2004Sabin

Awards

Sabin Vaccine

The newsletter of the Albert B. Sabin Vaccine Institute — dedicated to disease prevention

R E P O R TVolume VII, Number 1

Summer 2004

IIIII nside nside nside nside nsideViewPoint .................................................... 2President’s Message ..................................... 3Cancer Vaccine Consortium News ................ 4Hookworm Program Review ....................... 6Book Review: Vaccines ............................. 10Sabin Institute Relocates ........................... 14Walter Orenstein Joins Sabin Board .......... 15Calendar ................................................... 16

www.sabin.orgwww.sabin.orgwww.sabin.orgwww.sabin.orgwww.sabin.org

SVI Celebrates DNA Pioneer James Watson and Biotech Leader Chiron At Awards GalaEvent in New York City Emceed by CBS News Chief Washington Correspondent Bob Schieffer

The Sab in Vacc ine Ins t i tu t ece lebrated a Salute to Life SavingDiscoveries during its annual benefitdinner at The Pierre Hotel in New YorkCity May 12, 2004. The evening fea-tured the presentation of awards toNobel laureate James D. Watson, PhD,and to Howard Pien, president andCEO of Chiron Corporation.

“This was an enlightening evening ofcelebration dedicated to the landmarkdiscoveries that have so greatly en-hanced our understanding of biologicalscience,” said Sabin Chairman H.R.Shepherd. “Dr. Watson’s work hasopened wide the fields of biological sci-ence. Products and discoveries fromour colleagues at Chiron Corporationhave protected millions from life-threat-ening illnesses, and the company un-derlines this impact with a generousspirit of corporate philanthropy, mostnotably demonstrated by its donationsof polio vaccine to support global eradi-cation efforts.”

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Sabin Board Names New Institute PresidentDean D. Mason Appointed President and CEO

The Board of Trustees of the AlbertB. Sabin Vaccine Institute announcedthe appointment of Dean D. Mason asits new president and chief executiveofficer. The appointment was effectiveApril 7, 2004. “We look forward to Mr.Mason’s leadership of the Institute at thisimportant time in the organization’s evo-lution,” said Board chairman H.R. Shep-herd.

At the U.S. Centers for Disease Con-trol and Prevention (CDC) since 1974,Mason served in local and state healthdepartments and the National Immuni-zation Program (NIP). As chief of theProgram Support Branch of the NIP forthe past ten years, Mason managed an

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At the Sabin Vaccine Institute Annual Awards Celebration are, from left, emcee Bob Schieffer, CBS NewsChief Washington Political Correspondent; Howard Pien, Chiron President and Chief Executive Officer;Sabin Institute Chairman H.R. Shepherd; and genomics pioneer James D. Watson.

annual budget of more than $1 billion.His role has been to establish terms andconditions for the negotiation of CDC’spediatric and adult vaccine contracts,which make up more than half of thenational market share. He has been re-sponsible for all Vaccines for Children(VFC) and 317 grant vaccine awardsto immunization projects around thecountry. He also has overseen monitor-ing and reporting of the nation’s vaccinesupply, including aspects of vaccine or-dering, storage and distribution for allvaccines purchased by the states throughCDC contracts. Further, he has takenthe lead in planning and development ofthe nation’s pediatric vaccine stockpiles.

2004 Sabin Gold Medal Awardedto William S. Jordan, Jr., MD, p 7.

The Sabin Vaccine Reportis published by the

Albert B. Sabin Vaccine Institute

Subscriptions are freePlease direct inquiries to:

SABIN VACCINE REPORT161 Cherry Street

New Canaan, CT 06840-4818phone: 203.972.7907/fax: 203.966.4763

www.sabin.orgemail: raymond.macdougall@sabin.org

EEEEEDITORDITORDITORDITORDITOR

Raymond MacDougall

SUMMER 2004 SABIN VACCINE REPORT2

AAAAASSOCIATESSOCIATESSOCIATESSOCIATESSOCIATE E E E E EDITORDITORDITORDITORDITOR

Veronica KornCCCCCOPYOPYOPYOPYOPY E E E E EDITORDITORDITORDITORDITOR

David BedellOOOOOFFICERSFFICERSFFICERSFFICERSFFICERS OFOFOFOFOF THETHETHETHETHE SVI B SVI B SVI B SVI B SVI BOARDOARDOARDOARDOARD OFOFOFOFOF T T T T TRUSTEESRUSTEESRUSTEESRUSTEESRUSTEES

H. R. Shepherd, DSc, ChairmanWilliam R. Berkley, Co-ChairmanMichael E. Whitham, Esq., Secretary/

Treasurer

SVI SSVI SSVI SSVI SSVI STAFFTAFFTAFFTAFFTAFF

Dean D. Mason, President/CEOFran G. Sonkin, Executive Vice PresidentPaul J. Vilk, RPh, RAC, Vice President,

Program Management and RegulatoryAffairs, Hookworm Vaccine Initiative

Nathan Tinker, PhD, Executive Director,Cancer Vaccine Consortium

Ciro de Quadros, MD, MPH, Director,International Programs

David Bedell, Director, EducationalPrograms

Raymond MacDougall, Director ofCommunications

Ana Carvalho, Assistant to the Director,International Programs

Ellen Clerc, Assistant to the President/CEO

Veronica Korn, Research AssociateChristel Lane, Receptionist/Staff AssistantVanessa Santiago, Assistant to the

Executive Vice PresidentEvan Sonkin, Information CoordinatorJean-Serge Valcourt, Accounting

SVI ADVISORS

Philip K. Russell, MD, Senior Advisor tothe Chairman

Peter J. Hotez, MD, PhD, Senior Fellow& Chair, Scientific Advisory Council

Anne Gershon, MD, Co-chair, ScientificAdvisory Council

Hugh E. Evans, MD, Sabin FellowWilliam Muraskin, PhD, Sabin FellowPatricia Thomas, Sabin FellowNancy Gardner Hargrave, Development

Counsel

This spring there’s been a global thanksgiving in both developed and developing nationsabout an event that took place in an affluent Washington suburb fifty years ago.

