Safety of intradermal Bacillus Calmette-Guerin vaccine for neonates in Eastern Saudi Arabia.

Objective: To evaluate the safety of Bacillus Calmette-Guerin (BCG) in Saudi infants and outline our management for BCG related lymphadenitis.

Methods: The records of infants who developed BCG related complications were retrospectively reviewed from March 2008 to March 2011 at the Maternity and Children Hospital, Dammam, Saudi Arabia for age, gender, birth weight, presentation, and outcome. All our patients were immunized with the BCG vaccine within 48 hours after birth, and the total number of vaccinated newborns was obtained from the vaccination registry.

Results: During a 3-year period (March 2008 to March 2011), 26,000 newborns received BCG and 81 (51 males and 30 females) developed complications. This gives an incidence of 3.12 complications/1000 newborns. Their presentations were: left axillary lymphadenitis (n=62), supraclavicular lymphadenitis (n=9), collection at immunization site (n=6), and one each (left cervical lymphadenitis, bilateral axillary lymphadenitis, left arm abscess, left axillary lymphadenitis and collection at immunization site). Two were immunocompromized and 6 with local collection were aspirated. The arm abscess had drainage. Simple lymphadenitis (n=6) were treated expectantly, while those with suppurative lymphadenitis (n=68) had excision (n=65) or incision and drainage (n=3) without anti-tuberculous treatment.

Conclusion: Bacillus Calmette-Guerin is safe but is associated with a relatively high incidence of suppurative lymphadenitis. Non-suppurative lymphadenitis can be treated conservatively, while suppurative lymphadenitis should be treated with excision. This is safe, avoids rupture, and shortens the recovery period without anti-tuberculous treatment. Although, the use of BCG vaccine may be associated with side effects, the potential morbidity and mortality from tuberculosis outweighs that from BCG related complications.