Impact of BRICS' investment in vaccine development on the global vaccine market.

Brazil, the Russian Federation, India, China and South Africa--the countries known as BRICS--have made considerable progress in vaccine production, regulation and development over the past 20 years. In 1993, all five countries were producing vaccines but the processes used were outdated and non-standardized, there was little relevant research and there was negligible international recognition of the products. By 2014, all five countries had strong initiatives for the development of vaccine technology and had greatly improved their national regulatory capacity.

Tools and approaches to ensure quality of vaccines throughout the cold chain.

The Expanded Program on Immunization was designed 40 years ago for two types of vaccines: those that are heat stable but freeze sensitive and those that are stable to freezing but heat labile. A cold chain was developed for transport and storage of such vaccines and established in all countries, despite limited access to resources and electricity in the poorest areas. However, cold chain problems occur in all countries.

Global support for new vaccine implementation in middle-income countries.

Middle-income countries (MICs) as a group are not only characterized by a wide range of gross national income (GNI) per capita (US $1026 to $12,475), but also by diversity in size, geography, governance, and infrastructure. They include the largest and smallest countries of the world-including 16 landlocked developing countries, 27 small island developing states, and 17 least developed countries-and have a significant diversity in burden of vaccine-preventable diseases. Given the growth in the number of MICs and their considerable domestic income disparities, they are now home to the greatest proportion of the world's poor, having more inhabitants below the poverty line than low-income countries (LICs).

WHO policy development processes for a new vaccine: case study of malaria vaccines.

Background: Recommendations from the World Health Organization (WHO) are crucial to inform developing country decisions to use, or not, a new intervention. This article analysed the WHO policy development process to predict its course for a malaria vaccine.

Methods: The decision-making processes for one malaria intervention and four vaccines were classified through (1) consultations with staff and expert advisors to WHO's Global Malaria Programme (GMP) and Immunization, Vaccines and Biologicals Department (IVB); (2) analysis of the procedures and recommendations of the major policy-making bodies of these groups; (3) interviews with staff of partnerships working toward new vaccine availability; and (4) review and analyses of evidence informing key policy decisions.

The role of emerging manufacturers in access to innovative vaccines of public health importance.

The role of developing country manufacturers in assuring global access to innovative vaccines was compared to the situation in 2005. These producers now supply over 60% of traditional vaccines doses globally and an increasing value (up to 15% in 2007) of innovative products. More suppliers are now strong players in global market, and an even larger group has potential to do so.

Reaching international GMP standards for vaccine production: challenges for developing countries.

Standards for vaccine production have been increasing at a rapid rate. Current standards of good manufacturing practice (GMP) had been thought to be out of the reach of developing country vaccine producers, many of whom are in the public sector, overseen by unvalidated national regulatory authorities (NRAs). With the advent of the GMP regulations in 1963 and their application to vaccine production, even many industrialized country manufacturers with stringent NRA oversight had difficulties.

The GAVI Financing Task Force: one model of partner collaboration.

The Global Alliance for Vaccines and Immunization, now called the GAVI Alliance, was launched in 2000 as a coalition of partners, including countries, international organizations, bilateral donors, the vaccine production industry, and nongovernmental organizations; most activities were to be implemented through these partner organizations. Four task forces were established at the outset to define issues relevant to GAVI Alliance goals and to recommend actions. This paper describes the innovations and outputs of the Financing Task Force (FTF), which worked in three areas: country support to sustainably finance vaccines and immunization programs in the context of introducing new vaccines; vaccine supply and demand issues as they impact vaccine choice, production costs and price/dose; innovative financing mechanisms for vaccines and immunization programs through, for example, capital markets.

Strategies for financial sustainability of immunization programs: a review of the strategies from 50 national immunization program financial sustainability plans.

Financial sustainability plans (FSPs) were developed by over 50 of the world's poorest countries receiving funding support from the Global Alliance for Vaccines and Immunization (GAVI) to introduce new and underused vaccines, injection safety and immunization service support between 2000 and 2006. These plans were analysed with respect to the strategies selected to promote financial sustainability, allowing classification of FSP strategies in three areas: (1) mobilizing additional resources, (2) increasing the reliability of resources, and (3) improving program efficiency. Despite some country successes and the magnitude of planned financial sustainability strategies, huge funding gaps remain for these countries due to the initial underlying assumptions of the GAVI and financial sustainability plan model.

Introducing new vaccines in the poorest countries: what did we learn from the GAVI experience with financial sustainability?

