The Lancet Series: New Decade of Vaccines

The Lancet Series: New Decade of Vaccines
Launched in London on June 9, 2011
Vaccines are undoubtedly one of the best investments in health. Immunisation programmes have contributed enormously to reducing the burden of infectious diseases, and are responsible for much of the falling rates of morbidity and mortality worldwide. In December 2010, global health leaders committed to making the next 10 years the Decade of Vaccines – to ensure discovery, development, and delivery of lifesaving vaccines globally, especially to the poorest countries. This Series looks at every aspect of this medical technology, including the developments expected over the coming decade and what we can expect from translation of the latest vaccine science. Improving vaccine coverage and financing of both existing and newer vaccines together with how we communicate the benefits of vaccines and ensure public trust and confidence, are also examined.

Series Comments
The vaccine paradox
Richard Horton, Pamela Das
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A call to action for the new decade of vaccines
E Richard Moxon, Pamela Das, Brian Greenwood, David L Heymann, Richard Horton, Orin S Levine, Stanley Plotkin, Gus Nossal
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Will the Decade of Vaccines mean business as usual?
Helen Rees, Shabir A Madhi
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Is immunisation child protection?
Adam Finn, Julian Savulescu
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Public–private collaboration in vaccine research
Juhani Eskola, Terhi Kilpi
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The last mile in global poliomyelitis eradication
Zulfiqar A Bhutta
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Series Papers
The next decade of vaccines: societal and scientific challenges
E Richard Moxon, Claire-Anne Siegrist
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Summary
Vaccines against microbial diseases have improved the health of millions of people. In the next decade and beyond, many conceptual and technological scientific advances offer extraordinary opportunities to expand the portfolio of immunisations against viral and bacterial diseases and to pioneer the first vaccines against human parasitic and fungal diseases. Scientists in the public and private sectors are motivated as never before to bring about these innovations in immunisation. Many societal factors threaten to compromise realisation of the public health gains that immunisation can achieve in the next decade and beyond—understanding these factors is imperative. Vaccines are typically given to healthy individuals and safety issues loom high on the list of public concerns. The public needs to regain confidence in immunisation and trust the organisations responsible for the research, development, and implementation of vaccines. In the past, by use of a judicious amalgam of knowledge and empiricism, successful vaccines were largely developed by microbiologists who identified antigens that induced immune responses to conserved pathogen components. In the future, vaccines need to be developed against deadly diseases for which this strategy is often not feasible because of the extensive antigenic variability of relevant pathogens. High microbial diversity means that immunity after natural infection is often ineffective for prevention of disease on subsequent exposure, for example in HIV infection and malaria. Additionally, vaccines need to be generated to protect the people who are most vulnerable because of age or underlying diseases. Thus, in the future, a much deeper understanding of the immunological challenges—including the diversifying role of host genetics and environmental factors, leading perhaps to more personalised approaches—will be the touchstone for rational design and development of adjuvants that result in novel safe and effective vaccines.

Vaccine discovery and translation of new vaccine technology
Rino Rappuoli, Steven Black, Paul Henri Lambert
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Summary
An unprecedented increase in new vaccine development has occurred over the past three decades. This activity has resulted in vaccines that protect against an increased range of vaccine-preventable diseases, vaccines that reduce the number of required injections, and vaccines with improved safety and purity. New methods of discovery, such as reverse vaccinology, structural biology, and systems biology, promise new vaccines for different diseases and efficient development pathways for these vaccines. We expect development of vaccines not only for infectious diseases in children but also for healthy adults, pregnant women, and elderly people, and for new indications such as autoimmune disease and cancer. We have witnessed a concomitant development of new technology for assessment of vaccine safety to rapidly identify potential safety issues. Success of these new approaches will depend on effective implementation of vaccination programmes, creative thinking on the part of manufacturers and regulators as to how best to ensure that safe and effective vaccines are available in a timely manner, and improvement of public awareness about the benefits and risks of new vaccines in a way that encourages confidence in vaccines.