The event was the vaccination of six-year-old Randy Kerr from McLean, Virginia with anexperimental polio vaccine developed by Jonas Salk in his University of Pittsburgh laboratory.

That polio vaccination eventually led to the virtual eradication of one of the world’s mostdread diseases and saved millions of lives in the process—a large majority of them in thepoor nations of Africa, Asia and Latin America.

In the months following young Randy’s vaccination, thousands of other American childrenwho became known as “Polio Pioneers” stepped up to receive their polio injections as partof an enormous vaccine field trial.

Within a year, the data from this extraordinary trial were collected and tabulated and itbecame obvious that the polio vaccine was a success. Parents all over the world started tobreathe a sigh of relief that their children would not die or become permanently paralyzedfrom annual summer polio epidemics that had killed and crippled so many.

The Salk vaccine was just the first in a string of new vaccines against the great virus infectionsof humankind that were developed over the next two decades. These new vaccines cameabout largely because of earlier efforts by John Enders and his colleagues at Harvard MedicalSchool who had discovered a way to culture disease-causing viruses in the laboratory. Thelegacy of these viral vaccines is a story of epic proportions.

For instance, widespread use of the measles vaccine, first developed by Enders, TomPeebles and Sam Katz in the 1960s, began with the start of the World Health Organization’sExpanded Program on Immunization (EPI) in 1974 when measles was the planet’s singlegreatest childhood killer responsible for 7 million deaths annually. Through the EPI thenumber of annual measles deaths has now been reduced ten-fold to less than 800,000deaths annually. The number of lives saved through the EPI’s measles vaccination programwas recently estimated to be equivalent to the number of lives lost in all wars during the 20thcentury. Putting it in those terms, one could say that the measles vaccine became our firstweapon of mass peace!

Another extraordinary achievement was a second generation polio vaccine developed byDr. Albert Sabin. Employing live-attenuated virus strains that could be administered orally,rather than using killed virus administered by the Salk injections, the Sabin vaccine gainedfavor worldwide.

Few of us realize that the Sabin vaccine was licensed in the U.S. only after it was first testedin tens of millions of Soviet schoolchildren during the late 1950s shortly after the launch ofSputnik. This came about through a little-known but remarkable piece of back-channeldiplomacy between the Eisenhower Administration and the Communist regime in Moscow.

Today, through widespread use of the Sabin vaccine, polio has been eradicated in all butsix nations. They are Nigeria, India, Pakistan, Niger, Afghanistan, and Botswana. However,

Polio Vaccine’s Successful Debut 50 Years AgoSpurred Advances That Saved Millions of Lives—by Peter J. Hotez, MD, PhD and H.R. Shepherd, DSc

THIS OPINION COINCIDES WITH THE 50TH ANNIVERSARY OF

THE FIRST POLIO VACCINE TRIALS IN 1954

VIEWVIEWVIEWVIEWVIEWPOINTPOINTPOINTPOINTPOINT

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dedicated to disease prevention www.sabin.org 3

Dean Mason Appointed Sabin Institute PresidentCDC Experience Accompanies New Leadership at Sabin Institute

In 1993, when the VFC program waslegislated, Mason was detailed on a spe-cial assignment for eight months to de-velop and implement the unique program.He was responsible for planning, policydevelopment, training, and implementa-tion of the program in which more than80,000 doctors participate as enrolledproviders. “Currently, the VFC programis one of the best national examples ofpartnership between the public and pri-vate health care sectors,” Mason said.“The program encourages widespreadprovider participation to better ensureequal access for immunization servicesthrough the purchase and supply of vac-cines for eligible children.”

“I look forward to applying my lead-ership and management skills with theAlbert B. Sabin Vaccine Institute,” Ma-son said. “I am particularly eager to de-velop the public and private consortia thatadvance the cause of public health andthat serve to promote the use of effec-

tive vaccines and immunization programson a global scale.”

Dean Mason began his CDC careerin 1974 in Florida, where he served aspublic health advisor for sexually trans-mitted diseases for the Dade CountyHealth Department and subsequently forthe St. Louis, Missouri Health Depart-ment. He began his service with the Na-tional Immunization Program in 1978with an assignment as regional programdirector in Kansas City, Missouri, andsubsequently in Houston, Texas and waslater appointed state immunization pro-gram director for South Carolina. TheNational Immunization Program trans-ferred him in 1985 to its headquarters inAtlanta. He served as development andcampaign coordinator of the Immuniza-tion Action Plan (IAP) that in the early1990s worked to accomplish local andnational immunization goals in the coun-try. This two-year effort led to the de-velopment of Immunization Action Plansin all states. The IAP serves today as a

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key planning and reference documentfor state and local immunization programoperations. He has been for the pastseveral years a principal advisor to theAdvisory Committee on ImmunizationPractices and the National Vaccine Ad-visory Committee on vaccine supply is-sues, where he has delivered formal pre-sentations several times a year.

Mason is a graduate of Texas A&M-Commerce, where he attained a Bach-elor of Science degree. He is recipientof numerous professional honors andawards, including the 1995 Public HealthService Superior Service Award for ex-ceptional leadership in the developmentand implementation of the Vaccines forChildren program, as well as being hon-ored for the VFC program that sameyear during President Clinton’s RoseGarden Ceremony. In 1992, he was rec-ognized during President George H.Bush’s Rose Garden Ceremony for con-tributions to the development of Immu-nization Action Plans. He has publishedreports in the Journal of Health Carefor the Poor and Underserved and inPublic Health Reports.

Dean D. Mason

Entering an Exciting New Era in Which Vaccines Hold Great PromiseMessage from the President

On April 7, 2004, I began work with the Albert B. Sabin VaccineInstitute (SVI) as the President and Chief Executive Officer. I amindebted to the Chair, Co-chair, and Board of Trustees for giving methis opportunity to contribute to the legacy of Dr. Sabin. His globalvision is easy to understand: we can and must save and improvepeople’s lives through research, development, promotion and deliveryof vaccines.

SVI is committed to partnering with industry, government, and otheradvocacy groups; with philanthropic organizations; and with countriesglobally to help realize the goal of enabling all children to have accessto vaccines that reduce and prevent morbidity, sequelae and death.

