Origins of the Children's Vaccine Initiative: The political foundations

~ Pergamon 0277-9536(95)00382-7 Soc. Sci. Med. Vol. 42, No. 12, pp. 1721 1734, 1996

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ORIGINS OF THE C H I L D R E N ' S VACCINE INITIATIVE: THE POLITICAL F O U N D A T I O N S

W I L L I A M M U R A S K I N

Department of Urban Studies, Queens College, City University of New York, New York, U.S.A.

Abstract--The Children's Vaccine Initiative (CVI) was founded in 1990/91 as a means to revolutionize the way that vaccines were developed for the South• The system for the creation of vaccines was a dis-articulated one in which basic research, product development and delivery were handled by different, often insufficiently linked groups. The public sector was deeply involved in research and delivery but not the vital product development area. That area was left to the private sector which was increasingly driven by the needs to maximize profits. Potential vaccines for diseases found in the South, where a hard currency market was limited, were often left undeveloped. The CVI was designed to change that situation• The CVI hoped to exploit the discoveries of biotechnology and produce not only new and improved vaccines, but ultimately to work towards a single multi-antigen vaccine given near birth that would immunize children for life. This article deals with the events that directly led to the creation of the CVI, and to the political problems caused by organizational and national rivalries that the new venture faced from its inception. Copyright © 1996 Elsevier Science Ltd.

Key words--CVl, vaccines, UNICEF, WHO

The Children's Vaccine Initiative (CVI) was founded in 1990/91 as an attempt to revolutionize the way vaccines were made for the developing world. It arose in response to a number of opportunities and problems that became manifest during the 1980s. The foremost opportunity of the period was the spectacu- lar emergence of biotechnology which promised remarkable advances in the understanding, development and delivery of vaccines. As Dr Barry Bloom of the Albert Einstein Medical College colorfully put it,

You used to make vaccines by grinding up bugs [germs] and pickling them and now we ha[d] modern vaccinology, recombinant DNA techniques, carbohydrate protein conju- gates in chemistry . . .

and a whole host of other techniques to make and deliver vaccines effectively.* This meant

[i]n considering the various criteria for new vaccines for the Third World, genetically engineering live attenuated vaccines to become multi-vaccine vectors that can immunize simultaneously against multiple antigens is particularly appealing . . . . The ability to change living organisms by genetic engineering has given rise to the possibility [that s]uch multi-vaccine vehicles can be developed from either viral or bacterial vaccines . . . [I]

These cutting-edge techniques could make possible the ' ideal ' vaccine that Dr William Foege, Chairman of the Task Force on Child Survival, had envisioned as early as 1985:

•.. a multi-antigen vaccines (that is, containing all antigens

*Interview with Dr Barry Bloom, M.D., 29 February 1995. tWilliam Foege, "Applied Research," Protecting the

WorM's Children, Bellagio II, Cartagena, Colombia, October, 1985.

in a single injection), that would: (1) provide life-long immunity with a single dose; (2) have no short-term or long-term adverse reactions; (3) be inexpensive; (4) be easily administered without costly equipment or techniques by relatively untrained workers; (5) be stable at tropical temperatures for months, or even years; (6) be efficacious any time after birth.t

If great possibilities fueled the founding of the Children's Vaccine Initiative, so did the dangers that faced the children of the South• The 1980s had seen the consolidation of the pharmaceutical and vaccine industries into an increasingly small number of giant European and American companies• Those enterprises increasingly saw vaccines both as less important that their more lucrative drug business, and as a commodity whose profit had to be maximized. Traditionally, vaccines had been produced by public institutes or private sector companies that had treated vaccines as a quasi-public service and sheltered them from the full rigors of the market- place. That protective attitude increasingly was seen as old-fashioned. Under the new regime the necessi- ties of achieving a lucrative return on capital increasingly drove companies to invest only in vaccines with a high-profit potent ia l - -which meant producing primarily for the Northern market. The needs of the South would be met only insofar as its people shared illnesses that afflicted the more prosperous countries. For diseases that only afflicted the South, and no hard currency market existed, the private sector showed little or no interest [5].

It became clear that if something were not done to help develop vaccines for the South, that millions

1721

1722 William Muraskin

of children would needlessly die from vaccine- preventable diseases. This danger was especially severe because the existing system of vaccine R&D was highly fragmented:

Vaccine research, development, manufacturing, purchasing, delivery and final use have . . . been separate and independent responsibilities of different segments of our immunization system.*

In addition, while the public sector was deeply involved in financing basic research and vaccine delivery, it had little input into vaccine product development (i.e. the expensive and complex process of scaling-up from laboratory model to pilot, and then full-production, conducting clinical and field trials, meeting governmental requirements for licensing, carrying out elaborate advertising campaigns). This part of the process was "largely guided by manufactureRs"t whose actions were restrained by the private sector's need to generate profits.

While the Children's Vaccine Initiative had its intellectual roots in the period 1980-1985, the direct impetus for it came out of the decision of James Grant, Executive Director of UNICEF, to dedicate 5% of his budget to 'applied' and 'operations' research. He did so as the result of the synergistic influence exerted on him by: (1) Dr D. A. Henderson, Dean of the School of Public Health, Johns Hopkins University, who argued for the importance of UNICEF funding heat stable polio research; (2) the Commission on Health Research and Development's chief of staff, Dr Lincoln Chen, who argued that multilateral donors should dedicate part of their budget to health research; and (3) the long-term effect of Dr William Foege's vision of a multi-antigen 'ideal vaccine' given near birth, that would immunize children for life [4].

When Grant in April 1990 submitted a proposal to the UNICEF Executive Board that called for funding vaccine research he was rebuffed by the majority who felt that UNICEF was a field organization that should be concerned with the delivery of vaccines, not their research and development. In an attempt to salvage the proposal Grant asked Dr James Sherry, M.D., to find a way to make the proposal more palatable to its opponents. In Sherry's attempt to do so he conferred with Dr Scott Halstead, Acting Director of Health Sciences of the Rockefeller Foun-

*S. Ramachandran and Philip Russell, "A New Technologic Synthesis: the Children's Vaccine Initiative," Draft. Pre- pared for Meeting on "Vaccines and Public Health: Assessing Technologies and Global Policies for the Children's Vaccine Initiative," Bethesda, Maryland, 5-6 November 1992.

tAnthony Robbins and Isao Arita, "The Global Capacity for Manufacturing Vaccines: Prospects for Competition and Collaboration Among Producers in the Next Decade," Draft. Prepared for Meeting on "Vaccines and Public Health: Assessing Technologies and Global Pol- icies for the Children's Vaccine Initiative," Bethesda, Maryland, 5-6 November 1992.

dation and told him of UNICEF's desire to funnel large amounts of money into the vaccine research area, but to do so in a way that its Board would find acceptable. While talking about the problem, Sherry mentioned that in order to de-emphasize the research aspect of the proposal--which had talked of a name- less "single dose, multi-antigen vaccine"--Grant and the staff had started to talk of it as "a children's vaccine." Halstead found the idea of creating "A Children's Vaccine" electrifying, and made Sherry realize how powerful that imagery could be in motiv- ating scientists and policy makers to support such an effort. As a result of their conversations it was agreed that Halstead, a noted scientist, would present the idea of "the Children's Vaccine" to the scientific community--which would give it a legitimacy in scientific circles that UNICEF did not possess; and that Grant and Sherry would push the idea among political and policy making leaders [4].

As a first step in the process, they agreed that Halstead would prepare a paper for the next meeting of the Scientific Advisory Group of Experts (SAGE) that oversaw the work of the World Health Organiz- ation's Programme for Vaccine Development (PVD). In order to give added weight to the presentation, Halstead asked Frank Harvelt, Deputy Director of the Division for Global and Interregional Projects of the United Nations Development Program (UNDP), to sign on as a co-author. (The UNDP had recently become a full sponsor, along with WHO, of the PVD, which was now called the WHO/UNDP Programme for Vaccine Development.)

Halstead had a special interest in speaking to the SAGE and the PVD meetings because the Rockefeller Foundation had been instrumental in the creation of the program and subsequently been disappointed when the PVD had not lived up to its expectations. Halstead believed that the Children's Vaccine concept, and the UNICEF money that would fund it, could dramatically revitalize the program and make the PVD the center for effective public sector influence on vaccine product development that it had been created to be.

