Ambiguous Capture: Collaborative Capitalism and the Meningitis Vaccine Project

Article (PDF Available)inMedical Anthropology 35(5) · March 2016with 27 Reads
DOI: 10.1080/01459740.2016.1167055
Cite this publication
The primary healthcare approach advanced at Alma Ata to address social determinants of health was replaced by selective healthcare a year later at Bellagio. Subsequently, immunization was endorsed as a cost-effective technical intervention to combat targeted infectious diseases. Multilateral efforts to collaborate on immunization as a universal public health good ambiguously capture the interests of the world's governments as well as private, public, and not for profit institutions. Global assemblages of scientists, governments, industry and non-governmental organizations now work in public-private partnerships to develop and make essential vaccines accessible, with vaccines marketed as single fix solutions for global health. Drawing from ethnographic fieldwork in France and Burkina Faso that followed the development, regulation and implementation of the group A meningococcal conjugate vaccine for sub-Saharan Africa, in this article I describe events during and after the development of MenAfriVac. A technological success narrative steeped in collaborative capitalist rhetoric disguises neglected healthcare systems.
Ambiguous Capture: Collaborative Capitalism and the Meningitis
Vaccine Project
Janice Graham
Faculty of Medicine, Dalhousie University, Nova Scotia, Canada
The primary health care approach advanced at Alma Ata to address social
determinants of health was replaced by selective health care a year later at
Bellagio. Subsequently, immunization was endorsed as a cost-effective
technical intervention to combat targeted infectious diseases. Multilateral
efforts to collaborate on immunization as a universal public health good
ambiguously capture the interests of the worlds governments as well as
private, public, and not-for-profit institutions. Global assemblages of scien-
tists, governments, industry and nongovernmental organizations now work
in public-private partnerships to develop and make essential vaccines
accessible, with vaccines marketed as single fix solutions for global health.
Drawing from ethnographic fieldwork in France and Burkina Faso that
followed the development, regulation, and implementation of the group
A meningococcal conjugate vaccine for sub-Saharan Africa, in this article I
describe events during and after the development of MenAfriVac. A tech-
nological success narrative steeped in collaborative capitalist rhetoric dis-
guises neglected health care systems.
Burkina Faso; public-private
partnership; regulatory
capture; technology transfer;
vaccine development
In 2006, two vaccines targeting different populations were reviewed at the annual meeting of the
World Health Organizations (WHO) Expert Advisory Committee on Biological Standardization. The
human papilloma virus (HPV) vaccine, fast-tracked through a remarkable marketing campaign, would
sell for US $400 as a cancer preventive (Lippman et al. 2007; Tomljenovi and Shaw 2012). In contrast,
an experimental Meningococcal serogroup A conjugate vaccine developed for endemic outbreaks in
sub-Saharan Africa and projected to cost US 40¢ a dose received significantly less critical scholarly
attention over the next few years. There are double the number of bacterial meningitis cases every year
(1.2 million) compared to an estimated 610,000 cancers attributed to HPV infection (Center for
Disease Control and Prevention 2011;Formanetal.2012), yet efficiencies of regulatory capture gained
the HPV vaccine record breaking licensing approval and the adoption of the vaccine worldwide. While
decisions concerning the HPV types to be included in the vaccine revolved around epidemiology,
costs, and marketing (Graham and Mishra 2011; Mishra and Graham 2012), the decision to target only
one meningococcal serogroup (MenA) as the appropriatetechnology for MenAfriVac
was driven by
its affordability.
Each vaccine characterizes a different set of circumstances, geographies, and collaborative capi-
talist opportunities and challenges for global vaccine development and regulation. Pitching a multi-
lateral humanitarian effort in response to local priorities while building country capacity for disease
surveillance, the Meningitis Vaccine Project promised better health, equity, and health system
capacity building. In this article, I examine ambiguities in representation, the appropriateness of
the technology chosen, and the extent that its promise was accomplished.
CONTACT Janice Graham, PhD Professor, Pediatrics (Infectious Diseases) and Medical
Anthropology, Dalhousie University, Technoscience & Regulation Research Unit, Faculty of Medicine, 5849 University Ave, C-302
Halifax, Nova Scotia CANADA B3H 4H7.
© 2016 Janice Graham
This is an Open Access article. Non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly
attributed, cited, and is not altered, transformed, or built upon in any way, is permitted. The moral rights of the named author(s) have been asserted.
2016, VOL. 35, NO. 5, 419432
Drawing from anthropology, health technology assessment, science studies, and bioethics, this
project is part of a longitudinal ethnography of regulatory practices for emerging health bio-
technologies that began in 2000 (Graham 2008). While observing Canadian health regulators
during the 2006 WHO Biological Standardization expert advisory meeting, I met several scientists
involved in the MenA vaccine development. Dr. Marc LaForce, a seasoned international health
physician and Director of the Meningitis Vaccine Project (MVP) (Jódar et al. 2003; Tiffay et al.