Above and beyond its past accomplishments and future promise,the most appealing aspect of the SVI to me is the caliber andcommitment of the people who are affiliated with the organization. Inthe world of people who are dedicated to vaccines, it is a “Who’sWho” list of accomplished scientists, dedicated physicians, and leadersin industry, government, and education.

The SVI creates a network of caring, knowledgeable peoplededicated to saving lives. Some are research scientists, who throughtheir expertise forge medical discoveries, some are business andpublic leaders whose decisions may bring about more enlightened

social policy, and some are leaders whosegenerosity provides the needed resources forunlocking vaccines’ vast potential.

During my tenure at SVI I hope we can buildon past relationships and forge new ones. Thisis an exciting era in which new and improvedvaccines and new technologies for shipping,storing and administering vaccines hold greatpromise. I greatly look forward to working withthe many collaborators and friends of this institute. Through yourcontinued engagement with us, we will promote the kind of interactivedialogue among thought leaders that will benefit their formulation ofcomprehensive and prudent long-range policies to address thevaccine needs of all people everywhere.

Sincerely,

Dean D. MasonPresident and Chief Executive Officer

SUMMER 2004 SABIN VACCINE REPORT4

Cancer Vaccine Consortium Engages Regulatory ProcessClinical and Manufacturing Working Groups Created to Develop FDA Engagement Policies

The regulation of cancervaccines by the U.S. Foodand Drug Administration(FDA) and European Unionoffers both opportunities and potentialpitfalls for industry and research, ac-cording to speakers at the April 2004meeting of the Cancer Vaccine Consor-tium (CVC), “Federal Regulation andCancer Vaccines.” As part of the meet-ing, the CVC launched two new work-ing groups to address regulatory issuesand engage the FDA in policy discus-sions. The meeting, held in Orlando,Florida, was the CVC’s third semi-an-nual meeting.

The meeting featured a workshop withDr. Steven Hirschfeld, MD, PhD, of theFDA’s Center for Biological Evaluationand Research. Dr. Hirschfeld’s presen-tation outlined the process FDA uses inevaluating and licensing cancer vac-cines. He said that the FDA was inter-ested in working with industry to developprocesses and procedures for evaluat-ing cancer vaccines.

Dr. John Calfee, Resident Scholar atthe American Enterprise Institute,

warned, though, that thecancer vaccine marketcould be ripe territory forprice controls, especially

in light of the newly-passed Medicarebill. His talk, entitled “Cancer Vaccines:The Economics Is as Tough as the Sci-ence,” looked skeptically at the FDA’sregulatory process and questioned theagency’s success in pharmaceutical li-censing.

Other presentations at the meeting in-cluded an overview of the cancer vac-cine regulation process in the EuropeanUnion by Dr. Thomas Hinz of the Paul-Ehrlich-Institut, and an analysis of theemerging cancer vaccine market bySteven Heffner of Kalorama Informa-tion.

The meeting prompted the CancerVaccine Consortium to launch two new

working groups to address issues andchallenges in federal regulation of can-cer vaccines. The working groups, fo-cused, respectively, on clinical issues andmanufacturing issues, will prepare a se-ries of position papers on specific issuesand engage the FDA in a series of meet-ings to address these issues.

“These clinical and manufacturingworking groups are an important step inthe Cancer Vaccine Consortium’s de-velopment,” said Dr. Nathan Tinker, ex-ecutive director of the CVC. “TheCVC’s ultimate goal is to help cancervictims by getting cancer vaccines outof the laboratory and into patients. Byaddressing regulation directly with FDA,we can have a tangible impact on theprocess and, hopefully, find opportuni-ties to bring these important therapiesto market.”

The Sabin Vaccine Institute partici-pated as co-sponsor of the SecondBiodefense Vaccines, Therapeuticsand Diagnostics Conference inWashington, DC in mid-April. Themeeting focused on the state of theart in biodefense vaccines, therapeu-tics and diagnostics and the regula-tory framework for testing and ap-proving these products.

The conference addressed the U.S.government’s commitment to rapidlydevelop biomedical countermeasuresagainst bioterrorist threats, which hasstimulated a tremendous boost tobiodefense research. The effect hasbeen growing interest in expandingresearch resources and facilities, and

evident dedication to build a robustbiodefense industry.

Representatives from universities,pharmaceutical companies, the bio-technology industry, medical serviceand diagnostic companies, and the pub-lic health community gathered to ex-plore the latest information about theopportunities to participate in the vitalnational effort to quickly bring newbiodefense vaccines, therapeutics, anddiagnostics to market. The conferencealso focused on the national work un-derway to put in place the structureand incentives needed to enable a ro-bust biodefense industry for vaccines,therapeutics, and clinical diagnostics.

Philip K. Russell, MD, SVI found-ing president and acting director ofthe Office of Research and Devel-opment Coordination in the Office ofthe Assistant Secretary for PublicHealth Emergency Preparedness,U.S. Department of Health and Hu-man Services, delivered the keynotespeech at the opening of the meet-ing. He addressed the government’sbiodefense vaccine, therapeutic, anddiagnostic goals, priorities, and pro-grams. Lance Gordon, PhD, Presi-dent and CEO of VaxGen, Inc. andSVI trustee, delivered a lunch key-note on creating effective public-pri-vate partnerships in biodefense.

SVI Co-sponsors Washington Conference on Biodefense VaccinesSVI Board Members Philip K. Russell, MD and Lance Gordon, PhD Lend Expertise in Keynote Talks

About the CVC The Cancer Vaccine Consortium was founded in 2003 under the auspices of theAlbert B. Sabin Vaccine Institute. The mission of the CVC is to pursue common goals and overcomecommon hurdles in the development of cancer vaccines, and to serve as a vehicle through whichto engage the public, regulators, policymakers, and patients about developments in this emergingfield. More than 25 companies, universities and research institutes comprise the CVC. For moreinformation about the CVC, call (203) 972-7907, write to cvc@sabin.org, or visit www.sabin.org/cv_consortium.

The next meeting of the theCVC will be Nov. 7-8, 2004in San Francisco.

