Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing: The global vaccine safety multi country collaboration initiative. Issue 3 (8th January 2018)

• Record Type: Journal Article
• Authors: Kuli-Lito, Georgina; Kostaqi, Entela; Petrela, Elizana; Castellano, Vanesa E.; Chiarvetti, Lucia; Falcó, Adriana; Gentile, Angela; Guirau, Karina; Carrega, Maria Eugenia Pérez; Rasjido, Susana; Testino, Sofía; Vizzotti, Carla; Buttery, Jim; Mcminn, Alissa; Quinn, Julie; Avendaño, Marcela; González, Marcela; Lagos, Rosanna; Maturana, Marcelo; Muñoz, Fernando; Saldaña, Adiela; Soza, Guillermo; Zhang, Tao; Zhang, Xiyan; Ding, Yunfang; Zhang, Jun; Alvarez-Olmos, Martha I.; Sastoque, Luz Amparo; Mezerville, Marcela Hernández-de; Machado, Vicenta; Roverssi, Ileana; Camacho, Angélica Vargas; Luque, Marco Tulio; Mendoza, Liset; Ravi, Mandyam; Manjunath, V.G.; Karimi, Abdollah; Ghanaie, Roxana Mansour; Seifi, Kimia; Shirvani, Fariba; Ashrafi, Mahmoud Reza; Parvaneh, Nima; Kochakzadeh, Leily; Mamishi, Sertareh; Kompani, Farzad; Eshaghi, Hamid; Pirmoazen, Vahideh; Aquije Hernández, Renne F.; Díaz, Maria Esther Castillo; Mamani, Gladys Turpo; Thoon, Koh Cheng; Oh, Bee Khiam; Yelen, ; Cutland, Clare; Madhi, Shabir A.; Groome, Michelle; Velaphi, Sithembiso; Izu, Alane; Diep, Linh; Hwinya, Cleopas; Pérez-Vilar, Silvia; Díez-Domingo, Javier; Martín-Navarro, Marian; Soriano-García, Esther; Pande, Stephen Legesi; Alaroker, Florence; Amulen, Dorothy; Akareut, Margaret; Areto, Esther; Komo, Richard Samson; Quinto, Ogwang; Giachetto, Gustavo; Speranza, Noelia; Zunino, Carlos; Guillard-Maure, Christine; Elango, Varalakshmi; Black, Steven; Perez-Vilar, Silvia; Castro, Jose Luis; Bravo-Alcántara, Pamela; Molina-León, Helvert Felipe; Weibel, Daniel; Sturkenboom, Miriam; Zuber, Patrick L.F.;
• Is Part Of: Vaccine. Volume 36:Issue 3(2018)
• Page Start: 355
• Page End: 362
• Publication Date: 2018-01-08
• Subjects: Post-marketing surveillance -- Vaccine safety -- Global Vaccine Safety Initiative (GVSI) -- Adverse events following immunization (AEFI); AEFI adverse events following immunization -- AM aseptic meningitis -- CRF case report form -- GVSI Global Vaccine Safety Initiative -- ITP immune thrombocytopenic purpura -- ERC Ethical Review Committee -- GBS Guillain-Barre Syndrome -- IRB Institutional Review Board -- LMICs low and middle-income countries -- PPV positive predictive value -- QAC quality assurance committee -- SCCS self-controlled case series -- WHO World Health Organization; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2017.07.085
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Timely and effective evaluation of vaccine safety signals for newly developed vaccines introduced in low and middle- income countries (LMICs) is essential. The study tested the development of a global network of hospital-based sentinel sites for vaccine safety signal verification and hypothesis testing. Twenty-six sentinel sites in sixteen countries across all WHO regions participated, and 65% of the sites were from LMIC. We describe the process for the establishment and operationalization of such a network and the lessons learned in conducting a multi-country collaborative initiative. 24 out of the 26 sites successfully contributed data for the global analysis using standardised tools and procedures. Our study successfully confirmed the well-known risk estimates for the outcomes of interest. The main challenges faced by investigators were lack of adequate information in the medical records for case ascertainment and classification, and access to immunization data. The results suggest that sentinel hospitals intending to participate in vaccine safety studies strengthen their systems for discharge diagnosis coding, medical records and linkage to vaccination data. Our study confirms that a multi-country hospital-based network initiative for vaccine safety monitoring is feasible and demonstrates the validity and utility of large collaborative international studies to monitor the safety of new vaccines introduced in LMICs.