Sanofi Pasteur Wins US Zika Vaccine Aid

Sanofi Pasteur, the vaccines arm of French chemical producer Sanofi, has received a pledge of funding from the US Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, for the manufacture of an inactivated Zika vaccine for phase 2 development. The virus has been linked to severe birth defects such as microcephaly and severe fetal brain abnormalities.

BARDA provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public-health medical emergencies.

In February, shortly after the World Health Organization (WHO) declared an emergency, the French company’s US affiliate, based at Swiftwater, Pennsylvania, committed to researching and developing a vaccine to prevent Zika. In July, it signed a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a vaccine candidate.

With $43.2 million in financial support from BARDA, Sanofi Pasteur said it will take WRAIR’s Zika purified inactivated virus (ZPIV) vaccine into phase 2 development with manufacturing and characterization of the vaccine product as well as optimization of the upstream process to improve production yields. Phase 1 and 2 clinical trials are set to begin in the first half of 2018. Sanofi’s contract runs until 2022.  Alongside the funding for phase 2 and 3 clinical trials, the contract provides the drugmaker with an option to receive continuing support through phase 3 industrial and clinical development.

In early September, Japanese drugmaker Takeda Pharmaceutical said it had secured BARDA funding for its ongoing effort to develop a Zika vaccine. The arrangement could be worth as much as $312 million if the agency finds the vaccine worthy of moving through late stage testing and filing for approval, Takeda said.