Proof-of-concept study through multi-country collaboration

In 2011 WHO and partners published the Global Vaccine Safety Blueprint⁷ with the aim of optimizing the safety of vaccines through the effective use of pharmacovigilance principles and methods. An aspect of this was to enhance the capacity for vaccine safety assessment beyond basic pharmacovigilance in LMICs. The Global Vaccine Safety Initiative, jointly with PAHO and VACCINE.GRID,⁸ and through the WHO Secretariat, tested the development of a global network of hospital-based sentinel sites for vaccine safety signal verification and hypothesis testing in LMICs

A demonstration project was conducted to assess the feasibility, quality and potential for sustainability of a multi-country collaboration for the evaluation of rare vaccine adverse events. The process of setting up the collaboration and conducting a study along with preliminary results were presented to GACVS and complemented by the perspective from one participating institution. A total of 25 hospitals in 16 countries participated in the demonstration project. The project assessed the capacity of the network to verify the known association of measles-containing vaccines and idiopathic thrombocytopenic purpura (ITP) as well as aseptic meningitis associated with the mumps component of some measles/mumps/rubella (MMR) vaccines. The study sites offered training, either in person or by webinars, on the study protocol and study tools and procedures for data collection, local analysis and sharing to a central analysis hub through a secure portal. Case validation was retrospective, based on computer records or log book searches. Following validation, the pooled analysis identified the known ITP association with measles vaccine and the expected association of aseptic meningitis with some MMR vaccines.

GACVS recognized the effort required to successfully perform this complex study. The demonstration project contributed to the development of expertise at many sites involving interested physicians and nurses with GACVS focusing on the questions of sustainability and lessons learned. It is important that the site-specific experience in study implementation, and the collection of quality data, is documented; this will help the conduct of future studies of rare serious health events related to vaccines. In order to accomplish this, WHO must maintain contact with the sites and further communicate with their respective governments to demonstrate the value of this enhanced vaccine safety capacity. Integration of these capacities into the national vaccine pharmacovigilance system would ensure country ownership and sustainability. Sustainability also depends on future funding mechanisms, buy-in from the countries involved and whether there are relevant studies to be conducted. To maintain this expertise, one possibility discussed was to expand beyond vaccine safety to other relevant vaccine studies such as surveillance of vaccine preventable diseases. Following the publication of results from this collaboration, the next steps will be for further work to be carried out on sustainability and identifying relevant future projects.

⁷ WHO Global Vaccine Safety Blueprint.

⁸ See http://www.vaccinegrid.org/public.html

Full report of GACVS meeting of 15-16 June 2016, published in the WHO Weekly Epidemiological Record of 15 July 2016