In just a few months, Brazil will host the 2016 Olympics, the most competitive global athletic event of the year. But another important race for the people of that country–and millions more around the world–has already begun. BIO members and others across the public health community are aiming to break vaccine development records to find solutions for unpredictable diseases like Zika and dengue. Both produce a devastating impact on tropical and subtropical countries like Brazil, and this impact could worsen. Only one thing can bring them under control quickly: cross-border, cross-functional collaboration. As an industry, we need to actively participate evermore openly in scientific, regulatory, and operational connections amongst all of the players in the vaccine ecosystem to help address these urgent public health needs.
Collaboration needs to start at the highest levels of authority internationally. With Zika, this is thankfully already happening. In February, the World Health Organization (WHO) acted quickly, identifying Zika as a global public health emergency. The WHO called upon “partners, experts and resources to mobilize and coordinate’’[i] to unlock funding, enhance surveillance, and jump-start research.
The value of this kind of collaboration is evident in the successful development of the first vaccine against dengue. Decades of transparent data sharing and collective deliberation among global and local experts in both industry and public sectors made this achievement possible. Specifically, at the start, the WHO established guidelines for clinical development of dengue vaccines together with industry. Data-sharing over a two-year period between WHO and Sanofi Pasteur on the company’s candidate dengue vaccine culminated in publication of a pooled efficacy and integrated safety analysis on the vaccine in the New England Journal of Medicine in July 2015. The Strategic Advisory Group of Experts (SAGE) on Immunization issued a positive recommendation on the vaccine in April, a record four months after the first regulatory approval of the vaccine in Mexico in December 2015. This timely position on the dengue vaccine remains a critical milestone in the vaccine’s global introduction.
International organizations untraditionally focused on public health are also jumping into a more collaborative mode as the impacts of infectious diseases like Zika and dengue could derail entire economies. The G7’s health ministers have created the Global Research Collaboration for Infectious Disease Preparedness (GLoPID-R). This group has helped unlock rapid-response funding from multiple health authorities, even those in countries where diseases like dengue and Zika are not endemic. They’ve opened channels of communication between regulatory authorities, academic and biotech researchers, and patient and public-health institutions, so that we’re all continually sharing an enormous amount of information–on Zika in particular.
Collaborations like these will only work effectively if the exchange continues throughout the concerned regions and localities where dengue and Zika are endemic and spreading. We must collectively ensure speedy epidemiological and medical knowledge is widely shared among the investigators and clinicians on the ground. PAHO, WHO and the Dengue Vaccine Initiative have done an excellent job in this respect: last July, they brought together 10 regional regulatory agencies with dengue experts to share technical understanding and support for review of the dengue vaccine file. It bolstered preparedness in the region, leading to three countries’ approvals of the vaccine’s license by the end of the year. Collaborations like these can help knowledge spread further and faster than the virus, so the speed of access to new solutions can be accompanied by sustainable implementation.
New ways of collaborating must come from us in industry, too. Sanofi Pasteur is particularly well placed to help answer the call on Zika because of our experience with licensed vaccines against flaviviruses (namely, Japanese encephalitis and yellow fever) and our current work on dengue. For almost a century, we’ve built and bolstered a scientific research network, including top local, experts, to help address these previously neglected diseases. We’ve learned a lot about how these complex flaviviruses work in the human body and across large populations. It’s what’s helped us aim for animal testing of a candidate Zika vaccine as early as this year with human trials anticipated to begin soon thereafter. We’ve also established a new collaboration model with government stakeholders in regulatory and health systems that allow us to bring the new dengue vaccine first to people living in countries where the disease burden is highest. We are committed to employing these channels again with a future Zika vaccine candidate.
We are proud to share insights and knowledge about the steps taken along the way for dengue vaccine development and hope to continue in this spirit of open collaboration on Zika internationally through BIO, the WHO and GLoPID-R, regionally through PAHO, and, as importantly, locally with our colleagues and experts in each of the affected countries. The race is on, and we’re honored to run it hand-in-hand through collaborations with such passionate and committed organizations.