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- - - NON-SPECIFIC EFFECTS OF VACCINES ON MORTALITY

Saturday, 25th of May 2013

• NON-SPECIFIC EFFECTS OF VACCINES ON MORTALITY

SAGE previously requested that WHO review the evidence concerning the possible non-specific mortality effects of vaccines included in the routine infant immunization schedule. SAGE has now established a working group to review data on non-specific effects and consider whether current evidence is sufficient to merit adjustments in policy recommendations, or may warrant further scientific investigation and if so, to outline a path towards obtaining unequivocal evidence that would inform future robust, evidence-based adjustments in immunization policies, if warranted. SAGE recognized that there have been previous reviews on this topic by WHO committees, including reviews by the GACVS between 2000 and 2008.

SAGE was asked to review the protocols for 2 systematic reviews to assess the possible non-specific effects of vaccines: one regarding the epidemiological mortality studies and the other on human immunological studies of non-specific effects of vaccine on mortality in children <5 years of age.

SAGE noted that there are new published studies on non-specific mortality effects of vaccines and that there is a growing scientific debate on this topic. SAGE supported the proposed literature review that includes documentation of the current and proposed studies in the field. SAGE insisted that the reviewers should make efforted to include all available evidence and access all relevant data sets.

SAGE stressed that the primary focus of the working group will be to review the epidemiology on childhood mortality. The immunological review of human data will be performed to provide an additional source of evidence if the epidemiological review supports the need for further scientific investigation. SAGE advised that the reviews should focus on mortality as an outcome, and that the vaccines under review should be limited to BCG, DPT and measles, without including high titre measles vaccines, additional vaccines or animal studies at this point. SAGE also noted that the immunological studies should focus primarily on specific immune markers identified in previous studies as being affected by these vaccines.