Perspectives on the MCM response to the 2014 Ebola outbreak were provided by panelists from government and the private sector. (Detailed technical accounts of the MCM development process are included at the end of this chapter in the Chapter 4 Annex.) Michael Osterholm, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, referred participants to the Recommendations for Accelerating the Development of Ebola Vaccines: Report & Analysis.1 The report, released in February 2015, was authored by the Ebola Vaccine Team B, a joint project of CIDRAP and the Wellcome Trust. 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. This followed an interim Team B report, released in January 2015, on the minimal criteria for Ebola vaccines for use in epidemic settings, recognizing that there may be multiple vaccines developed for use in different strategies, and multiple regulatory pathways and governance authorities involved.2
1See http://www.cidrap.umn.edu/recommendations-accelerating-development-ebola-vaccines-0 (accessed June 30, 2015).
2Fast-Track Development of Ebola Vaccines: Principles and Target Product Criteria, available at http://www.cidrap.umn.edu/fast-track-development-ebola-vaccines-principles-and-target-product-criteria-0 (accessed June 30, 2015).
Norman Baylor, president and CEO of Biologics Consulting Group, and a member of Team B, reiterated that the Team B approach was a very rapid process in identifying issues and challenges and developing a roadmap with recommendations and a target product profile. During the Team B meetings, information was received from individuals on the ground in real time, and recommendations were modified accordingly. In outlining its recommendations, Team B considered both what a given group could do with what was in their “toolbox,” as well as what type of recommendations could be made if there were no restrictions on a group’s activity.
The Team B approach is a very effective process, Baylor said, but it needs to occur before the incident. The challenge is deciding when a particular risk needs to be taken up, as most often stakeholders find themselves trying to catch up with the crisis propelling ahead. Osterholm agreed that the Team B process could easily be applied in anticipation of an event, not just in response to an event. Important public health interventions can be brought to bear relatively quickly, but MCMs cannot be deployed if they do not exist.
Since August 3, 2014, BARDA has been in response mode to the Ebola epidemic, said Robin Robinson, director of BARDA. He noted that Ebola is both a bioterrorism threat and an emergent infectious disease, and he briefly discussed BARDA’s role and activities in response to the most recent outbreak. BARDA has been involved in the procurement and development of a number of therapeutic candidates for Ebola (e.g., monoclonal antibodies such as ZMapp). BARDA has also been supporting the advanced development, manufacturing, and testing of three Ebola vaccine candidates, and is in negotiations regarding the development of two other earlier-phase candidate vaccines. 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). Robinson emphasized the value of thermostable vaccines in regions where cold storage can be a problem. He added that BARDA is working with pharmaceutical colleagues on new formulations, including lyophilized vaccines. Of concern, Robinson
noted, was one or more of the vaccines that may provide waning immunity and require administration of a booster dose. BARDA is working with the Global Alliance for Vaccines and Immunization (GAVI) and the United Nations International Children's Emergency Fund (UNICEF) to understand what would be needed to manufacture vaccines, ensure supply, and establish appropriate pricing.
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. To build the U.S. infra-structure for these core activities, BARDA has established Centers for Innovation in Advanced Development and Manufacturing through public–private partnerships and a Clinical Studies Network. BARDA is also discussing with partners the need for a coordinated global infrastructure for response to emergent infectious disease.
To help facilitate timely Ebola vaccine development, the FDA has engaged in numerous meetings with IND sponsors to discuss product information (chemistry, manufacturing, and controls, or CMC), clinical development programs, and different pathways to licensure for Ebola virus vaccines, said Marion Gruber, director of the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research at the FDA. A dedicated team is committed to expedited review of CMC product information, preclinical and clinical protocols, and clinical trials data (where available) for Ebola vaccine candidates. For example, review of an IND is normally completed within 30 days as required by law; however, the FDA has been reviewing INDs for Ebola vaccine studies within days or weeks. The FDA has also approved several emergency-use INDs for postexposure prophylaxis products. For example, select vaccine candidates that have shown at least some protection in animal models were made available through emergency-use INDs to health care workers who have suffered needle stick injuries when taking care of Ebola patients.
This is a global effort, Gruber said, and the FDA is engaging in international consultation and collaboration with its sister national regulatory agencies (European Medicines Agency, or EMA; Health Canada; and others) to discuss the review of Phase I, II, and III clinical protocols and to try to reach regulatory convergence where possible. The FDA has also been assisting African regulators with reviewing Phase II and III clinical trial applications taking place in their countries. Through joint reviews convened under the auspices of WHO, the FDA has reviewed protocols, provided comments, and responded to questions from their African regulatory counterparts.
