Rapid Medical Countermeasure Response to Infectious Diseases Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary (2016) / Chapter Skim
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4 Rapid Development of Ebola Vaccines
4 Rapid Development of Ebola Vaccines
Pages 31-46
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From page 31... ...
The Team B panel was co-chaired by Osterholm and Farrar of the Wellcome Trust and consisted of 26 international vaccine experts, including 8 senior scientists from Africa. Over the course of about 3 months, the team reviewed the issues surrounding the development of Ebola vaccines and made 48 recommendations in 7 focus areas: manufacturing, safety and efficacy/effectiveness determination of Ebola vaccines, regulatory pathways, ethics, community engagement, vaccination strategies, and funding.
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From page 32... ...
Current and planned Ebola vaccine clinical trials include both randomized controlled trials and open-label trials. BARDA also provides funding to support manufacturing and analytical testing (e.g., scale-up from pilot to commercial scale, thermostability of vaccines)
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From page 33... ...
Robinson emphasized the value of BARDA's numerous partnerships with industry, federal partners, WHO, and, more recently, nongovernmental organizations, such as the Wellcome Trust and the Bill & Melinda Gates Foundation. Over the past 4 years, BARDA has developed a package of core service assistance programs to help MCM developers with preclinical animal studies, advanced development and manufacturing, fill finish manufacturing, and clinical studies.
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From page 34... ...
Because science informs regulatory decision making, the FDA coconvened a workshop in December with NIH on Ebola vaccine immunology. Understanding randomized clinical trials are not the only method to demonstrate vaccine efficacy, Gruber noted, the FDA was also planning a Vaccines and Related Biological Products Advisory Committee meeting that took place on May 12, 2015.
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From page 35... ...
However, the vaccine doses required to induce comparable immune responses may differ between humans and nonhuman primates with other concerns to consider, including stability, manufacturing consistency, and product testing. A compressed clinical development timeline means that the FDA is relying on interim data decide whether to allow a sponsor to proceed to the next phase of the study.
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From page 36... ...
Multinational pharmaceutical companies have a tremendous amount to offer, he added, and he shared his perspective on effectively engaging them as partners, based on Merck's recent experience in Ebola vaccine development. Developing an Ebola Vaccine Merck first heard about an opportunity to develop an Ebola vaccine on October 1, 2014, and it quickly became apparent that there was a public health imperative to advance a Our collective success will depend promising vaccine candidate.
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From page 37... ...
Clinical studies were done at multiple sites around the world, supported by WHO, NewLink, Merck, and the Public Health Agency of Canada, with funding from DoD, the National Institute of Allergy and Infectious Diseases (NIAID) , The Bill & Melinda Gates Foundation, the Wellcome Trust, and the European Commission.
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From page 38... ...
of the current response will inform and influence the global health community's response to future emerging infectious disease outbreaks. ENGAGING THE INNOVATORS: SMALL BIOTECHNOLOGY COMPANY PERSPECTIVE Small biotechnology companies are actively involved in innovation, said Wouter Latour, chief executive officer of Vaxart, and he urged their inclusion in public–private partnerships for MCM development.
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From page 39... ...
In August 2014, when the Ebola outbreak was emerging, NGDS Increment 1 was able to leverage this prior investment, and the program was the first to receive an EUA for an Ebola virus diagnostic. Dunn pointed out that, because of forward thinking, the assay had been developed not only for use with DoD deployed systems, but assay performance had also been evaluated on commercially available systems that are commonly used in the Laboratory Response Network across the United States and worldwide.
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From page 40... ...
Models of collaboration need to envision what might happen and lay the groundwork to combat emerging infectious diseases that may not even have a name yet. Regarding prioritization, Robinson said that BARDA conducts assessments of threats and the consequences of those threats, and then considers target products and specific needs.
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From page 41... ...
Latour agreed, and said that, while obtaining a priority review voucher was not the deciding point for his company, it was there as "a potential carrot." The indirect economic benefit plays into the equation when making the decision to invest, he said, which can vary depending on the target disease and corresponding perceived market (e.g., pandemic influenza strain, where there is likely a global need to purchase any product, or dengue fever, which has limited geographic spread and therefore carries a limited marketplace)
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From page 42... ...
Robinson stressed the need to identify, assess, and prioritize threats. BARDA can work with a prioritized list of the top 5 to 10 emergent infectious diseases and work with small companies, providing not only funding but also assistance with development.
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From page 43... ...
. BOX 4-1 Typical Timeline for Vaccine Development: 15 to 20 Years • Scientific opportunity • Translation and feasibility • Definition of desired target product profile • Clarity on anticipated vaccine demand and economic/public health value • Definition (and enforcement)
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From page 44... ...
Importantly, Merck committed on January 26 to providing this vaccine at no-profit prices to GAVI-eligible countries.6 According to Feinberg, licensure of the vaccine and target procurement by GAVI is projected for the second half of 2015. Wouter Latour Chief Executive Officer, Vaxart Similar to the rVSV vector vaccine described by Feinberg, Vaxart uses a viral vector platform.
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From page 45... ...
to make an Ebola vaccine construct, which scientists at USAMRIID then tested and found to be protective in mice. Vaxart submitted a request for funding for nonhuman primate studies, but the program was ultimately shelved due to limited resources.
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