Pharmacovigilance of malaria intermittent preventive treatment in infants coupled with routine immunizations in 6 African countries
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Published on: August 6, 2020
Alexandra de Sousa1, Leon Paul Rabarijaona, Ofori Tenkorang
1UNICEF New York, USA. alexandra.desousa@verizon.net
Insights
Intermittent preventive treatment in infants (IPTi) with sulfadoxine-pyrimethamine (SP-IPTi) is safe when given with routine immunizations. This malaria control strategy showed a low incidence of serious adverse events in infants.
Area of Science:
- Public Health
- Pediatrics
- Infectious Disease Control
Background:
- Intermittent preventive treatment in infants (IPTi) is a WHO-recommended malaria control strategy.
- It is administered with routine immunizations in endemic areas.
- This study evaluated the safety of SP-IPTi given simultaneously with infant immunizations.
Purpose of the Study:
- To assess the safety profile of SP-IPTi co-administered with routine immunizations.
- To identify potential adverse events (AEs) associated with this combined intervention.
- To evaluate AE reporting through active and passive surveillance.
Main Methods:
- A cohort event monitoring study involving 24,000 infants in two countries.
- Pharmacovigilance training and supervision to enhance passive AE reporting in six African countries.
- Active follow-up and retrospective review of hospital registers for AE detection.
Main Results:
- No serious adverse events were detected by active follow-up or hospital register review.
- The incidence of moderate AEs possibly linked to SP-IPTi and/or immunization was 1.8 per 1000 doses.
- Spontaneous AE reporting rates were less than 1% compared to active follow-up data.
Conclusions:
- Simultaneous administration of SP-IPTi and routine immunizations is a safe strategy for infants.
- The risk of serious adverse events is low.
- Strengthening spontaneous AE reporting systems in Africa requires involving beneficiaries and caregivers.
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.
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