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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.

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.

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.