First vaccination after birth: serious adverse events of Bacillus Calmette-Guérin (BCG) in real-world

Area of Science:

• Pediatrics
• Vaccinology
• Public Health

Background:

• The Bacillus Calmette-Guérin (BCG) vaccine is widely administered to newborns in China, with over 300 million doses given.
• While generally safe, rare adverse events following BCG vaccination can occur within the first 24 hours of life.

Purpose of the Study:

• To investigate serious adverse events following BCG vaccination in China between January 2010 and January 2022.
• To analyze the types of adverse events and their outcomes, particularly differentiating between preterm and full-term infants.

Main Methods:

• A comprehensive search of the Chinese legal documents database was conducted.
• Fourteen pediatric cases of serious adverse events post-BCG vaccination were identified and analyzed.

Main Results:

• Identified adverse events included interstitial pneumonia, lymphadenitis, septicemia, myocarditis, muscle atrophy, epilepsy, and disseminated BCG.
• The mortality rate was 100% in preterm infants (7 cases) and 28.6% in full-term infants (7 cases), with all deaths occurring within 24 hours.
• Despite rare severe events, the BCG vaccine demonstrates good safety for the majority of newborns.

Conclusions:

• Serious adverse events from BCG vaccination are extremely rare but can be severe, especially in preterm infants.
• The findings underscore the importance of monitoring vaccine safety and prompt reporting of adverse events.
• BCG vaccination remains a critical public health intervention with a favorable safety profile for most neonates.