Global Vaccine Safety

Potential adverse impact of routine vaccination

Extract from report of GACVS meeting of 20-21 June 2002, published in the WHO Weekly Epidemiological Record on 22 November 2002

A study in Guinea-Bissau published in the British Medical Journal in December 2000 suggested a nonspecific effect of routine vaccination that might influence survival in infants, either negatively or positively, depending upon the vaccine. Increased mortality was reported in children vaccinated with DPT in the 6 months following vaccination. Female gender was suggested as a modifier of the outcome.

GACVS reviewed this issue and urged WHO to arrange for testing of the hypothesis on different data sets from different countries where vaccination data, death, and other factors possibly influencing mortality had been recorded. Following an open call for proposals, WHO funded or cofunded studies in Bangladesh, Burkina Faso, Indonesia, and Papua New Guinea.

Analysis of those studies was completed: all of them showed reduced mortality in the children vaccinated with all of the vaccines. In particular, the studies showed no negative effect of DPT vaccination and no difference between males and females. Preliminary results of an independent analysis conducted to test the hypothesis on another six data sets have been communicated to GACVS. None of these confirmed the observations from Guinea-Bissau with respect to the DPT vaccine.

GACVS concluded that the evidence is sufficient to reject the hypothesis for an increased nonspecific mortality following vaccination.

For the discussions on thiomersal, Bell palsy, viral hepatitis B and MS, and MMF and aluminium-containing vaccines, GACVS invited additional experts to participate in the discussions.

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