Here we explore Takeda’s efforts to develop a Zika vaccine and the crucial role vaccine development programs play in tackling emerging diseases.

Laurence De Moerlooze, Vice President & Global Lead Zika, Takeda Vaccines; Gary Dubin, Senior Vice President and Head of the Global Medical Office, Takeda Vaccines; and Rahul Singhvi, Chief Operating Officer, Takeda Vaccines, underline the importance of partnerships and innovation in Takeda’s efforts.

Introduction

In 2015 and 2016, an outbreak of Zika virus spread rapidly from its epicenter in Brazil to a number of countries across the Americas. Infected travelers carried this virus to other continents but luckily didn’t cause major outbreaks. First identified in humans in 1952, Zika is primarily transmitted by the bite of an infected mosquito in tropical and subtropical regions, which usually bite during the daytime but are also active in the evening and at night. The virus can also be transmitted from mother to fetus during pregnancy as well as through sexual contact, transfusion of blood, and organ transplantation.

For most people, a Zika infection is minor and may cause mild illness. However, during the recent outbreak, Zika was linked to the devastating birth defect microcephaly (where the baby’s head is smaller than normal) and other congenital brain abnormalities, as well as miscarriage and the rare nerve disease Guillain-Barré syndrome. As these serious neurological associations became apparent and with the number of cases rising fast, a global public health emergency was declared by the World Health Organization (WHO) in 2016. With no available vaccines, the crisis called for a coordinated and collective response from the vaccine research and manufacturing community.

Vaccine development

Takeda, having expertise in the Flavivirus vaccine field acquired through the ongoing development of a vaccine candidate for dengue, believed that this could be leveraged to support a rapid, collaborative response to the outbreak of Zika, a mosquito borne Flavivirus. By partnering with the Biomedical Advanced Research and Development Authority (BARDA), a U.S. Department of Health and Human Services office, Takeda was able to develop the vaccine candidate TAK-426. It entered a Phase I trial within 15 months of initial development, joining a number of other Zika vaccine candidates. Gary Dubin explains: “Application of a well-established platform, the inactivated virus approach used for other licensed Flavivirus vaccines (such as tick borne encephalitis virus and Japanese encephalitis virus vaccines), gave us a higher probability of technical success in addressing the problem urgently.”

In developing vaccines, pharmaceutical companies often face barriers that require innovation to overcome. As Dubin explains: “It was clear that there were substantial challenges as Zika was a relatively new emerging virus. There were limitations in the medical community’s knowledge and in the availability of reagents and assays that were needed to allow detection of the virus.” This is where working collaboratively with a number of organizations was key to success.

Partnerships

Partnerships are crucial to the innovation demanded from the pharmaceutical industry. For Takeda’s Zika vaccine development, it was partnership with bioprocess equipment manufacturers that enabled Takeda to increase productivity and reduce cost of manufacturing while maintaining high quality in its vaccine candidate.

As is often the case, circumstance also played a role in the development of the vaccine candidate, alongside expert knowledge, partnerships and innovation. As Rahul Singhvi shares: “We had manufacturing capacity in the company that could be deployed to rapidly establish a commercial-scale manufacturing operation for our Zika vaccine candidate. That helped our proposition to BARDA for a rapid response.”

Public health emergencies encourage collaboration and innovation from regulators, too. In January 2018, the U.S. Food and Drug Administration (FDA) granted Takeda’s Zika vaccine Fast Track designation. This Fast Track process is designed to facilitate the development and expedite the review of drugs and vaccines for serious conditions that fill an unmet medical need.

Thankfully, WHO declared an end to Zika’s global public health emergency in late 2016 as the outbreak became contained. Whilst good news, this does highlight the challenge faced by pharmaceutical companies in their decision to respond to public health emergencies given the significant costs involved. WHO’s Zika Vaccine Development Technology Roadmap continues to state the vision and strategic goals for a licensed Zika vaccine and Takeda will endeavor to progress its candidate through clinical development. “The much welcomed declining epidemiology of Zika will make wide-scale efficacy testing more challenging. But with experts agreeing that, unfortunately, Zika will return at some point, we have to continue to adapt and innovate as we go along,”  says Laurence De Moerlooze.

Development programs for emerging diseases such as Zika require a special response that cannot afford to follow a traditional drug or vaccine development route. Takeda’s fast response to the global Zika emergency, utilizing prior knowledge and working collaboratively to innovate in the face of a major public health concern, is a great illustration of how innovation and partnerships can help to tackle the threat of emerging infectious diseases.

Author

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  Laetitia Bigger Director, Vaccines Policy l.bigger@ifpma.org