Is the U.S. making progress on a Zika vaccine?

Sanofi SA became the latest pharmaceutical manufacturer working on a vaccine for the Zika virus in late September, when the U.S. Department of Health and Human Services (HHS) approved $43.18 million for vaccine development by Sanofi.

Already, HHS has awarded around $433 million for Zika response and preparedness activities. In addition, the new Senate and House budget, passed in late September, contained $1.1 billion in Zika funding.

While HHS and the U.S. government are throwing millions of dollars at the problem, many are worried about the rapid spread of Zika, which has infected hundreds of thousands of people in the Americas and Southeast Asia– and caused birth defects in some babies.

As of September 22, the Centers for Disease Control and Prevention (CDC) said there were 808 pregnant women in the US with Zika and 1,490 in the territories (mainly Puerto Rico). Zika is spreading quickly, since  the territories reported 1,348 cases the week before.

Plus, there are now 119 cases of locally-acquired Zika in Florida, along with 15 cases in visitors to the state.

In late June, HHS provided funding to Emergent BioSolutions Inc., which also developed the anthrax vaccine, via its Biomedical Advanced Research and Development Authority (BARDA). With the funding, valued at up to $21.9 million, Emergent BioSolutions will develop and manufacture three lots of a Zika vaccine for use in a Phase 1 clinical trial.

“The threat posed by Zika presents an urgent need for vaccines and diagnostics,” said Dr. Richard Hatchett, acting BARDA director. “To meet that need as quickly as possible, we need to leverage the infrastructure, experience and expertise available within BARDA, other federal agencies, industry and academia,” Dr. Richard Hatchett said.

In early September, BARDA also gave $20 million to Japan-based Takeda Pharmaceutical Co. to develop a Zika vaccine.

Meanwhile, Sanofi’s funding from BARDA will be used for mid-stage trials that will likely begin in the first half of 2018, and for manufacturing the vaccine. Work on the vaccine already began in March as a collaborative effort between the U.S. Department of Defense's Walter Reed Army Institute of Research (WRAIR), BARDA and the National Institutes of Health.

Sanofi’s contract runs through June, 2022, but if the data is positive, the contract includes an option for up to additional $130.45 million for late-stage trials.

While a Zika vaccine has not yet been developed in the U.S., the first U.S. test for the virus became available in early May after Quest Diagnostics received an Emergency Use Authorization (EUA) for its Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test).

Until then, the only Zika tests authorized by the FDA were available from the CDC, which could only be used in qualified laboratories designated by the CDC.