THE CHILDREN'S VACCINE IDEA IS UNVEILED

Scott Halstead's paper, "Children's Vaccine: A Strategy to Provide More and Better Vaccines," was first presented to the Programme for Vaccine Devel- opment at its meeting on "Innovative Approaches for the Development of Third-World Vaccines," on 24 June 1990; then it was re-presented the next day to the SAGE. It was a simple paper that reviewed the stages of vaccine product development: vaccine research that included safety trials, and efficacy field tests; licensing and quality control; production, marketing and pricing. It went on to review the World Health Organizations key programs dealing with vaccines (i.e. Programme for Vaccine Develop° ment/Transdisease Vaccinology, Tropical Disease

Origins of the CVI--political foundations 1723

Research [TDR], Control of Diarrheal Diseases [CDD], and the Research and Development arm of the Expanded Program on Immunization [EPI]). Halstead lauded the work that they had accomplished but pointed out bottlenecks and problem in each of the major areas of research, quality control, production, etc. It was a short, succinct overview that was in keeping with the position that others----especially Anthony Robbins and Phyllis Freeman, consultants to the Rockefeller Foundation and the Task Force for Child Survival--had been championing for a number of years; and which was widely accepted by most of Halstead's listeners. He then boldly stated what the title of his presentation meant:

What is a Children's Vaccine? In abstract it is a multi- antigen vaccine against the major child killers, stable at ambient temperature, administered orally, and which pro- duces life-long immunity when administered as a single dose early in childhood.*

He went on to say that some might ask if such a dream can be realized, but "We will never know unless we try." He then challenged the PVD and the SAGE to organize and plan for such a Children's Vaccine (CV).

Halstead in his presentation denied credit for coin- ing the term Children's Vaccine, rather he attributed it to Jim Grant of UNICEF. Despite his disclaimer, when Halstead decided to put that term in the spotlight and employ it as the 'hook' to galvanize support from the SAGE and PVD scientists for the goal of establishing a systematic effort to achieve a multi-antigen vaccine, he radically transformed the nature of the situation. Such a goal would no longer be simply an 'ideal,' or 'wish list,' as it had been when William Foege originally raised the issue back in 1985. For the first time someone was calling for immediate action to achieve 'the dream'--not just talk about it. By giving it an appellation, 'the Chil- dren's Vaccine,' Halstead was providing it with a potency that an anonymous 'single dose multi-antigen vaccine' could never have achieved. In addition, Halstead as an internationally respected scientist, and Acting Director of Health Sciences of the Rockefeller Foundation, could demand a hearing for his idea that Jim Grant, as a lay person, could not directly obtain by himself,

Halstead's call for the commencement of immediate work leading toward the development of a multi-antigen vaccine was thus a revolutionary change in direction for the international health com-

*Scott Halstead and Frank Hartvelt, "Children's Vaccine: A Strategy to Provide More and Better Vaccines," presented at the Programme for Vaccine Development meeting, WHO, 24 June 1990, Geneva.

~'Interview with Dr John LaMontagne, Director of Division of Microbiology and Infectious Disease Program, Na- tional Institute of Allergy and Infectious Diseases, NI- AID, 12 December 1994.

$Interview with James Sherry, 19 April 1995. §Interview with Dr Philip Russell, 14 April 1994.

munity--despite the fact that the concept had roots in ideas that had been in circulation for at least ten years.

THE CHILDREN'S VACCINE IDEA IS ATTACKED AND DEFENDED

That this old wine in a new bottle was indeed a momentous sea-change for the health community was made very clear by the reaction of Dr Friedrich Deinhardt, M.D., the powerful and outspoken Chair- man of the SAGE. He thought it was the most ludicrous thing he had ever heard!* "It was not science but science fiction," he said.~ Deinhardt denounced the concept as foolhardy and destructive, in a way that no one had ever condemned the earlier 'inspirational' presentations of the concept. He protested that it was a false goal that would raise the public's hopes beyond anything which could be achieved by science--now or ever. He said such an ill-advised promise would fail, and thereby fatally undercut the credibility of the scientific community in the same way that the ill-fated campaign to eradicate malaria had done in the 1950s--a debacle whose effects still reverberated in the international health community. Deinhardt said he would never support such a goal.

The initial response to Halstead's challenge by other members of the SAGE was not significantly more positive. Even those who would ultimately become indispensable supporters of the concept were taken-a-back by its boldness (or foolhardiness). Dr Philip Russell, Commander of the Army Research and Development Command, Ft Detrick, Maryland, who would soon become one of the architects and leaders of the Children's Vaccine Initiative, at first saw the speech as "overkill/over-promise." To him, and to most of the others present, the concept went beyond the limits of credibility. He felt the speech "went over like a lead balloon."§ One SAGE member went so far as to dub it "the childish vaccine not the children's vaccine." Dr John LaMontagne, Director of the Division of Microbiology and Infectious Dis- eases, National Institute of Allergy and Infectious Diseases (NIAID), felt that the "biggest concern was that the idea was so far in the future that we would be dead by the time it was delivered on." LaMon- tagne was anxious that 'science' was already under attack on many fronts, from the scandal over the discovery of the AIDS virus, to falsified data in scientific publications, that it was vital to be "more cautious and conservative about what we [as scientists] promised."t

Halstead's attempted revolution might have ended there, but for the intervention of Dr Barry Bloom, M.D., a noted professor/researcher at the Albert Einstein College of Medicine in New York. Bloom had given a great deal of thought over time to the problem of new vaccines and had recently written a highly influential article in the journal Nature which


had taken a broad look at the problems and promises of vaccine research and development [1]. After an initial bout of incredulity concerning the Halstead proposal, Bloom was inspired to come to its defense. He proceeded, in the public sessions, and more importantly in private meetings, to challenge Dein- hardt's "absolutely rigid and negative" position [1]. He rallied around himself many members of the SAGE. Phil Russell and John LaMontagne, for instance, re-thought the issue during the following discussions and came to the conclusion that a significant opportunity to move forward in vaccine development for the South had been presented and should not be allowed to slip away. They believed that the idea had problems and needed modification. Yet, in this simplicity and idealism it possessed the capability of inspiring people--both inside and outside the scientific community-- to act, rather than wait for events to unfold.

Bloom's interpretation of the Halstead speech was that while the PVD worked on a variety of vaccines, and the EPI delivered six specific ones, far more could be accomplished if we "sell it as a package to the world" rather than "pushing" one vaccine at a time. According to Bloom, vaccinology was increasingly science-driven, however, the "new tools . . . were not terribly focused but could be if we made them into a package." The problem was how to create excitement over such a prospect without promising more than could be successfully delivered. Deinhardt insisted that nothing should be promised until after it had been actually achieved--thus avoiding all potential embarrassment. Bloom disagreed because he believed that some risks were worth taking. By the end of the SAGE meeting Bloom believed that the majority of the SAGE had come to see the issue as he d id--as a way to focus resources and get products out.* However, that view did not receive official recog- nition at the end of the SAGE. While Halstead, Hartvelt and Sherry had hoped for a ringing endorsement of the Children's Vaccine concept by the SAGE, Deinhardt's vehement opposition made that impossible---neither the SAGE nor the World Health Organization would publicly repudiate the views of the meeting's Chairman.

Nevertheless, Deinhardt did give Halstead a face- saving gesture--an ambiguous statement which could be portrayed to those outside the SAGE as a quasi- endorsement, though in fact it was not. Deinhardt in his prepared statement for the SAGE carefully picked his words:

the Scientific Advisory Group of Experts , . . discussed the programme "Children's Vaccine: a strategy to provide more and better vaccines." SAGE enthusiastically endorses this vaccine development programme, and has great interest in providing . . . guidance . . . for this project through SAGE's . . . existing . . . steering committees.f

*Interview with Dr Barry Bloom, 2 February 1995. i'SAGE statement "Children's Vaccine" by Professor Dr

med, Friedrich Deinhardt, 29 June 1990.

The Children's Vaccine as a product or goal was ignored, in favor of a 'programme' or 'project.' But the Children's Vaccine proponents could put a different face on the statement if they wished.

