Volume VIII, Number 3 Sabin Winter 2005 EPORT The newsletter of the Albert B. Sabin Vaccine InstituteR — dedicated to disease prevention www.sabin.org Introduction and Sustainable Use of in Developing Countries Colloquium Considers Vaccine Availability to World’s Poor

International public health, government, developing country challenges for long- in developing countries die each year be- and industry experts convened October term programs, vaccine fi- cause they weren’t immunized.” He 19-21 for the 12th Sabin Vaccine Policy nancing, vaccine supply, political com- added that “[the colloquium can] address Colloquium, which focused on the “In- mitment, and how best to coordinate the some of the most important obstacles to troduction and Sustainable Use of Vac- working relationships and responsibilities expanding access to lifesaving vac- cines in Developing Countries.” The col- among the myriad of organizations that cines.” loquium, sponsored by the Bill & Melinda provide assistance for immunization pro- “ programs that can be Gates Foundation, was conducted at the grams. sustained over a long period of time will Banbury Center of Cold Spring Harbor The 35 participants represented mul- be essential to the health and well being Laboratory in Lloyd Harbor, New York. tilateral agencies, and the manufactur- of generation after generation of chil- The past 12 years, the Institute has ing sector with international delegates dren in developing countries,” said Dean organized a meeting where experts con- from countries including Angola, Bra- Mason, SVI president. “The stakes, in sider a vaccine policy issue of global im- zil, Ethiopia, Ghana, Guyana, terms of life quality and human suffer- portance. The group set out to address Mozambique, Sudan, Tanzania, ing, are most significant.” some of the most critical issues facing Uganda, Vietnam, and Zimbabwe. Co- The proceedings of the colloquium, financiers, industry and the developing chairs were Kevin Reilly, an expert on including recommendations reached dur- countries that receive or need funds for vaccine production and marketing, and ing the consensus, will be published in vaccine purchase; define performance Francisco F. Songane, MD, MPH, the early part of 2006. criteria that can help benefactors and MSc, former minister of health of Read from the colloquium keynote developing countries measure their Mozambique. address by Sir George A.O. Alleyne, progress; and make realistic recommen- Steve Landry, senior program officer MD on page 6. dations that best enhance the prospects for Global Health Strategies at the Bill for sustained use of needed vaccines in & Melinda Gates Foundation, said, “It developing economies. Topics included is unacceptable that millions of children I nside SVI Vaccine Policy Colloquium del- President’s Message...... 2 egates review pre- Colloquium on ... 3 sentation notes: ViewPoint: Neglected Diseases ...... 4 from left, Jean-Marie Consortium News.... 5 Okwo-Bele, direc- tor, Immunization, Book Corner ...... 8 Photo by Miriam Chua, CSL. Vaccines and ACIP Recommendations ...... 9 Biologicals, World Interview: Communicating About Health Organization; Children’s Health ...... 10 Davies Dhlakama, Calendar...... 11 director, Technical Services, Ministry of Health, Zimbabwe; Sir George Alleyne discusses im- and Mary Kitambi, munization and human develop- EPI manager, Dar es ment, page 6. Salaam, Tanzania. 2 WINTER 2005 SABIN VACCINE REPORT The Sabin Vaccine Report A Top-Ten List of Vaccine Needs is published by the Message from SVI President, Dean D. Mason Albert B. Subscriptions are free. Direct inquiries to: I acknowledge a certain affinity for top-ten rankings, effective a vaccine as can SABIN VACCINE REPORT ranging from David Letterman’s nightly subjects to be developed under the 1889 F Street, N.W., Suite 200S the best ten teams in different sports. In that spirit I circumstances. Washington, DC 20006-4400 have prepared a list of the vaccine and immunization 4... More Vaccine phone: 202.842.5025/fax: 202.842.7689 issues that I believe to be among the most critical Manufacturers www.sabin.org/email: [email protected] topics that we must address. Between 2000 and 2004

EDITOR 10... Clone the Bill & Melinda Gates in the we Raymond MacDougall Foundation It is probably not fair to single out experienced vaccine Dean D. Mason one group when there are a number of shortages in nine of the 13 COPY EDITOR David Bedell philanthropic organizations committed to the vaccines that were a part of the routine pediatric promotion of good health through global schedule. For seven vaccines we are now dependent OFFICERS OF THE SVI BOARD OF TRUSTEES H. R. Shepherd, DSc, Chairman vaccination programs. However, the impact of this upon only one manufacturer. An additional concern William R. Berkley, Co-Chairman foundation cannot be denied. The commitment of to supply disruptions is manufacturing capacity. Michael E. Whitham, Esq., Secretary/Treas. other philanthropic groups gives greater global 3... Support for the Research and promise for the equal access of all children to life Development of New Vaccines We must expand SVI STAFF saving vaccines. Dean D. Mason, President/CEO our commitment to find safe and effective vaccines Fran G. Sonkin, Executive Vice President 9... Vaccine Stockpiling Domestic vaccine against AIDS, and Tuberculosis. We must Ciro de Quadros, MD, MPH, Director, supply shortages remain a very real threat. Though also add to the armamentarium by developing International Programs some progress has been made, we need to establish vaccines against “orphan diseases” such as Robert Allen, MD, Health and Science a six-month vaccine inventory for each of our hookworm and schistosomiasis. Another exciting Director routinely recommended pediatric vaccines. area with much promise is in support of research to David Bedell, Director, Educational develop anti-cancer vaccines. Programs 8... Vaccines Against Continue Karen Bodick, Assistant to the Chairman to support vaccine research, development and 2... Global Vaccination Programs Those most Ana Carvalho, Assistant to the Director, preparedness plans in anticipation of terrorist threats impoverished suffer the most from diseases that are International Programs to introduce infectious organisms into our society. preventable through vaccination. We are in need of David J. Diemert, MD, Chief Medical 7... Liability Protection and Fair Compen- a global strategy that will allow for the supply of Officer, HHVI sation To better assure a viable industry and vaccines in a sufficient and timely way to all infants Kristin Lee, Assistant to the President produce vaccines at reasonable costs, manufacturers and children. The major issues involve adequate Raymond MacDougall, Director of Commu- and sustainable funding, government commitments nications need government protections against frivolous or Jean Mitchell, Development Officer financially excessive lawsuits. An equal responsibility and affordable pricing that includes necessary Noor Seddiq, Fiscal and Grants Manager is to assure there is adequate compensation (most profits for those manufacturing the vaccines. Ami Shah-Brown, PhD, MPH, QA & often through the Vaccine Injury Compensation ...and most importantly Regulatory Manager, HHVI Program) for those rare instances when a child is 1... Adequate Vaccine Financing In the United Kari Stoever, CCRP, Program Director, injured or dies as a consequence of a vaccination. Human Initiative States the introduction of each new vaccine brings a 6... Parental Education and Vaccine Safety crisis in funding. States express concerns about

