Over the past decade researchers have seen a dramatic rise in the incidence of infectious diseases including dengue, chikungunya, SARS, and zika virus. Mathematical modeling has been used to understand potential relationships between climate variables and biologic parameters such as mosquito breeding, survival, biting rates, and parasite incubation time. Changes in environmental variables such as ocean warming, elevated precipitation, urbanization, and urban crowding have also been linked to the rising incidence of mosquito borne diseases in previously unexposed regions. Modeling of new dengue fever hot-spots has suggested that small temperature increases can play a significant role in disease transmission. Specifically, models of a global temperature increase of 2-3ºC have predicted a 3-5% increase in the risk of dengue infection, which amounts to several hundred million new cases per year. In the 1960’s, less than ten countries had experienced severe dengue epidemics. Now, over 100 countries in the WHO regions of Africa, the Americas, the Eastern Mediterranean, South-East Asia and the Western Pacific, have seen dengue spread to their shores.
Dengue fever is transmitted between people through the bite of infected female Aedes aegypti mosquitos. The WHO has set the objective of reducing dengue related mortality by 50% and morbidity by 25% in endemic countries by 2020. Their strategy to reduce the transmission of dengue includes infection prevention, mosquito control, public education, and vaccination.  In 2016, the first dengue vaccine, Dengvaxia made by French pharmaceutical giant Sanofi, was registered and distributed in several countries with the goal of reducing the global burden of dengue fever.
Dengvaxia was produced using Sanofi’s ChimeriVax technology platform which is based on a yellow fever viral backbone. Given the rising burden of dengue, Sanofi received “fast track” status in 2010 from the U.S. FDA and became the world’s first dengue vaccine to start Phase III trials. The FDA fast-track designation “recognized that a dengue vaccine would address an important unmet medical need for a serious disease” with increased incidence trends linked to climate change. In anticipation of a common challenge in vaccine development – the shortage of vaccine manufacturing and process development capacity – Sanofi strategically invested in a €300 million production facility in France well in advance of the Phase III efficacy trial. This facility has been operating since 2014 and has a yearly production capacity of 100 million vaccine doses. Dengvaxia is currently approved for use in Mexico, Brazil, the Phillipines and El Salvador.
Given its recent success launching Dengvaxia, I would encourage Sanofi Pasteur to leverage its unique manufacturing platform and the readiness of regulators to fast-track clinical steps to accelerate the simultaneous development and Phase I testing of multiple new vaccine candidates. While Sanofi has announced a plan to develop a vaccine against Zika virus, their 2016 Letter to Shareholders doesn’t mention growing the R&D pipeline. In addition to investing in product development, Sanofi should focus on streamlining its clinical trial processes which rely on decade-old technology and suffer from bottlenecks in data transferring. By optimizing early clinical trial processes, Sanofi can promote rapid data acquisition and processing to facilitate smart decision making. By focusing on manufacturing excellence, Sanofi will continue to be a world leader in the vaccine industry.
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