2015) invited me in February 2007 to visit the project headquarters in Ferney-Voltaire, France. I
engaged in daily ethnographic participant-observation, attending meetings, interviewing, and
talking with a core group of 15 scientists, clinical trial researchers, technology transfer experts,
and policy and communications personnel at the WHO/PATH (Program in Appropriate
Technologies in Health) MVP headquarters. In October 2007, I attended the WHO African
Vaccine Regulatory Forum meeting in Ouagadougou, Burkina Faso, where the MVP was presented
to around 50 participants. Having experienced a MenA epidemic earlier that year, Burkina Faso
officials were receptive to countrywide implementation once the vaccine achieved regulatory pre-
authorization, although Burkinabé health officials, scientists, and clinical researchers seemed less
enthusiastic than those at the MVP about the vaccines potential to control meningitis. I subse-
quently obtained funding to hold two workshops, in Burkina Faso (February 2009) and Canada
(April 2009), attended by a total of 54 researchers and knowledge users to explore conceptual and
methodological issues related to African decision-making frameworks for vaccines. From 2010 to
2014, I engaged in annual two to three week fieldtrips to Burkina. Taking an ethnographic
approach, the methods of participant-observation, field notes, document analysis, and formal
and informal interviews were employed. Structured and informal interviews were conducted
with 68 clinicians, scientists, government officials, health workers, and community members in
the district of Nouna and in Ouagadougou over those five years. Data were scrutinized in search of
identifiable patterns, clustered, and sorted until distinct and comprehensive themes were gener-
ated. They were used to describe, organize, further explore, and interpret the activities, experi-
ences, and understandings about MenAfriVacs development and implementation.
Developing the Meningitis A conjugate vaccine for sub-Saharan Africa: MenAfriVac
The African meningitis beltstretches from Senegal to Ethiopia (Lapeyssonie 1963). Meningitis
outbreaks typically start in late December when the hot dry harmattan winds generate dust and sand
that invade nasopharyngeal mucosa, while cooler nights and the annual pilgrimage to Mecca bring
people together in small, enclosed areas. Rains in May and June mark the end of the dry meningitis
season and the beginning of the wet malaria season. In 1996 a particularly devastating epidemic,
mostly meningitis group A, killed approximately 25,000 people (WHO 1997). The WHO (1999)
brought together 26 representatives of African ministries of health to a meeting in Ouagadougou. As
the story is told by MVP, countries were calling for a solution.The solution offered at the meeting
was to shift their strategy from epidemic response to epidemic preparedness(Aguado et al. 2015:
S392). Building on MenC conjugate vaccine development, WHOs Immunization, Vaccines, and
Biologics department supported a combined MenA/C conjugate vaccine. By the late 1990s, however,
there was a rising MenC infection rate in the United Kingdom, with a thousand deaths during the
decade. Vaccine manufacturers pooled resources for the MenA/C conjugate vaccine to develop a
monovalent MenC vaccine to meet that emergency (Rappuoli 2003). In sub-Saharan Africa during
the same period, 700,000 people were infected by meningitis, 100,000 died, and 20% to 30% of
survivors were left with life-long disabilities (Jódar et al. 2003). The immunization needs of the
United Kingdom trumped those of AfricaMenA was not considered a market driver(Aguado
et al. 2015:S392). No manufacturer was interested in developing a vaccine for 300 million people too
poor to purchase it. WHO formalized the Epidemic Meningitis Vaccines for Africa project to address
the inequity (Aguado et al. 2015).
Significantly, no alternatives to address social and economic determinants of poor health were on
the table. Nonvaccine solutions never made it to the WHO meeting in Burkina Faso, one of the
worlds poorest countries, where female and male literacy is approximately 16% and 36%, respec-
tively (World Bank 2013). With 11 million inhabitants in 1996 (18.5 million by 2015) from 60
different ethnic groups, almost half the population of Burkina Faso are younger than 15 years. Those
younger than 5 years in low income countries have particularly high mortality rates, picked off by
opportunistic infections exasperated by malnutrition, lack of clean water, and sanitation (Sié 2013).
Vulnerability to periodic drought and desertification severely affects agricultural activities, popula-
tion mobility, and the economy. Formal health services for the rural population are limited to small
health centers staffed by a nurse and midwife. Most of the population cannot afford medications or
the poor quality health care services (Sié 2013:18).
Where people were in need of food, jobs, arable land, education, and health care, conditions that
compromise immune systems, vaccines alone were presented as a solution. As Blume, Jani, and
Raolkvam stated, [t]echnological approaches to complex health problems appeal to policy-makers
furthest removed from cultural and social practices(2013:23). In 2000, fueled by a feasibility
study of existing intellectual property and an economic analysis supporting a MenA vaccine, WHO
again convened scientific experts and representatives from African ministries of health to endorse
their plan. In 2001, the Bill and Melinda Gates Foundation seeded $70 million for technology
transfer to the partnership between WHO and the Seattle based PATH to develop a monovalent
MenA vaccine as a humanitarian appeal to global inequity in disease response (Jódar et al. 2003).
The WHO/PATH/MVP consortium advanced a strategy to eliminate epidemic meningitis through
the development, testing, licensure, and introduction of vaccines. According to an informant, the
CEO of PATH, Chris Elias, wanted to just get the vaccine and leave though he wouldnt say that
now.Previous experience leading a UNICEF task force, however, had taught the Director of MVP
that public health strategies depend on technology and development, external donor assistance,
politics and government, organizational structure and operations(UNICEF 1996:xv). Community
participation, commitment, and mobilization are integral tools in creating an essential demand for
vaccines. Country capacity building for surveillance, monitoring, communication, and vaccine safety
reporting would complement the MVP.
A vaccine, however, needed materials and a manufacturer. LaForce orchestrated the negotiation
of intellectual property rights and business investment models for the technology transfer among a
series of public and private actors. While an established vaccine manufacturer was the preferred
partner required of Gatesprojects, after almost two years of negotiations during an era of
blockbuster pharmaceutical industry profits and despite the humanitarian appeal, the large vaccine
companies could not be persuaded (personal communication).
The Serum Institute of India, Ltd. (SIIL), a family-owned biotechnology manufacturer located in
Pune, was burdened by neither a Board nor shareholders. Government scientists at the US Food and
Drug Administrations Center for Biologics Evaluation and Research (FDA-CBER) had already
developed a conjugation method. MVP worked with the US National Institutes of Health to obtain
the technology for SIIL at a very low cost(personal communication). SynCo Bio Partners, a
biopharmaceutical Good Manufacturing Practice Contract Manufacturing Organization based in the
Netherlands, supplied the antigen, meningitis A polysaccharide (MenA PS), while SIIL provided the
protein tetanus toxoid (TT) to which the antigen would be conjugatedthe binding together of these
two materials generates the enhanced immunity of conjugate technology for PsA-TT MenAfriVac.
Working with leading conjugate vaccine scientists, by 2004 SIIL had a vaccine for preclinical
studies. Human clinical safety trials began in 2005 in India (Phase 1), Mali, Ghana and the Gambia
(Phase 2, 2006-9), and in Mali, Senegal and the Gambia (Phase 2/3) in 2007. To manage rumors, an
integrated communications strategy ensured the active cooperation of stakeholdersthroughout the
clinical trials and introduction (Berlier et al. 2015:S451; Idoko et al. 2015). MVP concentrated
primarily on building technical capacity for surveillance at the Multi Disease Surveillance Center
(MDSC) in Ouagadougou. As a reference center for surveillance and response, MDSC became a fully
equipped microbiology and DNA laboratory providing support for 13 sub-Saharan African countries
(WHO 2009). Equipped with new in-country capacity and reinforced by seconded staff from the US
Center for Disease Control and Prevention (CDC), detailed analyzes could be done to evaluate
meningitis trends and bacteriology. By April 2007, the Burkina Faso Ministry of Health had reported
22,255 suspected cases of meningitis including 1490 deaths and 34 districts, surpassing epidemic
threshold. The Intercountry Support Team (IST) was now in a position to support public health
salaries, epidemiological surveillance, and laboratory activities across the meningitis belt, and
on September 4, 2008, health ministers from the belt signed the Yaoundé Declaration on
Elimination of Meningococcal Meningitis type A Epidemics as a Public Health Problem in Africa
(WHO 2008).
MenAfriVac was approved on January 22, 2010 by the Drugs Controller General of India, who
received regulatory support from Health Canada. SIIL scaled up production to more than
300 million doses after the vaccine met WHOs prequalification procedure for international stan-
dards of safety, quality, and efficacy on June 23, 2010. WHO/MVP provided training for national
regulatory authorities to fine-tune their strategies for the vaccines introduction. WHO/AFRO and
national Ministries of Health were to be integral to the positioning of the MenA vaccine into the
Expanded Program on Immunization (EPI) within five years of its initial introduction,
and in
tracking activities related to changes in serogroup prevalence and incidence after the vaccines
Gatesfunding for MenAfriVac included neither vaccine purchase nor implementation (more
than ten-fold the cost of vaccine development). As a result, a network of collaborative capitalist
relationships were established to fund the introduction. The Global Alliance for Vaccines and
Immunization (GAVI), established by the Gates Foundation in 2000 to broker private-public
partnerships integral to funding vaccines in poor countries, facilitated the purchase (GAVI 2014).
WHO, UNICEF, the World Bank, and the Gates Foundation each hold permanent seats on GAVIs
The strategic unknown of meningitis pathogens and subgroups
The success of the WHO/PATH/MVP SIIL partnership is without precedent (LaForce and Okwo-Bele
2011;Bishaietal.2011; Sow et al. 2011; Marchetti et al. 2012). During six days in December 2010,
MenAfriVac was introduced across Burkina Faso for everyone aged 1 to 29 years. To date, more than
250 million people have been vaccinated across the meningitis belt and Meningitis A appears to have
been eliminated in immunized regions. The capricious epidemiology of meningitis disease, however,
tells a different story, and the degree that MenAfriVac has resolved meningitis epidemics and
succeeded in improving general health systems and economies is not certain.
Bacterial meningitis is caused by three pathogens, Haemophilus influenza, Streptococcus pneu-
moniae, and Neisseria meningitides (Nm). The monovalent vaccine for Neisseria meningitides A
(NmA) tackles only one, albeit the most prominent, of six vaccine preventable subgroups of Nm that
threaten sub-Saharan Africa (Men W-135, Y, X, recently C, and potentially B). These lurking
subgroups represent what McGoey (2012) might call strategic unknowns; their potential to change
with the shifting dynamics and epidemiology of a MenA-free sub-Saharan Africa was largely side-
lined by MVP during MenAfriVac development.
Arriving in Burkina Faso in September 2007, I was struck by the skepticism surrounding
MenAfriVac of several West African clinical researchers. Their experience with the three pathogens
and numerous subtypes of meningitis disease suggested that controlling meningitis would take more
than a MenA vaccine. While no one denied that the conjugate vaccine would be superior to its
polysaccharide predecessors, many regions were already seeing a rise in Men W135 and X, as well as
Streptococcal pneumonia (Djibo et al. 2003; Traoré et al. 2009). MenA was already in decline in
Burkina Faso after the 2007 outbreak, and there were other priorities.
By 2011, these cliniciansconcerns were proving justified. Frustrated Senegalese public health
workers had no appropriate vaccine to treat outbreaks of Men W135 during that countrys MenA
vaccine campaign. In Chad, the preponderance of serogroup W and A varied between areas, while
MenA immunization continued (Caugant et al. 2012). Short duration meningitis outbreaks followed
MenAfriVac immunization in districts of Benin, Burkina Faso and Nigeria, necessitating response,
heightened surveillance, case management, and sensitization (Delrieux et al. 2011; WHO 2013).
Risks of serogroup replacement reported in the literature (Gagneaux et al. 2002) were largely ignored
during the implementation MVP communication-hype. Concerns about reliability and partial
surveillance challenged MVPs claims of herd immunity based on decreased carriage rates. Even in
post-implementation success stories, bracketed caution warranted continued monitoring for poten-
tial replacement strains (Novak et al. 2012; Daugla et al. 2014). While meningitis A is in decline,
positive success stories may be premature. Community outbreaks of Streptoccoccus pneumonia,
Men X, W135, and most recently Men C (Funk et al. 2014; WHO 2015b) gain concern. The
subgroups and pathogens of meningitis disease continue to shift in Africa.
Setting appropriategoals to capture success
Success stories about controlling a disease can be seductive, partial accounts concealing complicated
histories and unpredictable currents of biologies, seasonalities, and shifting pathogenic and ser-
ogroup ecologies. Such narratives mask failures and ignore the social, political, and institutional
exigencies that disrupt science (Clemens and Jódar 2005) and collaborative capitalist projects alike.
In 1980, Halfan Mahler, then WHOs Director-General, warned that single-disease projects would
divert attention and resources from the structural and economic roots of ill health, and from the
commitment to strengthening primary health care(Blume, Jani, and Roalkvam 2013:7).
Critical to success narratives is the setting of achievable goals. At the start, MVP identified an
existing (appropriate) vaccine technology. In 1983, conjugate technology had been proven safe,
effective, and immunogenic while conferring long-term protection in infants with the development
of Haemophilus Influenza type b (Hib) vaccine (Hamidi et al. 2014). Acknowledgement of what
constitutes the success of some programs, however, can meet resistance. Cubas innovative public
good approach to vaccine biotechnology, for instance, produced the first meningitis B vaccine in
1985, and the first affordable synthetic Hib vaccine in 2003 (Reid-Henry 2010; Thorsteinsdóttir et al.
2004). In much the same manner, FDA-CBER and CDC contributed publicly owned conjugate
technology methods to SIIL. The FDAs publicly funded technology transfer eliminated affordability
as the major constraint, and SIIL, a private company, was guaranteed a 10-year publicly funded
market. Through GAVI support, MVP gained commitments in excess of $500 million from
charitable, not-for-profit and nongovernment organizations, to help countries purchase and imple-
ment MenAfriVac.
Meanwhile, what constitutes health systems strengtheninghas gained interest, first from WHO
(2007), and more recently from the Gates Foundation with interest in documenting the impact of
vaccine interventions on health systems (Hyde et al. 2012; Burchett et al. 2012,2014; Mounier-Jack,
Griffiths et al. 2014; Mounier-Jack, Burchett et al. 2014). Building indicators has proven challenging,
however. Complex relationships, numerous interventions, and broad outcomes are neither imme-
diately discernible nor easily counted.
Tallies of MVP success looked only at the vaccine itself. They did not dock points for disrupted
routine services (Mounier-Jack, Burchett et al. 2014) nor document the inability of communities to
respond to the outbreaks of Men W135, C, and Streptococcus pneumonia after the MenAfriVac
campaign. Resourcing local clinics to treat the diseases that replaced MenA was not in the calcula-
tion. WHO IST workshops held in Abidjan and Geneva in 2013 aimed instead at technical
collection, conservation, and transportation of biologic substances; and providing training on
standard operating procedures for enhanced surveillance of meningitis, data management, and
laboratory confirmation work. In the end the overarching goal is to promote standardized
laboratory practices and to enhance the information for decision making(MVP 2013:2). In the
shadow of the UNICEF report that had recommended balancing the technical, political, and cultural
uncertainties of public health, a rhetoric of successful technical vaccine innovation inspired by
international partnerships trumped the more unwieldy social determinants of health and pathogen
subgroup replacement.
A technical political game trumps health systems strengthening
Marchal, Cavalli, and Kegels (2009) questioned claims made about strengthening health systems in
disease-specific initiatives. Such programs leave in their wake duplications, imbalances, and inter-
ruptions to existing programs. They impose external goals, neglect national priorities, and commu-
nity training and resource needs (Mills 2005; Cavalli et al. 2010). Developed to facilitate investments,
the elegance and simplicityof the WHO (2007) building blocks approach has contributed to its
wide adoption and provided a common language and shared understandingfor health systems
strengthening (Mounier-Jack, Griffiths et al. 2014:6). The framework fails, however, to address the
complexity between the blocks, or to articulate subtle issues surrounding workforce, governance, and
community (Mounier-Jack, Griffiths et al. 2014:56).
The MVP was aware of the role communications and social mobilization perform in creating
demand for a vaccine; these instruments were used to obtain high vaccine coverage rates (101% in
some communities). With success counted as numbers vaccinated and ridding Africa of MenA, there
was no need to build sustainable community engagements, health systems, or address social
determinants. There are no scorecards for these.
The gaming of metrics to show success is not new. It proves particularly challenging with the
scarcity of independent appraisers in collaborative capitalist ventures in global health. An interna-
tional call for open access for independent critical appraisal of clinical trial methodologies and data
in recent years raises concerns about such gaming (British Medical Journal 2016; Open Trials 2016).
Undermining claims for the efficacy and safety of health products, evidence grows of institutional
corruption that compromises transparency and accountability in clinical research, and in the
selection of methodologies used to measure success (Light, Lexchin, and Darrow 2013). Conflicts
of interest play a significant role in regulatory decision making (Abraham 1995; Nik-Khah 2014;
Dunn et al. 2014; Pham-Kanter 2014). Global health has its own set of players.
In Far-Fetched Facts, Richard Rottenburg (2009:88, 177) described how attention to externally
driven technical facts renders invisible the cultural and political aspects of development. At the country
level, disease eradication campaigns distract attention and resources from regular immunization
programs and remove essential human resources from primary health care services. Producing mean-
ingful metrics to account for people, their relationships, and geographies requires infrastructure and
human resources against a backdrop of unrestricted education available equally for all.
The opportunity for such a vision was lost in 1979. The year before, at the 1978 Alma Ata
conference, WHO had advocated for socioeconomic development and community participation in
health care. In response, delegates at a Rockefeller sponsored Bellagio Conference in 1979 parsed
primary health into measurable selective primary health care targets for malnutrition, oral rehydra-
tion, breastfeeding, and immunization. Structural adjustment policies by the World Bank and
International Monetary Fund from Organization of the Petroleum Exporting Countries oil revenues
of rich countries were invested in targeted development loans to low income countries. As interest
rates shot up in the 1980s, these countries could not afford to repay these loans and the programs
floundered. To address resource and supply inequities, the 1987 Bamako Initiative recommended
increasing access to essential medicines to decentralize primary health care decision making to the
local level, expecting communities to finance the purchase, delivery, and monitoring of medicines
through revenue from sales (van Olmen et al. 2012). The United States decreased its financial
contributions in protest over WHOs Essential Drug Programme, which was seen to oppose the
pharmaceutical industry: By 1990, the Banks loans for health surpassed WHOs total budget
(Brown, Cueto, and Fee 2006:68). Initiatives advancing systems approaches, where countries might
set their own priorities and where vaccines are but one mechanism to achieve their overall goals,
have received relatively short shrift by the international financial consortia that replaced WHO
(Storeng 2014). As Marc-André Gagnon (2011) described the global pharmaceutical industry
operating as a cartel, so too these consortia do not adhere to capitalist laws of value creation in a
free and open market. Economic analyses are offered without access to raw data and the full
inventory of health determinants. Old and new arguments alike reinforce the claim that vaccines
prevent costly disruptions to health delivery and that, administered through regular schedules, they
contribute to a healthier economy (Hardon 1990; Colombini et al. 2011). Yet, for a range of reasons
a failure to maintain vaccine coverage, an inadequate management or procurement strategy, the
lack of food or health carethe burden of disease is not reduced. According to Rottenburg (2009),
the determination of variables that go into the calculation of disrupted routine health care or
emergency response is a technical game.Löwy and Zylberman remind us, however, that in another
century, [e]ven RF [Rockefeller Foundation] officers were obliged to acknowledge that poverty
generates disease, not the other way round(2000:378).
In Burkina Faso, the MDSC emerged as a technoscientific center of calculation(Latour 1987)
that collected and analyzed technical facts about meningitis disease. While Burkinabé clinical
researchers were optimistic about the lives saved from MenA by MenAfriVac, they called attention
to the persistent challenges (and higher prevalence) of malaria, respiratory infections, and diarrheal
disease. In Burkina Faso, poor quality, fee for service health infrastructures did not improve, and the
inclusion of the monovalent MenA vaccine into the routine immunization program sat uneasily with
the rising incidence of other vaccine preventable meningitis diseases.
With GAVI-facilitated financing, the WHO/PATH/MVP consortium set technically achievable
outcomes with no platform for basic health care. According to Muraskin (2005:237), For the
dedicated cadre that enables the GAVI to function, and which constitutes its indispensable human
infrastructure, the primacy of immunization is nonnegotiable.Using mechanisms that lack trans-
parency, guaranteed markets are negotiated for select vaccine manufacturers, indemnifying them
from risk and relegating vaccine development to the largest companies capable of meeting the
standardsof required criteria. Multilateral approaches absorb all potential actors as collaborators
in a common initiative, leaving few detractors to critique claims of success (Light 2009). Stories of
technical success ignore the distraction of politics and social realities; they disregard the challenges of
international trade agreements that disrupt country markets. Local market failures need not be
associated with global financial markets in these partial accounts.
When vaccines stand in for general health systems
The development of MenAfriVac contains at least three paradoxes. First, publicly funded resources
(scientists, regulators, public health officials, donors, and citizens) were captured within an ideology
that vaccines are the only solution, and that they must be developed through the private sector as an
industrialized science (Blume and Geesink 2000; Blume 2008). Second, general health systems were
neglected while a multilateral program was prioritized. And third, it targeted a single disease
subgroup across an entire continent despite long-term epidemiological evidence of community
outbreaks of different subgroups over time. While MenA was the most common, other types existed
and would move in where a gap could be found, as Burkinabé clinical scientists told to me in 2007.
Vaccines are transnational commodities developed through multilateral negotiations (i.e., product
development partnership funding mechanisms) involving scientists, governments, industry, and
their cultural brokers. They are undeniable techno-social-scientific innovations (Lakoff 2005;
Petryna, Kleinman, and Lakoff 2006; Petryna 2009; Closser 2010; Huzair, Borda-Rodriguez, and
Upton 2011). Networks of scientists choreograph chemistry, bacteriology, microbiology, and
cytology with epidemiological surveillance, disease burden, seroprevalence, and antigen protection to
produce vaccines that boost individual and population response to foreign invasion. Much persua-
sion has gone into capturing scientists, regulators, and citizens into believing that vaccines have
primacy over health systems and that they must be developed through a private sector. Funded by a
complicated, not always transparent constellation of suprastate agencies, nations, and donors,
vaccines as public health goods are swept up in neoliberal negotiations surrounding trade secrets,
patents, intellectual property, and procurement mechanisms.
Public health authorities continue to battle the derailment of immunization programs without
questioning the challenge to public confidence in vaccines from rumors, industry conflicts of interest,
deception, and manipulation of evidence (Renne 2006, Leach and Fairhead 2007;Kaler2009;Deer
2011; Godlee, Smith, and Marcovitch 2011; Larson and Schulz 2015). Threatened by public misinfor-
mation campaigns, distrust and failing to understand the sources of discontent through legitimate
engagement of local community priorities, public health vaccine advocates often forget the principles
of scientific skepticism. Instead, they vilify their detractors, and expect compliance in evidence
vacuums. Clinical scientists arguing for better vaccines in better health systems (Osterholm et al.
2012) get charged with heresy in the public health world(Caryn-Rabin 2012:D5), even when their
concerns gain wider acceptance (Cohen Marill 2015).
Characterized as valuable public goods when polio campaigns and smallpox eradication were seen
to serve society, different vaccines in world systems with profound health care inequities can give the
appearance of value extraction (Mazzucato 2013). The rent-seeking behaviors and corrosive cap-
ture(Carpenter 2013:152172) of a flawed free market model sidelines public health services for
economic commodities.
I have examined ambiguities in the representation and appropriateness of the technology chosen,
and shown how MenA came to stand metonymically for meningitis in Africa. Daniel Carpenter
(2013:63) posited three markers for evidence of regulatory capture by influential special interest
groups, which I suggest correspond to the ambiguous collaborative approach of MVP. An interested
public (African leaders) were gathered to endorse the WHO/PATH/MVP plan three times in this
account (Carpenters first marker); MVP showed action and intent (second element) in developing
an affordable vaccine and building country surveillance capacity, but only partially completed each
taskMenA did not rid the belt of meningitis, and capacity building for country surveillance was
not extended to community surveillance (Graham et al. 2012). Finally, the vaccine diverted the public
interest (Carpenters third element) regarding general health systems strengthening.
Quadrivalent meningitis and Streptococcus pneumonia vaccines were available but unaffordable
to most Africans. When no major vaccine manufacturer would produce the vaccine, the MVP
consortium provided a push incentive to build SIILs capacity for vaccine development. Advance
purchase contracts offered a guaranteed market pull. The MVP supported SIIL in becoming Asias
largest vaccine manufacturer, positioned to be a major supplier to the global south. When public
private partnerships are essentialto develop vaccines for the worlds poorest, evidence of their real
world effectiveness should be required (Barr 2007; Atun, Bennett, and Duran 2008; Mounier-Jack,
Griffiths et al. 2014). Real value added innovations in vaccine development and health systems
strengthening should do more than de-risk private investment (Mazzucato 2013).
While publicly funded organizations lend vital expertise to global health, philanthro-capitalists
determine the agenda and specify the goals (Storeng 2014; McGoey 2014). The declining capacity of
WHO in global health policy and governance, along with the weakening of public health as the
World Bank eschewed policies that advanced a global social contract was criticized by Kickbusch and
Payne (2004:1112) as a scandal of global health governance that WHO member states would
allow a situation to arise in which private philanthropy, the Gates Foundation, has more money to
spend on global health than the regular budget of their own organization, the World Health
Organization.This only accelerated in the ensuing years.
Meningitis A certainly appears to be under control. But Men B, C, W-135, X, Y, and
Streptococcus pneumonia have filled the gap created by the control of MenA. In Ouagadougou,
capacity building for MDSC surveillance failed to extend to communities where outbreaks occur.
Procedural rules required by centers of calculation reduce localized, complex realities(Rottenburg
2009:190) which remained in the margin. I heard much speculation about why they introduced
Men A when they knew it was already under controlin Burkina Faso, where scientists and
clinicians expressed an array of concerns and skepticism surrounding the project although they
welcomed the few resources available from the activities surrounding the campaign. As one
researcher said, They targeted Men A when they knew it was already under control. When you
want to appear to control the wind, you wait until the wind is low and already in control.
MenAfriVacs development exemplifies collaborative capitalism that does not quite achieve what
should have been the goalbetter health within a sustainable health system developed through local
priorities. In purporting to address north-south health inequities, it embodied free market tenets,
priorities from a top down vertical program, and staked claims for intellectual property while
guaranteeing a large market for a small return on investment. There was never any risk involved,
but uncertain risks to come.
1. The Expanded Programme on Immunization (EPI) was established in 1974 through a World Health Assembly
resolution to provide universal access to all relevant vaccines. The goal of EPI is to control disease and achieve
better health for all. It has become an essential public health service in low income countries, especially
regarding their immunization needs. Adding a vaccine to the standard EPI can take 10 to 15 years. Seven
countries (Burkina Faso, Cameroon, Chad, Ghana, Mali, Niger, Nigeria) were scheduled to introduce
MenAfriVac into their routine EPI by the fourth quarter of 2015 (WHO 2015a).
This project was approved by the Burkina Faso Ministry of Health Research Ethics Committee, by the Nouna District
Secretariat General to the President of the Research Ethics Committee and by Research Ethics, Dalhousie University.
I wish to thank Elwyn Griffiths, David Wood, Marc LaForce and the MVP team, Gilles Bibeau, Hélène Broutin,
Oumy Thiongane, Ali Sié, Bocar Kouyaté, Boubakar Coulibaly, Maurice Yé, Aboubakary Sanou, Helene Sawadogo and
the many others who made time to talk with me.
This project was funded entirely by the Canadian Institutes of Health Research through various grants, including
North-South workshop for an African decision-making framework for vaccines CIHR-88301; Regulatory challenges to
the development of new vaccines: Mapping emergent relations between science, evidence and policy CRC-99978,
Articulating Standards: translating the practices of standardizing health technologies CIHR OGH-111402, and my
Canada Research Chair in Bioethics (2002-12).
Notes on contributor
Janice Graham is a research professor in medical anthropology and infectious diseases in the Faculty of Medicine at
Dalhousie University. Interested in the moral basis of profit when disease becomes a market opportunity, she works
among those who develop, regulate, commercialize, implement, and use emerging pharmaceuticals and vaccines.
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      Linsey Mcgoey
    Over the past decade a new form of philanthropy has emerged, termed 'philanthrocapitalism'. Champions of philanthrocapitalism suggest that private giving can fill the void left by diminished government spending on social and development programmes. Critics suggest that philanthropy is no substitute for strong governmental support for social welfare. Both arguments perpetuate a dichotomy between the public and the private, implying that philanthrocapitalism operates in a vacuum largely divorced from governmental interventions. In this article I challenge that assumption, exploring how new philanthropic initiatives have compelled increased financial support from governments toward the private sector. Drawing on three cases - advanced market commitments (AMCs) in drug development; impact investing; and direct philanthropic and governmental grants to corporate entities - I illustrate the ways that governments remain one of the most powerful - if not the most powerful - philanthropic actors in the philanthrocapitalist turn.
  • Article
    • Daniel Carpenter
      Daniel Carpenter
    Modern government offers few if any agencies more powerful, more watched, or more pressured than the U.S. Food and Drug Administration (FDA). Rough estimates suggest that the FDA regulates more than one quarter of U.S. gross domestic product, with primary responsibilities for food, pharmaceuticals and medical devices, cosmetics, and, since 2009, tobacco products. Over a wide range of these products – drugs, medical devices, food additives, and certain tobacco products – the FDA has expansive gatekeeping power: the congressionally mandated task of deciding whether the products in question can be marketed at all. Gatekeeping power has many facets. Gatekeeping can be used to protect the public or provide it with false confidence; create market-wide confidence in new products; enhance or stifle innovation (often both); snow and guile consumers into thinking that poor, unsafe products are safer and better than they are; and hone the production, dosage, and information about drugs to help doctors and patients optimize their use. If ever there were a plausible prima facie case for capture, a gatekeeping regulator like the FDA would seem to provide it. In its governance of pharmaceuticals, the FDA regulates a vast industry, one that supplies a global market approaching $1 trillion in size. Given its size and its historical connections to science and technology, this industry possesses broad economic, political, and cultural power. When Samuel Huntington and Marver Bernstein wrote about the potential capture of regulatory agencies in the 1950s and 1960s, it was with just such an agency-industry relationship in mind (although neither wrote about the FDA). Large industries like these would seem to be primed to limit entry and preserve market access for themselves. And when George Stigler looked for examples of when “regulation is acquired by the industry,” he found his examples among entry-limiting regulation: weight limits for trucks (shaped by the lobbying of railroads and farmers) and occupational licensing (in which those with market power limit the entry of their potential competitors, restraining supply and inflating equilibrium price).
  • Article
    • Svea Closser
    The number of global polio cases has fallen dramatically and eradication is within sight, but despite extraordinary efforts, polio retains its grip in a few areas. Anthropologist Svea Closser follows the trajectory of the polio eradication effort in Pakistan, one of the last four countries in the world with endemic polio. Journeying from vaccination campaigns in rural Pakistan to the center of global health decision making at the World Health Organization in Geneva, the author explores the historical and cultural underpinnings of eradication as a public health strategy, and reveals the culture of optimism that characterizes-and sometimes cripples-global health institutions. With a keen ethnographic eye, Closser describes the complex power negotiations that underlie the eradication effort at every level, tracking techniques of resistance employed by district health workers and state governments alike. This book offers an analysis of local politics, social relations, and global political economy in the implementation of a worldwide public health effort, with broad implications for understanding what is possible in global health, now and for the future. This book is the recipient of the annual Norman L. and Roselea J. Goldberg Prize for the best project in the area of medicine.
  • Article
    Full-text available
    • Monique Berlier
    • Rodrigue Barry
    • John Shadid
    • Enricke Bouma
    Background. A new group A meningococcal conjugate vaccine was developed to eliminate deadly meningitis epidemics in sub-Saharan Africa. Methods. From the outset of the project, advocacy and communication strategies were developed and adjusted as the project evolved in Europe, Africa, India, and the United States. Communications efforts were evidence-based, and involved partnerships with the media and various stakeholders including African ministries of health, the World Health Organization, UNICEF, Gavi, the Centers for Disease Control and Prevention, and Médecins Sans Frontières. Results. The implementation of an integrated communication strategy ensured the active cooperation of stakeholders while providing an organized and defined format for the dissemination of project-related developmental activities and the successful introduction of the vaccine. Conclusions. Early in the project, a communications strategy that engaged stakeholders and potential supporters was developed. The strategy was implemented and adapted as the project matured. Linked communication proved to be key to the successful wide-scale introduction of the PsA-TT (MenAfriVac) vaccine in Africa.
  • Article
    Full-text available
    • Kathleen Tiffay
    • Luis Jodar
    • M.-P. Kieny
    • Francois Marc Laforce
      Francois Marc Laforce
    Background. In 2001, the Meningitis Vaccine Project (MVP) was tasked to develop, test, license, and introduce a group A meningococcal (MenA) conjugate vaccine for sub-Saharan Africa. African public health officials emphasized that a vaccine price of less than US$0.50 per dose was necessary to ensure introduction and sustained use of this new vaccine. Methods. Initially, MVP envisioned partnering with a multinational vaccine manufacturer, but the target price and opportunity costs were problematic and formal negotiations ended in 2002. MVP chose to become a “virtual vaccine company,” and over the next decade managed a network of public–private and public–public partnerships for pharmaceutical development, clinical development, and regulatory submission. MVP supported the transfer of key know-how for the production of group A polysaccharide and a new conjugation method to the Serum Institute of India, Ltd, based in Pune, India. A robust staff structure supported by technical consultants and overseen by advisory groups in Europe and Africa ensured that the MenA conjugate vaccine would meet all international standards. Results. A robust project structure including a team of technical consultants and 3 advisory groups in Europe and Africa ensured that the MenA conjugate vaccine (PsA-TT, MenAfriVac) was licensed by the Drug Controller General of India and prequalified by the World Health Organization in June 2010. The vaccine was introduced in Burkina Faso, Mali, and Niger in December 2010. Conclusions. The development, through a public–private partnership, of a safe, effective, and affordable vaccine for sub-Saharan Africa, PsA-TT, offers a new paradigm for the development of vaccines specifically targeting populations in resource-poor countries.
  • Article
    Full-text available
    • Olubukola Idoko
      Olubukola Idoko
    • Aldiouma Diallo
      Aldiouma Diallo
    • Samba O Sow
      Samba O Sow
    • Godwin C. Enwere
    Background. The Meningitis Vaccine Project (MVP) was established to address epidemic meningitis as a public health problem in sub-Saharan Africa and, to that end, worked to develop a group A meningococcal conjugate vaccine, PsA-TT. Methods. Experiences in 4 clinical trial sites are described. Culturally sensitive collaborative strategies were adopted to manage acceptable communication methods, peculiarities with the consent process, participant medical issues, community care, and death. Results. The clinical trials were completed successfully through community acceptance and active community collaboration. The trials also strengthened the capacities in the participating communities, and actively worked to resolve community problems. Conclusions. The understanding and integration of sociocultural realities of communities were major assets in the conduct and acceptance of these trials. MVP succeeded in these sites and provided a sound example for future clinical studies in Africa. Clinical Trials Registration. ISRTCN78147026 (PsA-TT 002); ISRCTN87739946 (PsA-TT 003); ISRCTN82484612 (PsA-TT 004); PACTR ATMR2010030001913177 (PsA-TT 006); and PACTR201110000328305 (PsA-TT 007).
  • Article
    Full-text available
    • M. Teresa Aguado
    • Luis Jodar
    • Dan Granoff
      Dan Granoff
    • Gordon W. Perkin
    Background. Polysaccharide vaccines had been used to control African meningitis epidemics for >30 years but with little or modest success, largely because of logistical problems in the implementation of reactive vaccination campaigns that are begun after epidemics are under way. After the major group A meningococcal meningitis epidemics in 1996–1997 (250 000 cases and 25 000 deaths), African ministers of health declared the prevention of meningitis a high priority and asked the World Health Organization (WHO) for help in developing better immunization strategies to eliminate meningitis epidemics in Africa. Methods. WHO accepted the challenge and created a project called Epidemic Meningitis Vaccines for Africa (EVA) that served as an organizational framework for external consultants, PATH, the US Centers for Disease Control and Prevention (CDC), and the Bill & Melinda Gates Foundation (BMGF). Consultations were initiated with major vaccine manufacturers. EVA commissioned a costing study/business plan for the development of new group A or A/C conjugate vaccines and explored the feasibility of developing these products as a public–private partnership. Representatives from African countries were consulted. They confirmed that the development of conjugate vaccines was a priority and provided information on preferred product characteristics. In parallel, a strategy for successful introduction was also anticipated and discussed. Results. The expert consultations recommended that a group A meningococcal conjugate vaccine be developed and introduced into the African meningitis belt. The results of the costing study indicated that the “cost of goods” to develop a group A – containing conjugate vaccine in the United States would be in the range of US$0.35–$1.35 per dose, depending on composition (A vs A/C), number of doses/vials, and presentation. Following an invitation from BMGF, a proposal was submitted in the spring of 2001. Conclusions. In June 2001, BMGF awarded a grant of US$70 million to create the Meningitis Vaccine Project (MVP) as a partnership between PATH and WHO, with the specific goal of developing an affordable MenA conjugate vaccine to eliminate MenA meningitis epidemics in Africa. EVA is an example of the use of WHO as an important convening instrument to facilitate new approaches to address major public health problems.