Abstract
We analyzed an attempt to develop and clinically test a pneumococcal conjugate vaccine for the developing world, undertaken by public health institutions from the Netherlands, Sweden, Denmark, Norway and Finland: the Dutch Nordic Consortium (DNC), between 1990 and 2000. Our review shows that the premature termination of the project was due less to technological and scientific challenges and more to managerial challenges and institutional policies. Various impeding events, financial and managerial challenges gradually soured the initially enthusiastic collaborative spirit until near the end the consortium struggled to complete the minimum objectives of the project. By the end of 1998, a tetravalent prototype vaccine had been made that proved safe and immunogenic in Phase 1 trials in adults and toddlers in Finland. The planned next step, to test the vaccine in Asia in infants, did not meet approval by the local authorities in Vietnam nor later in the Philippines and the project eventually stopped.The Dutch DNC member, the National Institute of Public Health and the Environment (RIVM) learned important lessons, which subsequently were applied in a following vaccine technology transfer project, resulting in the availability at affordable prices for the developing world of a conjugate vaccine against Haemophilus influenzae type b. We conclude that vaccine development in the public domain with technology transfer as its ultimate aim requires major front-end funding, committed leadership at the highest institutional level sustained for many years and a competent recipient-manufacturer, which needs to be involved at a very early stage of the development.At the national level, RIVM’s policy to consolidate its national manufacturing task through securing a key global health position in support of a network of public vaccine manufacturers proved insufficiently supported by the relevant ministries of the Dutch government. Difficulties to keep up with high costs, high-risk innovative vaccine development and production in a public sector setting led to the gradual loss of production tasks and to the 2009 Government decision to privatize the vaccine production tasks of the Institute.
Highlights
In May 1974, the World Health Assembly adopted a resolution formally establishing what became known as the Expanded Programme on Immunization
In 2015, the African Vaccine Manufacturing Initiative (AVMI) brought together stakeholders to “develop a roadmap to reach a strategy for vaccine manufacturing and procurement in Africa”
The Dutch Nordic Consortium (DNC) management proposed to the European Commission to field-test the DNC vaccine in the Latin American region, by first building up local capacity for pneumococcal quality control and analytical tests followed by vaccine production technology transfer, for example to the Butantan Institute
Summary
In May 1974, the World Health Assembly adopted a resolution formally establishing what became known as the Expanded Programme on Immunization (or EPI). The DNC management proposed to the European Commission to field-test the DNC vaccine in the Latin American region, by first building up local capacity for pneumococcal quality control and analytical tests followed by vaccine production technology transfer, for example to the Butantan Institute. Abbreviations AMC, advanced market commitment; cHib, conjugate Haemophilus influenzae type b vaccine; CVI, Children’s Vaccine Initiative; DNC, Dutch Nordic Consortium; EPI, Expanded Programme on Immunization; GAVI, Global Alliance for Vaccines and Immunization; GMP, good manufacturing practice; MSF, Médicins Sans Frontières; PAHO, Pan American Health Organization; PCV, Pneumococcal conjugate vaccine; RITM, Research Institute of Tropical Medicine; RIVM, National Institute of Public Health and the Environment, the Netherlands; SBL, State Bacteriological Laboratory, Sweden; SIIDC, Swedish Institute for Infectious Diseases, Sweden; SIREVA, SIstema de REdes de Vigilancia de los Agentes bacterianos responsables de neumonía y meningitis; SSI, Staten Serum Institute, Denmark; TFCS, taskforce for child survival; UNDP, United Nations Development Programme
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