UNICEF TAKES THE LEAD

While Halstead carried out his part of the agreement with Sherry by speaking to the SAGE, Sherry and the UNICEF staff continued to make prep- arations for convening the international meeting of experts that the UNICEF Executive Board had required as a pre-requisite to re-consider Grant 's rejected research proposal. The conference was to be assembled for the purpose of advising UNICEF on the reasonableness of the agency's funding vaccine research in general. However, the focus of the advisory meeting was shifted to emphasize the possibility of UNICEF supporting the Children's Vaccine concept.

Setting that meeting up was a complicated and delicate process because of the necessity of muting the powerful rivalries that existed between United Nations agencies, especially UNICEF and WHO. The UNICEF Executive Board was concerned that any move into funding vaccine research be coordinated with the World Health Organization--which held the world's mandate to deal with health matters and was already supporting a vaccine research program. Conflict and competition between UNICEF and WHO had grown severe ever since UNICEF in the early 1980s had declared the "Children's Revolu- tion" and entered the area of promoting Children's health in a direct way--resulting in an increase in turf issues between the two organizations as well as disagreement on style and approach in numerous cases. While the two organizations had produced a successful collaborative effort in their joint promotion of the Expanded Programme on Immuniz- ation (EPI), it was not without considerable tension because UNICEF's intervention implied that WHO could not achieve success acting on its own [3].

The experts' meeting was scheduled for early September in the hope that it would add momentum and enthusiasm to the World Summit for Children-- an unprecedented meeting of 71 heads of s ta te-- which was to assemble in late September. Jim Grant hoped that a favorable verdict by the earlier meeting for the idea of a 'Manhattan Project' for vaccines, with specific emphasis on the Children's Vaccine, would influence some of the heads of state attending the Summit to present that idea as a goal for the world's leaders.

To set up the experts' conference, and push the Children's Vaccine concept, the UNICEF staff had to get the cooperation of the World Health Organization. This was a delicate matter. Initially UNICEF had decided to ask the Task Force on Child Survival to host the meeting. It appeared the logical choice since the Task Force was a non-partisan body


specifically created at Bellagio I in 1984 to provide a neutral forum for U N I C E F and W H O to meet and settle their differences. Its constituent organizations included U N I C E F , WHO, U N D P , the World Bank and the Rockefeller Founda t ion- - the groups most interested in the potential of immunization, and most likely to support a Children's Vaccine. William Foege, Chairman of the Task Force, agreed to sponsor the meeting, with the Nobel Laureate Fredrick Robbins, M.D., chairing it, and W H O as a major participant.*

While the U N I C E F staff was arranging the meeting, Anthony Robbins and Phyllis F r e e m a n - - w h o m Sherry had earlier consulted with on how to make funding research more acceptable to the U N I C E F Board- -worked to use their formidable advocacy skills to generate support for the forthcoming conference, and specifically for the Children's Vaccine concept, in the scientific community. They did so in a way that put a favorable 'spin' on the S A G E meeting's reception of Halstead's speech. They sent a letter to the editor of the Lancet, ostensibly in the form of a 'brief Conference report, ' which said:

In an unusual twist to the annual meeting of the Scientific Advisory Group of Experts . . . the international panel directed their expertise to envisioning the ideal vaccine(s) for maximum protecting of the world's children . . . . A formal statement of support is being drafted for presentation to the organizers of the first heads-of-state Summit Conference on Children . . . . Participants recognized that the idea of a single vaccine is perhaps too optimistic but not impossible, and it is the kind of image that could capture the imagin- ation of the public. Representatives from SAGE were designated to participate in a pre-Children's Summit scientific conference . . . sponsored by the Task Force on Child Survival . .t

Within two days, however, Freeman had to rush a second letter to Lancet modifying the first letter. Apparently, Dr Hiroshi Nakajima, Director-General of WHO, had become concerned about WHO's re-

*Dr Terrell Hill, "Note for the Record" 4 June 1990, concerning a Memo of 22 May from Sherry that was discussed with WHO representatives on 30,31 May in Amman, Jordan.

tLetler from Anthony Robbins to Dr Robin Fox, Deputy Editor, Lancet 14 July 1990.

~Fax from Dr Phyllis Freeman to Scott Halstead, 16 July 1990.

§Interview with Dr William Foege, Chairman of the Task Force for Child Survival, 24 January 1995.

~Letter from Anthony Robbins to Dr Robin Fox, Deputy Editor, Lancet 26 July 1990.

IIMemo from Director, National Vaccine Program Office [Dr Kenneth Bart] to the Assistant Secretary for Health [Dr James Mason] concerning "The Children's Vaccine and the World Summit for Children," 26 July 1990.

**Interview with Ms Linda Vogel, Director, Office of Inter- national Health, Department of Health and Human Services, 31 January 1995.

t tMemo from Deputy Assistant Secretary of Health, Dr Audrey F. Manley, M.D., to Assistant Secretary of Health, James Mason, "Follow up on Discussion with James Grant Regarding Eradication of Polio and Chil- dren's Vaccine Initiative," 2 July 1990.

lationship to the concept of the Children's Vaccine, and wanted a more dynamic and central role in any proposed program. Nakaj ima made it clear to U N I C E F that he did not want the Task Force for Child Survival to host the pre-Summit meeting, rather he wanted the World Health Organization as sponsor, and himself as Chairman of the meeting. The way Freeman explained it in a fax to Scott Haistead was that supporters of the Children's Vac- cine concept at W H O were "in a tight spot with Nakaj ima on 'ownership' by W H O " of what was going on,$ and the Task Force for Child Survival felt it was wise to withdraw gracefully and avoid competition over the issue--thus protecting the Task Force's role as a neutral forum for the United Nations agencies.§ As Robbins would later put it, "[t]he politics of international organizations are often very sticky .. , , r and while Nakaj ima's increased interest was a clear plus, the danger of conflict over 'ownership' of the Children's Vaccine concept posed a significant threat to the inter-agency cooperation that was indispensable for success. Many feared that W H O was like 'a black hole' that would absorb and stifle anything that it took into its orbit. The World Health Organization's support was necessary but its total embrace could be deadly.

THE AMERICAN GOVERNMENT GETS INVOLVED

While U N I C E F and W H O were negotiating over the September conference, Grant was simultaneously championing the Children's Vaccine idea on another, but equally important, front: the United States Gov- ernment. Even before the initial Sherry/Halstead meeting, Grant had planned to visit the Secretary of Health and Human Services, Dr Louis Sullivan, M.D., and ask him to help get American support for a 'Manhat tan Project ' on vaccines for the South. Now, using the term 'Children"s Vaccine' as his verbal and conceptual wedge, he would meet with the Secretary and make his plea for American help.

At the meeting between Grant and Sullivan on 29 June 1990, Grant

asked the Secretary that the U.S. take a leadership role internationally to help bring about a coordinated multi- country program to develop a "Children's Vaccine."ll

Grant linked the Children's Vaccine to his desire to launch a new form of 'Manhat tan Project ' saying if we could build an atomic bomb we could create a Children's Vaccine.** He also wanted the U.S. to announce, in connection with the upcoming World Summit for Children, a strengthened American com- mitment to the eradication of polio by the year 2000, and asked for the U.S. to call a meeting of experts, prior to the World Summit, to push for the Children's Vaccine . I t (At this early point Grant was looking for the U.S. to sponsor the meeting the U N I C E F board demanded. Later he turned to the Task Force for Child Survival, and ultimately to WHO.)

SSM 42/12--E


Sullivan responded by asking Assistant Secretary of Health, James Mason, M.D., to deal with the issue. Both Sullivan and Mason had significant doubts about the feasibility of the Children's Vaccine,* despite the overly positive gloss on the SAGE meeting that Jim Sherry provided to the group. (Sherry left the SAGE early to be present at the Grant/Sullivan parlay, where he "less than candid[ly] . . . reported that the SAGE had a vigorous and enthusiastic discussion [of Scott's proposal].")t Before committing the government to supporting the concept (or sponsoring any international gathering) Sullivan and Mason felt that a group of scientific experts had to be convened to review the issue and advise the Department on a proper response.$ Dr Kenneth Bart, Director of the National Vaccine Program Office, who was a member of the SAGE, and was still in Geneva, would be assigned the task to organize such a meeting.§

In the period before Bart could be reached an urgent conference call was set up among leading Public Health Service officials (Dr John LaMontagne, Director, Microbiology and Infectious Diseases Program, NIAID, Dr George Curlin, MIDP, NI- AID, Dr Alan Hinman, Centers for Disease Control, Linda Vogel, Office of Health, PHS, and Dr Audrey F. Manley, Deputy Assistant Secretary of Health) to discuss what the Americans should do. It is probably during this phone session that LaMontagne first

*Letter from Louis Sullivan, M.D., Secretary of Health and Human Services to James Grant, Executive Director of UNICEF, 27 September 1990.

tlnterview with Dr James Sherry, 19 April 1995. ~Letter from Louis Sullivan, M.D., Secretary of Health and

Human Services to James Grant, Executive Director of UNICEF, 27 September 1990; interview with Ms Linda Vogel, 31 January 1995.

