Didier Nzolo1, Aline Engo Biongo2, Andrea Kuemmerle3, Mariano Lusakibanza2, Yves Lula4, Ntamabyaliro Nsengi5, Celestin Nsibu Ndosimao2, Gaston Tona Lutete2, Jean-Pierre Van Geertruyden6. 1. Unit of Clinical Pharmacology and Pharmacovigilance, University of Kinshasa, Kinshasa, The Democratic Republic of the Congo; Centre National de Pharmacovigilance, Kinshasa, The Democratic Republic of the Congo; Global Health Institute, University of Antwerp, Antwerp, Belgium. Electronic address: Didier.Nzolo@student.uantwerpen.be. 2. Unit of Clinical Pharmacology and Pharmacovigilance, University of Kinshasa, Kinshasa, The Democratic Republic of the Congo; Centre National de Pharmacovigilance, Kinshasa, The Democratic Republic of the Congo. 3. Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: andrea.kuemmerle@swisstph.ch. 4. Unit of Clinical Pharmacology and Pharmacovigilance, University of Kinshasa, Kinshasa, The Democratic Republic of the Congo; Centre National de Pharmacovigilance, Kinshasa, The Democratic Republic of the Congo; Global Health Institute, University of Antwerp, Antwerp, Belgium. Electronic address: yves.lula@unikin.ac.cd. 5. Unit of Clinical Pharmacology and Pharmacovigilance, University of Kinshasa, Kinshasa, The Democratic Republic of the Congo; Centre National de Pharmacovigilance, Kinshasa, The Democratic Republic of the Congo. Electronic address: nsengi.ntama@unikin.ac.cd. 6. Global Health Institute, University of Antwerp, Antwerp, Belgium. Electronic address: jean-pierre.vangeertruyden@uantwerpen.be.
Abstract
BACKGROUND: In early 2016, there was a Yellow Fever (YF) outbreak in Central Africa with several deaths reported from Angola and the Democratic Republic of Congo. Due to a shortage in vaccine supply, fractional dosing (0.1 ml) of 17DD Yellow Fever Vaccine (YFV) was proposed in preventive vaccination campaign in Kinshasa in August 2016. A Pharmacovigilance surveillance at community level was implemented to track Adverse Events Following Immunization (AEFIs). The objective of this study was to describe AEFIs as captured from community-based pharmacovigilance and to compare the safety profile of the fractional dosing of YFV between gender. METHODS: PV information sessions were organized in churches, academic institutions, and pediatrician, obstetrician and friend networks. Prior to data collection, education about AEFI was provided through face-to-face discussions, phone calls, SMS and WhatsApp messages. Individuals reported AEFIs though the above communication channels to assigned individuals. Reported AEFIs were entered into VigiFlow and extracted for statistical analysis using Stata 12. Only vaccinees who received fractional dose (subjects from the age of 2-year-old and non-pregnant women) were included in analysis. Proportional t-test was used to compare AEFI preferred terms among males and females. RESULTS: A total of 4020 subjects reported 5409 AEFIs. Reporters were mostly males (54.9%) with an average age of 26 ± 10.7 years. Fever and injection site pain were the most reported systemic and local AEFI respectively. The safety profile was similar between gender although females reported more diarrhea and dizziness whilst males reported more asthenia (P < 0.001). Five individuals reported serious AEFIs. Among them, 4 were less-immunocompetent. CONCLUSION: Fractional dosing of 17DD YFV has a good safety profile, which is similar between gender. These findings complement the documented immunogenicity profile to support recommendation of fractional dose of YFV for outbreak control.
BACKGROUND: In early 2016, there was a Yellow Fever (YF) outbreak in Central Africa with several deaths reported from Angola and the Democratic Republic of Congo. Due to a shortage in vaccine supply, fractional dosing (0.1 ml) of 17DD Yellow Fever Vaccine (YFV) was proposed in preventive vaccination campaign in Kinshasa in August 2016. A Pharmacovigilance surveillance at community level was implemented to track Adverse Events Following Immunization (AEFIs). The objective of this study was to describe AEFIs as captured from community-based pharmacovigilance and to compare the safety profile of the fractional dosing of YFV between gender. METHODS: PV information sessions were organized in churches, academic institutions, and pediatrician, obstetrician and friend networks. Prior to data collection, education about AEFI was provided through face-to-face discussions, phone calls, SMS and WhatsApp messages. Individuals reported AEFIs though the above communication channels to assigned individuals. Reported AEFIs were entered into VigiFlow and extracted for statistical analysis using Stata 12. Only vaccinees who received fractional dose (subjects from the age of 2-year-old and non-pregnant women) were included in analysis. Proportional t-test was used to compare AEFI preferred terms among males and females. RESULTS: A total of 4020 subjects reported 5409 AEFIs. Reporters were mostly males (54.9%) with an average age of 26 ± 10.7 years. Fever and injection site pain were the most reported systemic and local AEFI respectively. The safety profile was similar between gender although females reported more diarrhea and dizziness whilst males reported more asthenia (P < 0.001). Five individuals reported serious AEFIs. Among them, 4 were less-immunocompetent. CONCLUSION: Fractional dosing of 17DD YFV has a good safety profile, which is similar between gender. These findings complement the documented immunogenicity profile to support recommendation of fractional dose of YFV for outbreak control.
Authors: Rebecca M Casey; Jennifer B Harris; Steve Ahuka-Mundeke; Meredith G Dixon; Gabriel M Kizito; Pierre M Nsele; Grace Umutesi; Janeen Laven; Olga Kosoy; Gilson Paluku; Abdou S Gueye; Terri B Hyde; Raimi Ewetola; Guylain K M Sheria; Jean-Jacques Muyembe-Tamfum; J Erin Staples Journal: N Engl J Med Date: 2018-02-14 Impact factor: 91.245