Vaccines of the 21st Century and Vaccinomics: Data-Enabled Science Meets Global Health to Spark Collective Action for Vaccine Innovation

The Parallel Rise of Vaccinomics and Global Health

Why dedicate an entire issue of the OMICS to 21st century vaccine design and vaccinomics for innovation in global health? Decades after the above plea made by Jawaharlal Nehru, India's first and longest serving Prime Minister and a scientific visionary (Pang, 2011), we still lack safe and highly effective vaccines against the common pathogens seriously affecting global society such as neglected tropical diseases and helminth infections, tuberculosis, human immunodeficiency virus, and malaria. These gaps in global health are deepened further by the lack of development of new antimicrobial drugs. Although marked person-to-person and population variability in safety and efficacy of vaccines does exist (Thomas and Moridani, 2010), diagnostics that accurately identify vaccine outcomes are currently not available. Novel diagnostics would help improve customized use of vaccines in subpopulations wherein they display enhanced safety and efficacy. Moreover, signaling an expansion in the classic framing of public health from “prevention” to include “therapeutics,” vaccines are finding new applications in treatment of chronic noncommunicable diseases such as cancer and obesity that increasingly impact health in developing countries (Daar, 2010). Truly, a fresh new look at how we design vaccines and apply them judiciously to benefit global health is essential and timely in the present age of data enabled science and postgenomics integrative biology.

The term “vaccinomics” was coined by Poland and colleagues in 2007 (Poland, 2007; Poland et al., 2007). It refers to the integrated use of data enabled multiomics approaches to understand the mechanisms responsible for heterogeneity in humoral, cell-mediated, and innate immune responses to vaccines at both the individual and population level. As with other examples of data enabled sciences (e.g., pharmacogenomics, nutrigenomics) (Kolker, 2011; Ozdemir et al., 2009), vaccinomics can also be conceptualized as a “science of understanding biological heterogeneity” in vaccine effectiveness and safety. Following the rapid rise of vaccinomics over the past few years, and despite its clear importance for the global public health community, there has been no focused multidisciplinary discussion to synthesize these two strands of knowledge.

Omics technologies, when considered under a sound public health genomics framework (Burke et al., 2010; Khoury et al., 2009; O'Leary and Zimmern, 2010), can offer innovative and potentially cost-effective solutions to current priorities in global health. On May 5, 2009, the Obama Administration announced the U.S. Global Health Initiative which, if appropriated by Congress each year, would provide US$63 billion over 6 years (2009–2014) (Hotez, 2011; The White House, 2009). On January 29, 2010, Bill and Melinda Gates, through the Gates Foundation, pledged $10 billion over 10 years to fund research, development, and delivery of vaccines to the world's poorest countries. The Foundation also recently collaborated with the Grand Challenges Canada Program and the Canadian Institutes of Health Research in awarding the first Canadian Grand Challenges grant, which addresses debilitating parasitic diseases in the developing world. PATH, the Program for Appropriate Technology in Health, has projects for a number of vaccines and vaccine technologies, and has experienced recent historic success with a new meningitis vaccine tailored for Africa.

More recently, a policy report released by the Global Health Technologies Coalition, a group of nearly 40 nonprofit organizations working for vaccines, diagnostics, and drugs that can save lives in the developing countries, emphasized that global health activities provide societal returns that extend well beyond health (PATH, 2011). For example, in the State of California, global health activities in 2007 supported 350,000 high-quality jobs and $19.7 billion in wages and salaries (University of California, 2009). Interest in global health, however, is not limited to industrialized countries of the North or to North–South collaborations. Thorsteinsdóttir et al. (2011) has shown, for example, that South–South entrepreneurial collaboration in health biotech among the developing countries is substantial, and that such cooperation is on the political agenda of many developing countries' governments.

