BCG vaccination safe, effective in low birth weight infants: JAMA

A new study published in JAMA Pediatrics has reported that no evidence of increased BCG-associated adverse events was found when vaccination was administered within 7 days of birth in clinically stable neonates, compared with vaccination at later points.

Bacillus Calmette-Guerin (BCG) is the most widely administered vaccine worldwide. It remains the only approved vaccine for the prevention of tuberculosis (TB), which globally affects more than 10 million individuals annually.

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Shiraz Badurdeen and his associates conducted a systematic review and meta-analysis to determine the safety, immunogenicity, and protective efficacy against tuberculosis (TB) of BCG vaccination given at or before 7 days after birth vs vaccination more than 7 days after birth among infants who are preterm and/or had (low birth weights)LBW.

The BCG vaccine is usually given soon after birth to infants who were full term and reduces the incidence of TB disease and TB-associated mortality in childhood. However, among the 15 million infants born preterm and 20 million born with low birth weight (LBW) each year worldwide, BCG is commonly delayed because of uncertainty about safety and immunogenicity.

The investigators extracted the data from Medline, Embase, and Global Health databases from inception until August 2017.

The study encompassed Clinical trials, cohort studies, and case-control studies that included infants who were preterm and/or had LBW and reported safety, mortality, immunogenicity, proxies of vaccine take, and/or efficacy against TB.

The key analysis included are:

• There was no evidence of increased BCG-associated adverse events when vaccination was administered within 7 days of birth in clinically stable neonates, compared with vaccination at later points.


• Meta-analyses of BCG scar formation and TST conversion suggested no differences between the 2 groups.


• Immunogenicity could not be evaluated owing to inadequate data.


• No studies reported efficacy against TB disease in BCG within 7 days vs vaccination at later points.


• Studies of adverse reactions comparing infants who were preterm and/or had LBW to infants who were full term and/or had NBWs predominantly reported no differences.

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“Our independent findings strongly support the most recent WHO advice of early vaccination in healthy infants born moderately preterm and with moderate LBW and synthesizes more extensively the evidence for early vaccination safety in this population,” write the authors.

The study concluded that on the basis of current evidence, a uniform policy of early BCG vaccination of clinically stable infants who are preterm and/or had LBW appears justified.

For full information log on to the following: 10.1001/jamapediatrics.2018.4038