5dedicated to disease prevention www.sabin.org

Researchers Explore Cutting-Edge Cancer Vaccine Development2004 Sabin Colloquium on Cancer Vaccines and Immunotherapy Held at Walker’s Cay

Approximately forty of the world’sleading cancer vaccine researchers metfrom March 10-13, 2004 at a scientificcolloquium organized by the Albert B.Sabin Vaccine Institute to report on thelatest developments in cancer therapies.Cancer vaccines—alternatives to radia-tion and chemotherapy—are more tar-geted and would not cause the unwantedside effects cancer patients now face.The promising field looks to the body’simmune system to attack existing can-cerous cells.

Goals of the meeting included inspir-ing novel bench-to-bedside ventures andat the same time providing feedbackabout promising or otherwise novel clini-cal results that could help re-frame somescientific question or guide the designof future trials. Several topics were cov-ered that included tumor antigen discov-ery and validation, platforms for vaccinedevelopment, tolerance, immune sup-pression and tumor escape mechanisms,adoptive T cell therapy and dendritic cell-based therapies, clinical trials and as-sessment of response. Animated discus-sion followed each individual presenta-tion.

The meeting took place at Walker’sCay in the Bahamas and was the sixthin the annual series of meetings knownas the Sabin Vaccine Institute Collo-quium on Cancer Vaccines and Immu-

notherapy. According to H.R. Shepherd,chairman of the Sabin Vaccine Institute,“Each time that this many talented anddedicated scientists meet to advancecancer vaccine research, there is greaterpromise for vaccine therapies to becomeavailable for cancer patients—and all thesooner.”

Walker’s Cay, a small island in theBahamas, is otherwise known for sportfishing and as the retreat where, in 1969,President Richard Nixon originated thenow famous declaration of “war on can-

cer.” From the time of that declaration,however, cancer rates have climbed,though survival for many patients hasbeen prolonged by research efforts andimproved therapies. Vaccines would bethe newest of the products available totreat cancer.

This meeting was the first since thedeath this past August of RobertAbplanalp, who owned the sport fishingcompound on Walker’s Cay and providedthe venue to the Institute for its meet-ing.

Participants were drawn from bio-medical research departments at sev-eral of the nation’s leading universitiesand institutions abroad, the pharmaceu-tical industry, nongovernmental organi-zations, members of biological researchinstitutes and government research labo-ratories. This year’s colloquium was co-chaired by W. Martin Kast, PhD, WalterA. Richter Chair for Cancer Researchand professor of molecular microbiologyand immunology at the University ofSouthern California, and Hyam Levitsky,MD, professor of oncology, medicine,urology and immunology at JohnsHopkins University.

Participants convened for the 2004 Sabin Institute Cancer Vaccines and ImmunotherapyColloquium at Walker’s Cay, Bahamas.

David Bedell, Sabin Vaccine InstituteNeil L. Berinstein, MD, Aventis Pasteur Ltd.Ivan Borrello, MD, Johns Hopkins UniversityRobert K. Bright, PhD, Texas TechMaurizio Chiriva-Internati, MD PhD, Texas TechTyler Jay Curiel, MD MPH, Tulane UniversitySoldano Ferrone, MD PhD, Roswell Park Cancer

InstituteLothar Finke, MD, EMD Pharmaceuticals Inc.Bernard A. Fox, PhD , Robert W. Franz Cancer

Research CenterAllan L. Goldstein, PhD , George Washington Univ.Kristen Hege, MD, Cell GenesysW. Martin Kast, PhD (Co-Chair), Univ. of Southern

CaliforniaTibor Keler, PhD, Medarex, Inc.Rolf Kiessling, MD PhD, Karolinska InstituteHyam I. Levitsky, MD (Co-Chair), Johns HopkinsHans Loibner, PhD, Igeneon AG

Colloquium ParticipantsAlain Luxembourg, MD PhD, Ichor Medical SystemsH. Kim Lyerly, MD, Duke University Medical CenterFrancesco M. Marincola, MD, NIHMatthew F. Mescher, PhD, University of MinnesotaSally Mossman, PhD, Corixa CorporationMichael I. Nishimura, PhD, University of ChicagoGerry Rowse, PhD, Stressgen BiotechnologiesMichel Sadelain, MD PhD, Memorial Sloan-KetteringStephen P. Schoenberger, PhD, La Jolla InstituteHans Schreiber, MD PhD, University of ChicagoH.R. Shepherd, DSc,Sabin Vaccine InstituteEduardo M. Sotomayor, MD, H. Lee Moffitt Cancer

CenterNathan Tinker, PhD, Sabin Vaccine InstituteDavid L. Urdal, PhD, Dendreon CorporationJohn Vasilakos, PhD, 3M PharmaceuticalsRobert H. Vonderheide, MD, DPhil, Univ. of Penn.Michael E. Whitham, Esq., Whitham, Curtis &

Christofferson, P.C.Hua Yu, PhD, H. Lee Moffitt Cancer Center

SUMMER 2004 SABIN VACCINE REPORT6

Human Hookworm Vaccine InitiativeAnnual Review Takes Stock of Milestone Accomplishments, Looks Ahead to Clinical Trials of the Vaccine

The annual review for the HumanHookworm Vaccine Initiative (HHVI),with team members and external reviewguests from the United States, as wellas from the United Kingdom and Brazil,convened June 22, 2004 in Bethesda,Maryland.

The team led by Peter J. Hotez, MD,PhD, professor and chair of microbiol-ogy and tropical medicine at The GeorgeWashington University (GW) achievedmost of the milestones under the firstfive-year grant from the Bill and MelindaGates Foundation to identify and begintests on a vaccine with a preventive ef-fect against the parasitic infection. Thegrant is facilitated through the SabinVaccine Institute. The team presentedits roadmap looking forward in the de-velopment process for the vaccine.

Hotez opened the meeting with anoverview of the project and its goals.What started as his vision while still inmedical school at the Cornell andRockefeller universities in New Yorkhas for the past four years been fundedin a significant way by the Gates Foun-dation. The fulfillment of his pursuit of ahookworm vaccine will benefit youngand old in tropical developing countrieswhere hookworm affects 740 millionpeople. A vaccine could stave off theeffects of anemia and stunted physicaland intellectual growth caused by theconstant blood loss from hookworm.

