Takeda Pharmaceutical Company has been selected by the US Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine in support of Zika response efforts in the US and affected regions around the world. BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services, will supply initial funding to Takeda of $19.8 million to cover vaccine development through Phase I, with potential funding of up to $312 million if ASPR/BARDA exercises all options to take the vaccine through Phase III trials and the filing of the biologics license application in the US.

Under the agreement, Takeda will develop an inactivated, adjuvanted, whole Zika virus vaccine. The objectives of the first stage of the work include developing and producing the investigational vaccine and completing preclinical studies, submission of an investigational new drug application to the US Food and Drug Administration, and execution of a Phase I clinical trial. Takeda will manufacture the vaccine at its facilities in Hikari, Japan.

The World Health Organization declared the Zika outbreak to be a public health emergency of international concern on February 1, 2016. On February 8, 2016 the Centers for Disease Control and Prevention elevated its Zika response efforts to its highest response level, Level 1. The virus has spread in recent years into more than 60 countries and territories, including the US.

Takeda is in discussions with the Cabinet Secretariat of the Prime Minister Office of Japan regarding potential participation of Japanese health agencies in this collaboration. Takeda is working with ASPR/BARDA and the Japanese government to explore further opportunities.

Source: Takeda Pharmaceutical Company