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Despite comprising 70% of the health workforce, women fill only 25% of senior and 5% of top health organization positions. Greater diversity in global health leadership, particularly greater representation of women, is essential to ensure diverse perspectives and ideas inform policies and priorities. Interviews and literature reviews surfaced many of the key challenges that women in global health face at individual, organizational and societal levels. Initiatives working to advance women’s leadership are encouraged to consider 5 key priorities that address these challenges.

U.S. global health investment has focused on detection, treatment, and eradication of infectious diseases such as tuberculosis, malaria, and human immunodeficiency virus/acquired immunodeficiency syndrome, with significant results. Although efforts should be maintained and expanded to provide ongoing therapy for chronic infectious disease, there is a pressing need to meet the challenge of noncommunicable diseases, which constitute the highest burden of diseases globally. A Committee of the National Academies of Sciences, Engineering, and Medicine has made 14 recommendations that require ongoing commitments to eradication of infectious disease and increase the emphasis on chronic diseases such as cardiovascular disease. These include improving early detection and treatment, mitigating disease risk factors, shifting global health infrastructure to include management of cardiovascular disease, developing global partners and private-public ventures to meet infrastructure and funding challenges, streamlining medical product development and supply, increasing research and development capacity, and addressing gaps in global political and institutional leadership to meet the shifting challenge.

Highlights • 8 factors predict the viability of vaccine manufacturers in developing countries. • These factors have evolved as the vaccine landscape has changed over 2 decades. • A new analysis updates a framework first published in 1997 to assess viability. • The updated framework is useful for assessing investments in vaccine manufacturers., In 1997, Milstien, Batson, and Meaney published “A Systematic Method for Evaluating the Potential Viability of Local Vaccine Producers.” The paper identified characteristics of successful vaccine manufacturers and developed a viability framework to evaluate their performance. This paper revisits the original study after two decades to determine the ability of the framework to predict manufacturer success. By reconstructing much of the original dataset and conducting in-depth interviews, the authors developed informed views on the continued viability of manufacturers in low- and middle-income country markets. Considering the marked changes in the market and technology landscape since 1997, the authors find the viability framework to be predictive and a useful lens through which to evaluate manufacturer success or failure. Of particular interest is how incumbent and potentially new developing-country vaccine manufacturers enter and sustain production in competitive international markets and how they integrate (or fail to integrate) new technology into the production process. Ultimately, most manufacturers will need to meet global quality standards to be viable. As governments and donors consider investments in vaccine producers, the updated viability factors will be a useful tool in evaluating the prospects of manufacturers over the mid to long term. The paper emphasizes that while up-front investments are important, other critical factors—including investments in a national regulatory authority, manufacturer independence, and ability to adapt and adopt new technology—are necessary to ensure viability.

As in the market in North America, major barriers to private investment in the development and production of vaccines exist for markets in developing countries. These include the risks of uncertain funding and demand and the difficulties created by historically low pricing. A number of promising and innovative approaches nonetheless are being explored to increase the incentives and reduce the risks of investing in vaccines for developing countries. These innovations are fueled by the growing recognition of powerful stakeholders that vaccines are a critical technology for ensuring global health.

Amie Batson (formerly with the WHO's Global Programme for Vaccines and Immunization and currently a World Bank Health Specialist) explains the relationship between public sector agencies and industry—each at the mercy of the other's strategic policies and both able to benefit from collaboration. Batson explores how a greater understanding and collaboration can lead to better strategies to assure global vaccine supply.

Most vaccines available to national immunization programs rely on old technologies, are produced by a wide range of laboratories, and meet a variety of standards. The world, however, is facing an explosion of new vaccine products and technologies. The challenge facing the international community is to facilitate global access to high quality, affordable vaccines against priority diseases. Strategies developed to address this challenge are targeting assistance to the neediest countries, tiering of prices for new vaccines according to a segmented market, and assuring access to new technologies for viable local producers. The international community may intervene in three major areas: vaccine development, introduction, and self-sufficiency. Necessary activities include prioritization of vaccine options based on epidemiological disease burden, coordinating research and development, minimizing risks and costs of clinical trials, and strengthening infrastructure so that countries can take responsibility for their own vaccine supply needs. The indication that these activities are being effectively managed is the degree to which new vaccines against important diseases are available in all countries for the majority of the population at risk.

Vaccine production exists in > 55 countries, but many production facilities cannot assure a reliable supply of existing or new vaccines. By analysing the characteristics of successful producers, we have identified seven critical elements for viability, each defined by several indicators. Each indicated weakness implies an investment to correct it. Thirty-one manufacturers were assessed based on these viability indicators and the implied investment costs. Three general groupings were found. 'Viable' producers scored well in all seven categories. Those with a 'low probability' of viability are weak in all areas. Facilities regarded as 'potentially viable' may produce sufficient vaccine to meet national needs, but must develop appropriate structures to effectively manage change. This analysis provides a logical system for governments and donors to evaluate the potential effectiveness of further investment in local vaccine production.

Since 1974, the Expanded Programme on Immunization (EPI) has provided technical support for the immunization of the world's children and women of childbearing age. Today, the vast majority of vaccines administered to these groups are delivered through the immunization programmes that have been established in developing countries. As these national programmes share many characteristics, the global use of a new or improved vaccine could be largely dependent on its compatibility with the priorities, existing antigens and vaccine delivery system of this network. Consequently, a framework has been developed for the systematic evaluation of candidate vaccines for use in EPI.