SVI ADVISORS Through the use of good and transparent science, unfunded mandates, insurance companies can be Philip K. Russell, MD, Senior Advisor to the promote the use of safe and effective vaccines that slow in adding coverage and children served through Chairman includes appropriate information on the benefits ERISA plans or who do not have adequate insurance Peter J. Hotez, MD, PhD, Senior Fellow & versus risks. Both the public and health care may have no vaccine benefits whatsoever. A Chair, Scientific Advisory Council providers must be adequately informed on true risks coordinated and comprehensive strategic financial Anne Gershon, MD, Co-chair, Scientific versus unsubstantiated or unlikely claims that plan should be developed between the public and Advisory Council discredit life-saving vaccines or discourage parents private market forces that shape our health care Hugh E. Evans, MD, Sabin Fellow William Muraskin, PhD, Sabin Fellow from fully protecting their children against vaccine delivery systems. The plan would systemize coverage Patricia Thomas, Sabin Fellow preventable diseases at the age appropriate times. for infants, children, adolescents and adults. Nancy Gardner Hargrave, Development 5... Pandemic Influenza Planning and What subjects would you add or subtract from this Counsel Response Through November 29, 2005 WHO list? How would you re-prioritize? I would welcome has reported 133 laboratory confirmed avian _____ your feedback. Please feel free to email your influenza cases with 68 deaths. The Spanish suggestions to [email protected]. influenza of 1918-1919 should be a grim reminder The Sabin Vaccine Institute gratefully Sincerely, acknowledges the generous unrestricted that we cannot await the domestic introduction of a educational grant from Chiron Foundation to deadly pandemic influenza strain before we respond. support the publication of this newsletter. Our plan must include early global detection, rapid response, anti-virals and treatment supports, stockpiling and the mass production of as safe and Dean D. Mason dedicated to disease prevention www.sabin.org 3

Colloquium Assesses 10 Years of Chickenpox Vaccination Newly-Approved MMRV and Potential Shingles Vaccine Also Focus of Global Forum

Many of the world’s leading experts rubella, and varicella vaccine) [see re- varicella vaccine booster shot to en- on the varicella-zoster (VZV)— lated news brief on page 9], the ef- hance immunity. which causes chickenpox (varicella), fectiveness of an experimental shingles Faculty presenters at the colloquium shingles (herpes zoster) and postherpetic vaccine in reducing the incidence of included infectious disease experts from neuralgia (PHN)—convened in New shingles, and the potential need for a Continued on page 12 York on Nov. 7, 2005 at the New York Academy of Medi- cine for a colloquium that co- COLLOQUIUM ON THE incided with the 10-year an- niversary for the licensure of VARICELLA VACCINE the vaccine in the United A DECADE OF PREVENTION & THE WAY FORWARD States. The “Colloquium on VARICELLA, HERPES ZOSTER, PHN the Varicella Vaccine: A De- cade of Prevention & the Way Forward,” was jointly sponsored by the Sabin Vac- The following abstract, The Effectiveness of Varicella Vaccine, 10 Years Later, is cine Institute (SVI) and The from the presentation at the Colloquium on Varicella Vaccine by Marietta New York Academy of Medi- Vazquez, MD, Yale University (Reprinted with permission of the author) cine. SVI Scientific Advisory Council co-chair Anne Live, attenuated varicella vaccine cella vaccine soon after the MMR vac- of age, but found that the vaccine’s Gershon, MD, Columbia Uni- was licensed in 1995 and is recom- cine (<28 days), and in children who effectiveness in the first year after vac- versity College of Physicians mended for susceptible persons 12 have received the vaccine more than 3 cination was substantially lower in and Surgeons, chaired the col- months of age. It is well recognized years before developing disease. those vaccinated at <15 months of loquium steering committee. that the efficacy of a vaccine as it is Duration of immunity after varicella age. Currently, available data do not Global VZV issues re- used in clinical practice, also referred vaccine continues to be an important support a delay in the earliest recom- ceived the focus of attention to as effectiveness, may be different question of public health concern; if mended age of immunization, as the at the meeting, including the from that in the setting of a carefully immunity is not long lasting, then will benefit of increased effectiveness impact of the vaccine in dis- controlled . As with other booster doses of vaccine be required? would have to be balanced against ease reduction, the FDA’s new vaccines, numerous questions Post-licensure studies following vac- both the risk of leaving children un- 68 recent approval of MMRV have emerged since licensure re- cines for up to 10 years after immuni- protected for 3 months and against (combined measles, mumps, garding varicella vaccine’s use and zation have shown that the long-term the possibility that such children may effectiveness. effectiveness of the vaccine remains not return at a later time for immuni- Post licensure studies have found good. Nevertheless, it should be zation with varicella vaccine. varicella vaccine to be highly effective pointed out that these studies have Widespread use of varicella vaccine (80-90%) in preventing varicella dis- assessed the effectiveness of the vari- in the US over the last 10 years has ease of any severity—its effectiveness cella vaccine in an environment in resulted in significant changes in the reaching almost 100% against mod- which primary varicella and of this viral — erate and severe cases of the infec- natural boosting of immunity are still most notable, a dramatic decline in tion. However, as the proportion of common. It is unknown if and how its annual incidence. Although recent children in the U.S. who have received the effectiveness of the vaccine will reports of vaccine failures in outbreak the varicella vaccine has increased, change once natural boosting of indi- settings have sparked controversy and there have been several reports in viduals ceases to occur. engendered multiple questions re- Among the full schedule which the effectiveness of vaccine was An ongoing community-based case- garding varicella vaccine, undeniably, of presentations, the substantially lower than expected. In control study of children with vaccination remains the most effec- abstract at right particular, reports during outbreaks chickenpox has found no statistically tive approach to prevent disease. Well- represents one of the many of varicella in children have noted in- significant differences in the overall designed, controlled studies that can excellent scientific reports creases in breakthrough disease in effectiveness of varicella vaccine in continue to monitor disease and as- delivered at the those vaccinated at an age less than children immunized at <15 months sess varicella vaccine and its effects colloquium. 15 months, in children with asthma, of age compared to those who have over time are necessary to guide fu- in those who have received the vari- received the vaccine at >15 months ture vaccine policies. 4 WINTER 2005 SABIN VACCINE REPORT

Controlling Neglected Tropical Diseases Could Help Make Poverty History From the Open Access Journal, PLoS Medicine, Available at www.plosmedicine.org

“The big three” infections—AIDS, TB, and $7-10 to treat a single episode TB and malaria—have caught the VIEW of malaria. world’s attention but other disabling and POINT Three of the drugs in the package fatal infectious diseases in Africa are (ivermectin, azithromycin, and being ignored, say three eminent tropi- blindness, hookworm, elephantiasis, and albendazole) are being donated by their cal disease researchers in the interna- blinding trachoma. These diseases af- manufacturers, and the fourth tional health journal PLoS Medicine. fect several hundred million people, and (praziquantel) now costs only 7 cents per The article by David H. Molyneux, kill at least half a million annually, yet tablet. The researchers suggest that a Peter J. Hotez, and Alan Fenwick con- they garner little attention from donors, rapid impact package against some of siders the neglected tropical diseases, policymakers, and public health officials. the neglected tropical diseases could which include sleeping sickness, river The researchers argue that a “rapid permanently reduce their incidence. impact package”— For costs that are relatively modest distribution of four compared to controlling “the big three,” anti-parasitic drugs an integrated control package for ne- across Africa to treat glected tropical diseases could have a seven neglected dis- proportionately greater impact on more eases—would bring poor people’s health as well as being tangible benefits to more equitable for the majority of the world’s poorest Africa’s poorest and marginalised com- communities. munities. The cost of the The researchers “urge policy makers package, they say, and health economists to recognize that would be negli- although HIV, TB, and malaria are the gible—a mere 40 most serious problems facing health cents per person per planners, other diseases exist that can year, compared with be addressed at realistic costs with ef- $200 per person per fective interventions.” year to treat HIV/ “Controlling Africa’s neglected dis- Range of Treatment Costs/Year for Treating HIV/AIDS, TB, AIDS, $200 to treat eases is one of the more convincing Malaria, & Neglected Tropical Diseases (“Rapid Impact a single episode of ways to ‘make poverty history’ through Package”) affordable, pro-poor, effective, and tested strategies.” Citation: Molyneux DH, Hotez PJ, Fenwick A (2005) “Rapid-impact inter- ventions”: How a policy of integrated control for Africa’s neglected tropical diseases could benefit the poor. PLoS Med 2(11): e336. The authors were cited in a story ap- pearing in the Oct. 10, 2005 BBC News World Edition and the October 11, 2005 edition of The Guardian.

All works published in PLoS Medicine are open access. Everything is immediately available without cost to anyone, anywhere—to read, download, redistribute, include in databases, and otherwise use— subject only to the condition that the original authorship is properly attributed. Copyright is retained by the authors. The Public Library of Science uses the Creative Commons Attribution License. Geographic Overlap of the Neglected Tropical Diseases (Molly Brady, Emory University) dedicated to disease prevention www.sabin.org 5

Say It Ain’t So Cancer Vaccine Consortium Update Straightening the Record on Cancer Vaccine Trials and ELISPOT Proficiency Take Spotlight Uncharitable Op Ed The Sabin Vaccine Institute spon- be given to the FDA as the basis for a by H.R. Shepherd, Chairman, SVI sored the workshop of the Cancer guidance document governing drug I recently read a New York Times op-ed that Vaccine Clinical Trials Working Group development and approval processes took to task the good intentioned efforts of (CVCTWG), Nov. 10, 2005, and the for cancer vaccines. wealthy and celebrity philanthropists. The au- meeting of the Cancer Vaccine Con- ELISPOT Proficiency Panel thor had experience serving in the Peace Corps sortium (CVC), November 13-14, in Sylvia Janetzki of ZellNet Consult- in a developing country and a perspective that Alexandria, Virginia. poor countries would do better to eschew the ing presented the results to date of the charity garnered by wealthy or celebrity West- Cancer Vaccine Clinical largest ELISPOT proficiency panel erners whose efforts he characterized as Trials Workshop ever conducted. Thirty-six labs in nine “dumping more money in the same old way.” The CVCTWG was a yearlong, countries participated in this standard- This op ed represented, I believe, a simpli- multi-disciplinary, international joint ini- ization and validation experiment and fied and skewed perspective. It simplifies the tiative of the CVC and the Interna- then met in Alexandria to discuss re- efforts of wealthy and celebrity philanthropists, tional Society for the Biological sults and next steps. A follow-up prejudicing their efforts as uninformed and Therapy of Cancer (iSBTc). Over ELISPOT panel will be conducted in brash. It skews good intent, since the goal of 150 stakeholders of the cancer vac- 2006, and new initiatives for Tetramer philanthropy is to buoy the underserved and cine community, representing academic and Cytokine assays are in the works demonstrate compassionate humanity. institutions and biotech and pharma- as well. Laboratories interested in What the author of that op ed might not real- ceutical industries, came together at participating should contact CVC Ex- ize is the degree of scientific rigor and eco- the culminating workshop to reach a ecutive Director Susan Geiger. nomic analysis that precedes the allocation of broad consensus on a new paradigm In addition to these working group funding for global development and health pro- for clinical trials. In addition, the accomplishments presented at the grams. Decisions about where funds are tar- CVCTWG was strongly supported by meeting, three keynote speakers geted are conducted in an atmosphere of sci- representatives from regulatory au- shared their perspectives from indus- entific expertise and consultation. There also thorities through active participation in try, regulatory, and academic back- exists a high degree of accountability for use of its discussions. grounds. Rachel Humphrey, MD, funds dispersed. At least that is the case for the The workshop addressed four broad Vice President of Global Immuno-On- foundations with which I have been impressed. topics: 1. Clinical Endpoints to Support cology at Bristol-Myers Squibb, spoke Sure, the Western media enterprise puts Efficacy, 2. Design Methodologies for on the limitations and promises of can- immense value on celebrity voice and popular Cancer Vaccine Trials, 3. Technical cer vaccine research, reviewing a va- reach. So be it. The economists and scientists Challenges in Cancer Vaccine Trials, riety of single-agent and combination that work behind the scenes to develop medi- and 4. Enabling Technologies and Com- vaccine strategies. Celia Witten, cines and vaccines and programs to reach the binations of Investigational Agents. MD, PhD, Director of the Office of impoverished may not have a popularity to “The CVCTWG initiative was char- Cellular, Tissue and Gene Therapies match such celebrity voices. But they work to- acterized by an unprecedented degree (OCTGT) at the Center for Biologics ward a goal of providing for the underserved of open discussion and collaboration Evaluation and Research (CBER), pre- and desperately in need the hope of global between a broad array of major stake- sented the workings of OCTGT, in- health and economic relief that may ultimately holders in cancer immunotherapy de- cluding early and late phase clinical lead to freedom from neglect and underdevel- velopment,” said Axel Hoos, MD, development plans, how to interact opment. PhD, of Bristol-Myers Squibb Global with FDA, guidance documents and Given the resources of wealth or celebrity, it Clinical Oncology, one of the four other FDA resources available for is far better that these be utilized for the benefit workshop organizers. “It is remark- product development. Carl June, of the poor and underserved, than if they con- able that the consensus reached on the MD, Director of Translational Re- tinue to benefit only the economic and enter- clinical development paradigm for can- search at the Abramson Cancer Cen- tainment interests of popular Western culture. cer vaccines and related immunothera- ter at the University of Pennsylvania, Wealthy and celebrity philanthropists, or any pies can be regarded as representa- discussed combination immunotherapy charitable contributors, play a role that is tive for the entire field.” and showed how vaccination may re- unique and is among the best things that they The group is now in the process of store tumor immunity and lead to im- can do with the resources at their disposal. submitting reports for publication in proved outcomes following high dose scientific journals. A report will also chemotherapy. 6 WINTER 2005 SABIN VACCINE REPORT Immunization for All — A Condition for Health and Development From the Keynote Address by Sir George A.O. Alleyne to the 12th Sabin Vaccine Institute Annual Vaccine Policy Colloquium, October 19, 2005

I call this talk “An Apology for Immuniza- tity and quality of the human capital stock. tion.” I use the word “apology” in the origi- Also, savings rates are higher in countries nal sense of the Greek term as Socrates used that are healthier. As people are healthier and it—”apologia”—”a speech in defense of.” have a better perspective on what life has to So this is a speech in defense of immuniza- offer, their savings rates increase. We know tion, and why immunization needs to be de- that increasing savings leads to increased fended if it is to achieve the proper place that economic growth. it richly deserves. David Bloom describes the phenomenon The hypothesis proposed to me for com- of a demographic dividend, which is related ment is: “If we provide the vaccines we al- to immunization—I will explain how that ready have to all who need them, we will con- phenomenon can be responsible for much tribute to health and human development.” of a country’s economic growth. The negative aspect, of course, is also Human Development obvious. If there is ill health, then there is a Among at least three books that I have read cost of illness, and the cost of illness is not and reread over the last few years is the UNDP borne only by the person who is ill, but the Sir George A. O. Alleyne, MD 1990 Human Development Report. In it, for persons who are a part of his or her sup- expectancy at birth is due to childhood the first time much of the thinking of the port group. Numerous studies show the immunization. economists actually got synthesized into some direct and indirect costs of illness. It is also For eight years I worked in nutrition, mainly idea of what human development stood for. well established that health leads to on child malnutrition. It was tragic to see Let me quote from what Mahbub ul Haq wrote increased productivity. We know from stud- children start with measles, have recurrent in the 1990 report: “People are the real ies that whatever metric you use of a country’s bouts of infection, and then becoming more wealth of a nation. The basic objective of investment in health, after a suitable lag pe- and more malnourished, until they eventu- development is to create an enabling envi- riod, you can see that investment reflected ally would die. I had absolutely no doubt that ronment for people to live long and creative in economic growth. the application of the antigens known then lives. Human development is a process of en- More recently, economists have decided would stop a child from stepping onto that larging people’s choices. In principle, these that the products and income accounts that slippery slope which would lead inevitably to choices can be infinite, and they can change have been the standard ingredients in gross death, and that immunization against measles over time. But at all levels of development, domestic product do not really reflect actual is a potent protector of a child’s nutrition. the three essential ones are for people to live human welfare, and they have come up with I mentioned the demographic dividend a long and healthy life, to acquire knowledge, other metrics. They have established a mea- and the extent to which health contributes to and to have access to resources needed for a sure of full income which adds a value of life it. The evidence from all over the world shows decent standard of living.” expectancy to GDP. They point out that in the that decreased child mortality is followed by Role of Health in Human Development United States, certainly, the contribution of a fall in fertility. As child mortality falls and There has been a consensus about the health to full income is as great as the contri- fertility falls later on, there is a gap in which contribution of health to a country’s economic bution of goods and services. there is a bulge of persons with the capacity growth only over the last 15 or 20 years. to produce. Given the other infrastructure Role of Vaccines in Health’s Contribu- Nobel Prize winner Robert Fogel points out necessities or possibilities, you find that bulge tion to Human Development that some 30 to 50 percent of Europe’s eco- of persons of a productive age contributes How does immunization contribute? Sim- nomic growth in the 19th century was due to enormously to a country’s economic growth. plistically, one could say that vaccines pre- health and nutrition. It has been shown in such “Asian tigers” as vent deaths; therefore, they must contribute Health figures prominently among the Korea and Singapore that demographic divi- to economic growth. But let us examine this a things that contribute to economic growth. dend corresponds very well with take-off in bit further and try to separate out some of the By good health we contribute to the quantity terms of their economic growth. diverse functions of immunization. and the quality of the capital stock. Everyone In cases in which immunization has an We would all agree, I think, that child- agrees now that human capital is critically impact in reducing child mortality and in- hood immunization prevents deaths. We all important for economic growth. So, health creasing life expectancy, the effect is to con- would agree that much of the increased life does contribute fundamentally to the quan- tribute to the quantity of the capital stock. dedicated to disease prevention www.sabin.org 7

We know that there are good data from infectious diseases and for the new and cess that came with smallpox and the discus- economists showing the value of dollars in- emerging infectious diseases, and that even sion about the savings resulting from small- vested in immunization. Studies in this coun- when we have the vaccines, they are not pox immunization, have seduced us into not try show that when children are vaccinated employed on an appropriate scale. doing as much as we should. against nine vaccine-preventable diseases, About the obscenity of otherness. Per- Success, Otherness, and Modesty this can save almost $18 in direct and indi- haps until very recently there was not the con- I would posit three reasons for this. One is rect costs of illness. cept of a global partnership, a global interre- the seduction of success; two is the obscenity The October 13, 2005 article “Vaccination: lationship. There has been humanitarian as- of otherness; and three is the modesty of A Drop of Pure Gold,” in The Economist sistance for “the others.” There is the view medicine. I would cite the seduction of suc- points out that an investment in GAVI is good that charity is fine, but it is not quite so good cess, the obscenity of otherness, and the business; that in the short term there is a to engage in cooperation. Our experience in modesty of medicine as reasons for our diffi- 12 percent return, and over the long term PAHO has corrected this misperception. If you culty in surmounting the two challenges. this increases to 18 percent put forward the right scheme then it is pos- The seduction of success. The world en- What about immunization and health in sible to demonstrate to all countries that they tered a period of apathy after the great fan- terms of education? Again, there is no doubt will all benefit. Although it is accepted that fare of the elimination of smallpox. The suc- that immunization of children makes them Continued on page 9 healthier, more able to learn. But another important component, which was pointed out some 30 years ago, is that life expectancy, when it increases, allows an increase of the returns from investment in education. If you die at age twenty-five, you have lost most of that investment in your education. So immunization, primarily by increasing Photo by Miriam Chua, CSL. life expectancy at birth, is likely to lead to a greater return from the investment in educa- tion, not to speak of the quality of life of the children who have been immunized. You can’t look at the effect of immuniza- tion apart from economic growth and edu- cation. We in PAHO have been very keen on the idea that things like immunization have helped to reduce the possibility of war. There is no doubt that war—certainly war in the countries that are warring—is a great deter- rent to those countries’ economic growth. Participants in the 2005 Sabin Vaccine Institute Vaccine Policy Colloquium assembled for the group Something engraved in my memory forever photo above, include Kwadwo Odei Antwi-Agyei, MD, National EPI manager (Ghana); Jon Kim Andrus, is going to El Salvador during the period when MD, Pan American Health Organization (Washington, DC); Tesfanesh Belay, Ministry of Health (Ethiopia); the whole of Central America was riven by Jean-Marie Okwo-Bele, MD, MPH, World Health Organization (Switzerland); Louis Z. Cooper, MD, Columbia war and conflict, and going there to partici- University (New York, NY); Rudolph O. Cummings, MD, MPH, Ministry of Health (Guyana); Ciro A. de Quadros, MD, MPH, SVI (Washington, DC); Davies Dhlakama, Ministry of Health (Zimbabwe); Mary pate in a national immunization day. On that Harvey, USAID (Washington, DC); Stephen Jarrett, UNICEF-Supply Division (New York, NY); Samuel L. day, not a shot was fired. The guerillas came Katz, MD, Duke University Medical Center (Durham, NC); Mary Kitambi, EPI manager (Tanzania); Geoffrey up in their jeeps saying, “Bring out your chil- Lamb, World Bank (Washington, DC); Steve Landry, PhD, Bill & Melinda Gates Foundation (Seattle, dren,” and the government forces came and WA); Luciana de Cerqueira Leite, PhD, Butantan Institute (Brazil); Ruth Levine, Center for Global said, “Bring out your children.” They went Development (Washington, DC); Julian Lob-Levyt, GAVI (Switzerland); Dean D. Mason, SVI (Washington, back to fighting afterward, but on that day not DC); Raymond MacDougall, SVI (Washington, DC); Adel Mahmoud, MD, PhD, Merck and Co., Inc. a single shot was fired. (Whitehouse Station, NJ); Issa Makumbi, Ministry of Health (Uganda); Lewis A. Miller, WentzMiller and We know the impact of health on economic Associates LLC (Darien, CT); Samantha Naidoo, World Bank (Washington, DC); Deo Nshimirimana, World Health Organization (Congo); Melanie H. Ram, PhD, Japan International Cooperation Agency growth; that is now well described. We know (Washington, DC); Kevin L. Reilly, former president, Vaccines and Nutrition, SVI trustee (US); the power of immunization; that is well Francisco F. Songane, Former Minster of Health (Mozambique); Hilary Sunman, Department for known. Yet we are still contending with two International Development (London, UK); Fatima Valente, EPI manager (Angola); Walter Vandersmissen, major overriding challenges: that safe and GSK Biologicals (Belgium); Nguyen Van Cuong, MD, MCTM, National EPI (Vietnam); Maja Zecevic, PhD, effective vaccines are lacking for some old MPH, The Lancet (New York, NY). 8 WINTER 2005 SABIN VACCINE REPORT

New Book by Dr. Explores Impact of Cutter Incident

pany executives, attorneys, Cutter em- new vaccines that hold the promise of BOOK ployees, and victims of the vaccine, as preventing other fatal diseases. CORNER well as previously unavailable archives, “Dr. Offit brings us into the entangled Vaccines have saved more lives than Dr. Paul Offit offers a full account of world of medicine and law. Readers will any other single medical advance. To- the Cutter disaster. He describes the have a better understanding of the im- day, however, only four companies make nation’s relief when the vaccine pact that legal suits have on the vaccine vaccines for the US market, and there was developed by in 1955, industry, investment, and decisions not is a growing crisis in vaccine availabil- the production of the vaccine at indus- to pursue lifesaving vaccines because trial facilities such as the one operated of liability issues,” said Dean Mason, ity. Why has this happened? A new by Cutter, and the tragedy SVI president. book by Paul Offit, MD, The Cutter that occurred when 200,000 Incident: How America’s First Polio people were inadvertently in- ISBN: Vaccine Led to the Growing Vaccine jected with live virulent polio 0300108648 Crisis, explores this question in histori- virus: 70,000 became ill, 200 Publish Date: cal detail and current perspective.This were permanently paralyzed, 10/10/2005 remarkable book recounts for the first and 10 died. Dr. Offit also Publisher: time a devastating episode in 1955 at explores how, as a conse- Yale University Press in Berkeley, Califor- quence of the tragedy, one nia, that set the stage for many pharma- jury’s verdict set in motion ceutical companies abandoning vaccine events that eventually sup- manufacture. pressed the production of Drawing on interviews with public vaccines already licensed and health officials, pharmaceutical com- deterred the development of

David J. Diemert, MD, FRCPC Joins SVI Human Hookworm Vaccine Initiative Team

David J. Diemert, Allergy and Infectious Dis- tending physician on the infectious dis- MD, FRCPC recently eases, National Institutes of eases service for these two large ter- joined the SVI’s Hu- Health. There, he was princi- tiary care teaching hospitals, he taught man Hookworm Vac- pal investigator on Phase 1 medical students and internal medicine cine Initiative as chief clinical trials of candidate ma- residents and directed the hospitals’ mi- medical officer. He laria vaccines in Mali, West crobiology laboratories. will direct the HHVI Africa. He was also co-inves- Diemert received his medical degree clinical development tigator on multiple Phase 1 tri- from the University of Alberta in program, including als of malaria vaccines in the Edmonton, Alberta and completed his oversight of the plan- United States and had over- in internal medicine at McGill ning and execution of sight of the clinical program of University in Montreal followed by a all clinical trials of Dr. David J. Diemert the MVDB in Mali, which in- fellowship in infectious diseases and HHVI candidate vac- cluded establishing clinical test- medical microbiology at McGill. cines in both the United States and in en- ing sites, performing large-scale baseline “The HHVI team has a clear vaccine demic areas. With the ongoing field trials studies of malaria epidemiology and im- development plan with definite goals in in Minas Gerais, Brazil, and with the ap- munology, and establishing clinical labo- terms of vaccine trials,” said Diemert. proaching Phase I clinical trials, Diemert ratory testing facilities in the field. “The team is a fun and cohesive group has visited the site twice this past fall. He has also served as an attending of people but very productive at the Formerly, Diemert served for four consultant physician in the Department same time. They have a distinct need years as staff clinician/clinical trialist at of Infectious Diseases and Microbiol- for someone with my skills in setting up the Development ogy, Royal Victoria and St. Mary’s Hos- a field site for performing vaccine trials Branch, (MVDB) National Institute of pitals, in Montreal, Quebec. As an at- and actually conducting the trials.” dedicated to disease prevention www.sabin.org 9

Sir George Alleyne Offers Insights About Recommendations for MMR+V and Tdap Combination Immunization, Health, and Vaccines Introduced by Advisory Committee Development The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met in Atlanta this past October, from page 7 making several recommendations that would take advantage of new vaccine combinations available in the United States. Expanding its advisement from immunization will help children in the devel- earlier in the year, the committee recommended that adults from 19-64 years of oping countries, the idea that the economic age be vaccinated with a newly licensed adult booster tetanus, diphtheria and advance of those persons or their health is pertussis (whooping cough) vaccine (Tdap); the new vaccine was recommended good for everyone hasn’t gained currency. I in May for adolescents. The committee also recommended use of a new measles, still believe there is room for advocating that mumps, rubella, and varicella vaccine and for children. otherness has really no place in health. Tdap Addresses Need for Adults to Receive Pertussis Booster About the modesty of medicine. When I The ACIP recommended that adults receive a booster dose of Tdap vaccine look at most of the documents that make the against tetanus, diphtheria and pertussis if they have not received a tetanus and case for immunization, they are cast in wel- diphtheria (Td) booster dose in ten or more years. Adding the pertussis component fare terms—what a noble thing it is to save to the Td vaccine is an important new development. Pertussis, which can be the lives of millions of poor children. It is as if very severe and even life-threatening in infants, can be transmitted between it is a good thing but it has no instrumental adults and children. In adults, pertussis can result in weeks of coughing, cracked value. ribs from severe coughing spells, pneumonia, and other complications. Most I have learned over the years that it is fine reported pertussis cases among adolescents and adults occur because of decline to speak about the constitutive value of health, in protective immunity, which wanes five to ten years after the last vaccination. but you have to also advocate for some in- Susceptible infants acquire pertussis, quite often from siblings and parents at home. strumental value to what we do. Let me cite an Reported pertussis cases in the United States have increased from a low of example from Jeffrey Sachs’ recent book, 1,020 cases in 1976 to 25,827 cases in 2004, a 40-year high. Reported pertussis- speaking of investment and poverty, how some related deaths among infants increased from about ten per year in the 1990s to sectors see things differently. He writes: “Con- about 20 per year during this decade. According to the World Health sider the case of fertilizers, which are cur- Organization, in 2000, an estimated 39 million cases and 297,000 deaths occurred rently unused. Fertilizer application of $100 worldwide, due to pertussis. per hectare, combined with or substituted by MMRV Should Improve Chickenpox Vaccine Coverage Rates improved farrows, as appropriate, could raise The ACIP voted to recommend MMRV for inclusion in the Vaccines for crop yields in a normal season from one ton Children Program. The quadrivalent vaccine manufactured by Merck received per hectare to three tons per hectare, with a FDA approval this past September 2005 and is a combination of two well- marketable value of the increment of roughly established vaccines against measles, mumps, rubella and the other protecting $200-to-$400 per hectare.” That is how they against varicella (chickenpox). The vaccine is for children 12 months to 12 put their arguments. years of age. Vaccination with the MMR in the United States has contributed to What is the solution? a greater than 99 % reduction in the incidence of measles, mumps and rubella, Immunization for all is to be seen as a ma- diseases associated with serious complications that once claimed tens of jor contribution to human development, and thousands of lives each year in this country. Since 1995, the chickenpox vaccine not simply a mechanism for achieving one of has contributed to a significant reduction in cases in the United States and the Millennium Development Goals. I would declines in related hospitalizations and deaths. Potential advantages of say that there is a need for much more ag- combination vaccines include reducing multiple injections, improving timely gressive advocacy for the reduction in the vaccination coverage, reducing the costs of stocking and administration of obscenity of otherness, and certainly much separate vaccines for health care providers and reducing health care costs for less modesty on the part of people like our- extra health visits, according to the CDC. selves, who have not been brought up to be- Hepatitis A Recommended for All Children lieve that you get what you market. The committee also expanded to all children its recommendation for vaccination with hepatitis A vaccine. A 1999 ACIP recommendation called for When these are done, there will be no ques- in states with the highest rates of hepatitis A. The vaccine is to be tion, I think, that immunization will have come administered when a child is between 1 and 2 years of age in a two-dose series. in from the cold. 10 WINTER 2005 SABIN VACCINE REPORT

Q&A with , MD, PhD on Communication and Children’s Health Risks Researcher/Pediatrician/Parent Shares Insights from Years of Speaking to the Media about Children’s Health

The following interview is based on the remarks by Peter J. Hotez, MD, PhD presented at the and they are required to be educated about National Consumers League’s Risk and the Media Symposium, Oct. 14, 2005. With vaccines in order to pass board examinations. permission from Dr. Hotez, we present the remarks as an interview for our readers’ benefit. They know first-hand the consequences of not vaccinating children and the deadly na- SR. How are research findings about vac- for their money. Given our training, commu- ture of the diseases that vaccines are designed cines reported to the public and what are nicating with journalists is not something that to prevent. They also can provide reassur- some obstacles? comes naturally. It takes practice to get it right. ance that a vaccine adverse-events reporting PJH. Our society has some terrific mecha- However, this is worth the investment of time. system is already in place, which has had a nisms in place to ensure balanced science In the end our willingness to educate the pub- great track record of detecting problems in a reporting to the public. All professional sci- lic about what we do is the best way to erase timely manner. We are learning that the world- entists are aware that their findings must first ignorance and backwardness. Our profes- wide web is an avenue that must be negoti- be vetted through peer-review. This ensures sional future depends on living in a civil soci- ated with some caution, and yet one that can- that data and conclusions are not published ety with a high degree of scientific literacy. not be ignored because it is increasingly pro- in scientific journals unless they have been viding a lion’s share of information and mis- SR. Where do you stand on the vaccines reviewed objectively by other qualified scien- information about vaccines and about . and autism debate? tists and physicians. A scientist who tries to Pediatricians and nurses can help by provid- PJH. Although vaccines have some well circumvent this process is roundly con- ing URLs of legitimate and balanced websites, described side effects, from my review of the demned by scientific societies and funding and ones that provide some details about the current data and understanding about the agencies, and is usually put out of business in diseases that vaccines prevent. natural history and genetics of autism, I con- the process. Helping this system are estab- clude that there is no relationship between SR. What other message would you have lished science journalists who honor and , nor is there a relation- about communicating children’s health risks? respect the peer-review process and report ship between thimerosal and autism, or even PJH. I believe that childhood vaccines rep- findings in newspapers, magazines, and the mercury and autism. Autism is probably one resent one of humankind’s greatest victories, electronic media only after publication. I of our most common heritable genetic syn- having so far saved more lives than all of the believe that our nation’s professional science dromes, with a prevalence of 3 to 6 per 1,000, lives lost from wars during the 20th century. journalists are the unsung heroes in educat- and a male to female ratio of 3:1. Astonish- The fact that the safety record of vaccines has ing the public. This system breaks down in ingly, despite the enormous health and eco- been distorted to the point where some par- the rare occasions when scientists (and nomic impact of this genetic syndrome, the ents now think twice about vaccinating their sometimes pharmaceutical companies) send total NIH budget for autism research is less child is cause for grave concern. Our nation’s press releases and advertisements to the pub- than $100 million, or about 1/10th that of pediatric societies and federal agencies need lic before peer-review. In addition, another funds spent on bioterrorism, and roughly the to work closely and think creatively about how damaging circumstance occurs when un- amount of money we spend in less than a the media can be engaged in order to pre- scrupulous parent advocacy organizations week on the war in Iraq. As a result, we are in vent tragic deaths because a child did not have a bias and misrepresent scientific our infancy in identifying the genes linked to receive his vaccinations or because he re- findings or conclusions, or even com- autism, other than the two identified so far— ceived toxic and off-beat therapies that have pletely ignore the weight of scientific data in chromosomes 7 and 15. We have no genetic no rational or scientific basis. order to promote an agenda. screening and no gene targets to develop new SR. What is the responsibility of the drugs. I believe this situation exists because researcher in communicating with the pub- of the inability of Congress to keep its eyes on lic, especially when consumers are receiving the prize. This in turn is partly because of the mixed messages? distractions arising from the noise about PJH. As a profession, we do not try hard autism and vaccines. enough to communicate with the public, even SR. How should consumers weigh and though we have great advocates and allies in assess the health risks and benefits of vac- science journalists and correspondents. cines in a broader context? When a science journalist contacts us, I PJH. The best source of vaccine information believe we have an obligation to take the call. for parents is still the family pediatrician or Most biomedical scientists are federally pediatric nurse practitioner. Both receive a Peter J. Hotez, MD, PhD, discusses his position on funded and it is reasonable to expect that the significant amount of training on this topic, vaccine safety and the importance of immunization. public wants to know what they are getting dedicated to disease prevention www.sabin.org 11

