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Abstract Background This study aims to assess the effectiveness of OM-85 BV in treating recurrent acute tonsillitis in children and adults during the first year after treatment, as well as to identify response predictors. Results The study included 92 patients, and there was a significant decrease in the number of acute tonsillitis cases after OM-85 BV treatment (p < 0.001). Exposure to tobacco smoke predicts non-response or partial response to treatment (OR 5.24, p = 0.005, 95% CI 1.646–16.671/OR 4.57, p = 0.014, 95% CI 1.362–15.339). Conclusions The study concludes that OM-85 BV is effective in preventing new episodes of tonsillitis in patients with a history of recurrent acute tonsillitis. Patients exposed to tobacco smoke tend to have a poorer response to treatment.