§Dr Kenneth Bart, Director, National Vaccine Program Office, "Note to Participants of August 6 Meeting on the Children's Vaccine Initiative," 17 August 1990.

¶There is general agreement that LaMontagne changed the CV into the CVI but most sources assume it occurred at a meeting in late July. However, the memo of 2 July 1990 by Deputy Assistant Secretary A. Manley that summarizes this phone conversation calls the proposal the "Children's Vaccine Initiative" which is why I assume it is first mentioned on that date. Others believe it was first suggested immediately before the NIH 6 August meeting. However, Ken Bart on 26 July wrote a memo to the Assistant Secretary for Health James Mason that has a chart with the "Children's Vaccine Initiative" as the umbrella for the efforts of America and other countries.

II Interview with James Sherry, 19 April 1995; interview with Linda Vogel, 31 January 1995. Exact date of meeting is not clear but 25-6 July seems most likely.

**Interview with Dr Kenneth Bart, 22 November 1994. l"tMemo from Director, National Vaccine Program

Office [Kenneth Bart] to the Assistant Secretary for Health [James Mason] concerning "The Children's Vaccine and the World Summit for Children," 26 July 1990.

:[:~Assistant Secretary James Mason was the 'titular head.'

attempted to alter Scott Halstead's .concept of the Children's Vaccine in order to make it more politi- cally and scientifically respectable than Halstead had achieved in Geneva.¶ While LaMontagne had felt excited by the idea of a Children's Vaccine (CV), he could not fully accept it in its original form. The Children's Vaccine was a 'product' and one that might not be achievable in a reasonable amount of time. However, if it was seen as a 'process'--a series of incremental movements towards a goal--then it would work for him as well as others. He felt it should be called a "Children's Vaccine Initiative" (CVI). LaMontagne's simple verbal (but conceptually significant) change saved the Sherry/Halstead proposal from being dismissed as a pipe-dream. The new term kept the imagery and excitement of the Children's Vaccine concept but allowed more conservative scientists and policy makers to join in without fear of embarrassment. Later, at the end of July, LaMontagne repeated his message in a meeting with Sherry, Bart, Russell, and others, and the group agreed that a CVI strategy was more saleable than that of a Children's Vaccine. II The modification of the Children Vaccine idea was later adopted by the meeting of American scientific experts that Bart convened in early August at Sullivan and Mason's request.

Bart was willing to take on Mason's challenge of quickly assembling a meeting of experts to discuss the Children's Vaccine because he felt that the United States, with the largest research base in the world, had a moral obligation to become actively involved with this promising proposal from the beginning. According to Bart, the situation in vaccines was radically different from the circumstances that existed in the 1960s when money was prematurely 'thrown' at the National Institutes of Health to deal with cancer, stroke and heart disease. "Here [in vaccines] the science . . . [was] ready . . . [to] be harvested . . . " which it had not been true for the chronic diseases.**

The Children's Vaccine for Bart also had direct relevance to a pressing American domestic health problem:

The concept of a children's vaccine has its origins in the need to ensure that a sustainable infrastructure and capacity to deliver vaccines is in place. Underpinning the desirability of a Children's Vaccine is the need to simplify immunization schedules to improve access.., particularly among inaccess- ible inner-city, periurban and rural poor in . . . the developed

as well as the developing world.t? In addition, the Children's Vaccine idea had an

immediate importance to the National Vaccine Pro- gram, which Bart was the defacto head.:l::~ The NVP was designed to coordinate American domestic vaccine efforts, especially those carried out by a multitude of government agencies. He saw the NVP's advocacy of the Children's Vaccine as potentially useful in furthering the NVP's still fledging attempts to make that mandate into a reality. It could also help

Origins of the CVI--political foundations

provide a coherence to the domestic efforts that was sorely lacking:

United States Government agencies . . . are already inten- sively involved in vaccine development and delivery both domestically and internationally. Current efforts could be successfully catalyzed and focused as part of this initiative. Discussion about the concept of a Children's Vaccine has brought coalescence of U.S. Government Agencies around a recommendation for a broader USG [United States Gov- ernment] led Vaccine Initiative that the U.S. would catalyze and lead.*

Bart went so far as to suggest that

The United States could play a leadership and coordinating role, in cooperation with WHO, for the type of effort which Mr Grant is proposing . . . [and] serve as the Secretariat for a multi-national group and be the convener of periodic meetings

in other words function as the center of the CVI.* Support for the initiative would also give President

Bush a concrete proposal to contribute to the World Summit for Chi ldren--one of the requirements his staff demanded before he would even consent to attend the meeting. And his attendance was considered indispensable by Jim G r a n t - - h o w could the Summit have any lasting impact if the American President refused to be present? Finally, it was not lost upon Bart that "this broader initiative provides the United States with a unique opportunity to showcase its science and technology and vaccine delivery skills . . . " *

(Years later, Bart would express regret for the dynamic and aggressive role that the NVP took in support of the CVI because it "created the impression that it was a United States in i t ia t ive"--an unfortu- nate impression that neither he nor anyone else could successfully correct . t As we will see later, Grant 's tactically brilliant attempt to gain immediate support and momentum for the Children's Vaccine from the American government turned out to be a strategic error of tremendous proportions. It fanned the peren- nial rivalry that existed between the European countries and America and thus inadvertently stigma-

*Memo from Director, National Vaccine Program Office [Kenneth Bart] to the Assistant Secretary for Health [James Mason] concerning "The Children's Vaccine and the World Summit for Children," 26 July 1990. Under- lining in original dropped to avoid confusion.

tInterview with Kenneth Bart, 22 November 1994. §Interview with Dr Philip Russell, 5 April 1994. f"Note to Participants of August 6 Meeting on the Chil-

dren's Vaccine Initiative" from Ken Bart, M.D., 17 August 1990. During the 6 August meeting Bart would tell the assembled scientists that "he had recently re- turned from Taiwan where it t[ook] 14 separate contacts to fully immunize a child with the addition of JBE [Japanese Encephalitis] and hepatitis B vaccines; that clearly was not considered a sustainable immunization program," "AD HOC CONSULTATION ON A CHIL- DREN'S VACCINE INITIATIVE: The National Vac- cine Program Office, Office of the Assistant Secretary for Health, Department of Health and Human Services, 8 August 1990.

1727

tized the CVI even before its official birth. The taint of American domination would hound the new entity continually in the years to come. The truth of Bart's observation that the Children's Vaccine could favor- ably highlight American science and technology was not lost upon the Europeans, but they did not see it as a positive attribute in the slightest.)

The fact that Bart was able to quickly bring together an illustrious group of scientists from the United States, as well as industrial representatives from Europe and Canada, for a 6 August meeting at the National Institutes of Health (NIH), despite its being the middle of the summer, shows how important the issue was seen by all participants. The meeting was chaired by Major General Phil Russell, who at that time was still Commanding General, U.S. Army Medical R&D Command.