This paper reviews the experience of the Global Alliance for Vaccines and Immunization (GAVI) in introducing hepatitis B and Haemophilus influenzae type b vaccines in the poorest countries, and explores how financing for immunization has changed since GAVI Fund resources were made available during its first wave of support between 2000 and 2006. The analysis of Financial Sustainability Plans in 50 countries allowed for some of the original funding assumptions of the GAVI approach to be tested against the realities in a wide set of countries, and to highlight implications for future immunization efforts. While the initial GAVI experience with financial sustainability has proved successful through the development of plans, and many countries have been able to both introduce new vaccines and mobilize additional financing for immunization, for future GAVI supported vaccine introduction, some country co-financing of these will be needed upfront for the approach to be more sustainable.

The GO License: only part of the solution.

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.

Strengthening immunization in a West African country: Mali.

Unlabelled: OBJECTIVES AND CONTEXT: This paper describes the preliminary outcomes of a collaborative capacity-building initiative performed in Mali to strengthen the immunization program.

Methods: We conducted baseline assessments, training and post-training assessments in four programmatic areas: vaccine management, immunization safety, surveillance, and vaccine coverage, using adapted World Health Organization (WHO) tools. Impact assessment was done by evaluation of trainee performance, programmatic impact and sustainability.

Development of new tuberculosis vaccines: a global perspective on regulatory issues.

What are the regulatory challenges for testing and introducing investigative TB vaccines into countries where the disease is endemic?

The impact of globalization on vaccine development and availability.

Globalization is likely to affect many aspects of public health, one of which is vaccine-preventable communicable diseases. Important forces include increased funding initiatives supporting immunization at the global level; regulatory harmonization; widespread intellectual property rights provisions through the World Trade Organization agreements; the emergence of developing-country manufacturers as major players in vaccine supply; and the appearance of new communicable disease threats, including those potentially linked to bioterrorism. All of these forces can affect, either positively and negatively, the development and availability of vaccines.

Managing the effect of TRIPS on availability of priority vaccines.

The stated purpose of intellectual property protection is to stimulate innovation. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires all Members of the World Trade Organization (WTO) to enact national laws conferring minimum standards of intellectual property protection by certain deadlines. Critics of the Agreement fear that such action is inconsistent with ensuring access to medicines in the developing world.

Development of priority vaccines for disease-endemic countries: risk and benefit.

Decisions regarding vaccine regulation and use made by institutions in industrialized countries can have an unintended impact on vaccines' availability in disease-endemic countries. However, regulatory and programmatic decision making by such countries, taking into consideration local risks and benefits, requires adequate resources, both human and financial. Such differing risk-benefit determinations between industrialized and disease-endemic countries will increase product divergence.

Regulation of vaccines: strengthening the science base.

This paper aims to review the history of development of vaccine regulatory approaches, to assess practices that may be barriers to access to innovative products, and to suggest possible approaches to address these practices. Despite the appearance of new vaccines in the past few years, many vaccines are based on old technologies, and are still subject to regulatory practices devised many years ago. Vaccine regulation began with a foundation on vaccine testing, and only in response to tragedies associated with vaccine use did new concepts begin to be defined.

Regulatory pathways for vaccines for developing countries.

Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval.

Emergency response vaccines: lessons learned in response to communicable diseases.

In response to recent political and epidemiological events, the availability of emergency response vaccines has received high priority on the global agenda. An emergency response vaccine is defined as a vaccine of public health importance that should be available to all people at risk against epidemic, pandemic or global threat situations. This review focuses on global threat vaccines, those that would be used in the case of an emerging pathogen or the intentional release of an agent to which there is a low level of population immunity.

Immunization safety priority project at the World Health Organization.

In 1999, the World Health Organization's (WHO) Department of Vaccines and Biologicals launched the Immunization Safety Priority Project with the aim of establishing a comprehensive system to ensure the safety of all immunizations given in national immunization programs. Countries are the primary focus of the project. WHO has a role, not only because of its technical and normative role, but also because of its privileged relationship with country authorities and other partners, and its global vision and mandate.

Regulatory processes and three Rs alternatives.

Previously, the role of the laboratory in the regulation of vaccines and other biological products was key to assuring vaccine quality, where tests for potency and safety in animals were used to predict vaccine efficacy and safety in humans. In the past, regulation of inherently variable biological products depended on the use of inherently variable biological tests. Today, the concepts of regulation are evolving.

Issues in selection of DTwP-based combination vaccines.

This study examines regulatory, supply, acceptance and financing issues of combinations based on diphtheria-tetanus-pertussis (whole cell) vaccines (DTwP). These combination vaccines are currently produced in Europe mostly for export. Future regulatory oversight issues could have an impact on their availability.