Immunization, Vaccines and Biologicals

Technical consultation with national regulatory authorities on the dengue vaccine dossier

WHO Headquarters, Geneva, Switzerland, 28-30 July 2015

A dengue vaccine candidate (CYD, developed by Sanofi Pasteur) has been studied in Phase III clinical trials in Asia and Latin America. A dossier has been submitted to register the vaccine in a number of disease-endemic countries.

The objective of this technical consultation is to assist informed decision-making on the registration of a vaccine. WHO, in collaboration with the Dengue Vaccine Initiative (DVI), is holding a consultation with National Regulatory Authorities (NRA) experts that have received the dengue vaccine dossier along with additional experts from other countries.

The knowledge gained by the participants during the consultation may be used by each NRA at their discretion and the final decision will be individually and independently reached by each NRA according to their own timeline and as per national procedures and guidelines. Participation in this consultation is not required for registration nor will there be a commitment nor decision by the regulatory authorities expected at the meeting.