Volume VI, Number 3 Sabin Winter 2004 EPORT The newsletter of the Albert B. Sabin Vaccine InstituteR — dedicated to disease prevention www.sabin.org Solutions to Vaccine Supply Pursued at Policy Colloquium Task Forces Return to Report on Financing, Stockpiling, Regulatory Harmonization and Advocacy

Pressing vaccine supply issues— age of the 2003/04 season illustrates the Influenza and Other Used financing, advocacy, product harmo- potential for ongoing supply problems. to Control Outbreaks of International nization, and stockpiling—each Three keynote speeches set the tone Importance. Steve Cochi, MD, deputy shared the attention of participants at for this year’s meeting. David Heymann, director of the National Immunization the 10th Annual Sabin Vaccine Institute MD, World Health Organization Polio Program (NIP) CDC, presented remarks Policy Colloquium this past October. Surveillance and Immunization Program, on U.S. Vaccine Shortages: From “Feasible Solutions to Global Vaccine discussed Issues Around Vaccine Threats to Answers. Robert Giffin, PhD, Shortages,” the second Sabin meeting Needs: From Smallpox and Polio to Continued on page 6 to consider the vaccine supply issue, re- sumed discussion of the topics identified 12 months before, with a goal of achiev- Cancer Vaccine Consortium Meets in Maryland ing consensus on practical recommen- Bethesda, Maryland Meeting Focuses on Regulatory, IP Issues dations for the next three to five years. The meeting was held at the Banbury The Sabin Vaccine Institute convened Conference Center of the Cold Spring the second meeting of the Cancer Harbor Laboratory at Cold Spring Har- Vaccine Consortium (CVC) this past bor, New York and was co-chaired by November 2-4. The meeting was held Lewis A. Miller, chairman of in Bethesda, Maryland and drew Intermedica, Inc., and Nancy Tomich, attendees from the United States, managing director for the U.S. Medi- Canada and Europe. The purpose of the cine Institute. CVC is to enhance collaboration among Forty medical and public health ex- companies undertaking research and perts attended the colloquium, about half development on cancer immuno- of whom were return participants. Most therapies. The goal is to speed the time Kathryn Zoon, PhD, deputy director of the National participated in task forces that studied it will take to make cancer vaccines Cancer Institute (center) is welcomed by Nathan each of the topic issues and presented available among the range of therapies Tinker, PhD, CVC executive director, and H.R. Shep- findings during the meeting. for cancer patients. herd, DSc, SVI chairman. Vaccine shortages, at a crisis point just The meeting began with a dinner and more than a year ago, prompted the first networking session. The first full day I nside colloquium on this topic in 2002. The focused on administrative and regulatory problem’s complexity warranted the fol- issues, with presentations from Thomas ViewPoint ...... 2 low-up colloquium. Despite the resolu- Sommer of MassMEDIC (Massa- Hotez Awarded Ashford Medal ...... 3 tion of the acute crisis, the focus of chusetts Medical Device Industry Cancer Vaccine Consortium News...... 4-5 2003 was on long-term solutions to vac- Council) and Kathryn Zoon, deputy Vaccine Supply Colloquium ...... 6-7 cine supply issues. The flu vaccine short- Continued on page 4 Remembering Bob Abplanalp ...... 8 Balmis-Salvany Immunization Expedition ....9 Human Update ...... 10 Flu Vaccine Shortage Takes Health Officials By Surprise... Hugh Evans, MD, Sabin Fellow ...... 11 Institute Chairman Proposes Solution to Future Flu Vaccine Shortages, Calendar ...... 12 see ViewPoint on page 2. 2 WINTER 2004 SABIN VACCINE REPORT

The Sabin Vaccine Report VIEW is published by the POINT Albert B. Sabin Vaccine Institute Subscriptions are free Flu Vaccine Shortage Solution: Please direct inquiries to: Back-End Funding for Private Sector SABIN VACCINE REPORT —by H.R. Shepherd, DSc 58 Pine Street New Canaan, CT 06840-5408 THIS OPINION APPEARED ON DECEMBER 22 IN THE HARTFORD COURANT AND phone: 203.972.7907 ON DECEMBER 26 IN THE WASHINGTON POST. fax: 203.966.4763 The demand for flu vaccine has skyrocketed, much to the surprise of manufacturers and www.sabin.org the nation’s medical community. Flu suddenly is a resounding public fear, and with good email: [email protected] reason—the death toll from flu in recent years has been about 36,000, and this year’s EDITOR projection is higher. Public health officials have been telling Americans to take the flu seriously, Raymond MacDougall ASSOCIATE EDITOR COPY EDITOR and now the public apparently is doing just that. Veronica Korn David Bedell During the previous flu season, the supply of vaccine exceeded the demand. Consequently, OFFICERS OF THE SVI BOARD OF TRUSTEES traditional vaccine manufacturers scaled back production this year because unused product H. R. Shepherd, DSc, Chairman had to be discarded last year. But now people are clamoring for the preventive vaccine and William R. Berkley, Co-Chairman around the country dismay has replaced indifference. Michael E. Whitham, Esq., Secretary/ Treasurer It is easy to see that this inconsistency of market forces has a dangerous outcome. The manufacturers cannot predict the public perception that it can weather flu season unprotected SVI STAFF Fran G. Sonkin, Executive Vice President versus their realization of their vulnerability. They also cannot accelerate the four-month Paul J. Vilk, RPh, RAC, Vice President, production schedule if the public suddenly decides it is not impervious. Program Management and Regulatory A full supply of vaccine for all U.S. citizens with a stockpile for sudden demand can solve the Affairs, Hookworm Vaccine Initiative Nathan Tinker, PhD, Executive Director, flu vaccine supply problem. Funds should be appropriated and allocated for this supply, Cancer Vaccine Consortium which is the only solution to the flu vaccine market. These funds would provide for back-end Ciro de Quadros, MD, MPH, Director, reimbursement for vaccine not sold in a given year. With assured payment, the vaccine International Programs manufacturers would certainly hike production to meet or exceed