publications Directory managed by COVID-19 vaccine injured group React19. In this directly which consists mostly of peer-reviewed journal entries—many in the form of case series. See the link.

TrialSite reminds, however, that the overwhelming number of these published studies are not designed to establish causation.

Lead Research/Investigator 

  • Michal Shani, MD, Department of Family Medicine Faculty of Medicine, Tel Aviv University’; Clalit Health Service, Department of Family Medicine

  • IritHermesh, Gastroenterology Department Rambam Health Care Campus 

  • IlanFeldhamer, Research and Information Department, Wing of Planning and Strategy, Clalit Health Services 

  • OrnaReges, Department of Health Systems Management, Ariel University

  • GilLavie, Branch of Planning and Strategy, Clalit Health Services; Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology

  • RonenArbel, Community Medical Services Division, Clalit Health Services; Maximizing Health Outcomes Research Lab Sapir College, 

  • Yael WolffSagy, Research and Information Department, Wing of Planning and Strategy, Clalit Health Services

  • https://www.trialsitenews.com/a/large-israeli-real-world-evidence-investigation-pfizer-mrna-vaccine-linked-to-surge-in-psoriasis-colitis-and-polymyalgia-rheumatica-099e8319