BACKGROUND: There is no consensus on managing common adverse reactions to Bacille Calmette-Guerin (BCG) vaccination. We systematically reviewed the management of BCG-associated regional lymphadenitis and injection site abscess in immunocompetent individuals. METHODS: Searches of Medline, Embase and PubMed were done until November 2020. Randomized controlled trials (RCTs) and cohort studies that compared management strategies for complications of intradermal BCG vaccination were included. RESULTS: Of 1338 individual articles, 15 met inclusion criteria. Six RCTs, 4 prospective and 4 retrospective cohort studies compared management in 1022 children with BCG-associated lymphadenitis. For nonsuppurative lymphadenitis, no antimicrobial was found to significantly impact on time to resolution or prevention of suppuration. For suppurative lymphadenitis, there was some evidence that needle aspiration shortens time to resolution and prevents sinus tract formation. Surgical excision (mainly offered for persistent suppurative lymphadenitis) generally had favorable outcome. Two cohort studies (including 1 aforementioned) compared management strategies in up to 36 children with BCG injection site abscess; one showed no difference in outcome in children treated with antibiotics and the other reported complete resolution without treatment. CONCLUSIONS: Evidence does not support a role for antimicrobial therapy in the management of localized reactions to BCG vaccination in immunocompetent children. Needle aspiration may shorten the recovery period for BCG-associated suppurative lymphadenitis. BCG injection site abscess usually heals without treatment. However, studies are limited and cases are not well defined. Growing research into novel BCG applications provides opportunities to investigate optimal management strategies for adverse reactions in a prospective manner using active safety surveillance.

  • Children (2-9 years)
  • Newborn (0-1 years)
  • Safety
  • Tuberculosis