Simon Brooker, an epidemiologist atthe London School of Hygiene and Tropi-cal Medicine, presented a mathemati-cal model of the impact of a hookwormvaccine, demonstrating that in terms ofdisability affected life years (DALYs)a vaccine would significantly improvethe lives of the poor in tropical areaswhere hookworm is endemic.

HHVI program manager and SabinVaccine Institute Vice President forRegulatory Affairs Paul Vilk outlined theorganizational structure of the project.The Sabin Institute’s new site inBethesda where Vilk is situated was thehost location for the annual review meet-

ing. The building also houses the AerasGlobal TB Foundation, another GatesFoundation grantee.

Maria Elena Bottazzi, PhD, assistantprofessor of microbiology and tropicalmedicine at GW, and project managerfor the HHVI, provided an overview ofthe product development process for thevaccine, known as Na-ASP-2 hook-worm vaccine. She described theworkflow, cloning and constructionphase, process development and manu-facture phase, quality control measures,pre-clinical testing fortoxicity, and regulatoryissues involved in mak-ing the vaccine.

An illuminating pre-sentation on the bio-chemical structuralstudies of the Na-ASP-2 hookworm vaccinewas provided by ToyinAsojo, research assis-tant professor at theUniversity of NebraskaMedical Center. Herpresentation slides in-cluded images of crys-tals formed within thevaccine’s chemicalstructure. She also pre-sented various depictions of the makeupof the vaccine, through microbiologicalillustrations and DNA mapping.

As the scientific project unfolds, someaspects of intellectual property must beaddressed. Michael Whitham, from thelaw firm Whitham, Curtis, andChristofferson, provided an informativediscussion regarding patent issues andintellectual property guidelines as theproject ensues.

Jeff Bethony, PhD, assistant profes-sor of microbiology and tropical medi-cine at GW, and field scientist for theHHVI project, described the clinicaldevelopment plan and clinical testingphases for the vaccine. He was assistedin this discussion by presentations fromDon Shepard on the strategies for de-

livery of the vaccine and cost effective-ness; from Gary Simon, MD, with GWMedical Faculty Associates, who willconduct the Phase I clinical trial in theUnited States; from Matt Veatch fromthe clinical trials consulting firmQuintiles, describing the epidemiologicalstudies and Phase I-IIa and Phase IIbclinical trials in Brazil; and by SimonBrooker of the London School of Hy-giene and Tropical Medicine.

Since the vision for the HHVI projectis to provide a vaccine for the areas that

are most impacted by the disease, twospecial guests of this annual reviewwere Isaias Raw, from the Brazilian fed-eral vaccine laboratory known asButantan, and Rodrigo Correa-Oliveira,PhD, head of the Laboratory of Cellularand Molecular Immunology for the Bra-zilian Ministry of Health.

To conclude the day’s presentations,Alex Loukas, PhD, Queensland Instituteof Medical Research, and ongoing col-laborator on the HHVI project, pre-sented his research on hemoglobinasesas anti-hookworm vaccines. He alsopresented the case for a second antigenbeing added to Na-ASP-2 hookwormvaccine for an attack on the adult stageof the parasite as well as the larval stage.

Gathered for a preparation meeting for the Human HookwormVaccine Initiative project are, from left, Sabin trustee MichaelWhitham, field researcher Jeff Bethony, technical advisor PhilRussell, program manager Paul Vilk, principal investigator Pe-ter Hotez, project manager Maria Elena Bottazzi, and SVI Presi-dent and CEO Dean Mason.

7dedicated to disease prevention www.sabin.org

Prestigious Sabin Gold Medal Presented to Physician William S. Jordan, Jr., MDSabin Vaccine Institute Recognizes 2004 Medal Recipient at May 25 Ceremony

William S. Jordan, Jr., MD, physician,teacher, and noted vaccine researcherwas presented with the prestigious 2004Albert B. Sabin Gold Medal at a cer-emony on May 25, 2004. Dr. Jordan isthe twelfth recipient of this recognitionby the scientific community, awardedannually by the Sabin Vaccine Instituteto honor achievements by vaccinologistsand infectious disease experts. The cer-emony was held at the Crystal GatewayMarriott in Arlington, Virginia in conjunc-tion with the 2004 Conference on Vac-cine Research.

Dr. Jordan’s distinguished career in thefield of preventive medicine spans morethan 60 years as a practicing physician,dedicated teacher, and noted infectiousdisease researcher. “There are fewnames in vaccine research as recogniz-able and few who have contributed asmuch to this life-saving field as WilliamJordan,” said H.R. Shepherd, chairmanof the Sabin Vaccine Institute.

Dr. Jordan established an annual sci-entific review, known as the Jordan Re-port, considered by many in the scien-tific community to be the most completereference available on vaccine researchand development today. During thecourse of his career he advanced na-tional and global disease preventionstrategies as well as promotion of vac-cine research. He helped launch aunique program at the National Instituteof Allergy and Infectious Diseases(NIAID) that today serves to focusneeded attention and resources on newvaccines and vaccine improvements.

Dr. Jordan received a tribute and in-troduction from John R. LaMontagne,PhD, deputy director, NIAID, NationalInstitutes of Health. “His tremendous ex-perience in dealing with respiratory in-fections and influenza in particular wasinvaluable to me,” Dr. LaMontagne saidof Dr. Jordan’s mentorship at NIAID.“I cannot think of anyone more deserv-ing of the recognition of this award.”

Recalling Jordan’s outstanding scien-tific achievements, LaMontagne said,

“He was the creator and chiefadvocate for a new effort,which he dubbed the ‘Accel-erated Development of Vac-cines.’ He sensed that scien-tific progress was accelerat-ing and that the very pace ofdiscovery was going to yieldmany new ideas for vaccinesof all kinds.

“It was this marriage ofnew science and the practi-cal application of that sciencein the form of new vaccinesand other interventions thatmotivated him and us—hissubordinates in the Microbi-ology and Infectious Diseases Program.