the full potential demand. Raymond MacDougall, Director of Communications The Department of Agriculture has played a similar role in modulating grain and dairy David Bedell, Executive Assistant to production. The Department of Defense purchases weapons hopefully never deployed. The the Chairman law of the land should extend to provide adequate protection to its citizens from preventable Ana Carvalho, Assistant to the Director, flu viruses. International Programs Martha Fleischer, Information The dilemma now faced by the Centers for Disease Control of making recommendations Coordinator for rationing and stretching the flu vaccine supply is unacceptable. Flu prevention should not Veronica Korn, Research Associate be treated as a game of survival of the fittest or race to the flu vaccine dispensary. Christel Lane, Receptionist/Staff Assistant The demand for flu vaccine is apparent, made more obvious this year due to the powerful Vanessa Santiago, Assistant to the punch wielded by a virulent strain. Flu vaccine development and production is a humanitarian Executive Vice President Jean-Serge Valcourt, Accounting and personal security issue. Corporate sales projections should not govern flu vaccine availability, but there should be guaranteed back-end funding to cover overstock that can SVI ADVISORS Philip K. Russell, MD, Senior Advisor to occur with an unpredictable flu vaccine market. the Chairman Peter J. Hotez, MD, PhD, Senior Fellow H.R. Shepherd, DSc, Chairman & Chair, Scientific Advisory Council Sabin Vaccine Institute Anne Gershon, MD, Co-chair, Scientific Advisory Council Hugh E. Evans, MD, Sabin Fellow William Muraskin, PhD, Sabin Fellow Patricia Thomas, Sabin Fellow Nancy Gardner Hargrave, Development Counsel dedicated to disease prevention www.sabin.org 3 SVI Scientist, Hookworm Vaccine Researcher Receives Tropical Medicine Medal Honored with 2003 Bailey K. Ashford Medal at Annual ASTMH Meeting The American Society of Tropical Hotez is the principal investigator on Hotez’s path to recognition by the Medicine and Hygiene awarded Peter a Human Hookworm Vaccine Initiative tropical medicine community has been J. Hotez, MD, PhD, FAAP the 2003 from the SVI and Bill & Melinda Gates achieved over many years of dedicated Bailey K. Ashford Medal at their cen- Foundation to develop a recombinant pursuit. As a child, Hotez was fascinated tenary meeting on December 3 in Phila- vaccine for hookworm-in- by the microscopic life be- delphia, Pennsylvania. duced malnutrition and ane- low the murky waters of a Hotez is professor and chair of the de- mia. An anti-hookworm vac- brook near his home. He partment of Microbiology and Tropical cine would be an important was especially impressed by Medicine, The George Washington Uni- technological advance for daphnia, one of the most versity, and senior fellow of the Albert use in rural developing common crustaceans to be Sabin Vaccine Institute. He is also visit- economies where traditional found in lakes and ponds. At ing professor of the Institute of Para- methods have previously age 14, Hotez volunteered at sitic Diseases of the Chinese Academy failed. The vaccine would the Connecticut State De- of Preventive Medicine in Shanghai. also decrease reliance on partment of Health, compil- The award was presented to Hotez continuous use of anthelm- Peter Hotez, MD, PhD ing records of parasite inci- by Sabin Institute founding president inthic drugs and thereby re- dence in fecal samples. As Maj. Gen. Philip K. Russell, MD (USA duce the likelihood of emerg- an undergraduate at Yale Ret.), who is currently special advisor ing drug resistance. University, he held onto his boyhood fas- on vaccine production and development He is also the principal investigator on cination and was mentored by an inter- for the U.S. Department of Health and grants from the NIH, March of Dimes, national expert in the field of molecu- Human Services Office of Public Health American Heart Association and the lar parasitology. Preparedness. Sabin Institute chairman China Medical Board. He is the author While pursuing both his medical and H.R. Shepherd, DSc, said, “The dedi- or co-author of over 120 scientific and doctorate degree from Rockefeller Uni- cation and humanism of vaccine re- technical papers in molecular and versity, he began studying the parasitic searchers cannot be overestimated, and immunoparasitology and tropical disease, hookworm. There was almost nothing Peter Hotez exemplifies this dedication as well as two books, Parasitic in the scientific literature regarding this to an extraordinary degree. He is as Diseases (Apple Tree Press) and parasite, and it was then that Hotez saw deserving of this special recognition as Krugman’s Infectious Diseases his singular opportunity to make a dif- any of the great investigators of our time of Children. ference in the field of medical molecu- or any time.” lar parasitolgy and on humanity. Despite its lack of dramatic clinical manifesta- tion, the hookworm causes devastating debilitation in its victims by causing ane- mia and protein deficiency, inhibiting physical and intellectual development Say Big Cheese! in children. First given in 1941 as a triennial award Hookworm for mid-career scientists, the Ashford Vaccine Project Medal is given for distinguished work in Lab Manager tropical medicine and recognizes the Serving in Iraq work of individuals who have provided Participates in important breakthroughs in the under- President’s standing and control of tropical diseases. Historic Visit on It is especially fitting for Hotez to re- Thanksgiving ceive the award named for Bailey Ashford, who determined the cause of Pictured in Baghdad, Iraq on Thanksgiving Day 2003 with U.S. President George Bush is Idong Essiet- hookworm disease among Puerto Rican Gibson, to the president’s immediate right. Idong is on leave from the Human Hookworm Vaccine farmers in 1899.Until his death in 1934, Initiative lab since being deployed to Iraq as an active military reservist last March. Bush’s clandestine Ashford was a professor of Tropical travel plan on Thanksgiving made big headlines at home and produced some broad grins among this Medicine and