Pharmacovigilance Of Malaria Intermittent Preventive Treatment In Infants Coupled With Routine Immunizations In 6 African Countries

Background. Intermittent preventive treatment in infants (IPTi) is a new malaria control strategy coupled with the delivery of routine immunizations recommended by the World Health Organization since 2009 for countries with moderate to high endemicity. To evaluate its safety profile and identify potential new adverse events (AEs) following simultaneous administration of sulfadoxine- pyrimethamine (SP- IPTi) with immunizations, we measured AE incidence and evaluated spontaneous AE reporting.Methods. A cohort event monitoring study was conducted on 24 000 infants in 2 countries after administration of SP-IPTi during routine immunizations. Additional pharmacovigilance training and supervision were conducted to stimulate AE passive reporting in 6 African countries.Results. No serious AEs were found by active follow-up, representing 95% probability that the rate does not exceed 1 per 8000. No serious AEs were found by retrospective review of hospital registers. The rate of moderate AEs probably linked to immunization and/or SP-IPTi was 1.8 per 1000 doses (95% confidence interval, 1.50-2.00). Spontaneous reporting of AEs remained < 1% of cases collected by active follow-up.Conclusions. Simultaneous administration of SP-IPTi and immunizations is a safe strategy for implementation with a low risk of serious AEs to infants. Strategies toward strengthening spontaneous reporting in Africa should include not only the provider but also beneficiaries or their caregivers.