Because science informs regulatory decision making, the FDA co-convened 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. While safety and effectiveness in trial design are still paramount, they will be discussing options for regulatory approval of Ebola vaccines to be based on outcome measures other than clinical disease endpoints.
Pathways to Licensure
Approval of a new vaccine by the FDA typically requires specific evidence and is based on a clinical disease endpoint trial that shows protection against the disease, or immunologic response as a marker of protection from disease. However, such clinical trials are not always possible or may not be successful because decreasing disease incidence impedes endpoints from being met. In these cases, alternative pathways to licensure are available, Gruber explained. Accelerated approval can be given to products for serious and life-threatening illnesses that provide meaningful benefit over existing treatment (21 CFR 601.40/41). Ebola vaccines would clearly fall into this category, she said, and the sponsor can perform adequate and well-controlled clinical trials demonstrating an effect on a surrogate endpoint, such as an immune response marker that is reasonably likely to predict benefit. When the product is licensed, the sponsor must conduct confirmatory studies to verify the clinical benefit.
Another alternative pathway to licensure is the animal rule (21 CFR 601.90/91). The rule allows for approval of products for serious or life-threatening conditions when human efficacy studies are not ethical or feasible and approval based on other efficacy standards is not possible. If
a well-characterized animal model for predicting response in humans is available, adequate and well-controlled studies can be conducted in animals to provide evidence of effectiveness. Postmarketing studies are then required to verify the product’s clinical benefit and to further assess safety, at a time when such studies are feasible and ethical.
Gruber noted the importance of immunological assessments for Ebola vaccines. A clinical study or using a combination of human and animal data could potentially identify an immune marker that is reasonably likely to predict protection in vaccines. These could then be used to support accelerated approval, and the markers could be used to bridge doses between animals and humans for approval under the animal rule.
Scientific and Regulatory Issues
Gruber highlighted a variety of scientific and regulatory issues related to the approval of vaccines for Ebola. Nonclinical studies are very important. Nonhuman primates mimic human infections in many important aspects, and they are also important for understanding the mechanisms of protection. 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. The FDA is often conducting parallel reviews of multiple candidate vaccines from different sponsors and must take care to preserve confidentiality in communications. Some of these studies are not conducted under a U.S. IND, but the results need to be considered in regulatory decision making. As discussed above, there are different pathways to licensure, so a challenge for alternatives is how to design and conduct postmarketing studies to verify the clinical benefit. For example, when the meningitis B outbreak began at several U.S. colleges and without any licensed vaccine in the United States, the FDA engaged with the manufacturers and made use of accelerated approval pathways to expedite review and approval of a vaccine. Gruber noted that past public health emergencies like this present important opportunities from which to learn in preparation for the next emergency. In closing, Gruber stressed that continued engagement with all stakeholders, such as vaccine manufacturers, clinical trial sponsors, and
national and international partners, is critical for successful clinical development and licensure of Ebola vaccines.
New partnership models can potentially deliver results in an area of great complexity and uncertainty where no one entity is well positioned or capable of doing it alone, said Mark Feinberg, vice president and chief public health and science officer at Merck Vaccines. 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
Our collective success will depend upon the extent to which we can develop effective new partnership models and networks to address these challenges.
— Mark Feinberg, vice president
and chief public health and
science officer at
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 promising vaccine candidate. At that time, the epidemic was expanding and expected to get much worse. Merck wanted to contribute in a way that would be valuable and impactful, using the company’s unique attributes to help fill a gap. According to Feinberg, the company recognized from the start that this was not a commercial opportunity and that vaccine development efforts would be best advanced in collaboration with public-sector partners to pool expertise, share costs and risks, and manage uncertainties. Merck was also encouraged by the commitment from donor organizations such as GAVI and UNICEF to support vaccine procurement.
A successful vaccine program advances through a very coordinated, multidimensional, aligned process where the individual stages of development are closely integrated from discovery to delivery, known as an “end-to-end” process. Many mechanisms are in place to hold the people and the company accountable for delivering results in a timely way. This is challenging enough for a single company where accountability, tracking, and incentives are internally aligned, he said. When multiple stakeholders are involved, delivering timely results
becomes much more complex, given different levels of experience, different priorities, and different awareness of product development issues. Success is predicated entirely on the extent to which effective partnership models exist, he said, and developing them during a crisis adds to the task.