(Bart, Russell and LaMontagne had consulted in the month after the Grant/Sull ivan meeting and tried to 'brainstorm' the U.S. response. This had led to their decision to both change the CV to the CVI and to the invitation for Russell to chair the August N I H meeting. That in turn was followed by Bart offering Russell the position of Special Advisor to the Na- tional Vaccine Program when he retired from the Army in September 1990. Bart could then provide direct support for the CVI by allowing Russell to spend most of his time working on the initiative. After the September U N I C E F meeting of experts, the World Health Organization asked Russell to accept the responsibility to help organize the CVI as a program.)§

The N I H scientific meeting was far more successful in generating support for the Children's Vaccine idea than the SAGE meeting had been, but only after LaMontagne 's modification of the Children's Vac- cine into the Children's Vaccine Initiative had been adopted by the group. The meeting was energized by the concept of making the fruits of the biotechnological revolution available for practical application. But the meeting was careful not to promise a single vaccine. The group recognized the attractiveness and urgency of some dramatic step:

Underpinning the desirability of a Children's Vaccine is the need to simplify immunization schedules to improve access. [Multi-contacts impedes vaccination efforts] A single dose multi-antigen vaccine would do much to improve access . . . It]he current delivery system both domestically and internationally will not tolerate the addition to the immunization schedules of new vaccines currently on the drawing board. ¢

However, they felt the necessity to 'recast ' the CV as an initiative which would allow the production of a mult i-component vaccine(s) in a series of stages:

The group recognized no tension between the approach it recommended and the UNICEF vision, but rather viewed the recommended approach as a multi-stage iterative initiative . . . . The notion of one vaccine that could provide full


protection was restated as vaccines that could be delivered with only one or a few heaqiii care contacts.*

This could be done effectively, using existing technology, within ten years. Further progress in new vaccines would take more basic science. The meeting concluded that the Department of Health and Hu- man Services should accept the challenge and move toward "the ultimate goal of a children's vaccine."*

In Bart's report on the meeting to Assistant Sec- retary James Mason he said that he had conducted conversations with Dr Ralph Henderson, Assistant Director-General of WHO, about the usefulness of a coordinated approach to the initiative by both the U.S. and WHO, since it was vital that the U.S. not compete with the World Health Organization. Hen- derson's reply was that he was "frankly concerned about the lack of technical depth in Geneva to coordinate adequately such an initiative." And it was agreed that the United States would continue to communicate with Geneva if the U.S. decided to lead such a project . t

The result of the August N I H gathering was that the September U N I C E F meeting could be presented

*"Note to Participants of August 6 Meeting on the Chil- dren's Vaccine Initiative" from Ken Bart, M.D., 17 August 1990.

tMemo from Director, National Vaccine Program Office [Kenneth Bart] to the Assistant Secretary for Health [James Mason] subject; "The World Summit for Chil- dren and the Children's Vaccine: Technical Feasibility," 7 August 1990.

:~There is a great deal of disagreement over the Declaration of New York. Kenneth Bart says flatly that he wrote it at the end of the August NIH meeting. (Interview with Kenneth Bart, 22 November 1994.) This is supported by Barry Bloom. (Interview with Barry Bloom, 29 February 1995.) D. A. Henderson says of the New York meeting "It was all settled by the NIH meeting [in August]. It [the NY meeting] was ceremonial. The major decision was made at the NIH." (Interview with D. A. Henderson, 1 May 1995.) However, while the substance of the New York meeting was decided in the August meeting, "We did not have a document at the end of August. It had to have been written after." (Interview with D. A. Henderson, 11 July 1995.) Scott Halstead has contended that no such draft existed prior to the New York meeting and it was written de novo there. Ralph Henderson of WHO, who actually wrote the final New York document says that based on his notes "Ken Bart may well have presented an initial draft, and the final Declaration may well have reflected . . . [those] ideas . . . [But] the Decla- ration [was]... the work of many. . . Scott Halstead also presented an early draft . . . we gathered suggestions from many persons . . . " (Fax from Ralph Henderson, M.D., Assistant Direct-General WHO to William Mu- raskin, Ph.D., 25 April 1995.) A reading of Barry Bloom's summary of the meeting ("Summary of Ad Hoc Consultation on A Children's Vaccine Initiative") and Kenneth Bart's more detailed summary show no direct verbal carry over in the language used by the Declara- tion of NY.

§Interview with Dr Scott Halstead, 22 December 1994. ¶"Mr Grant's Speech at Vaccine Development Meeting on

September 9, 1990," dated 10 September 1990.

with strong scientific support for going forward with a world-wide project aimed at the development and improvement of vaccines. To further that support a few of the NIH meeting participants, including Bart, Bloom and Robbins met separately from the larger group, and worked on writing a document that could be used at the New York meeting. Their ideas were ultimately incorporated into the resulting "Declara- tion of New York.":~

THE DECLARATION OF NEW YORK

The big 9-10 September meeting at U N I C E F House, sponsored by the W H O and U N I C E F finally took place. Unlike the N I H meeting it was not primarily a meeting of scientists but a general meeting of interested groups and individuals concerned with immunization. Positions hammered out at the SAGE and elsewhere over the last three months were brought into the meeting. Friedrich Deinhardt, head of the SAGE, continued his vocal opposition to the CVI concept. Nevertheless, a pro-CVI consensus was built within the gathering, and a high level of enthusiasm was generated. At first Grant 's powerful image of a 'Manhat tan Project ' for vaccines guided the meet ing--and there was an attempt to issue a 'Declaration of Manhat tan ' to express that vision. However, there were objections to such a militaristic metaphor and it was dropped in favor of a 'Declara- tion of New York: The Children's Vaccine Initiat- ive.'§

James Grant of U N I C E F , in his customary fashion, gave an enthusiastic and buoyant speech. He put the 9 September meeting within the context of the coming World Summit for Children when the heads of 71 nations would assemble and consider how to help the children of the world achieve a brighter future. He said the gathering would be the largest meeting of heads of state in history, bringing together the leaders of North, South, East and West; and those meeting at U N I C E F House to consider a Children's Vaccine have an opportunity to have a significant input to that Summit by making it clear how important research on vaccines is in the fight to save children's lives. In the 1980s U N I C E F and W H O had revolutionized immunization by working together to create a new mechanism to deliver vaccines to the South. Now in the 1990s the new challenge was to have a new infusion of technology.¶

Grant went on to say that he did not believe that the stated world goals of eradicating polio, and controlling measles could be achieved without improved vaccines. And for this reason he had gone to the U N I C E F Executive Board and asked for $50 million over the next three years to support vaccine and immunization research involving both applied technology and delivery system work. He claimed that the Board had responded positively but wanted a U N I C E F / W H O meeting convened to look more closely at the issue. It was Grant 's goal to have a


marriage between "the bench guys and the bush guys" (i.e. the laboratory scientists and U N I C E F workers in the field). He closed by saying that if current death rates continued then 100 million children will die in the 1990s. Of these two-thirds were basically preventable, and thus 50 million lives could be saved.*

Dr Hiroshi Nakajima, Director-General of W H O also spoke. He made it clear that the new work on vaccines would require much coordination and

WHO is prepared to assume the leadership in this area. It is at your service to play the role of honest broker for the exchange of information, to provide forums for . . , scientists about appropriate goals and priorities, to help monitor and evaluate research results, to help organize and coordinate clinical trials . . .

If there was enough support for the new initiative Nakaj ima would establish an international group to act as the steering committee for vaccine development and to represent all public and private organizations interested in vaccine product development. t

The Declaration of New York which resulted from the meeting, signed by the conference participants in their individual rather than official capacities, showed that the initiative enjoyed wide support. It called on the world to work to use "current science to make new and better vaccines." The vaccines should be one or two doses, given early in life, combined in unusual ways so as to reduce the number of injections, be more heat stable, be useful against a wide variety of diseases, and be affordable. In addition, investments should be made to simplify production and quality control methods, support field trials, speed licensing, and help national production in developing countries. The Declaration called on world leaders to "commit themselves to a children's vaccine initiative that aims to produce and deliver ~ideal' children's vaccines . . . " It went on to request that the World Health Organ- ization take the lead in establishing an International Task Force for Vaccine Development, along with U N I C E F , U N D P , the World Bank and other interested international and national groups.:~

With the Declaration of New York the official movement toward accelerating the development and improvement of vaccines for the South received a semi-official, but powerful endorsement. At this point the long-term 'movement ' of individuals who believed

*"Mr Grant's Speech at Vaccine Development Meeting on September 9, 1990:" dated I0 September 1990. The figure '50 million' should logically be 66 million.

"t"Vaccine for the 1990s: A Time For Action," UNICEF House, New York, 9-10 September 1990. Address by Dr Hiroshi Nakajima, Director-General, WHO.