NPR Reports from Brazil, Ciro de Quadros Receives Honors in Chile, Mexico Site of Hookworm Recognition Follows Years of Creative Immunization Program Strategies Vaccine Field Trial Fall 2005 was a season of Report Airs in Conjunction with international recognition for Time Global Health Summit Held Director of SVI International in New York City Programs Ciro de Quadros, MD, MPH. In Chile, he re- National Public Radio Science cor- ceived the Order of Bernardo respondent Joe Palca and producer O’Higgins, and in Mexico he Brigid McCarthy travelled with the was named an honorary mem- SVI Human Hookworm Vaccine Ini- ber of the Mexican Academy tiative team to prepare a report titled, of Medicine. “In Brazil, a New Effort to Wipe Out The Order of Bernardo Hookworm,” which aired on October O’Higgins was established in 29, 2005. The audio and text of the 1956 to honor distinguished for- report can be accessed at eigners and friends of Chile. It www.npr.org or at the SVI website, is the highest honor bestowed www.sabin.org. The story was part upon foreign citizens for out- of the Global Health: Rx for Sur- standing contributions to the vival: A Global Health Challenge arts, sciences, education, in- series, with reports from around the dustry or commerce. Captain world on some of the most urgent General Bernardo O’Higgins emerging global health issues. The was Chile’s hero of indepen- wave of reporting on global health dence and first president. The topics ranged from making affordable award was presented in a cer- Ciro de Quadros, MD, MPH, director of SVI International drugs in Africa, to efforts in Vietnam emony in Santiago, Chile, by Programs, is congratulated by Chilean Minister of Health Minister of Health Pedro Pedro García Aspillaga, upon receipt of the Order Bernardo to head off a flu pandemic, to a re- O’Higgins, the highest honor of the government of Chile. port on reaching remote Africa with García Aspillaga. new malarial therapy.

SAVE THE DATE ANNOUNCING OUR NEW ADDRESSES Sabin Gold Medal Ceremony National Headquarters 1889 F Street, N.W., Suite 200S 7 pm Washington, DC 20006-4400 Tuesday, May 9, 2006 Ph. 202-842-5025/Fx. 202-842-7689 Grand Ballroom Marriott Chairman’s Office Inner Harbor P.O. Box 848 New Canaan, CT 06840-0848 Baltimore, Ph. 203-972-7907/Fx. 203-966-4763

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www.sabin.org 12 WINTER 2005 SABIN VACCINE REPORT

SABIN Colloquium Hosted by SVI CALENDAR and NYAM Marks 10th JANUARY-JUNE 2006 Anniversary of Safe and January 2006 April 19 - 21 Vienna, Austria Effective Varicella Vaccine January 30 - February 1 Baltimore, Maryland Second International Conference on TB Phacilitate Vaccine Forum Baltimore 2006 Vaccines for the World www.meetingsmanagement.com/tbv_2006 from page 3 www.phacilitate.co.uk May 2006 the United States—including the Cen- February 2006 February 7 - 8 Washington , DC May 8 - 10 Baltimore, Maryland ters for Disease Control and Prevention National Vaccine Advisory Committee (NVAC) Ninth Annual Conference on Vaccine Research (CDC) and the National Institutes of Meeting www.nfid.org Health (NIH)—in addition to leading www.hhs.gov/nvpo/nvacv May 9 Baltimore, Maryland scientists from Australia, Belgium, Sabin Gold Medal Ceremony Canada, Finland, Germany, Japan and February 22 - 23 Atlanta, Georgia Advisory Committee on Immunization Practices www.sabin.org the United Kingdom. Keynote presen- (ACIP) Meeting June 2006 tations included a lecture on the research www.cdc.gov/nip/ACIP/dates.htm into the varicella vaccine by its devel- June 6 - 7 Washington, DC National Vaccine Advisory Committee (NVAC) oper, Michiaki Takahashi, MD, DMSc, March 2006 Meeting Research Foundation for Microbial Dis- March 3 - 7 Miami Beach, Florida 62nd Annual Meeting of the American Academy www.hhs.gov/nvpo/nvac eases of Osaka University, Japan. of Allergy, Asthma and June 12 - 13 Lisbon, Portugal Dalya Guris, MD, MPH, of the CDC, www.aaaai.org discussed the impact of the varicella 7th International Symposium www.sabin.org vaccine since its introduction in 1995. March 6 - 9 Atlanta, Georgia Michael N. Oxman, MD, chairman of 40th National Immunization Conference June 19 - 21 Amsterdam, The Netherlands www.cdc.gov/nip/NIC the Shingles Prevention Study, re- Phacilitate Vaccine Forum Amsterdam 2006 viewed the findings of a recently-com- March 19 - 22 Atlanta, Georgia www.phacilitate.co.uk pleted study which concluded that an International Conference on Emerging June 20 - 21 Atlanta, Georgia experimental signifi- Infectious Diseases Advisory Committee on Immunization Practices cantly reduced the incidence of www.iceid.org (ACIP) Meeting shingles and PHN. March 20 - 23 Washington DC www.cdc.gov/nip/ACIP/dates.htm The colloquium was attended by SVI World Vaccine Congress June 26 - 28 Bethesda, Maryland president, Dean D. Mason. “To my www.lifescienceworld.com/2006/wvcm%5FCA Annual Conference on Antimicrobial Resistance knowledge this was the most compre- April 2006 www.nfid.org hensive public meeting specifically fo- April 16 - 20 Varadero, Cuba June 28 New York, New York cused on varicella, herpes zoster and 3rd International Workshop on Vaccine Sabin Annual Awards Celebration shingles--related subjects held to date,” Adjuvants and Glycoconjugates www.sabin.org he said. “The colloquium focused our www.finlay.edu.cu/adjuvant attention on the challenges ahead in ad- vocating for the introduction of safe and effective vaccines against zoster, pro- NON-PROFIT ORG. moting studies concerning the need for U.S. POSTAGE a second dose of varicella vaccine, and PAID evaluating the country’s response to the MONTROSE, PA introduction of the MMRV combination PERMIT NO. 2 vaccine.” 1889 F Street, N.W., Suite 200S RETURN SERVICE REQUESTED The colloquium received key sponsor- Washington, DC 20006-4400 ship from the Research Foundation for U.S.A. Microbial Diseases of Osaka University, Osaka, Japan; GlaxoSmithKline Biologicals, Rixensart, Belgium; and the March of Dimes. A forthcoming pro- ceedings document is in press.