Successes and Challenges of Multistakeholder Partnerships
Multistakeholder international partnerships have enabled the rapid development thus far. Feinberg noted the vaccine candidate came through the Public Health Agency of Canada and NewLink Genetics. 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.
However, Feinberg highlighted several issues that still need to be clarified moving forward. The magnitude and timing of the vaccine need are not yet clear. As discussed by Gruber of the FDA, there are challenges in expediting and integrating regulatory and policy decisions, including the path to licensure if the Ebola epidemic wanes, thereby hindering a formal demonstration of efficacy. A need exists to generate data that inform next-generation products and delivery strategies (e.g., more thermostable formulations, multivalent vaccines). If the pace of the epidemic wanes, the maintenance of momentum and commitment to Ebola product development may be put into question, which may put the progress seen thus far in Ebola MCM development in question as well. Further questions transpire from this process regarding leadership, decision making, risk bearing, and responsibility and accountability for success.
Ultimately, the ability of a company to provide vaccines in desired scale, at the appropriate time, and at the most affordable price is primarily dependent on external factors, Feinberg commented. These include the feasibility and timing of formal demonstration of efficacy, the timing of regulatory approval, need for and timing of WHO prequalification,3 and timing of the WHO Strategic Advisory Group of
3To ensure that medicines purchased and supplied by international procurement agencies for use in resource-limited countries meet acceptable standards of quality, safety, and efficacy. See http://www.who.int/mediacentre/factsheets/fs278/en (accessed June 30, 2015).
Experts on Immunization recommendation. Additionally, affordability is an important factor that Feinberg said is actually a community responsibility. If the manufacturer knows the magnitude and timing of vaccine demand, it can make a product affordably, but when there are many uncertainties up front, the initial supply is often less than the demand, and prices end up being higher, he said.
In closing, Feinberg said we need to consider how best to optimize these partnership models to accelerate vaccine development and delivery efforts in response to current and future public health needs. We should learn from the current outbreak to inform and enable the development of better products to prevent or contain future outbreaks. In addition, we should recognize that the precedent set by the nature and success (or failure) of the current response will inform and influence the global health community’s response to future emerging infectious disease outbreaks.
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. Latour described Vaxart’s work on an oral vaccine administered by room temperature-stable tablets as an example of emerging technology.
Latour pointed out that, for a small company like Vaxart with no revenue, developing breakthrough technologies is dependent on capital. There is pressure to deliver on milestones that drive economic value and help to raise the next level of financing. It is very difficult to convince traditional investors to put their money in a company that is working on Ebola, he said. Vaxart is very interested in working on meaningful targets such as Ebola, but there is a real limit on how much a small company can do without a clear development path and government funding or public–private partnerships to help spread the risk and cost.
DoD has been very interested in diagnostics for Ebola for some time, said Thomas Dunn, program manager for Next Generation Diagnostics
System (NGDS) Increment 1. NGDS is located in the Joint Project Management Office for Medical Countermeasures Systems, which develops medical devices for the warfighter and the deployed environment. Dunn explained that NGDS Increment 1 was developing about 70 different assays for various indications of interest to DoD, and the development of assays for Ebola and some of the other viral hemorrhagic fevers were among the indications that had been prioritized. In 2010, the capability to detect Ebola was developed (a high-complexity-nucleic-acid-test), and a pre-positioned Ebola EUA diagnostic package was submitted to the FDA. Dunn noted that, at the time, there was no expectation that this assay would ever be used in a real-world context. The Ebola diagnostic was intended for pre-positioning a capability to service the warfighter, simply as a precaution.
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. Therefore, the EUA cleared the use of the assay on multiple assay devices, so it was not limited to DoD purposes, but was able to be deployed to support the Ebola response. Unlike other approaches to diagnosing Ebola that can take days, this test can be completed in about 2 to 3 hours.
This is one example of how DoD is able to meet DoD-specific requirements for servicing the needs of the warfighter and to find areas of synergy where a product also meets the needs of the civilian sector. As a government program manager, Dunn noted the challenges of finding industry partners willing to work with the government. He acknowledged that it can be cumbersome and laborious for industry partners to work with the government, and he expressed appreciation for those companies that have expressed their willingness to engage in public–private partnerships.
