Bacille Calmette-Guérin lowers in-hospital mortality

From 2002-13, Bandim Health Project conducted three randomized controlled trials of BCG-Denmark vs. no-BCG to low birthweight infants.

The landmark trials included 6,583 infants and showed a remarkable effect on mortality; Early BCG lowered the neonatal (first 4 weeks of life) mortality by 38% (Mortality Rate Ratio 0.62 (95% CI 0.46-0.83) and the infant (first year of life) mortality by 16% (MRR 0.84 (0.71-1.00)).

We have now analyzed hospital data among the same infants and we interestingly found that BCG had no effect on neither neonatal or infant hospital admission risk, the neonatal and infant Incidence Rate Ratios (IRRs) being 0.97 (0.72-1.31) and 0.96 (0.84-1.10). Interestingly, BCG rather affected the severity of hospital admissions. We thus identified 56 in-hospital deaths in the BCG group and 79 in the control group. With 3,297 infants randomized to early BCG and 3,286 to the control group, this means that the number-needed-to-treat with BCG-Denmark to prevent 1 fatal admission was 143 children during this period of high-mortality in Guinea-Bissau. The case-fatality Risk Ratio (RR) for the neonatal and infant periods were 0.58(0.35-0.94) and 0.72(0.53-0.99) and the protective effects were most marked against fatal neonatal sepsis admissions, of which there were 7 in the BCG group and 20 in the control group. There was no effect on pneumonia and zero cases of tuberculosis in the cohort; the observed effects are thus entirely non-specific.

You can read more about the subject here: Early Bacille Calmette-Guérin vaccination, hospitalizations and hospital deaths: Analysis of a secondary outcome in three randomized trials from Guinea-Bissau.