• Badria Al Waili, Nasra Al Mufarajii, Samiyah Al Hashmi, Abdullah Al Ajmi, and Nashat Al Sukaiti.
• From the Department of Pediatrics, Royal Hospital, Muscat, Oman.
• Ann Saudi Med. 2021 Jan 1; 41 (1): 243024-30.

BackgroundBacillus Calmette-Guérin (BCG) vaccine-related complications are frequently observed in children in Oman. There are a few regional studies on BCG complications, but none from Oman.ObjectiveEvaluate the spectrum of BCG-vaccine related complications and immune status in Omani children.DesignRetrospective cross-sectional study.SettingReferral tertiary hospital.MethodsChildren aged younger than 13 years old and with complications of BCG vaccination recorded from 2006-2018 were included in this study. Clinical characteristics, treatment, immune workup and outcome were reviewed from hospital records.Main Outcome MeasuresDifferent BCG vaccine-related complications categorized by the site of involvement.Sample Size226.ResultsOf the 226 children had BCG-vaccine related complications, 99% received BCG vaccine immediately after birth. The median age of presentation was 4 months. The most common complication was isolated BCG lymphadenitis (85%, n=192), followed by BCG-related osteomyelitis (10.2%, n=23) and disseminated BCG infection (4.9%, n=11). The median age of presentation of disseminated BCG was 5 months, with different organs involved. Out of 11 children with disseminated BCG infection, 72.7% (n=8) had primary immune deficiency (PID), including chronic granulomatous disease (CGD, n=5), severe combined immunodeficiency (SCID) (n=2); 1 patient had Mendelian susceptibility to mycobacterial disease (IFNGR2 deficiency); 2 patients with PID not yet identified and the 1 with a non-specific PID had blood or saliva samples sent for whole-exome sequencing.ConclusionBecause of the spectrum of BCG vaccine-related complications, including the most severe in children with PID, we suggest that delaying the BCG vaccine from birth to 6 months may prevent disseminated BCG diseases and their complications in children with PID because any PID will have been identified before 6 months. Further studies are needed to guide this recommendation.LimitationsSingle center-based study that may not provide a full overview of all BCG vaccine-related complications in Oman. Unavailability of details of some microbiological results and an inability to determine the detailed management for all patients.Conflict Of InterestNone.

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