The Generic Open (GO) License is a proposal to make patents more accessible for vaccines and drugs in low- and middle-income countries. However, for some health-related products, such as vaccines, intellectual property is frequently not the primary constraint. Technical know-how and assurance of a viable market built on reliable demand at prices that cover costs are the most critical factors for vaccine access. Together with innovative efforts to reduce product development risks and costs and to assure credible markets at profitable prices, the GO License may yet play a role in assuring access for drugs and vaccines for poor countries.

The costs of developing and producing new-generation vaccines have increased compared to many of the older, "traditional" vaccines because of new technologies and regulatory requirements. While the public sector often supports basic research costs, private manufacturers are usually responsible for the investments in product development and production scale-up. When considering investments, firms evaluate the probability of a market. Unfortunately, the developing country vaccine market is small (in revenue terms) and often unpredictable, particularly given inaccurate forecasting in the past. Low-income developing countries expect low prices. Demand (actual decisions to pay for and introduce the vaccine) is almost always lower than need (estimates of requirements to achieve optimal public health outcomes), a distinction that may be even more significant for HPV vaccines given the number of new vaccines against priority diseases that will become available over the coming 5 years. One new mechanism under consideration to address some of these challenges is Advanced Market Commitments (AMCs). By providing an assured price subsidy for developing country purchase of a future vaccine meeting predefined standards, an AMC would provide industry with greater assurances of earning a reasonable return on their investment to serve the poorest developing countries. The AMC mechanism could provide critical motivation for increased industry (private) investment that would otherwise not occur. HPV vaccines are one of six vaccines being considered for a possible AMC pilot.

Historically, the introduction of new vaccines in developing countries has been delayed due to lack of a coordinated effort to address both demand and supply issues. The introduction of vaccines in developing countries has been plagued by a vicious cycle of uncertain demand leading to limited supply, which keeps prices relatively high and, in turn, further increases the uncertainty of demand. The Pneumococcal Vaccines Accelerated Development and Introduction Plan (PneumoADIP) is an innovative approach designed to overcome this vicious cycle and to help assure an affordable, sustainable supply of new pneumococcal vaccines for developing countries. Translational research will play an important role in achieving the goals of PneumoADIP by establishing the burden of pneumococcal disease and the value of pneumococcal vaccines at global and country levels. If successful, PneumoADIP will reduce the uncertainty of demand, allow appropriate planning of supply, and achieve adequate and affordable availability of product for the introduction of pneumococcal vaccines. This model may provide a useful example and valuable lessons for how a successful public-private partnership can improve global health.

This chapter discusses the role that the economics plays in vaccine development. The characteristics of the vaccine market and how they influence investment in vaccine research and development are described. An understanding of the economic factors encouraging or inhibiting investment in priority products allows public partners to work with the vaccine industry in new ways such as public-private partnerships that are designed to share risk and returns. A series of options for addressing the economic challenges categorized as “push” and “pull” approaches, and the types of public-private partnerships are also discussed. The vaccine market encompasses distinct product and target customer groups where children are the main recipients of vaccines, receiving between 8 and 12 different vaccines in the first year of life. The Vaccine Fund works in parallel with the Global Alliance for Vaccines and Immunization (GAVI) to support the immunization objectives.

Immunization prevents over 3 million child deaths from vaccine preventable diseases such as diphtheria, pertussis, tetanus, measles and polio every year. New vaccines against respiratory and diarrhoeal diseases have the potential to prevent an additional 8 million deaths. Assuring that the existing and new vaccines are available to all children in the world is a global health priority. The health benefits of new vaccines like hepatitis B and Haemophilus influenzae type B (Hib) are indisputable. In the case of hepatitis B, over 1.2 millions deaths could be prevented each year if children and at risk adults were immunized with the hepatitis B vaccine. However, despite the clear health need and benefit, many countries have been unable to provide the 'new' vaccines, like hepatitis B vaccine, to their populations. For these countries, the limitation is not the delivery structure. Most countries now have immunization delivery structures which can provide immediate access to 80% of the country's newborns. Nor is it the vaccine availability as adequate capacity exists to meet the demand. The limitation has been the inability of governments to finance the vaccine because of a combination of factors including dependence on donors, donor policy, inadequate recognition by governments of the value of vaccines and, for some countries, the absolute price of the vaccines. The successes and failures in introducing a 'new' vaccine like hepatitis B vaccine into the world have clearly illustrated that it is economics and not epidemiology which dictates introduction of the vaccine into national immunization programmes. UNICEF and the WHO Global Programme for Vaccines and Immunization (GPV), have now developed and adopted a framework which differentiates countries based on their capacity to be financially self-sufficient for their vaccine needs. This framework forms the basis of strategies designed to co-ordinate the actions of governments, donors, agencies and vaccine manufacturers in order to ensure all countries have rapid access to affordable vaccines.

Immunization programmes, having made significant progress in protecting over 80% of the world's children against six vaccine-preventable diseases, are now facing a crisis in funding for their vaccine supply. Contributing to this situation are changing donor priorities, rising prices, increased needs for vaccines for new disease control initiatives, and the availability of costly new or improved vaccines. The Task Force on Situation Analysis for Vaccine Supply (TFSA) of the Children's Vaccine Initiative (CVI) has developed a framework which provides a logical division of countries into groups that might share similar vaccine supply systems. This framework provides a basis on which to analyse the needs and potential solutions for vaccine supply in countries based on their populations, national wealth, and current ability to produce vaccine. This framework has facilitated the development of strategies to strengthen national vaccine supply systems. It has also provided guidance for governments, donors and development agencies on the most appropriate actions for assuring the objective of sustainable vaccine supply.