Serum polyethylene glycol-specific IgE and IgG in patients with hypersensitivity to COVID-19 mRNA vaccines.

BACKGROUND: The mechanism of allergic reactions to COVID-19 mRNA vaccines has not been clarified. Polyethylene glycol (PEG) is a potential antigen in the components of vaccines. However, there is little evidence that allergy after COVID-19 mRNA vaccination is related to PEG. Furthermore, the role of polysorbate (PS) as an antigen has also not been clarified. The objective of this study was to investigate whether PEG and PS allergies are reasonable causes of allergic symptoms after vaccination by detecting PEG-specific and PS-specific antibodies. METHODS: Fourteen patients who developed immediate allergic reactions to BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccines and nineteen healthy controls who did not present allergic symptoms were recruited. Serum PEG-specific immunoglobulin E (IgE) and immunoglobulin G (IgG) and PS-specific IgE and IgG were measured by enzyme-linked immunosorbent assay. Skin tests using PEG-2000 and PS-80 were applied to five patients and three controls. RESULTS: Serum levels of PEG-specific IgE and IgG in patients with immediate allergic reactions to the COVID-19 mRNA vaccine were higher than those in the control group. Serum levels of PS-specific IgE in patients with allergy to the vaccine were higher than those in patients of the control group. Intradermal tests using PEG verified the results for PEG-specific IgE and IgG. CONCLUSIONS: The results suggest that PEG is one of the antigens in the allergy to COVID-19 mRNA vaccines. Cross-reactivity between PEG and PS might be crucial for allergy to the vaccines. PEG-specific IgE and IgG may be useful in diagnosing allergy to COVID-19 mRNA vaccines.

Concurrent onset of acute lupus myocarditis, pulmonary arterial hypertension and digital gangrene in a lupus patient: a possible role of vasculitis to the rare disorders.

Acute lupus myocarditis and pulmonary arterial hypertension (PAH) are rare complications associated with systemic lupus erythematosus (SLE). No previous reports have shown the coexistence of these disorders. Here we present a 41-year-old patient with SLE who concurrently developed severe acute lupus myocarditis and PAH with digital gangrene as an initial manifestation. Acute lupus myocarditis and PAH were successfully treated with prednisolone and intravenous cyclophosphamide pulse therapy (600-700 mg × 6) along with anticoagulant therapy. Catheter-directed thrombolysis was required for digital gangrene caused by vasculitis. Concurrent development of these rare disorders may represent a common mechanism such vasculitis as an underlining cause of SLE.

Anti-IL-10 antibody in systemic lupus erythematosus.

PURPOSE: IL-10 is a cytokine known to inhibit inflammatory cytokines. To determine its role in the pathogenesis of systemic lupus erythematosus (SLE), the presence of anti-IL-10 antibody is required to be examined. Although antibodies against cytokines are known to be present in SLE, no studies have determined the role of IL-10, particularly in Japanese patients. We assayed anti-IL-10 antibody in SLE and examined the clinical significance. PATIENTS AND METHODS: We performed a retrospective study of 80 Japanese patients with SLE. Sixteen scleroderma patients, 19 rheumatoid arthritis (RA) patients, 23 Behcet's disease patients, and 23 healthy subjects were selected as control groups. Clinical information was abstracted from medical records. Anti-IL-10 antibody level was determined with an ELISA. RESULTS: With the cutoff established as serum absorbance +2 SDs (OD 0.729) in healthy subjects, we defined any sample above this cutoff as anti-IL-10 antibody-positive. Fourteen patients with SLE (17.5%) were found to be anti-IL-10 antibody positive. Absorbance was significantly higher in serum from patients with SLE and RA than in healthy individuals. In SLE, patients with low complement values were significantly more common in the antibody-positive group. Serum IgG levels were significantly higher in the antibody-positive group. In multivariable analysis, high level of serum IgG is associated with anti-IL-10 antibody positive. CONCLUSION: The present study found that anti-IL-10 antibody is present in SLE and related to clinical parameters. These results suggest that the presence of anti-IL-10 antibody was associated with high level of serum IgG, but is not associated with disease activity in patients with SLE.

[Economic evaluation for the prevention of cervical cancer by vaccination--from perspective of health insurance society and industry].

OBJECTIVE: The aim of this study is to estimate the budget impact in a health insurance society and an industry of promoting decision-making for endowing grants for vaccination as prophylaxis against cervical cancer (CC) by the health insurance society for employees. METHODS: The target population was Japanese female employees aged 20 to 34 and partners and daughters of male employees working for an overseas IT industry. By using a prevalence-based model, the author estimated expected costs in non-vaccination and vaccination scenarios and evaluated the 10-year financial impact on the industry after vaccination by employing a cost-benefit analysis. The incidence of CC in a target group was derived from the actual number of patients with CC in addition to data from JMDC's receipt database and estimated by a Bayesian method. The epidemiological parameters such as mortality rate, screening rate, detailed exam rate and detailed exam consultation rate were taken from epidemiology statistics and published articles available in Japan. Healthcare costs for cancer treatment, screening, detailed exam and vaccination estimated based on medical fee points were input into the model, 'but the analysis did not consider side effect-related costs. In addition, productivity costs for mortality in employees and their families due to CC, estimated by the national employee's statistics, were also input into the model. An annual discount was unconsidered. RESULTS: From the perspective of the healthcare insurance society, expenditure of approximately 129 million yen in the non-vaccination scenario was expected for ten years, but healthcare-related costs were saved by expenditure of approximately 73 million yen with 100% of employees and their families being vaccinated at expenses of approximately 55 million yen. The insurance society lost approximately 1.8 million yen in total if subsidy for vaccination was set at ten thousand yen. In the case of a 100% vaccination rate, the company can save losses in productivity of approximately 563 million yen in ten years as compared with non-inoculation. Furthermore, family finance can save approximately 2.6 million yen, based on our analysis. Sensitivity analyses suggested that subsidy expenses, the uptake rate of vaccination, and time horizon influenced the mortality cost from the perspectives of the company and the employees' families. CONCLUSION: A grant for vaccinating women, who are an untargeted population for a public grant, by the health insurance society is meaningful for the prevention of CC. It was deemed that a grant for vaccination of women by the health insurance society would be approximately ten thousand yen.