Osterholm of CIDRAP asked panelists to consider whether, knowing what they know now, they would have made the same decisions at the
start of the outbreak and what they might have done differently. Latour responded that when making a decision to engage in a project like this, companies weigh the risks and look at the potential benefits from a financial point of view. In the case of Ebola, however, his company felt a definite calling to develop a potentially useful tool that they had in concept. Multiple outbreak scenarios were still possible when the decision to reactivate the Ebola program was made in the August–October 2014 timeframe, and there were several unknowns regarding the spread. In retrospect, he said, they learned a lot, and it was still the right decision to make an investment, even for a small company like Vaxart with numerous budget constraints.
Identifying models of collaboration between public and private partners, and potentially between private-sector partners, is critically important for success in the future, Feinberg of Merck said. Expecting that any individual entity could do this on its own is unreasonable. Particularly when there is no clarity around what the need is, it is unreasonable to expect even a large company like Merck to launch a project. To feel comfortable engaging in a high-risk area where there will likely be no return on investment, a framework is needed for partnership and collaboration where different stakeholders step up and contribute what they can uniquely provide. The Merck experience with the current response has been very positive, Feinberg said, but there is still room for improvement regarding how different partners work with each other. 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. Questions include how and when the top threats should be prioritized, who is going to do the prioritization, and how the workload will be distributed. While Robinson reiterated Feinberg’s point that no single institution or government should be responsible for addressing threats, he said it is necessary to determine where the resources and infrastructure will come from when unknown threats arise. Robinson called for a coordinated global group to conduct an assessment to identify the top 25 threats, and subsequently, to determine how to distribute the resources and labor to properly address those top threats. He suggested that the approach to influenza risk assessment and measured response could be a template for other types of
diseases.4 Both Feinberg and Gruber agreed that, as we move forward, greater clarity about expectations and deliverables will be needed given the range of parties involved, including vaccine manufacturers, clinical trial sponsors, and others.
Participants discussed potential incentives or rewards to drive industry participation in the MCM enterprise. Feinberg said that for small companies dealing with tight budgets and questionable survival beyond the next quarter, commercial incentives are clearly important (e.g., creating a market, awarding priority review vouchers). Osterholm added that for a smaller start-up company, incentive funds may offer a lifeline for the business. 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).
For a larger company, Feinberg opined, although financial considerations are important, it is unlikely that enough commercial incentive could be created for that to be the primary driver behind involvement. Other reasons, he said, such as wanting to contribute their expertise and demonstrate social responsibility, play into this decision. Still, research budgets at large pharmaceutical companies are tight, and they need to maximize the productivity of their pipeline. Feinberg noted that every project a company takes on affects the pursuit of other endeavors. While companies do not necessarily want to make a lot of money in this space, they do not want to lose a lot of money either. Feinberg reiterated that a possible way to increase private-sector involvement in high-risk/low-reward endeavors is to have trusted partners come together in a collective effort through shared responsibility, financial support, and clarity about efforts to define the best path forward in circumstances of uncertainty.
4Influenza risk assessment is discussed further in Chapter 5.
Guiding Industry from the Federal Sector
Past emergencies illustrate the importance of formally mapping out a pathway to licensure for many products that could aid in a future public health emergency. In the case of meningitis, discussions and planning for how the FDA would license meningitis B vaccine products took place well ahead of the college outbreaks. Still, because limited resources have inhibited the FDA from doing this in other instances, Baylor inquired whether the FDA could go through an exercise of defining the regulatory pathway to licensure for early-phase products. While this pathway seems to be a necessary tool for mitigating future public health emergencies, Gruber noted that company commitment also plays a large role. In the event of the Ebola outbreak, the FDA received some applications for vaccines in Phase I that were ultimately either withdrawn or not actively pursued by the sponsor. Therefore, company commitment to pursue development is equally important, especially given the difficulty many products have in advancing beyond early clinical development. At the end of 2013, the FDA was thinking about H7N9 clinical trials and development when the EVD outbreak emerged in West Africa and the agency had to readjust and redirect resources because of the crisis at hand. Because there was no sustainable continuity mechanism in place, work on H7N9 will suffer, and in the event that virus emerges on a global scale, MCMs will again be inadequate.
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. Without prioritization, though, this becomes very difficult and diffuse, to the point where nothing will get done. Feinberg suggested thinking not just about specific targets, as they will always be numerous and likely with specific needs, but also about platforms or mechanisms that could expedite development for multiple targets. For example, developing a platform that could be used for all coronaviruses, not just the current outbreak of Middle East respiratory syndrome (MERS), would be useful for the next unknown coronavirus that may emerge. Following a question from Mansoura at Novartis about dealing with public opinion when an investment has been made and the threat did not materialize, Osterholm replied that preparedness is never wasted. Any preparedness work done will not be wasted, because we do not know what will happen next year, or the year after, or in the future.
