Sanofi recently issued a global statement providing new data on our dengue vaccine that helps to further define the population that would best benefit from its protective value.[ii] Stopping the spread of dengue is a WHO priority and the organization has set clear objectives for endemic countries to “reduce mortality and morbidity from dengue by at least 50% and 25%, respectively, by the Year 2020 (using 2010 as the baseline)”.[iv],[vi],[viii] These published findings helped to substantiate the overall public health value of the vaccine in settings where dengue continued to be widespread.
The new analysis that we compiled and released in November 2017 revealed that the dengue vaccine works differently based on prior dengue infection history. Based on this finding, Sanofi is proposing that regulators update the prescribing information requesting that healthcare professionals assess the likelihood of prior dengue infection in individuals before vaccinating. Vaccination should only be recommended when the potential benefits outweigh the potential risks. For individuals who have not been previously infected by the dengue virus should not be recommended. The analysis did, however, confirm that vaccination provides persistent protective benefit against dengue infections in those who have had a prior dengue infection.
We made this new information available first to health authorities and then, shortly thereafter, to the public. Our goal in all of our actions is to ensure proper understanding of this situation by all stakeholders and allow for informed decision making on vaccination between individuals and their healthcare providers.
Together with country health authorities, Sanofi will continue to monitor the long-term impact of vaccination in the ongoing and post-authorization safety and effectiveness studies. We will also invest in efforts to develop and register reliable, rapid and cost-effective diagnostic tests to better support field use of the vaccine.
Sanofi remains committed to the considerable challenge of reducing the threat that dengue presents to four billion people living in tropical and subtropical regions of the world. Together with global and regional health authorities, and the broader scientific community, we continue to work to bring down the burden of this pervasive public health menace.
Head of Global Medical Vaccine
[viii] Limkittikul, Kriengsak, et al. Long-term (6-year) follow-up in Thai children from phase IIb proof of concept efficacy study of cyd-tdv dengue vaccine. Presentation at ACPID, Bangkok, Thailand, 7 – 10 November 2016.