Sanofi to get $ 43.2 mn from US HHS to fund Zika vaccine research

The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (HHS) will provide $ 43.2 million to Sanofi for developing vaccines against Zika virus. The funds will be used for phase II development and manufacturing of an inactivated Zika vaccine. 

The company’s vaccines global business unit Sanofi Pasteur committed to researching and developing a vaccine to prevent Zika in February, shortly after the World Health Organization (WHO) declared an emergency.

In July 2016, Sanofi Pasteur announced a cooperative research and development agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate. The BARDA funding is to take WRAIR’s Zika purified inactivated virus (ZPIV) vaccine into phase II development with manufacturing and characterisation of the vaccine product as well as optimization of the upstream process to improve production yields.

Sanofi Pasteur is in the process of creating a clinical development and regulatory strategy while WRAIR and the National Institute of Allergy and Infectious Diseases (NIAID) - part of the US National Institutes of Health (NIH) - are conducting a series of phase I ZPIV trials.  Beyond the funding provided by BARDA for the two phase I/II clinical trials, there is an option in the contract that BARDA can exercise for continuing support through Phase III industrial and clinical development. 

“Given the devastating effects that this infectious disease can have on babies of infected mothers and the fact that the disease appears to rapidly spread, Sanofi Pasteur decided to get involved early on. We are very pleased that the U.S. government is committed to working with us to develop a Zika vaccine. Based on this collaboration, we can bring together resources and expertise which are essential in fighting this public-health concern,” said David Loew, Sanofi executive vice president and head of Sanofi Pasteur.

Sanofi Pasteur has developed and provides several vaccines against flaviviruses, such as yellow fever, dengue, and Japanese encephalitis. It developed its first yellow fever vaccine in 1979 and has since sold more than 400 million doses; it is licensed in more than 100 countries around the world. In 2010, Sanofi Pasteur licensed its first vaccine against Japanese encephalitis, which is now licensed in 14 countries with more than 1.5 million doses sold to date. Sanofi Pasteur’s newest flavivirus vaccine is licensed for the prevention of dengue fever in several endemic countries; Dengvaxia was first licensed in Mexico, the Philippines and Brazil late last year and picked up six more licensures so far this year in El Salvador, Costa Rica, Paraguay, Guatemala, Peru and Indonesia.