The FINANCIAL — Takeda Pharmaceutical Company Limited [TSE: 4502], on September 2 announced that BARDA, the Biomedical Advanced Research and Development Authority, has selected Takeda’s Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions around the world.
Initial funding from BARDA, which is a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services, is for $19.8 million to cover the vaccine development through Phase 1, with potential funding of up to $312 million if ASPR/BARDA exercises all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application (BLA) in the US, according to Takeda.
On February 1 2016, the World Health Organization declared the Zika outbreak to be a Public Health Emergency of International Concern. On February 8, 2016 the Centers for Disease Control and Prevention (CDC) elevated its Zika response efforts to its highest response level, Level 1. There is no vaccine or medicine for Zika2, and infection during pregnancy can cause a serious birth defect called microcephaly and other severe fetal brain defects. Current research suggests that Guillain-Barre syndrome (GBS), which is an uncommon sickness of the nervous system, is strongly associated with Zika; however, only a small proportion of people with recent Zika virus infection get GBS. Many people infected with Zika will have no symptoms or mild symptoms that last several days to a week. The virus has spread in recent years into more than 60 countries and territories including the US.
Dr. Rajeev Venkayya, Corporate Officer and President of the Global Vaccine Business Unit at Takeda said: “The Zika emergency demands swift action by governments, public health agencies, medical and scientific communities, industry and others, and partnerships are essential for success. Working with BARDA, Takeda is deploying its world-class expertise and capabilities in vaccine development for emerging infectious diseases, and our outstanding team and manufacturing facilities in Hikari, Japan. This Zika vaccine program joins our work in dengue, norovirus, our partnership with the Japanese Government on pandemic influenza, and the recently announced partnership with the Bill & Melinda Gates Foundation to help eradicate polio. These efforts to develop a vaccine against the Zika virus reinforce Takeda’s commitment to the health of people everywhere, including the most vulnerable populations that are threatened by Zika.”
Given the Japanese Government’s commitment to preparedness for outbreaks of infectious diseases, recently reinforced by Prime Minister Abe at the G7 Summit in Ise-Shima, Japan, Takeda is in discussions with the Cabinet Secretariat of the Prime Minister Office regarding potential participation of Japanese health agencies in this collaboration. Takeda is working with ASPR/BARDA and the Japanese Government to explore these opportunities further.
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 pre-clinical studies, submission of an Investigational New Drug Application (IND) to the US Food and Drug Administration, and execution of a Phase 1 clinical trial. Manufacturing of the vaccine will occur at Takeda’s facilities in Hikari, Japan.
Takeda’s Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health. For 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, norovirus and polio. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs.