Frequency, Structure and Predictors of the Development of Post-Vaccination Reactions to the Administration of Influenza Vaccine in Patients with Severe Bronchial Asthma Receiving Genetically Engineered Biological Therapy

Relevance . Patients with severe bronchial asthma (SBA) receiving genetically engineered biological therapy (GEBT) are at increased risk of a complicated course of influenza. Data on the tolerability of adjuvanted influenza vaccines in this category of patients are limited. Aim . To study the frequency, structure, and predictors of post-vaccination reactions to the administration of a quadrivalent adjuvanted subunit influenza vaccine in patients with SBA while receiving GEBT. Materials and methods . A prospective observational cohort study was conducted with the participation of 221 patients (19–81 years old) with SBA (GINA 2026, stage 5) who received dupilumab, omalizumab, benralizumab or mepolizumab for at least 3 months. All patients were vaccinated with a single intramuscular dose of a quadrivalent adjuvanted subunit influenza vaccine. Post-vaccination reactions were recorded using individual questionnaires. Statistical analysis included logistic regression. Results . The frequency of local reactions was 38.9 % (mainly pain at the site of injection – 24.9 %), systemic – 41.6 % (mainly weakness/malaise – 24.0 %). All reactions were mild and short-term. There were no differences in the frequency of reactions between the age groups (<60 and ≥60 years) and by gender. In the post-vaccination period, no exacerbations of asthma, bacterial complications, or delays in the administration schedule of GEBT were recorded. Independent predictors of systemic reactions were chronic respiratory diseases (COPD/bronchitis): OR = 7.53 (p = 0.007) and allergic/atopic diseases: OR = 4.28 (p = 0.001). Conclusion. Vaccination of patients with SBA receiving GEBT with adjuvanted quadrivalent influenza vaccine is characterized by a favorable safety profile and does not require correction of basic therapy. Chronic respiratory and allergic diseases are independent risk factors for the development of systemic post-vaccination reactions.