Mycology at Columbia crowd of military personnel. University in New York. 4 WINTER 2004 SABIN VACCINE REPORT Cancer Vaccine Consortium Continues First-Year Strides 200 Cancer Immunotherapies Estimated In Development Continued from page 1 discussion of patent and IP issues. CVC mission statement and exploring a director of the National Cancer Institute Participants from the 22 member range of topics of analysis, from issues and former chief of the U.S. Food & companies also heard presentations on pertaining to navigating FDA procedures, Drug Administration’s Center for intellectual property from speakers who Phase III clinical trials assessment, Biologics Research and Evaluation. The included Michael Whitham, Esq., a patient populations, and clinical trials day focused on the regulatory framework Virginia-based attorney specializing in support, to potency, surrogate markers, for cancer vaccines, including the drug intellectual property law with Whitham, microarrays and genomics and and biologic development cycle. Curtis & Christofferson, P.C. and his proteomics. According to Dr. Zoon, approximately associate Robert N. Cook of the same For more information about the 200 immunotherapies for cancer are firm. Whitham addressed patents in the Cancer Vaccine Consortium, visit under development and 19 of those are consortium setting, while Cook outlined www.sabin.org or contact Nathan in the Phase III, or efficacy clinical patent pools and antitrust. Tinker, [email protected], trials. The meeting was the first for new 203-972-7907. The second day featured presentations CVC executive director, Nathan Tinker, from Thomas Davis and Howard PhD. “It was good to Streicher of the NCI Cancer Therapy meet the participants Evaluation Program as well as a and to experience the energy and drive that is behind these very CVC2 Roll Call dedicated innovators,” Tinker said. “We hope Pharmaceuticals: to meet at least twice • Aventis Pasteur a year to keep the • Bristol-Myers Squibb strong momentum • GlaxoSmithKline that has been • Merck established within the Biotechnology firms: group.” • Advaxis Intracel Among the group’s • From left, Nathan Tinker, executive director, SVI Cancer Vaccine Consor- • AnGes • Medarex next steps will be conceptualizing the tium; Robert N. Cook, Whitham, Curtis & Christofferson, P.C.; and Michael • BioVex • MediGene Whitham, Whitham, Curtis & Christofferson, P.C. • Dendreon • MedImmune • Favrille • OncImmune Raising Rotavirus Awareness • Igeneon • Sanaria New Vaccine Trials Pique Media Interest in Dangerous Childhood Disease • Immuno-Rx • Therion Ciro A. de Quadros, director of international programs for the Sabin Vaccine Institute, Non-profit organizations: provided reporters in Latin America with expert medical analysis regarding rotavirus and • Ludwig Institute for Cancer potential new vaccines. A rotavirus vaccine would prevent this most severe of childhood Research diarrheal diseases that leads to dehydration requiring a doctor visit in about 10 percent of • MassMEDIC cases and from which one in 250 children in developing countries die. • Sabin Vaccine Institute The media interest has been piqued by clinical trials on rotavirus vaccine now underway in Government agency: the region. A Phase III clinical trial of the GlaxoSmithKline (GSK) rotavirus vaccine is underway • National Institutes of Health and enrolling a 60,000-child cohort. During a visit to Columbia and Peru in August and September, de Quadros participated in Service firms: • Amvir Associates press conferences and follow up interviews. The newspapers El Ojo and Republica ran • Virginia Tech Intellectual stories following the press conferences. He provided a primetime interview with the TV station Properties Panamericana and participated in a special one-hour radio call-in program at the Radio • Whitham Curtis & Programas del Peru. Christofferson, P.C. In December, de Quadros was a guest on the Spanish-language TV networks Telemundo and Univision. He was a guest for an hour-long program on Telemundo on December 4 and appeared on Despierta America, Univision’s top rated morning news show on December 5. The topic of both interviews was rotavirus and the prospects for a vaccine. dedicated to disease prevention www.sabin.org 5 Institute Appoints Executive Director, Cancer Vaccine Consortium Nathan Tinker Draws from Business Leadership Expertise in New SVI Post

Nathan Tinker, PhD, was Internet and telecommunica- sortium, and in expanding the named executive director of tions technology companies, organization’s membership,” said H.R. the Cancer Vaccine Consor- and public relations and mar- Shepherd, DSc, Sabin Institute chair- tium (CVC), organized by keting businesses. An accom- man. “We are counting on his astute the Sabin Vaccine Institute plished businessman and aca- leadership of the Consortium, which this past year. Dr. Tinker will demic with more than a de- can be a great asset for progress to- be the principal organizer of cade of business leadership wards new avenues of therapy in vac- the Consortium program, experience, he has helped cine treatments of cancer.” which works with a grow- Nathan Tinker, PhD launch more than 12 high-tech- As executive director of the CVC, ing list of biopharmaceutical nology companies. He is a Dr. Tinker will guide the Consortium’s companies to advance discovery of founder of the NanoBusiness Alliance, programming and administration, in- new therapies for a range of cancers. a nonprofit trade association of cluding policy analysis, member ser- Dr. Tinker brings to the Institute and nanotechnology organizations and holds vices and fund raising efforts. “The the CVC a broad range of experience a PhD from Fordham University. Cancer Vaccine Consortium will be a from both academia and the business “Dr. Tinker’s background and experi- vital element in the ongoing war against sector. He acquired management and ence in building technology networks will cancer,” said Dr. Tinker. “I am proud leadership expertise with biotechnol- be a great asset in developing the scope to be a part of this important en- ogy and nanotechnology companies, and mission of the Cancer Vaccine Con- deavor.”

