Safety profile of fractional dosing of the 17DD Yellow Fever Vaccine among males and females: Experience of a community-based pharmacovigilance in Kinshasa, DR Congo

Implementation of pharmacovigilance (PV) systems in resource-limited countries is a real endeavor. Despite country- and continent-specific challenges, the Democratic Republic of the Congo (DRC) has been able to develop one of the most active PV systems in the sub-Saharan Africa. The World Health Organization (WHO) regional Office identified the DRC experience to set up a PV system for antimalarial drugs safety monitoring as a ‘best practice’ that needed to be documented in order to help DRC improve its PV system and to be scaled up in other African countries. In response to the WHO request, a best practices and bottlenecks analysis was conducted in 2015. This analysis was updated in 2018 in the light of the minimum requirements of the WHO to set up a PV system taking into account other guidance for PV systems. The following themes were retained for analysis: (1) creation of the national PV center; (2) implementation of PV in the health system; (3) data collection and analysis; (4) collaboration with public health programs; (5) collaboration with the National Regulatory Authority. Lessons learnt from the DRC experience show that it is possible to implement PV systems in order to promote patients’ safety in resource limited sub-Saharan African countries with no guaranteed funding. The ability of national PV centers to collaborate with Public health stakeholders, including public health authorities at all levels as well as public health programs, and to use existing health information systems are considered the main key to success and may substantially reduce the cost of PV activities.

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“…In a country where illiteracy is a concern, this was considered as an alternative to patient reporting. 15,16…”

Section: Best Practices and Bottleneck Analysismentioning

confidence: 99%

Development of a pharmacovigilance system in a resource-limited country: the experience of the Democratic Republic of Congo

Nzolo

Kuemmerle

Lula

et al. 2019

Therapeutic Advances in Drug Safety

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“…Recently, a study was published in which an attempt was made to monitor pharmacovigilance of the fractional-dose vaccination in Congo in 2016. 8 More than 4000 persons reported over 5000 adverse events, mostly fever and pain at the injection site. Five adverse events were serious events requiring hospitalization, but all occurred on the same day of vaccination, so before the onset of viraemia could be expected.…”

Section: Introductionmentioning

confidence: 99%

Fractional-dose yellow fever vaccination: an expert review

Roukens

Visser

2019

Journal of Travel Medicine

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Rationale for review: The global yellow fever vaccine supply is insufficient to provide full-dose vaccination to millions threatened by outbreaks. Given the excess of live-attenuated 17D yellow fever virus in the current single dose vials, dose sparing would increase available vaccine doses manifold. Fractional-dose yellow fever vaccination is now accepted as an emergency solution, as short-term protection has been confirmed in an outbreak situation in the Democratic Republic of Congo, but broader application of this dose-sparing strategy is still not recommended. In this review, important knowledge gaps that hamper this application such as long-term protection after fractional-dose vaccination, safety, comparability across different genetic backgrounds and different World Health Organization-licensed yellow fever vaccines and immunogenicity in infants are addressed. Main findings: Recently, published results on long-term protection after fractional-dose vaccination in healthy young volunteers indicate that if a person mounts a protective response shortly after vaccination, the protective response will persist for 10 years and possibly longer. It also appears that fractional-dose vaccination does not elicit more serious adverse events than standard dose vaccination. Short-term immunogenicity studies are currently underway in specific populations (infants, human immunodeficiency virus (HIV)-infected persons and healthy adults living in Uganda and Kenya), of which the results will become available in 2021–22. Conclusions: Available results on long-lasting immunogenicity of fractional-dose yellow fever vaccination are encouraging, although confirmation is required in larger populations including young children living in yellow fever endemic areas.

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Tracking health commodity inventory and notifying stock levels via mobile devices: a mixed methods systematic review

Agarwal

Glenton

Tamrat

et al. 2020

Cochrane Database of Systematic Reviews

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Safety profile of fractional dosing of the 17DD Yellow Fever Vaccine among males and females: Experience of a community-based pharmacovigilance in Kinshasa, DR Congo

Cited by 10 publications

References 22 publications

Development of a pharmacovigilance system in a resource-limited country: the experience of the Democratic Republic of Congo

Development of a pharmacovigilance system in a resource-limited country: the experience of the Democratic Republic of Congo

Fractional-dose yellow fever vaccination: an expert review

Tracking health commodity inventory and notifying stock levels via mobile devices: a mixed methods systematic review

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