Seeking science-based solutions such as vaccinomics for the extant global public health priorities can only be achieved in a sustainable manner through a tri-partite integration of the biological, social, and political determinants of health (Khoury, 2011; Kickbusch, 2005; Marmot, 2010). Indeed, one cannot help but recognize the importance of the “causes of the causes” for health disparities noted in the quote above by Sir Marmot in his British Medical Association Presidency acceptance speech (Marmot, 2010). It is under this overarching tri-partite integrative vision that the current Vaccinomics and Global Public Health Special Issue has been planned and edited to inform our readership with contributions from leading experts in this rapidly emerging new subfield of data enabled science.

The contents of the Vaccinomics Special Issue are diverse, inclusive, and forward-looking, yet grounded and complementary. In the spirit of the subject matter on global health and vaccinomics, a geographically distributed group of expert authors made contributions from Australia, Asia, Europe, and North America. They provide the conceptual background and the rationale for vaccinomics; attendant high throughput “game changing” experimental approaches and biotechnologies; examples of applications including hitherto neglected tropical diseases vastly affecting the developing countries (e.g., vaccinomics for helminth infections); the new therapeutic cancer vaccines; and the current strategies for vaccinomics-enabled rational vaccine design deployed by the vaccine industry. Recognizing that knowledge-based innovations are coproduced by both technologies and the social systems in which they are embedded (Jasanoff, 2006), we feature in parallel in-depth social science and policy analyses of the new convergence of vaccinomics and global public health.

The following editorial analysis underscores additional related topics and their context that may decisively shape the vaccinomics innovation trajectory as its applications expand globally in both developed and developing countries.

Fostering Vaccinomics Infrastructure Science and Public Health Ethics

Vaccinomics is a prototype example of a data-enabled science that contributes to an infrastructure science—along with the classic discovery science (National Science Foundation, 2011). Infrastructure science includes, for example, population biobanks, vaccinomics data commons, high throughput computational tools, and cyberinfrastructure to transition bioinformatics to cloud applications and thus enable vaccinomics research and development. These two domains of 21st century postgenomics data enabled science—infrastructure science and discovery science—are inseparable and firmly dependent on each other. Hence, a new culture of collaboration and collective action beyond individual-based entrepreneurship is essential for the success of vaccinomics and innovative vaccine design in the 21st century (see also further discussion below on complex collaboration across the knowledge boundaries).

Vaccinomics infrastructure science would greatly benefit from the current broadening of bioethics to include public health ethics. Recently, Onora O'Neill's Nuffield Council 2011 Lecture highlighted the transformative potential of public health for bioethics that hitherto tended to emphasize individual medical ethics (O'Neill, 2011). The latter narrow focus has hitherto marginalized ethical questions about public health and unfortunately emphasized the tensions and risks created for individual autonomy and privacy. According to O'Neill, for public health bioethics, we need to look beyond individual choice and informed consent in deciding what interventions are permissible and necessary for global health. As public goods and as a public good, it would seem that vaccinomics epitomizes such “permissible” public health interventions for the benefit of many. This framing of public health ethics and understanding of vaccinomics as public goods are as justifiable (if not, as necessary for the vaccinomics infrastructure science) as the current principles of protection and individualism underlying the ethics of participation in biomedical research (Knoppers et al., 2010). For the public infrastructure that is necessary for vaccinomics, lessons can be learned from international consortia modeling and data sharing. Indeed, the model tools built in the Public Population Project in Genomics (P³G) and the International Cancer Genome Consortium (ICGC) to promote interoperability and data sharing reflect the building of public infrastructure science alongside discovery science (Schofield et al., 2010). The Wellcome Trust and Hewlett Foundation have come together with a number of other notable signatories, such as the Gates Foundation and the NIH, to publish a joint statement of purpose regarding this topic (Walport and Brest, 2011). In the statement the funders pledge to promote greater access to and use of data in ways that are equitable, ethical, and efficient. They recognize that research progress is best supported by thorough and timely use of data by all interested parties, not just the original research group.