“Bill embodies all of the elements thatmake a Sabin Award winner,”LaMontagne concluded. “His commit-ment and belief that research is the keyto new developments in vaccinology isunquestioned, his commitment to a rig-orous scientific approach in the pursuitof vaccines is unassailable, and his com-mitment to the translation of basic re-search into tangible interventions thatbenefit people is unambiguous.”

A graduate of Harvard MedicalSchool, Dr. Jordan held faculty posts atthe Western Reserve University in theDepartment of Preventive Medicine,with the University of Virginia Schoolof Medicine as chair of PreventiveMedicine, and subsequently atthe University of Kentucky asdean of the College of Medi-cine. He also served as direc-tor of the Commission ofAcute Respiratory Diseasesof the Armed Forces Epide-miological Board. He spent asabbatical year at the LondonSchool of Hygiene and Tropi-cal Medicine.

From 1976 to 1987, Dr. Jor-dan served as director of theMicrobiology and InfectiousDiseases Program at the Na-tional Institute of Allergy and

Infectious Diseases. A key part of hismission there, where he remains activetoday on a voluntary basis, was the ad-vancement of vaccine research initia-tives. He is author or co-author of morethan 100 papers, textbook chapters andtwo books.

The Sabin Gold Medal Advisory Com-mittee is composed of previous recipi-ents and is chaired by Maj. Gen. PhilipK. Russell, MD (USA Ret.), who is theseventh recipient of the honor. The listof previous Sabin Gold Medal recipientsincludes some of the foremost contribu-tors to the modern era of public health.Noted vaccine developers and diseaseeradication experts are among the re-cipients of the award.

An auspicious meeting: William S. Jordan, Jr., MD andHeloisa Sabin, widow of the late Dr. Albert B. Sabin, takean opportunity prior to the ceremony to get acquainted.

Sabin Institute Chairman H.R. Shepherd, at right, con-gratulates Dr. Jordan following presentation ceremony.

SUMMER 2004 SABIN VACCINE REPORT8

Dean Mason, SVI president, repre-sented the Sabin Vaccine Institute (SVI)during immunization events in Haiti onApril 23-24, 2004. The events were partof Vaccination Week in the Americas,a cooperative effort among 42 countriesin the Western Hemisphere to vaccinateboth children and adults.

Coordination of the overall campaignwas led by the Pan American HealthOrganization (PAHO) with the coopera-tion and the conduct of programs led bythe ministries of health within the par-ticipating countries. In addition to the ac-tual vaccination effort, there was anextensive education campaign introducedthroughout the region. For the first timeevents coincided with “National Immu-nization Week” in the United States.

A number of organizations lent theirname and support to the campaign. InHaiti, representing a joint vaccine initia-tive between Haiti and the DominicanRepublic were the ministers of health

Immunization Week Is Launched in HaitiSVI President Dean Mason Represents the Institute at International Gathering for Immunization

from each country, U.S. Ambassador toHaiti James B. Foley, PAHO DirectorMirta Roses, and agencies includingUNICEF, the Red Cross, and SVI.

The highlight of the campaign was anofficial launching of the vaccination cam-paign on April 24th in Fond Parisien, asmall rural community in Haiti situatedclose to the border with the DominicanRepublic. About 100 children partook inthat vaccination effort, which under-scored the need to reduce the morbidityand mortality resulting from vaccine pre-ventable diseases.

“Though the infrastructure of Haiti isin disarray and the government is pres-ently unstable, it is evident that both gov-ernment officials and representatives ofthe different support organizations arecommitted to effective vaccination pro-grams,” observed Mason. The poorestcountry of the continent, Haiti set animpressive example during the week byvaccinating 150,000 children, of whom

20 percent had never received a vac-cine, according to PAHO officials.

Jon Andrus, MD, chief of PAHO’s Im-munization Unit, said, “The preliminaryresults speak for themselves. We arestill collecting data, but it looks like wewill be very close to reaching the 40million people targeted across the Re-gion.”

Immunization activities were carriedout along 18 border areas throughout thecontinent. Both Canada and the UnitedStates supported the initiative with pub-lic awareness campaigns to raise con-sciousness about the importance of vac-cines, especially to immigrant commu-nities.

The campaign coincided with NationalInfant Immunization Week in the U.S.Over 500 communities across the coun-try participated, using the same themein support of the continental campaign:“Vaccination: An Act of Love: Lovethem, Protect Them, Immunize Them.”

MMR Vaccine and Thimerosal-Containing Vaccines Are Not Associated with AutismIOM Report Takes a Firm Stand with Science on Emotionally Charged Issue

Based on a thorough review of clini-cal and epidemiological studies, neitherthe mercury-based vaccine preservativethimerosal nor the measles-mumps-ru-bella (MMR) vaccine are associated withautism, says a new report from the Insti-tute of Medicine of the National Acad-emies. Furthermore, the hypotheses re-garding how the MMR vaccine andthimerosal could trigger autism lack sup-porting evidence and are theoretical only.Further research to find the cause of au-tism should be directed toward other linesof inquiry that are supported by currentknowledge and evidence and offer morepromise for providing an answer, said thecommittee that wrote the report.

“The overwhelming evidence fromseveral well-designed studies indicatesthat childhood vaccines are not associ-ated with autism,” said committee chairMarie McCormick, Sumner and Esther

Feldberg Professor of Maternal andChild Health, Harvard School of PublicHealth, Boston. “We strongly supportongoing research to discover the causeor causes of this devastating disorder.Resources would be used most effec-tively if they were directed toward thoseavenues of inquiry that offer the great-est promise for answers. Without sup-porting evidence, the vaccine hypothesisdoes not hold such promise.”

The report updates two earlier IOMreports, published in 2001, on possiblelinks between autism and the MMR vac-cine and thimerosal. At that time, thecommittee determined that the evidencedid not show an association between theMMR vaccine and autism, but there wasnot enough evidence to determinewhether thimerosal was associated withneurodevelopmental disorders such asautism. Given that mercury is known to

have a toxic effect on the nervous sys-tem and that prenatal exposures to an-other form of mercury have been shownto adversely affect early childhood de-velopment, the committee concluded in2001 that it was possible to hypothesizethat thimerosal might triggerneurodevelopmental problems. The com-mittee revisited these issues becauseseveral studies exploring the epidemiol-ogy and biological mechanisms of pos-sible links between vaccines and autismhave been undertaken during the pastthree years.