Vaccine production, distribution, access, and uptake
Jon Smith, Marc Lipsitch, Jeffrey W Almond
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Summary
For human vaccines to be available on a global scale, complex production methods, meticulous quality control, and reliable distribution channels are needed to ensure that the products are potent and effective at the point of use. The technologies used to manufacture different types of vaccines can strongly affect vaccine cost, ease of industrial scale-up, stability, and, ultimately, worldwide availability. The complexity of manufacturing is compounded by the need for different formulations in different countries and age-groups. Reliable vaccine production in appropriate quantities and at affordable prices is the cornerstone of developing global vaccination policies. However, to ensure optimum access and uptake, strong partnerships are needed between private manufacturers, regulatory authorities, and national and international public health services. For vaccines whose supply is insufficient to meet demand, prioritisation of target groups can increase the effect of these vaccines. In this report, we draw from our experience of vaccine development and focus on influenza vaccines as an example to consider production, distribution, access, and other factors that affect vaccine uptake and population-level effectiveness.

The future of immunisation policy, implementation, and financing
Orin S Levine, David E Bloom, Thomas Cherian, Ciro de Quadros, Samba Sow, John Wecker, Philippe Duclos, Brian Greenwood
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Summary
Vaccines have already saved many lives and they have the potential to save many more as increasingly elaborate technologies deliver new and effective vaccines against both infectious diseases—for which there are currently no effective licensed vaccines—such as malaria, tuberculosis, and HIV and non-infectious diseases such as hypertension and diabetes. However, these new vaccines are likely to be more complex and expensive than those that have been used so effectively in the past, and they could have a multifaceted effect on the disease that they are designed to prevent, as has already been seen with pneumococcal conjugate vaccines. Deciding which new vaccines a country should invest in requires not only sound advice from international organisations such as WHO but also a well informed national immunisation advisory committee with access to appropriate data for local disease burden. Introduction of vaccines might need modification of immunisation schedules and delivery procedures. Novel methods are needed to finance the increasing number of new vaccines that have the potential to save lives in countries that are too poor to afford them. Here, we discuss some options.

Addressing the vaccine confidence gap
Heidi J Larson, Louis Z Cooper, Juhani Eskola, Samuel L Katz, Scott Ratzan
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Summary
Vaccines—often lauded as one of the greatest public health interventions—are losing public confidence. Some vaccine experts have referred to this decline in confidence as a crisis. We discuss some of the characteristics of the changing global environment that are contributing to increased public questioning of vaccines, and outline some of the specific determinants of public trust. Public decision making related to vaccine acceptance is neither driven by scientific nor economic evidence alone, but is also driven by a mix of psychological, sociocultural, and political factors, all of which need to be understood and taken into account by policy and other decision makers. Public trust in vaccines is highly variable and building trust depends on understanding perceptions of vaccines and vaccine risks, historical experiences, religious or political affiliations, and socioeconomic status. Although provision of accurate, scientifically based evidence on the risk—benefit ratios of vaccines is crucial, it is not enough to redress the gap between current levels of public confidence in vaccines and levels of trust needed to ensure adequate and sustained vaccine coverage. We call for more research not just on individual determinants of public trust, but on what mix of factors are most likely to sustain public trust. The vaccine community demands rigorous evidence on vaccine efficacy and safety and technical and operational feasibility when introducing a new vaccine, but has been negligent in demanding equally rigorous research to understand the psychological, social, and political factors that affect public trust in vaccines.

Related Articles published in The Lancet
Making new vaccines affordable: a comparison of financing processes used to develop and deploy new meningococcal and pneumococcal conjugate vaccines
James R Hargreaves, Brian Greenwood, Charles Clift, Akshay Goel, Anne Roemer-Mahler, Richard Smith, David L Heymann
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Summary
Mechanisms to increase access to health products are varied and controversial. Two innovative mechanisms have been used to accelerate the development of low-price supply lines for conjugate vaccines. The Meningitis Vaccine Project is a so-called push mechanism that facilitated technology transfer to an Indian company to establish capacity to manufacture a vaccine. The Advanced Market Commitment for pneumococcal vaccines is a so-called pull mechanism that guarantees companies a supplement paid in addition to the purchase price for vaccines for a specific period. We compare these approaches, identifying key dimensions of each and considering their potential for replication. We also discuss issues that the Global Alliance for Vaccines and Immunisation (GAVI) face now that these new vaccines are available. Progress towards GAVI’s strategic aims is needed and funding is crucial. Approaches that decrease the financial pressure on GAVI and greatly increase political and financial engagement by low-income countries should also be considered.

Bill Roedy
Priya Shetty
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Helen Rees on the quest for global equity
Pamela Das
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