$"Declaration of New York: The Children's Vaccine Initiat- ive," 10 September 1990, issued at UNICEF House.

§It is interesting to note that the Declaration of New York does not in fact endorse the concept of a single children's vaccine. It does not even mention it. The Declaration speaks of "ideal children's vaccines." Despite this, the concept of a single vaccine as the ultimate goal was still maintained by its sponsors.

in the importance of a Children's Vaccine(s) was transformed into a practical attempt to create a mechanism to achieve, rather than talk about, that ideal.§

WHO's ROLE CAUSES DISSENTION

What the nature and configuration of this new mechanism was going to be, was far from clear. The leadership role, at least for the moment, was given to the World Health Organization. An agency that did not particularly want it, and certainly had not origi- nated the concept in its existing form. Many of its staff people felt that the World Health Organization lacked the technical or organizational ability to carr it out. Many more saw it as a potential rival to activities W H O already performed. The driving force behind the initiative was U N I C E F , with strong support from the U N D P and the Rockefeller Foundation. But it was still not clear if the U N I C E F Board would support Grant 's vision, or what role U N D P and Rockefeller would play in the future. Especially important, the question of whether the initiative would be a part of the World Health Organization, or a separate entity, was left unde- cided.

The implication of the "Declarat ion of New York" was that the World Health Organization would be the initiative's core. But there was good reason to believe that this was not acceptable to most of the major players. First, while Halstead had initially seen the CV as a means of revitalizing the Programme for Vaccine Development of WHO, that ' p ro -WHO' position was built upon his profound unhappiness with the functioning of the existing PVD. In a similar vein, while Sherry was busily working to get W H O to cooperate with U N I C E F in creating a means to funnel U N I C E F ' s money into vaccine research, U N I C E F had a long history of antagonism with the World Health Organization, and was determined never to allow the initiative to be a WHO-dominated enterprise. In a fundamental way the whole venture was driven by the fact that the World Health Organ- ization, which possessed the world's mandate for dealing with health problems, was seen, by external groups, as inadequate.

The nature of the perceived inadequacy may be best expressed not by an outside critic but by Ralph Henderson, Assistant Director-General of WHO:

[WHO is] an organization which has some very basic paradoxes. Each Regional Director is elected.., we have six regions, each with an elected Regional Director, and an elected Director-General [in Geneva]. The election process in international terms is not a very happy one . . , with a lot of horse trading going on, not always in the best interest of world health--at the regional level as well as at the global level. [Even making the bureaucracy work at the American CDC, which Henderson originally came from, is hard.] [Bureaucratic p]roblems.., are multiplied in WHO, because in international affairs, the bureaucracies are more complicated. You do have more sensitivities, more different cultures which you have to deal with.


And then to add to . . . [those bureaucratic and political problems], the tension between the regions which are oper- ating as independent political foci, . . . tension ... [that resulted from] headquarters programs [that had] to go through the regions and work at the country level .. .

In addition, WHO is "schizophrenic in the degree to which it should be pushing policies from above, as opposed to responding to national priorities . . . [but] we do both things and we think b o t h . . , are important . . . . " despite the fact that programs such as smallpox and polio eradication "can't be built up country by country from the bottom . . . "* The conflict between top-down vs bottom-up policy can be crippling.

There has been a general disillusionment with WHO by international donor agencies over the years. It has been manifested most dramatically by the increasing amount of money that has been given to the 'Special Programs' (e.g. PVD, EPI, TDR [the Tropical Disease Research Program]) which are 'co- sponsored' by WHO and other organizations--but lie outside of the Director-General's direct authority-- as opposed to the central WHO budget. The money under the Director-General's control has grown slowly, the other funds much more rapidly. While the figures that Dr Ok Pannenbourg, M.D., of the World Bank, give below are erroneous, he powerfully presents the ,eelings that many have about the implications of the situation:

These trust funds [i.e. the Special Programs] are not really under the control of the organization [WHO]. Nakajima does not like this. The lower the regular budget, the greater the other budget [of special programs is,] the less power he has over his own organization. This continues. The regular budget used to be $700 million and is now $400 million. This is because everyone is pulling out of the organization ... Less and less people are willing to fund the core of WHO ... [Many] shareholders [of the World Bank, when con- suited by the Bank] felt that WHO is not viable as an organization.t

So the initial impression that the Declaration of New York gave that the assembled groups and individuals recognized WHO's leadership of the new venture was quite misleading. The actual relationship of the initiative to the various international agencies was yet to be determined, but that WHO would be the actual leader was very much in doubt.

*Interview with Dr Ralph Henderson, Assistant Director- General of WHO, 25 April 1994.

tlnterview with Dr Ok Pannenbourg, 12 December 1994. $Interview with Dr Philip Russell, 5 April 1994. Russell says

that Rothermel was important in the gestation of the idea. However in an interview with Rothermel (21 February 1995) he said he had grave doubts as to the CGIAR's usefulness in health because it was simply a donors club and did not involve the private sector. He felt it was in real need of revitalization even as a mechanism for agriculture, alone health. It is not clear, however, if he held such a critical view in 1990.

§"Ad Hoc Meeting on the Children's Vaccine Initiative," 14 November 1990, PAHO, sent out to participants by the Rockefeller Foundation as "Minutes o f . . . " November 20, 1990.

In order to get the new initiative moving, the World Health Organization accepted the charge presented to it by the 'Declaration of New York,' and turned to Philip Russell, asking him to come to Geneva and write a concept paper for the organization of the CVI. As a result of Russell's talks with WHO personnel, Scott Halstead, Frank Hartvelt and Timothy Rothermel, the Director of the Division of Global and Interregional Projects, UNDP, the idea of using the Consultative Group for International Agricultural Research (CGIAR) as a model for the new organization was born. The CGIAR was seen by many in the international community as a remark- ably successful example of how to bring together donors and other interested parties to work towards a common goal in a directed and coordinated man- ner, that nevertheless utilized a non-coercive, decen- tralized structure. The Commission on Health Research for Development (the Evans Commission) had strongly suggested that "a health analogue of the CGIAR assessment and promotion structure could be of great value and should be established" [2]. Halstead was an enthusiastic supporter of the CGIAR concept and its application to health-- though Russell credits Harvelt and Rothermel of the UNDP as the chief influences on his thinking at this point.$

On 14 November 1990, an 'Ad Hoc Meeting on the Children's Vaccine Initiative," Chaired by Scott Halstead was held at the Pan American Health Organization (PAHO) in Washington, D.C. Dr Ralph Henderson of WHO presented the Russell plan as the World Health Organization's proposal for creating a structure for managing the CVI. The plan envisioned a large group of donors and interested agencies (a Consultative Group), and a smaller core group called the Management Committee which would function as the leader of the initiative. The Secretariat of the CVI would be housed in WHO but would carry out the orders of the Management Committee. After some discussion the proposal was modified to make it clear that the Secretariat would be independent of WHO despite its housing, and that the Chairman of the Management Committee, and any Technical Advisory Groups that might be formed, could be housed anywhere, not necessarily in Geneva.

In order to take this strategy further, two ad- ditional meetings were planned, the chief of which would be hosted by the Rockefeller Foundation and organized by Russell. It would be limited to 25 key individuals and agencies, from both the North and South, and the meeting would discuss both the CVI's management structure and Consultative Group. Later, WHO would sponsor a meeting to look at technical options, research and personnel needs. That meeting would also be chaired by Russell.§ Clearly, whatever happened, Phil Russell was slated to be the head of the new venture.