Public Engagement in Vaccinomics: Redefining the Public(s) and Expertise

Past public controversies in genetics/genomics, public health, and vaccines can present a “triple threat” and add uncertainty in the course of social embedding of vaccinomics innovations. Indeed, vaccinomics is a field that is likely to create tensions and leave the public ambivalent, particularly regarding issues like access to vaccines and the companion vaccinomics diagnostics in pandemic situations, the disclosure of omics research results, and whether vaccine programs impinge on individual choices. Moreover, such issues are not easily resolved by governments and experts alone (Lehoux, 2011; Wynne, 2006; see also Einsiedel, 2011, this issue). A broader discussion on vaccinomics through greater public involvement is necessary. However, who is the public we hope to involve?

Avard et al. (2010) distinguish between the general public (e.g., lay public, citizens, consumers), and stakeholders who represent patient organizations and service users. Some view the public as the representative with links to a community organization such as a nongovernmental organization (NGO) or “interest group,” representing the views of the people in their organization; and all “users” of services, such as patients or families (Contandriopoulos et al., 2004). Others differentiate “the public” as action oriented: the inactive, the voting specialist, the parochial participant, the communalist, the campaign activist and the complete activist (Kasperson, 1986).

It is important to realize there is no “single” public, and that the term is highly heterogeneous, variously defined, and often used interchangeably (Condit, 2001). As the field of vaccinomics develops, the ability to meet global public health objectives depends on having a clearer understanding of the diversity of publics as a prerequisite for understanding their input. The 21st century “public” adopts various roles as patient, advocate, evaluator, volunteer, taxpayer, consumer, and citizen. As a result, their perspectives may change either over time or as their role cuts across these different responsibilities. It is critical to be conscious of how fluid, contested, and complex the concept of “the public” is. Also, we must be mindful that representation is another challenge. How much attention should we place on tacit and situated knowledge? Finally, how will the advances envisioned by vaccinomics be received by a heterogeneous public when contextual factors such as beliefs and values will influence the views of the public?

Although cognizant of the need to engage the public(s) in discussions on the above mentioned issues, it will be important to clarify some points when assessing the return of results from data enabled postgenomics science such as vaccinomics. Indeed, although communicating generalizable knowledge to the public is essential, there are limits to what can be returned on the individual level. First, with data-enabled sciences producing vast amounts of incidental and—in most cases—nonvalidated information (Zawati et al., 2011), it is consequently crucial to emphasize that “data” do not necessarily amount to “knowledge,” and that there are limits to what can be returned to participants (Hayeems et al., 2011). Second, it is important to recognize the difficulty of adjudicating results at the scientific level, where “distinctive cultures with respect to interpreting and reporting results” exist, thus making it more difficult to provide homogeneous ethical guidance to scientists in a field of scientific uncertainty (Hayeems et al., 2011). Vaccinomics science will be more context sensitive and thus socially robust and sustainable by early and broad engagement with the public(s) (Ommer et al., 2011).

Collective Action for Vaccinomics and Knowledge-Based Innovations

Many crossfunctional teams in knowledge-based organizations—whether they be universities, private companies, or NGOs—face situations where their members have not worked together before: they represent different knowledge domains, they are tasked with solving complex problems that have novel task demands, they have fluid team boundaries and temporary membership with partial or weak commitments to the broader organizational mandates, and they need to finish their work quickly because of time pressure. Hence, for data-enabled knowledge-based innovations such as vaccinomics that depend on crossfunctional teams, creation of socially robust and contextualized knowledge is not only contingent on access to new gen(omics) biotechnologies and public engagement. It also requires new ways of knowledge coproduction and coordination of collective action in crossfunctional teams (European Commission, 2007; Faraj and Yan, 2009; Majchrzak et al., 2011; Nowotny et al., 2001). That is, the barriers to and opportunities of vaccinomics reside as much in the culture and organizational architecture of data enabled health research in the postgenomics era. Vaccinomics raises collective action challenges as well as opportunities to learn from the management sciences in order to launch complex collaborations across the knowledge boundaries. Moreover, when individuals are embedded in organizational and disciplinary silos, one of the main challenges is to sustain collective action in the face of problems that are complex, long lasting, and with unclear causal effects. Resolution of the collective action challenges through market mechanisms does not generate societally adequate solutions and necessitates a more collective orientation to problem solving. Thus, policy makers and economic actors alike have to agree on a governance regime for emerging data enabled innovations such as vaccinomics (Ostrom, 1990).