This annex contains technical details from the
speakers’ presentations related to the development of
products targeting the Ebola virus.
Vice President and Chief Public Health and Science Officer,
The Merck Ebola vaccine candidate (rVSV-ZEBOV-GP) is a recombinant attenuated vesicular stomatitis virus (rVSV) vaccine vector that substitutes the Ebola glycoprotein for the VSV-G glycoprotein. It is replication competent, which means it has the promise of being a single-dose vaccine, and it provides 100 percent protection in nonhuman primates against a high-dose, lethal challenge. The manufacturing process is straightforward and scalable, and the vaccine could potentially be used for both general prophylaxis and postexposure prophylaxis, Feinberg explained.
The typical timeline for full vaccine development is 15 to 20 years, Feinberg said (see 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) of key milestones and “go/no go” criteria
- Process development
- Dose selection
- Establishment of proof of concept
- Additional Phase II evaluation
- Manufacturing/supply solution for affordable production
- Phase III demonstration of safety/efficacy
- Licensure (informed by broad and deep evidence base)
- Generation of evidence to guide policies and recommendations
- Demonstration of feasibility and impact of introduction
- Provision of affordable, appropriate, reliable, and sustainable supply
SOURCE: Feinberg presentation, March 26, 2015.
In describing the accelerated vaccine development timeline for rVSV-ZEBOV-GP, Feinberg said Phase I studies of the vaccine started on October 13, 2014, and Merck finalized a licensing deal with NewLink Genetics and the Public Health Agency of Canada on November 21. By January 25, 2015, enough clinical data had already been generated in collaboration with partners to make a dose selection decision for efficacy and effectiveness trials, and the NIH-Liberia Phase II/III study was initiated on February 2. A Phase III study was initiated by WHO in Guinea5 on March 7, and Feinberg added that a CDC study in Sierra Leone was slated to start on March 30. 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.
Chief Executive Officer, Vaxart
Similar to the rVSV vector vaccine described by Feinberg, Vaxart uses a viral vector platform. Latour described the many advantages of an oral vectored vaccine platform. First, there are advantages that are common across vectored vaccines, including versatility (suitable for delivery of virtually any protein antigen), speed and manufacturability (rapid construction, high yield, consistency), and safety (recombinant protein eliminates the need to work with pathogens). An advantage specific to Vaxart’s platform is oral delivery via room-temperature-stable tablets that are especially relevant for locations with limited infrastructure. The ability to store, distribute, and administer is greatly simplified. There are no needles, which eliminates the risk of needle sticks and increases patient acceptance (especially where there may be
5As of this summary’s release, in fall 2015, published interim results for the clinical trial in Guinea show the vaccine to be highly efficacious and safe in preventing EVD. See more at http://www.thelancet.com/pb/assets/raw/Lancet/pdfs/S0140673615611175.pdf (accessed August 5, 2015).
6Countries are eligible for GAVI support when their gross national income per capita is at or below 1,580USD. For more information see http://www.gavi.org/support/apply/countries-eligible-for-support (accessed August 5, 2015).
cultural resistance against injectable products, particularly if the products are coming from Western societies). There is also no need for a cold chain, allowing for shipment with far fewer controls and reduced cost.
In 2012, Vaxart began a collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) 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. In August 2014, because of the urgent need, USAMRIID and Vaxart reactivated the Ebola program. Latour noted that Vaxart committed some of its own very scarce resources to manufacture vaccine for nonhuman primate and Phase I studies, while resubmitting funding proposals. To date, Vaxart had received no concrete funding, but he was optimistic that it would be forthcoming.
Program Manager, NGDS Increment 1, Department of Defense
In 2013, NGDS Increment 1 began developing the next-generation Ebola test, awarding contracts to multiple vendors from the diagnostics sector to competitively develop an assay, which would lead to selection of a single system that DoD would further develop. In a period of about 6 months, multiple vendors were able to develop an Ebola test using government-furnished information and materials, with access to government sites for testing. The goal, Dunn said, was to develop a lower-complexity test with integrated sample preparation, a “single sample to answer” procedure that would drastically reduce the number of steps a technician would need to do. Analytical time, from sample to answer as a single test, was reduced from 2 to 3 hours to about 70 minutes. The test was designed to be multicomplex; however, due to the Ebola outbreak, it was developed expeditiously to deliver Ebola testing capability.