The Russell/WHO structure as envisioned in the


20 November document was consistent with WHO leadership of the initiative or the creation of a more independent organization. That Russell and Halstead had decided to move toward an independent entity was clear within two weeks of the PAHO meeting. On 28 November Russell sent Halstead a copy of a form letter which would invite participants to the scheduled Rockefeller-hosted meeting in early February, 1991. The letter stated that

At present there is no organizational structure or agreed upon management concept under which the CVI can be transformed from a political and scientific concept with a vaguely defined ideal into a managed and directed programme with specific goals and objectives.*

It then went on to say that the 'Declaration of New York' requested that the World Health Organization establish a Task Force for Vaccine Development with interested national and international public, as well as private, groups. This Task Force would now be expanded into an International Consultative Group for the CVI (ICGCVI). The role of the World Health Organization would be to form and provide support for the ICGCVI and to participate in its activities but the new group would be an independent entity where organizations could achieve consensus.*

It quickly became clear that the World Health Organization itself was not planning to relinquish its dominance of the CVI regardless of what Russell and Halstead were planning. WHO held a meeting in Geneva on 5 December 1990 called "Potential Role of the Private and the Public Sectors in the Acceler- ation of Research in Relation to the Children's Vaccine Initiative."t While many of the key backers of the CVI were present (e.g. Hartvelt of UNDP, Bart of NVP, Sherry of UNICEF) it was significant that Scott Halstead of the Rockefeller ignored the conference. He felt it was an unimportant, rather obvious attempt by WHO to 'grab' the CVI as a WHO function. While the WHO speakers at the meeting emphasized the long tradition of WHO/private sector collaboration, it was the weakness of WHO in dealing with commercial vaccine producers that Halstead

*Letter from Dr Philip Russell, to Dr Scott Halstead, 28 November 1990.

t"WHO/UNDP Programme for Vaccine Development: Potential Role of the Private and the Public Sectors in the Acceleration of Research in Relation to the Chil- dren's Vaccine Initiative," Report of a Meeting Held at WHO, Geneva, 5 December 1990. (MIM. PVD. DOC/91.2.)

~Dr Richard Mahoney to "Distribution" [Program for Appropriate Technology in Health] "Subject Meeting on Private and Public Collaboration," Geneva, 5 December 1990.

§Anthony Robbins, M.D., "The Children's Vaccine Initiat- ive: The Challenge of Paying for New and Improved Vaccines," submitted to the Conference on Potential Role of the Private and Public Sectors in the Accelera- tion of Research in Relation to the Children's Vaccine Initiative," WHO, Geneva, 5 December 1990.

considered one of the World Health Organization's chief failings.

According to a perceptive observer of the WHO meeting, both Terrell Hill of UNICEF and Frank Hartvelt of the UNDP went to great lengths to assert that the CVI would be WHO ied.:~ If they were aware of the Russell/Halstead correspondence, they gave no hint of it. However, Anthony Robbins, who was in constant communication with most of the key players in the unfolding drama, took advantage of his independent scholar/activist position and publicly stated what many non-WHO representatives were thinking:

The international agencies launching the Children's Vaccine Initiative must create a public fund to provide stable management . . . . Incremental additions to existing programs will send the wrong message. The CVI is to be approximately one thousand times larger than the [WHO's] Programme for Vaccine Development . . . . It would be a mistake to assume that this program can be established within an existing agency, particularly one that has established bureaucratic traditions that have never managed this kind of effort. It is far harder to work within a bureaucracy that has ... an imperative to make new problems fit into old procedures.§

Robbins spoke for those who wanted the CVI be an entity separate from the World Health Organiz- at ion--a place where the major agencies could be equal, without WHO domination. And in so doing he more than hinted at the widespread disrespect that the World Health Organization's central bureaucracy was held in throughout much of the international health community--at least in the North.

At any rate, by the time the Rockefeller Foun- dation hosted the first general post-'Declaration of New York' meeting in Mt Kisco, New York, in February 1991, the decision had been made by four of the five international agencies that would 'co-found' the CVI (i.e. UNICEF, UNDP, the Rockefeller Foundation, the World Bank--WHO was the fifth) that the CVI would take the form of an independent entity with the World Health Organization housing the secretariat but not leading the initiative. It was at Mt Kisco that one can say that the CVI as a structure rather than an aspiration was finally born.

THE UNDERPINNINGS OF THE CVI PROVE UNSTABLE

The new organization embodied the hopes and dreams of countless scientists and public health officials. If it succeeded it would create nothing less than a revolution in the development and use of vaccines for the children of the South. The disjointed, inefficient, scientific-curiosity-driven and market-pro- pelled process of vaccine research and development would be finally shaped by the conscious input of public sector leaders dedicated to the saving of lives rather than profit or academic advancement.

Unfortunately, the new structure was being con- structed on top of a foundation that was crisscrossed


by fissures. These fault lines were at least five in number.

The first cleavage was created by European/ American rivalry, or to be more exact, Euro pean/North American rivalry. Frank Hartvelt's boss, Dr Timothy Rothermel, the Director of the Division of Global and Interregional Projects, UNDP, put it succinctly:

I have been burned many times in the past during the CVI and other international undertakings--[so] that [it is important that] the germs of ideas that come up from UNDP, UNICEF, etc., not be perceived as North American in origin . . . . So many initiatives that have been undertaken [over the years] have been seen as North American. It doesn't matter if it is the United States or Canad[a]--it is all seen as the idiots in North America are at it again. If you are launching something new you must have some European partners--that is what I have learned in my old age.*

The CVI did not have enough such partners at the start.

The early role which was played by Dr Philip Russell in the founding of the CVI as an independent entity, and his presumed leadership of the new group, also fanned European hostility. Russell was the archetypal American (i.e. direct, blunt, outspoken, truth-telling rather than diplomatic) and a retired American Major General to boot! He was a living provocation to European sensibilities.

The European nations were also resentful of what was perceived by them as American over-representation in the United Nations system, especially the agencies that founded the CVI. Americans headed UNICEF, UNDP and the World Bank. Even if the top leaders of these agencies had been Europeans, they would have been seen as co-opted, and de facto Americans (as was, indeed, the case with specific secondary leaders). Those 'American dominated' UN agencies constituted three-fifths of the founding organizations of the CVI. The fifth founder, the Rockefeller Foundation, despite its high prestige as a pioneer in health programs, epitomized by its very name the arrogant, domineering Robber Baron image of America that many Europeans steadfastly adhered to.

European unhappiness with the Americans was manifested as early as the UNICEF Executive Board's initial rejection of Grant's research proposal in April 1990. The Europeans saw that limited research proposal as little more than a way to fund D.

*Interview with Timothy Rothermel, 21 February 1995. tLetter from Dr D. A. Henderson, Dean, to Major General

Philip Russell, 8 May 1990. :~"Position Paper," Program Committee Item No. 13, 1993

UNICEF Executive Board, 26 April-7 May 1993. Final 19 April 1993.

§Nordic statement by the Delegation of Norway. UNICEF Board 1993, Programme Committee, Agenda items no: 13, 14 and 15, "Programme Reviews: Children's Vaccine Initiative (CVI), Acquired immune deficiency syndrome (AIDS), UNICEF/WHO Joint Committee on Health Policy."

A. Henderson (another prototypical American charismatic figure) and Johns Hopkins University at the expense of the rest of the world. Sherry and Grant's metamorphosis of the Henderson connection into the CVI looked to many of them as simply making a bad situation worse.

Not only were Americans such as D. A. Henderson and Johns Hopkins University over-represented in the original UNICEF research proposal, but the American government itself came to play an increasingly prominent role in the creation and support of the CVI after Jim Grant asked it to take the leadership role in a global movement to achieve the Children's Vaccine. Even within the UNICEF Execu- tive Board, in the years after 1990, the American delegation became increasingly identified as the major CVI backer of UNICEF's role in the initiative--in direct opposition to the Dutch and Nordic del- egations.

When the original research proposal was first presented to the Board in April 1990, the American delegation initially had taken considerable care to soothe European sensibilities by refusing to support it. It was so effective in its opposition that D. A. Henderson had been told that the Americans had been the cause of the proposal's rejection.t However, in the following years the U.S. took a decidedly less conciliatory position to the Europeans. As a 1993 American 'Position Paper' summarized the situation:

This item [financial support of the CVI by UNICEF] is of relatively high importance to the United States ... The United States worked effectively at both the 1991 and 1992 UNICEF Board meetings to assure that financial support was provided ... even in the face of significant opposition by some countries, particularly the Nordics. The U.S. delegation should support ... funds for CVI ... [again in 1993] even in the face o f . . . opposition.$

The Nordics in turn made their attitude quite clear when they said "Development, testing, and introduc- tion of new vaccines can only be [a] second [level] priority" for a CVI that UNICEF could support because "Little will have been gained if new vaccines are introduced into an EPI which might not be . . . able to sustain the present vaccine coverage in developing countries. UNICEF support for the CVI should not be product development focused but rather concentrate on supply and quality control issues.§

The result of these strong national, indeed continental, disagreements within the UNICEF Executive Board, was a situation in which UNICEF became a funder for the CVI but only for activities that did not directly involve research and development--at most it could fund infrastructure strengthening that made research possible. The irony could not have been more extreme since Scott Halstead and Jim Sherry originally set out to promote the idea of a Children's Vaccine in order for it to serve as a vehicle for funneling tens of millions of UNICEF dollars into vaccine product development.