The collaboration process that underlies collective action problems is less about traditional decision making and associated information processing, and instead is about suspending judgment, being open to and welcoming of novel ideas, and dialoguing and learning from other perspectives in order to act jointly toward the creation of an innovation. One cannot hope, however, that occasional meetings will engender the emergence of crossfield effective solutions in vaccinomics. Indeed, knowledge integration across specialists and professional disciplines is difficult because specialists often lack a common knowledge or language for representing and interpreting the knowledge of other specialists (Ozdemir, 2010). Each actor understands the same problem differently, does not agree on what aspect of the work is most important, and cannot agree on how to proceed. Much of the extant research on cross-specialty knowledge integration argues that specialists must engage each other intensively across the boundaries in a dialogue that leads to extensive knowledge sharing (Carlile, 2004). There is an urgent need for development of collaborative and integrated vaccinomics knowledge platforms where participants can develop a shared language in order to find a shared solution.

A Final Word on Data-Enabled Science and Vaccinomics

We all feel it. The people so glued to their phones that they walk into a signpost as they hurry down the street; the “bluetoothed” parent who juggles kids, groceries, and a tablet on the way to the car; the scientist who faces terabytes of data waiting to be analyzed. The data deluge it has been called, the overwhelming amount of information that is out there, waiting to be discovered, used, transformed—if only we could get our minds, our networks, our software tools, and our storage hardware to manage it. The overarching message of the Vaccinomics and Global Public Health Special Issue is the impending shift from the “one-scientist-one-project paradigm” to crossdisciplinary collaborative science and the need for the infrastructure science to support teams coming together to find solutions for the unparalleled amount of data to be processed to enable vaccine innovations in the 21st century.

Indeed, vaccinomics holds undeniable potential for improving vaccine efficacy and safety. However, for this approach to ultimately have an impact on public health improvement it has to be integrated into a strategic and cohesive global health and health research framework. Its Achilles heel, which should be addressed by such a framework, is the need to address the gen(omics) and environmental diversity of human and microbial populations and how, and to what extent, this influences humoral, cell-mediated, and innate immune responses to vaccines at both the individual and population levels. The establishment of such a framework requires improved coordination and harmonization of research efforts between external donors and supporters of vaccinomics research and researchers (and end-users) in developing countries. Of particular importance is the effort to link vaccinomics research to biobanks being established in many resource limited countries. Coincidentally, the need to strengthen national health research capacity in developing countries is the theme of WHO's World Health Report for 2012 (Pang, 2011).

To ensure that any resulting vaccine derived from the vaccinomics approach will have a concrete public health impact, there exists another dimension beyond the purely scientific realm: the practical implications of vaccinomics approaches. Too often research and development happen in the absence of practical considerations relating to local (e.g., developing country) context and needs, feasibility, cost, sustainability, capacity, and ease of use and, as a result, excellent products are not fully utilized. On a global level, WHO has recently launched an initiative to identify 10 grand challenges in genomics for public health improvement in developing countries (Brice, 2011). Hopefully, this initiative will identify a research priority agenda that can be used to inform relevant vaccinomics research in the near future. In the age of vaccinomics and postgenomics biology, and given the increasingly transnational and multisectoral nature of future health challenges, an understanding of the political determinants of health crises is also fundamental to addressing such problems through novel approaches such as global health diplomacy (Kickbusch, 2011).

Vaccinomics offers a fresh new look at how vaccines can be designed based on the tools of postgenomics biology in the 21st century, and a unique opportunity for responsible innovation through convergence of data enabled science and global public health priorities. Stay tuned to OMICS for the upcoming knowledge frontiers in postgenomics medicine and integrative biology!