CVC2 Presentations in Capsule

The following is a synopsis of the presentations that were delivered at the second Cancer Vaccine Consortium meeting. Day One tive network CTEP has developed between the various organiza- Tom Sommer, President, MassMEDIC tions overseeing aspects of drug development. CTEP sees itself as Tom Sommer’s presentation focused on the background and de- “filling a niche” where the agencies’ oversight of exploration of velopment of MassMEDIC, the Massachusetts Medical Device In- investigational cancer agents overlap. CTEP itself is structured as a dustry Council. He described the organization’s origins and devel- pharmaceutical company, without a marketing group. The organi- opment, with particular attention to its relationship with political zation develops collaborations with academia and industry to de- leadership in both Boston and Washington. Of special interest to velop specific therapy programs. the CVC was the founding and organization of MassMEDIC (the Howard Streicher, Cancer Therapy Evaluation kind of organization the CVC is trying to create) and its expansion to Program, National Cancer Institute some 310 members. Dr. Streicher discussed his responsibilities in overseeing the CTEP Dr. Kathryn Zoon, Deputy Director, National Can- vaccine portfolio and studies, comprising some 120 different re- cer Institute agents. He said that the CTEP approach had three important com- Kathryn Zoon’s presentation focused on regulatory issues and con- ponents: 1) developing potent vaccines; 2) vaccine strategies, in- siderations for companies developing cancer vaccines. Of particu- cluding not just the antigen, but the co-stimulatory milieu in which lar interest was her discussion of preclinical and clinical studies, the antigen is presented, including dendritic cell strategies and co- and the ways in which the FDA and other regulatory agencies ap- stimulatory molecules; 3) the re-emergence of suppression, either proach the issue from a licensing standpoint. Patient populations, by tumor milieu or by T-regulatory subsets and other molecules analytical assays, safety and efficacy, adjuvants, endpoints and sur- and family members. rogates were also discussed. IP Issues (Mike Whitham, Mike Martin, Bob Cook) Day Two Mike Whitham, Mike Martin and Bob Cook discussed various is- Tom Davis, Cancer Therapy Evaluation Program, sues concerned with the sharing of intellectual property in the con- National Cancer Institute sortium environment and the potential anti-trust issues associated Tom Davis discussed the mission and goals of the Cancer Therapy with sharing intellectual property. Martin addressed the donation of Evaluation Program (CTEP). Of particular interest was the interac- intellectual property to a nonprofit entity. 6 WINTER 2004 SABIN VACCINE REPORT Feasible Solutions to Vaccine Shortages: Sabin Vacci 10th Annual Sabin Vaccine Institute Vaccine Po Continued from page 1 therefore pertain to the minis- senior program director, Institute of try of finance, as well as the Medicine, addressed Key Elements of ministry of health. the Institute of Medicine Report on A further goal of this study Vaccine Financing. is to develop macroeconomic The four task force reports each ex- models that would depict the plored a key issue: 1. stockpiling, 2. complementary benefits of financing, 3. global harmonization, vaccines in a larger context and 4. advocacy. and would respond to such Three recommendations from a large questions as, “Would a vulner- list are being given top priority by the able unimmunized population Sabin Institute in the coming months. affect a country’s likelihood of From left, Lewis Miller, colloquium co-chair; H.R. Shepherd, attracting capital investment?” Sabin chairman; and Christine Grant, Aventis Pasteur U.S.. Recommendation to Conduct a Macroeco- nomic Cost-Benefit Analysis for Select Vac- Recommendation to Educate The advocacy initiative would not re- cines for the World Legislatures Re Vaccine Supply place the work of existing advocacy The first recommendation was pro- A second recommendation, proposed groups, but would adjust the focus from posed by the Financing Task Force and by the Advocacy Task Force, was to vaccines alone to a broader public health called for sponsorship of a macroeco- convene advocates to prepare them to scope. It will involve a road map to suc- nomic cost-benefit analysis for vaccines educate legislative bodies about the cessfully engaging domestic leaders who that would go beyond the standard health value of vaccines and to secure in- have shown interest and commitment to sector study. creased long-term funding for vaccines. global health and security issues. Fun- The proposed analysis would consider This initiative will seek input from all en- damental to this activity will be a recog- the benefit of vaccines as defined in both tities involved in the vaccine enterprise, nition that both domestic and interna- a health and finance context. Vaccines be inclusive, and draw upon the re- tional immunization issues are inextri- have a measurable impact on a country’s sources of the multiple organizations in- cably related. economy, much like the building of roads volved in domestic advocacy and inter- and infrastructure. The study would national immunization. Recommendation to Model Vaccine Intro- duction Via a Case Study A third leading recommenda- tion called for a case study that would provide a model of a new vaccine introduction. It would generate insight on innovative ways countries can finance vac- cines. The study would draw from valuable lessons derived through exploring the vaccine discovery, production, and de- livery cycle and by looking at the ways the public and private sectors can collaborate and compete in order to get vac- cines to market. The shelf life of each vaccine is among the factors that make Colloquium participants gathered at the Banbury Conference Center at Cold Spring Harbor Laboratory on Long Island vaccine introduction a very are, from left, front row: Akira Homa, Lew Miller, Nancy Tomich, Damian Braga; 2nd row: Elizabeth O’Mara, Diane complex issue. The opportunity Peterson, Eddie Wilder, Julie Milstien, Carol Ruppel, Angeline Nani; 3rd row: Louis Cooper, Julie Fischer, David Salisbury, L.J. Tan, Jerald Sadoff, Christine Grant, Veronica Korn; Sharon Hammer, Heidi Larson; 4th row: Seok Lee, exists, however, to look at fi- Anthony Robbins, John Zapp, Steve Cochi, Steven Bice, Jon Andrus, Jose Ignacio Santos, Robert Giffin, Suresh Jadhav, nancial mechanisms as well as Stephen Jarrett, Stuart Feldman, and Raymond MacDougall. Missing: Ciro de Quadros, H.R. Shepherd. the aspects of stockpiling, har- dedicated to disease prevention www.sabin.org 7 ne Institute Policy Colloquium at Cold Spring Harbor olicy Colloquium Convened October 8-10, 2003 “The U.S. saves the equivalent of its investment in smallpox eradication every 26 days.” —David Heymann, World Health Organization, speaking to participants at the Sabin Policy Collo- quium, October 2003

ing need for analysis in all ar- agencies, companies, and organizations, eas of vaccine supply. Con- such as Aventis Pasteur U.S., the Cen- tributing factors to be con- ters for Disease Control, the National tended with include vaccine Institute of Allergy and Infectious Dis- product divergence, shelf-life eases, Columbia and Tufts universities, limitations, liability issues, and Aeras Global TB Foundation, the Henry Ciro de Quadros, SVI, comments during discussion with, at left, the disparity between assess- Stimson Center, the American Medical Jose Ignacio Santos, Mexico’s National Immunization Council, ment of risk and the benefit Association, Every Child By Two, and and, at right, Angeline Nani, Johns Hopkins University/GAVI of vaccination. Likewise, the the Immunization Action Coalition. Pneumococcal ADIP. global political realities impact vaccine supply. monization, and advocacy for vaccines. Colloquium participants rep- New vaccines coming into the market resented global health organi- represent a window of opportunity for zations such as UNICEF and such a case study. the Pan American Health Or- In addition to the three highlighted ganization; foreign agencies recommendations, the task force pre- and companies, such as the sentations and discussions generated Korean Center for Biologics an impressive array of potential path- and Evaluation, the Brazilian ways toward remedying the vaccine Ministry of Health, the Mexi- supply problem. can Ministry of Health, the Some common threads that tie to- Serum Institute of India, and From left, Jerald Sadoff, Aeras Foundation, speaks to Louis Coo- gether the many additional recommen- the United Kingdom Depart- per, Columbia University, and Angeline Nani, Johns Hopkins Uni- dations of the experts include the ongo- ment of Health; and U.S. versity/GAVI Pneumococcal ADIP.

Alternate Recommendations to Address the Problem of Vaccine Shortages 1. Develop a prototype regional stockpile to learn lessons that can be ex- ported to other areas. 2. Establish a committee that would identify specific vaccine shortages and encourage dialogue between manufacturers and procurement agencies. 3. Convene a panel to upgrade the scientific bases for regulation of safety and efficacy. 4. Join in a Global Immunization Week program and develop activities that would encompass a global campaign. 5. Establish a coalition to develop strategies for gaining political support in the U.S. and elsewhere to provide human security around the world. 6. Study the financial impact of non-harmonization. 7. Develop best practices for stockpiling. 8. Explore decisions made by U.S. agencies and their implications and im- Foreground, from left, Diane Peterson, Immuniza- pact on global vaccine supply. tion Action Coalition, speaks with Carol Ruppel, 9. Promote ongoing efforts of the International Commission on Harmonization Every Child By Two; background, Stephen Jarrett, and the World Health Organization. UNICEF, speaks with Steve Cochi, CDC’s National 10. Develop case studies of a coordinated effort to mobilize resources. Immunization Program. 8 WINTER 2004 SABIN VACCINE REPORT Ciro de Quadros Addresses Global Measles Reduction Summit WHO and UNICEF Draw Sabin Institute Support for Measles Immunization Ciro de Quadros, director of interna- million individuals each year and claims of your countries here in Southern Af- tional programs for the Sabin Vaccine the lives of more than 700,000 children. rica, we have learned that to prevent Institute, endorsed a major new decla- More than half of the deaths occur in deaths from measles we have to pre- ration of global action to reduce measles Africa. Of the vaccine-preventable dis- vent the accumulation of susceptible deaths. He delivered a keynote address eases, measles is the leading killer. children. Therefore, we have an obliga- on “The Unacceptable Health Burden Two strategies have been used to im- tion to provide a second opportunity for of Measles” at the Global Meeting for munize populations with measles vac- these kids to receive this life saving Sustainable Measles Mortality Reduc- cine, the first through routine immuniza- medical tool.” He referred to the peri- tion and Immunization System Strength- tion, and the second through mass vac- odic “follow up” mass campaigns that ening this past October in Cape Town, cination campaigns. The approach that have become an integral feature of the South Africa. The meeting was called de Quadros advocated combines both measles mortality control initiative in the by the World Health Organization routine and mass vaccination. “Maybe Pan American region. (WHO) and the United Nations we are using the wrong approaches and In addition to explaining the two-fold Children’s Fund (UNICEF). strategies for using this incredibly effi- strategy for measles immunization, de The meeting raised awareness that cient tool science has put at our dis- Quadros called upon the national au- despite the 40-year availability of a safe, posal,” he posited. “From the experi- thorities in countries to change the highly effective and relatively inexpen- ences of many countries, particularly present norm of accepting measles sive vaccine, measles still affects 30 those in the Americas, as well as many deaths among children.

Sabin Vaccine Institute Benefactor Robert Abplanalp Is Remembered Businessman, Inventor Was President Nixon’s Friend, SVI Friend

Robert H. Abplanalp, a major spon- race and the 1962 California guberna- sor of the Albert B. Sabin Vaccine In- torial race. Abplanalp approached Nixon stitute, died August 30 at his home in and offered his support, then retained Bronxville, NY. He was 81 years old the future president’s law firm for and recently diagnosed with cancer. handling his company’s overseas le- Abplanalp was chairman of Precision gal affairs. Valve Corporation, a worldwide opera- During his years in the White tion headquartered in Yonkers, NY, with House, Nixon vacationed at Walker’s manufacturing facilities in 20 countries. Cay, Mr. Abplanalp’s private 125-acre The company produces four billion island in the Bahamas. While sojourn- valves a year and holds 300 aerosol-re- ing there in 1969, President Nixon made lated patents. Mr. Abplanalp was a long- the decision to initiate Cancer Control time business associate of H.R. Shep- Month, leading to his declaration of War herd, former chairman and CEO of on Cancer. Aerosol Techniques Inc., which became Because of this historical connection, Armstrong Laboratories, and chairman Abplanalp invited the Sabin Institute to of the Sabin Vaccine Institute. hold its annual cancer vaccine collo- When the Shepherds founded the quium at Walker’s Cay. The sixth such Albert B. Sabin Vaccine Institute in 1993, meeting will be held in March 2004. Abplanalp became one of its main In July of this year he made available sources of encouragement and support. his property at the Eldred Preserve, a Robert Abplanalp Mr. Abplanalp was also known as one retreat in upstate New York, for the first of President Richard M. Nixon’s clos- meeting of the Sabin Institute’s Cancer est friends, providing emotional and fi- Vaccine Consortium. When asked about Abplanalp’s death, nancial support to Nixon before, during Abplanalp has served every year as a Dr. Shepherd said, “He was an extraor- and after his presidency. member of the Benefit Committee for dinary individual, and his patience and He and Nixon became friends after the Sabin Awards Celebration, the ability to listen will be missed but never Nixon’s loss in the 1960 presidential Institute’s annual gala dinner. forgotten.” dedicated to disease prevention www.sabin.org 9 A Milestone in Vaccination History: The Balmis-Salvany Expedition of 1803 One of the Great Public Health Ventures of All Time Before the smallpox vaccine was dis- staggering proportions. A small group set America, and the Philippines, and Dr. covered, the disease killed people of all out by ship and horse to traverse within Salvany led the other to countries in ages and all socioeconomic classes. In present-day Puerto Rico, Venezuela, South America. the late 18th century 400,000 Europe- Panama, Colombia, Ecuador, Peru, The Balmis-Salvany expedition is sig- ans died and one-third of survivors went Chile, and Bolivia, carrying the vaccine nificant not only because of the vaccine blind as a result of the disease. Desper- and administering it in villages and cities but also because it institutionalized vac- ate demand greeted Dr. Edward along the way. The territory was not only cination boards that would keep records Jenner’s 1798 report on his experimen- vast but also brutally harsh, with pre- of the vaccinations performed and pre- tation with the vaccine. cipitous mountains, dense jungles, and serve the serum for future vaccinations. Like Europe, the new Spanish colo- uncharted rivers. The expedition trav- Since that expedition, worldwide col- nies incurred grave mortality and mor- eled in riverboats and on mules when laborative efforts have successfully vac- bidity due to smallpox. Since the arrival the terrain was too rugged for horses. cinated populations to the point that in in Hispaniola of Spanish conquistadors The expedition left the Spanish har- 1980 the World Health Organization was in 1518, which was quickly followed by bor of La Coruña on November 30, 1803, able to declare that smallpox had been a devastating outbreak, the disease with the smallpox vaccination expedition eradicated. The cost of getting rid of it– moved rapidly throughout the Americas. team consisting of a director, Dr. Fran- approximately US$313 million over 10 By the end of the 18th century, Spain cisco Xavier Balmis; an assistant direc- years–has been repaid many times in projected serious economic losses as a tor, Dr. Jóse Salvany Lleopart; and sev- saving of human lives and in the elimi- result of the diminishing labor force in eral assistants and paramedics. The ship nation of costs for vaccines, treatment, the colonies. With news of the use in reached Puerto Rico in February 1804 and international surveillance activities. Europe of a vaccine against smallpox, with its cargo of vaccine serum pre- Adapted from an article by Rafael E. Tarrago, the royal officers in present-day Colom- served between sealed glass plates; also titled “The Balmis-Salvany Smallpox Expedition: bia pleaded for access to the vaccine. on board were 21 children from the or- The First Public Health Vaccination Campaign On September 1, 1803, King Charles phanage at La Coruña who carried the in South America” from the website of the Pan IV of Spain, who had lost one of his own vaccine through arm-to-arm vaccina- American Health Organization. children to smallpox, issued a royal or- tions performed sequen- der to all royal officers and religious tially during the ship’s authorities in his American and Asian journey, and thousands of domains, announcing the arrival of a copies of a treatise de- vaccination expedition and commanding scribing how to vaccinate their support to vaccinate the masses and preserve the serum. free of charge, teach the domains how Upon arriving in Puerto to prepare the smallpox vaccine, and Rico, Balmis worked organize municipal vaccination boards with the governor general throughout the domains to record the and his chief doctor to or- vaccinations performed and to keep live ganize a central vaccina- serum for future vaccinations. tion board that would The Balmis-Salvany expedition was record the successful the first official program of mass vacci- vaccinations performed nation in Spanish America and the world. in Puerto Rico and would Ciro de Quadros, MD, MPH, director of international pro- Dr. Jenner demonstrated the effective- keep live serum for fu- grams, SVI, delivered a technical presentation at a forum in La Coruña, Spain, hosted by the Government of Galicia ness of the smallpox vaccine in 1796, ture vaccinations. The and by Galicia’s School of Public Health to recognize the and wrote on November 22, 1806, re- expedition teams estab- 200th anniversary of the Balmis-Salvany Expedition. He was ferring to the vaccination expedition lished vaccination boards presented a small-scale replica of the 10-foot commemora- sponsored by Spain’s King Charles IV: wherever they stopped. tive sculpture dedicated November 29 at dockside in La “I don’t imagine the annals of history From Puerto Rico the Coruña, where the expedition departed 200 years prior. The furnish an example of philanthropy so expedition went to Ven- sculpture by Acisclo Manzano is titled “Angel of Hope” noble, so extensive as this.” ezuela, and subsequently and depicts two of the orphan children who made the main The expedition to vaccinate the popu- divided into two groups. goal of the expedition possible by keeping the vaccinia lation in South America against small- Dr. Balmis led one group virus alive on their infected skin. The sculpture shows them pox was a public health undertaking of to Mexico, Central in the embrace of their guardian. 10 WINTER 2004 SABIN VACCINE REPORT Human Hookworm Vaccine Initiative Update Peter Hotez and Colleagues Select the Optimal Antigen Candidate The research team of the Human ing is a key milestone in clinical research I protocol for the vaccine will comprise Hookworm Vaccine Initiative, under the in which vaccine safety is assessed in essential parts of an Investigational New leadership of Peter Hotez, MD, PhD, healthy volunteer subjects. Drug (IND) application. chairman of the Department of Micro- Prior to clinical investigation the anti- An IND must be filed and reviewed biology and Tropical Medicine at The gen manufacturing process must be re- by the U.S. Food and Drug Administra- George Washington University, has se- fined. This is underway in Dr. Hotez’s tion before Phase I testing can com- lected the first antigen for the investiga- laboratories. Once this step in the pro- mence. Phase I testing will be done at a tional hookworm vaccine. This antigen, cess is completed, the manufacturing clinical site in the United States and is Na-ASP-2, will be the active constitu- activity will be transferred to the Walter expected to begin in late 2004. This will ent of the vaccine that will be tested in Reed Army Institute of Research be followed by similar Phase I testing in a Phase I clinical trial. (WRAIR) for contract manufacture fol- Brazil, a country where human hook- Antigen selection was made on the lowing Good Manufacturing Practices. worm is endemic. Local Brazilian regu- basis of immune response test results Manufacturing is scheduled for early in latory approval will be sought prior to of animal models that were challenged 2004. Pre-clinical assessment, analysis, initiation of this study. with hookworm parasites. Phase I test- the manufacturing record and the Phase If the Phase I trials prove the vaccine to be safe, larger field testing in Brazil- ian patients is planned. These Brazilian field trials are analogous to the tradi- The HHVI staff are, tional Phase II - III effectiveness tests from left, seated: Vehid done in investigations in the United Deumic, Yueyuan Liu, States. If the vaccine proves to be both Peter Hotez, Maria safe and efficacious, licensure of the Elena Bottazzi, Angela vaccine in Brazil and other countries Williamson; standing: will be pursued. Mohan Kocherla, Andre The selection of the antigen for the Samuel, Ricardo vaccine is the first element of what will Fujiwara, Lilian Bueno, Gaddam Goud, Jeff be a long scientific and regulatory pro- Bethony, Susana cess, starting in the United States and Mendez, and Alex moving abroad, to develop an antigen Loukas. Not pictured: vaccine to successfully control human John Hawdon and Bin hookworm disease.

Sabin Board, Regional Biotech Leaders Gather at VaBIO Summit ’03 The Sabin Vaccine Institute’s Board entific Advisory Council Chair of Trustees held their traditional pre- Peter Hotez, MD, PhD, high- meeting dinner at a novel venue this lighted the hookworm vaccine re- past October. The Board was hosted search funded by the Bill & by the Virginia Biotechnology Associa- Melinda Gates Foundation tion, during the regional biotech group’s through SVI. annual summit meeting, held from The association reported that October 13-15. the event drew a record number Nearly 600 biotech, medical device, of sponsors and exhibitors. Par- industry service professionals and uni- ticipants took part in numerous versity leaders participated in the Sum- concurrent sessions on topics mit held at the McLean Hilton Hotel such as biodefense, vaccine re- in Tysons Corner, Virginia. search, venture capital access, Peter Hotez, MD, PhD, presents the Human Hookworm In addition to the Board dinner, SVI nanotechnology, medical devices, Vaccine Initiative during an October conference of the was represented on the conference bioethics and federal funding op- Virginia Biotechnology Association. agenda. A presentation by SVI Sci- portunities. dedicated to disease prevention www.sabin.org 11 Support Builds for PAHO’s Goal of Rubella Elimination by 2010 Agreement Sealed by PAHO Member Country Health Ministers

The Sabin Vaccine Institute joined the immunity for life. Universal immuniza- of childbearing age who did not receive U.S. Centers for Disease Control, the tion of infants, coupled with ‘catch up’ the vaccine as infants, can eliminate con- March of Dimes, and regional health immunization of adolescents and women genital rubella syndrome. ministers in endorsing the rubella eradi- cation goals of the Pan American Health Organization. PAHO Director Mirta Roses Periago, MD, declared the broad support for its 2010 target at a press event in September. Ciro de Quadros, director of interna- tional programs for the Sabin Vaccine Institute, and former PAHO senior im- munization leader, participated in the press conference with the PAHO direc- tor and other health leaders. Walter Orenstein, MD, director of the U.S. Na- Announcing the PAHO Initiative to Eliminate Rubella by 2010 are, from left, Walter Orenstein, tional Immunization Program of the Cen- MD, director of the CDC’s National Immunization Program; PAHO Director Mirta Roses Periago, ters for Disease Control and Prevention, MD; Ciro de Quadros, MD, Sabin Institute director of international