(As we will see in later articles, the U N I C E F Board's anti-research mandate had positive as well as negative repercussions. U N I C E F , and its Nordic country donors, helped push the CVI leadership into broadening its focus and emphasis to include the vital areas of vaccine supply and quality cont ro l - -areas which had long been neglected by the World Health Organization. The work done in that area would ultimately be seen as the most important and far reaching contributions that the CVI made to world health. However, the restrictions on funding product development were a stiff price to pay for that undeni- able benefit.)

To make matters worse between the Europeans and North Americans, the Europeans were painfully aware that the biotechnological revolution that was at the heart of the Children's Vaccine Initiative was a creation of the United States, and that its foremost industrial practitioners were American biotechnology and pharmaceutical companies. This served to feed the widespread suspicion that the CVI was purpose- fully designed to further American commercial and scientific interests at the expense of their Continental rivals. For example, when Grant presented his Exec- utive Board in April 1991 with a document asking support for the newly formed CVI "[i]t was not well r ece ived . . , with their concerns i nc lud ing . . , that the CVI was really directed toward support for multina- tional corporations (principally U.S.)."*

The second fissure underlying the CVI structure was U N I C E F vs WHO. That the tension's between the two United Nations Agencies has been longstand- ing, and sometimes effected even miniscule issues, is made very clear by D. A. Henderson:

When did we get into this trouble [UNICEF vs WHO]. It goes back to the Charter of WHO--the professional organization for health. WHO felt it would set the health agenda. lit was v]ery territorial. If UNICEF [even] wanted to bring a technical man--[i.e.] a medical officer--on the UNICEF staff, WHO was hostile.t

This long-term inter-agency hostility was exacer- bated by Grant 's declaration of "the Children's Rev- olut ion" in the early 1980s which emphasized childhood vaccination as a major focus for U N I C E F efforts. While W H O found in practice that it could cooperate successfully with U N I C E F in key aspects of the EPI's work,

• . . they did not l ike. . , that UNICEF seemed to be reaping the credit for the successes [of the program] as Jim Grant jetted around the world, meeting with world leaders to convince them . . . to provide the political will to achieve universal childhood immunization. Moreover, [for a long time] WHO disliked UNICEF's advocacy of the campaign approach [e.g. national vaccine days] to achieve immunization coverage goals.:~

*Letter from Linda Vogel, Office of International Health to Dr Kenneth Bart, NVPO, concerning "UNICEF Paper on CVI for UNICEF Executive Board."

tlnterview with D. A. Henderson, I 1 July 1995. :~Letter from Linda Vogel, Director, Office of International

Health, to William Muraskin, 25 July 1995.

The CVI was originally conceived as a means for U N I C E F to funnel its money into research without directly giving it to the World Health Organization.

The third fault line was the tacit alliance between U N I C E F / U N D P the World Bank/Rockefeller Foun- dation vs WHO. While the key cleavage was between U N I C E F and WHO, the other founding organizations also had deep suspicions about the ability of W H O to carry out its health mandate. As we have seen many people in those organizations felt that W H O was a bureaucratic quagmire that verged on being non-viable. This feeling was exaggerated by the immense international bad-will generated during the highly politicized election campaign of 1988 that made Nakaj ima Director-General of WHO.

The perception of W H O that has agitated the leaders of the key international health organizations, and many others in the international health community, is very bluntly, almost brutally, summarized by D. A. Henderson:

WHO was pretty much a dead-ass operation. Over time [WHO] . . . became more politicized. At first it had pro- fessionals that knew international health. The Europeans had a big presence. But the colonial period past [and t]hey disappeared. There was a drying up of talent . . . . The fatal weakness was the election of regional directors. The regional directors approaches each nation. [The local government official] . . . sa[ys] I have a brother-in-law, [find him a job], then you get my vote. There was no secret about it. This became much worse under [Director-General] Mahler . . . There was a change in policy: before all appointments had been looked at and approved in Geneva . . . . Mahler said we don't have to do that; at senior level let the regions do that.

WHO's only reason for existence is [to provide] professional advice and talent . . . and guidance for what is needed. UNICEF then raises money and funds projects that WHO and the country have worked up. UNICEF [is] now unhappy with WHO guidance: which is piss poor. Why, asks UNICEF, don't we hire our own people. [Needless to say t]his made Director-Generals enraged.t

This negative view of W H O certainly helped fuel the desire to create a mechanism outside of W H O to champion vaccine product development. But since W H O could not be denied major representation in the new initiative, the resulting background tension between W H O and the other Founder agencies was of necessity, enormous.

The fourth fault line was the CVI vs the Pro- gramme for Vaccine Development (and to a lesser extent, the Expanded Programme on Immunization). The CVI was quickly, if not initially, seen by the leadership of the PVD as a potential competitor rather than collaborator. They felt the very existence of the CVI was an implicit attack upon their past activities and present competencies. At the very least it was seen as a potential competi tor for the limited supply of donor funds. Where the CVI sponsors believed the new program was capable of bringing in vast new financial resources that would benefit everyone, leaders of the PVD and EPI worried that international funds were shrinking because of 'donor fatigue."


Lastly, the fifth fissure arose when the founders of the CVI chose to establish an independent structure outside the World Health Organization because by so doing they alienated some of the CVI's initial supporters. Many of the CVI's original adherents would not accept anything less than WHO leadership. They feared conflict and competition would result if the CVI was not intimately involved with WHO. The most striking example of that loss of support was Barry Bloom of Albert Einstein Medical College. He had played an indispensable role in the defence of the Children's Vaccine concept at the June 1990 SAGE meeting; later he championed the initiative at the National Institutes of Health meeting in August; and finally he was active at the September expert's meeting at UNICEF House. As far as he was concerned, WHO, regardless of its weaknesses, was 'the only game in town.' To try to function indepen- dently of WHO, he felt, would be a ruinous and foolhardy policy that he could not support. When he went to the Rockefeller-hosted Mt Kisco meeting in February 1991 and heard Phil Russell (CVI-leader designate) lay out his vision of the CVI, Bloom found it a 'disaster.' He felt Russell's vision was little more than a blueprint for chaotic, overlapping and com- petitive turf fights between the CVI and the World Health Organization's Special Programs that could only end in a loss of financial support for all the groups. His alienation was shared by others.*

(The perceptive reader may wonder why a sixth major fissure does not receive attention at this point:

*Interview with Dr Barry Bloom, 29 February 1995.

the conflict between North and South. The reason for this omission is that no such struggle appears except insofar as the Europeans raise the issue of "the under-representation of the South" as a useful weapon in their own fight with the Americans. Why the South itself does not challenge the leaders of the CVI concerning this situation is an interesting topic, but not germane to the present discussion.)

The cracks in the foundation of the Children's Vaccine Initiative, if allowed to remain unrepaired, threatened to bring the ambitious new edifice down. At first they could be papered over, but ultimately the CVI would have to successfully mend them or suffer the consequences. How the CVI fares in the following years will be the subject of a series of future articles. Suffice it to say that major successes were achieved by the CVI despite all these disruptive elements, but the question of whether 'a house divided against itself can long stand has remained an active query until the present day.

REFERENCES

1. Bloom B. Vaccines for the Third World. Nature 342, 115, 1989.

2. Commission on Health Research and Development. Health Research: Essential Link to Equity in Develop- ment. Oxford University Press, New York, 1990.

3. Goodfield J. A Chance to Live: the Heroic Story of the Global Campaign to Immunize the WorM's Children. Macmillan, New York, 1991.

4. Muraskin W. The origins of the Children's Vaccine Initiative: the intellectual foundation. Soc. Sci. Med. 42, 1701, 1996.

5. Robbins A. and Freeman P. Obstacles to developing vaccines for the Third World. Scient. Am. 256, 126, 1988.

Origins of the Children's Vaccine Initiative: The political foundations

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