Five large epidemiological studies con-ducted in the United States, the UnitedKingdom, Denmark, and Sweden since2001 consistently provided evidence thatthere is no association between thime-rosal-containing vaccines and autism.Similarly, 14 large epidemiological stud-

Continued on page 14

9dedicated to disease prevention www.sabin.org

The awards program is a yearly tra-dition for the Institute and extols thecontributions made by scientists, phi-lanthropists, and humanitarians, whoshare in some aspect of the goals ofadvancing vaccine science for the ben-efit of humanity. The master of cer-emonies was CBS News Chief Wash-ington Correspondent Bob Schieffer.One of the nation’s most respected jour-nalists, Schieffer is the anchor and mod-erator of Face the Nation, CBS News’Sunday public affairs broadcast, and is

Salute to Life Saving Discoveries2004 Annual Awards Celebration

Sabin Institute Chairman H.R. Shepherd welcomes gueststo the 2004 Sabin Awards.

John Robbins, MD, makes introductory remarkshonoring Howard Pien, Chiron Corporation, whoaccepted the first Sabin Global Corporate Philan-thropy Award.

A giant in sports meets a giant in science: Dikembe Mutombo,New York Knicks’ center, congratulates James D. Watson, PhD,winner of the Sabin Humanitarian Award.

a member of the Broadcasting/CableHall of Fame.

James D. Watson, who received theSabin Humanitarian Award, is re-nowned for his discovery of the struc-ture of DNA (deoxyribonucleic acid),for which he shared with FrancisCrick and Maurice Wilkins the 1962Nobel Prize in Physiology and Medi-cine. The double helix is an elegantconcept central to the field of molecu-lar biology: its structure offers cluesabout the functioning of a particularmolecule. In 1968, Dr. Watson be-came Director of Cold Spring HarborLaboratory in New York, where he wasrecently appointed Chancellor.

Chiron Corporation, which was rec-ognized with the Global Corporate Phi-lanthropy Award, addresses human suf-fering with more than 50 diverse prod-ucts to detect, prevent and treat dis-ease worldwide. The company has glo-bal businesses in Blood Testing, Vac-cines and BioPharmaceuticals. HowardPien, the company’s president and chiefexecutive officer, was on hand to ac-cept the award on behalf of the com-pany. In addition to the development oflife-saving and life-enhancing products,

Chiron has worked to im-prove the quality of humanlife around the world throughcompany-sponsored pro-grams and philanthropy andby encouraging employeevolunteer efforts. ChironVaccines has donated 30 mil-lion doses of polio vaccine tothe Global Polio EradicationInitiative, spearheaded by theWorld Health Organization(WHO), Rotary Interna-tional, the U.S. Centers forDisease Control and Preven-tion (CDC) and UNICEF, forinternational vaccinationcampaigns.

Among several testimoni-als to the lifesaving power ofmedicine was that by

Dikembe Mutombo, the 7-foot-2-inchcenter for the New York Knicks. In-vited to speak about the foundation inhis name, he drew attention at first byhis sheer stature above the podium.Attention quickly turned to inspirationat the scope of the vision of Mutombo’sfoundation: building a hospital in hisnative Democratic Republic of theCongo, which will be the first new hos-pital in that area in 40 years. “Scienceis something I have wanted to do sinceeighth grade,” Mutombo said. He cameto the United States on a scholarshipto study medicine in 1987. “I have al-ways felt as a human being that wehave an obligation to society to givesomething back. We have to save theworld for the next generation. We willall be judged by the next generation.”The hospital is due to open in June2006.

Continued from page 1

Judah Folkman, MD introduces James D. Watson,recipient of the Sabin Humanitarian Award.

SUMMER 2004 SABIN VACCINE REPORT10

Vaccines: Preventing Disease and Protecting HealthReview of Comprehensive New Book on Vaccine Research from PAHO, Edited by Ciro de Quadros, MD, MPH

Vaccines have led to some of thegreatest public health triumphs.Smallpox has been eradicated, polio ison the verge of eradication, andsubstantial progress has been made oninterrupting measles transmission in theAmericas and in a number of othercountries around the world. During2002, the centennial year of the PanAmerican Health Organization (PAHO),a meeting was held to review theaccomplishments of vaccines andvaccination programs—both within theRegion of the Americas and throughoutthe world—and challenges for theFuture. Over 250 scientists, health careand public health officials participated.From that meeting, has come Vaccines:Preventing Disease and ProtectingHealth. The book, edited by Ciro deQuadros, the major driving force behindmany of PAHO’s successfulimmunization initiatives, represents acomprehensive and easily readablecompilation of outstanding articles on awide variety of immunization issues,ranging from improving the impact of

immunization programs using existingvaccines to the frontiers of vaccineresearch. The text consists of 48chapters written by 76 authors, most ofwhom are among the top internationalauthorities in their fields.

While many of the contributors arebasic scientists, the book is targeted ata level that public health and policymakers can understand, yet at the sametime, it does not compromise the needto report on key scientific challenges anddevelopments. The text is divided intoeight sections starting with a discussionof four diseases, polio, measles, rubella,and yellow fever, that are covered inPAHO’s current immunization program;a section on licensed vaccines in someindustrialized countries, some of whichare making their way into developingcountry immunization programs; severalsections on vaccines under development;sections on new technologies being usedto develop and administer vaccines; asection on vaccines against potentialagents of bioterrorism; and finallyseveral sections on regulatory issues,industry perspectives, consumerconcerns, and financing vaccines forimmunization programs.

The number of diseases preventableby vaccines is increasing. However,as Dr. Anthony Fauci, director of theNational Institute of Allergyand Infectious Diseases,notes in his chapter, theneed for more vaccines toprevent new infectiousburdens is also increasing.In the past decade, newinfectious agents such asthe corona virus thatcauses severe acute

respiratory syndrome (SARS) havebeen recognized, other infectious agents,such as West Nile Virus, have emergedaffecting new population groups, andbioterrorism has become a real threat.Thus, the development of new vaccineswill be a never ending process. In themeantime, there are many infectiousdisease burdens that are not beingoptimally controlled with availablevaccines because they have not yet beenincorporated into developing countryimmunization programs. Finally, thereare diseases that are not yet preventableby vaccines but for which current effortswill hopefully lead to vaccines.

