Sanofi Statement on Zika Vaccine License
Sep 1, 2017
On August 17, 2017, Sanofi Pasteur was informed by The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services that they completed an assessment of all Zika-related projects they are funding and have decided to focus on a more limited set of goals and deliverables.
As a result of their review, Sanofi Pasteur has been notified of BARDA’s decision to “de-scope” its contract with Sanofi Pasteur to fund the manufacture and clinical development of an inactivated Zika vaccine and will limit its funding to a case definition and surveillance study as well as any activities required to advance our vaccine development to a point where development would be indefinitely paused but could be restarted if the epidemic re-emerges.
Consequently, Sanofi does not intend to continue development of, or seek a license from, the Walter Reed Army Institute of Research for the Zika vaccine candidate at this time.
We are proud of our contributions to the productive collaboration to date, which will result in significant contributions to science and to others who may continue pursuing licensure for an effective and safe Zika vaccine.
One of the ways Sanofi Pasteur will continue to contribute to the field of knowledge on Zika is by completing, with partial BARDA support, the ongoing case definition and surveillance study which will provide guidance on Zika epidemiology and diagnosis that can be applicable to any vaccine subsequently developed to prevent the disease. The case-definition and surveillance study is currently being conducted in 4 countries—Colombia, Honduras, Mexico, and Puerto Rico—and we are looking to enroll 2,400 volunteers.
Given the evolving epidemiology of Zika, which has seen a profound reduction in the number of new Zika cases in the United States and around the world in 2017, as well as the results of the Phase I study, it was necessary to substantially extend our projected vaccine development timelines. Therefore, we respect BARDA’s decision to re-purpose limited resources to meet their priorities.
In February 2016, Sanofi Pasteur urgently responded to the WHO’s declaration of a public-health emergency of international concern (PHEIC). In doing so, we assumed significant opportunity costs and delayed other internal pipeline priorities to lend our expertise to the Zika global public-health threat. The epidemiology of the disease has changed significantly since that time, but we continue to believe that public-private partnerships are the right model to address these public health challenges and should continue to play a major role in response to emerging infectious diseases.