programs; and Micheal and Michael Katz, MD, senior vice presi- Katz, MD, president of the March of Dimes. dent for research and global programs of the March of Dimes, were also on hand. Hugh Evans, MD Named Sabin Fellow Rubella, or German measles, is nor- Pediatrician Explored the Medical Legacy of FDR in Recent Book mally a mild childhood illness caused by Hugh Evans, 1944 Election, published by M.E. a virus that is different from the one that MD, chairman of Sharpe, Inc., Armonk, NY, June 2002. causes measles. Although highly conta- pediatrics at the The book was reviewed in the Winter gious, it poses very little risk to children University of 2002/03 issue of The Sabin Report. —however, it is a major threat to a fe- Medicine and Dr. Evans completed a pediatric in- tus. The birth defects caused by this vi- Dentistry of New ternship and residencies at Johns rus are referred to collectively as con- Jersey, and medi- Hopkins Hospital. He served with the genital rubella syndrome (CRS). Ac- cal historian, was U.S. Public Health Service as a senior cording to PAHO, rubella and CRS are recently named a assistant surgeon early in his career. He two of the main health concerns in the Sabin Fellow. He Hugh Evans, MD also served as a faculty member of the Americas. is among a select group and scholars University of Pittsburgh College of Currently, 42 of the 44 countries and who contribute regularly to the research Medicine, Mt. Sinai School of Medicine, territories in the Americas are already and education mission of the Institute. New York, and Columbia University using rubella-containing vaccine in their A leading medical authority, Evans is College of Physicians & Surgeons. immunization programs. Countries of an alumnus of Columbia College, New He was professor of pediatrics at the the Caribbean and four in Latin America York and received his medical degree Downstate Medical Center of the State (Costa Rica, Honduras, Brazil and Chile) from the State University of New York- University of New York, Brooklyn, and have already launched a rubella elimi- Health Science Center, in Brooklyn. ultimately chairman of pediatrics at New nation initiative. In 1997, the Americas His major research interests are in neo- Jersey Medical School. He also has held reported more than 126,000 rubella natal oxidant induced lung injury and its numerous clinical appointments at hos- cases. By 2002, this number had been prevention and recently developed anti- pitals in New York and New Jersey. dramatically reduced to fewer than biotics. In addition, he has investigated Dr. Evans holds a joint appointment 12,000 cases. the medical heritage of President as professor of preventive medicine and While rubella in early preg- Franklin D. Roosevelt. In addition to community health. He is on the editorial nancy can be disastrous for a fetus, ex- numerous medical articles and publica- review boards of several medical jour- perts advise that it can be prevented by tions, he wrote the book, The Hidden nals and is a fellow of the American a safe and effective vaccine that offers Campaign: FDR’s Health and the Academy of Pediatrics. 12 WINTER 2004 SABIN VACCINE REPORT

NEWS SABIN BRIEFS CALENDAR Anne Gershon, MD To Co-chair FEBRUARY 2004 APRIL 2004 Sabin Scientific Advisory Board 3-4 Washington, DC 12-18 Whistler, British Columbia Anne Gershon, MD, will join Peter Hotez, MD National Vaccine Advisory Committee HIV Vaccine Development: Progress as co-chairs of the Sabin Vaccine Institute (NVAC) Meeting and Prospects Hubert Humphrey Building Whistler Resort Scientific Advisory Council. The council pro- (Photo ID required for entry.) www.keystonesymposia.org/Meetings/ vides a resource of expertise to the Institute www.cdc.gov/od/nvpo/calendar.htm ViewMeetings.cfm?MeetingID=693 regarding its education and research objec- tives and includes more than 30 noted 3-5 London, UK 17-20 Philadelphia, Pennsylvania vaccinologists and other medical experts. Dr. The Viability of DNA Vaccines The Society for Healthcare Epidemio- www.melifesciences.com/DNA logy of America Annual Meeting Gershon is professor of pediatrics and chief Wyndham at Franklin Plaza 27 - 28 Atlanta, Georgia of the Division of Pediatric Infectious Diseases www.shea-online.org at Columbia University College of Physicians International Conference on Women and Surgeons. She is recognized both na- and Infectious Diseases 17-21 Washington, DC tionally and internationally in the field of anti- Atlanta Marriott Marquis Experimental Biology 2004 (APS, www.womenshealthconf.org ASPET, ASIP, ASNS, AAA, AAI) viral therapy for her basic and clinical inves- Amer. Association of Immunologists 29 -March 3, 2004 Atlanta, Georgia tigations of varicella zoster virus, varicella Convention Center International Conference on Emerging zoster virus vaccine, herpes simplex and res- www.faseb.org/meetings/eb2004 piratory syncytial virus and their Infectious Diseases management. Atlanta Marriott Marquis 19-22 Brighton, UK www.iceid.org World Congress of Public Health ’04 Phacilitate Conference Features The Brighton Centre MARCH 2004 Sabin Scientific Advisors www.phaworldcongress.com Philip Russell, MD, special advisor for vac- 4-7 Cancun, Mexico 25-May 1 Nationwide cine production and development in the Of- 11th International Congress on Infectious Diseases (11th ICID) 2004 Nat’l Infant Immunization Week fice of the Assistant Secretary for Public Health Contact: International Society for www.cdc.gov/nip/events/niiw Preparedness, presented “Acquisition of Infectious Diseases (ISID) Medical Countermeasures for Biodefense,” 27-29 Montreal, Canada [email protected] World Vaccine Congress 2004 at the November 17-20 Phacilitate Vaccine www.isid.org Hotel Omni Mont Royal Forum in Boston. Also speaking at the event www.lifescienceworld.com/2004/ were Lance Gordon, PhD, CEO of VaxGen, 10-13 Abaco, Bahamas wvcm_CA who delivered remarks on “Case Study: A New 6th Annual Sabin Colloquium on Template for Biodefense Vaccine Develop- Cancer Vaccines and Immunotherapy 28-30 Montego Bay, Jamaica ment,“ and Jerald Sadoff, MD, Aeras TB Foun- Walker’s Cay Hotel & Marina Vaccines for Enteric Diseases dation president and member of the Sabin www.sabin.org/ Half Moon Club programs_walkers_cay.htm Scientific Advisory Council, who presented, www.meetingsmanagement.com/pdf/ “A TB Update: What Is the Latest Progress in VED_2004.pdf the Development of a Next Generation TB Vaccine?”

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