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New Business Models for Vaccines Targeting Diseases in Low-income Countries

Marie-Paule Kieny, MD
Assistant Director-General, Health Systems and Innovation
World Health Organization

There is no doubt that vaccination is among the most effective public health interventions—being accountable for the eradication, elimination, or control of many pathogenic agents which represented in the past major scourges for mankind—and that vaccines are also among the most cost-effective tools available to reduce global disease burden.

Yet vaccines are “special”.  They currently nearly exclusively target healthy persons, and among those mainly infants and children.  There is therefore an expectation that they should be 100 percent safe—which no intervention ever is.  Vaccination is also a global public good.  Indeed, vaccination of an individual also protects to a certain degree the family and friends of that person, and vaccination of many protects the community, through what is referred to as “herd immunity.”  Therefore, it is important to research and develop new vaccines, to improve the effectiveness and safety of those which are already available, to study how best to reach all populations in need and to advocate for universal vaccination.  This last point is critical to avoid the development of “free-rider” comportments (“why vaccinate my child and take any risk of side-effect, if all children in the neighborhood are immunized?”), which could compromise today’s impressive gains.

The U.S. 2010 National Vaccine Plan has very ambitious objectives in terms of fostering vaccine research and development.  It intends to develop evidence-based processes to prioritize investment, to advance the science of vaccines and of human immunology, to develop new production and administration methods, as well as new evaluation criteria.  All these are valuable goals, and they will benefit children and other populations in the United States, as well as in other countries.  They also hold promises to protect children where the toll of infectious diseases is the largest: in developing countries.

But the development of vaccines needed in low-income countries also needs new thinking in terms of research and development.  Indeed, traditional market approaches fail to deliver technologies for diseases which affect predominantly developing countries.  This is the purpose of the Global Strategy and Plan of Action for Public Health, Innovation and Intellectual Property, endorsed by the World Health Assembly in 2009, as well as of intense international negotiations around recommendations of the Consultative Expert Working Group on Research and Development: Financing and Coordination.  New models are thus being elaborated, and demonstration projects proposed to address the above challenge, with active participation of the United States in this endeavor within the World Health Organization’s processes.  Moving along the path of the great success of the MenAfriVac® meningitis A vaccine (developed for Africa by a consortium of willing partners, and used today in more than 100 million people), these novel approaches have potential to expand the benefits of vaccination to eliminate or control many infectious diseases that affect developing countries, such as HIV/AIDS, malaria, tuberculosis, or schistosomiasis, to name only a few.