Regional guidelines for dengue vaccine safety surveillance, QDENGA - TAK-003

Dengue is a viral disease transmitted by a vector of the genus Aedes and caused by a single-stranded positive-sense RNA virus of the genus Flavivirus. The virus has four serotypes (DENV-1, 2, 3, and 4), which share 65-70% of the nucleotide sequence identity and are capable of causing the full spectrum of disease. The Qdenga® (TAK-003) tetravalent dengue vaccine is available for use by countries in the Region of the Americas as an option for the control of dengue disease. To date, global and regional strategic committees, as well as several national regulatory authorities have indicated that the vaccine is safe and effective. However, there are additional identified risks that should be monitored during use in the general population and in a large number of individuals. This publication presents countries in the Region with the risks to consider when introducing the vaccine and recommends strategies for vaccine safety surveillance systems to generate sufficient necessary evidence to respond to safety-related questions and protect the general population. Related issues include preparedness for cases of hypersensitivity and anaphylaxis, as well as assessment of the risk of reactivation of virulence and vaccine-associated enhanced disease (VAED). This document includes guidance on preparing all aspects of the passive surveillance process, adaptation and harmonization with arbovirus surveillance systems, and technical recommendations on active surveillance strategies for the dengue vaccine. Countries that wish to introduce the Qdenga® vaccine are urged to review this document and critically assess their ESAVI surveillance systems to ensure that they are properly prepared and have sufficient tools for responsible introduction of the vaccine.