Joint evaluation of marketing authorization files of inactivated polio vaccines in countries of the eastern Mediterranean Region

Abstract

Background: In 2012, the World Health Assembly declared ending polio a “programmatic emergency for global public health”. In response, the Global Polio Eradication Initiative developed “The Polio Eradication and Endgame Strategic Plan 2013–2018” to address the eradication of all types of poliomyelitis. Aims: The World Health Organization invited selected countries in the Eastern Mediterranean Region to take part in a joint evaluation of the marketing authorization files of candidate standalone inactivated poliovirus vaccines (IPVs), aimed to facilitate the evaluation process and expedite the timelines for registration. Methods: This report describes the planning, organization and execution of the joint meeting among 6 countries of Eastern Mediterranean Region. Results: Participants prepared a joint list of questions and concerns which was shared and discussed with the respective manufacturers on the last day of the review. Manufacturer provided answers to the questions. The questions that could not be responded to immediately by the manufacturer remained to be addressed after the meeting directly between the manufacturer and the national regulatory authoritys. A final joint evaluation report was prepared before the end of the meeting by the participating countries. Conclusions: The report focuses on the benefits of the exercise and highlights its shortcomings as a sole strategy to secure the timely registration of the vaccine in target countries. We discuss additional aspects to be addressed to effectively accelerate registration, and hence access to priority vaccines.