Vaccines: Preventing Disease andProtecting Health will be a valuableresource to anyone working in the controlof vaccine-preventable diseases. In asingle text of only 368 pages, a vastarray of well-written, easilycomprehensible information ispresented, that informs the reader of thelatest developments in vaccinology andeducates the public health practitionerto make better use of existing vaccinesand to anticipate future vaccines.

—by Walter Orenstein, MD, Profes-sor of Medicine and Pediatrics,Emory University

BOOKBOOKBOOKBOOKBOOKREVIEWREVIEWREVIEWREVIEWREVIEW

To Order This bookVaccines is available from the Pan American HealthOrganization. Visit the following web page for orderinformation: publications.paho.org or call 301-617-7806.

2004,412p.,ISBN 92 75 11596 6Order code: SP 596Price: US$62.00 / US$46.00 in LatinAmerica and the CaribbeanLanguages Available: English

dedicated to disease prevention www.sabin.org 11

New Technologies Promise More Effective Vaccines, Experts SayCiro de Quadros Is Editor of New Book on the Impact of Vaccines in Our Time

A variety of new technologies drivingvaccine research promise effective andmore clearly targeted vaccines The con-stant evolution of microbes, however, canonly be combated by more biomedicalresearch, according to Dr. AnthonyFauci, director of the National Instituteof Allergy and Infectious Diseases.

To combat both new and old diseases,we must rely on research to make new,safer and better vaccines for HIV/AIDS, smallpox, anthrax, SARS, andothers, Fauci said today in a conferenceat the National Press Club organized bythe Pan American Health Organization(PAHO). Getting these vaccines topeople who need them is the most im-portant thing, he added.

Dr. D.A. Henderson founded theJohns Hopkins Center for CivilianBiodefense Strategies and led the globalsmallpox eradication program. He said,“Clearly, vaccines are a principalweapon in public health and it’s valid tohave a great emphasis on vaccine re-search, but we need much more fundingfor research.”

The cataclysmic September 11 attackand the anthrax events just afterwardraised awareness of bioterror and gotpeople to ask what we have and whatwe can get. The answer is that vaccinesare a major weapon against bioterrorismand we need new vaccines and moreresearch, Henderson said.

Henderson and Fauci both authoredchapters of a new book published byPAHO, Vaccines: Preventing Diseaseand Protecting Health, which was ed-ited by Dr. Ciro de Quadros, head ofinternational programs at the Sabin Vac-cine Institute and former director ofPAHO’s Division of Vaccines and Im-munization.

De Quadros, speaking at the pressclub event, said, “The good news is thatthe tremendous revolution in biotech-nology will give us several new vaccines,including vaccines for diseases that wethought were chronic. But the challengeis how to move these vaccines from the

bench to the bush.“Other chal-

lenges include main-taining political will,communicating withconsumers to showthe benefits of vac-cines, and makingsure people knowafter September11th that vaccineshave become an im-portant tool in thefight againstbioterrorism,” deQuadros added.

Henderson saidpublic healthachievements dueto vaccines havebeen dramatic, withsmallpox and polioeradicated, measles at an all-time low,and low numbers of cases of other dis-eases preventable by vaccines, at leastin the Americas.

But, Henderson recalled, 34 years agowhen smallpox eradication was starting,“We found that smallpox was the onlyvaccine being used. There were no publichealth vaccinations against polio,measles or other diseases, and we cre-ated the concept of anexpanded immuniza-tion program in ameeting at the PanAmerican Health Or-ganization.”

PAHO’s AssistantDirector, Dr. CarissaEtienne, said, “The Ex-panded Program onImmunization is one ofthe most significantachievements of thiscentury, and the roleof vaccines will bemagnified in the 21stCentury.” By 1990,Henderson said, “Wehad 80 percent of the

children in the world receiving vaccinesand this is truly remarkable.”

Dr. Peter Hotez, who chairs GeorgeWashington University’s microbiologyand tropical medicine department, said,“Twenty-five years into the genetic en-gineering revolution, major advanceshave not panned out yet.

Continued on page 12

Above, from left, Drs. de Quadros; Carissa F. Etienne, PAHOAssistant Director; Anthony S. Fauci, director of the NationalInstitute of Allergy and Infectious Diseases; and Peter Hotez,professor and chair of the Department of Microbiology andTropical Medicine at The George Washington University, andhead of the SVI Scientific Advisory Committee.

A panel of vaccine researchers was on hand at the National PressClub in Washington, DC to announce the publication of Vaccines:Preventing Disease and Protecting Health, edited by Ciro deQuadros, director of International Programs of the Sabin VaccineInstitute and former director of the PAHO Division of Vaccines andImmunization. The panel presentation included, at top, from left,Jon Kim Andrus, MD, chief of PAHO’s Immunization Unit; Donald A.Henderson, MD, MPH, professor of public health and medicine atthe University of Pittsburgh and resident fellow of the Center forBiosecurity; and Dr. de Quadros.

SUMMER 2004 SABIN VACCINE REPORT12

The International Programs of theSabin Vaccine Institute have broadenedin scope under the direction of Ciro deQuadros, MD. In recent months, he rep-resented the Institute at an array of sci-entific and international public healthmeetings. His activities spanned theglobe—from Japan to Finland, addressingpediatricians about measles immuniza-tion, and to all corners of Africa, partici-pating in the technical advisory groupson polio eradication. He also conferredon strategies for AIDS vaccine re-search, rotavirus vaccine introduction,and rubella vaccine implementation.

Dr. de Quadros was an invited speakerat an international symposium on theelimination of measles organized by theJapan Pediatric Society in collaborationwith the American Academy of Pediat-rics. Insufficient measles vaccinationcoverage in Japan has led to exporta-tion of the disease to other countriesaround the world. Dr. de Quadros ledthe effort at the Pan American HealthOrganization to achieve interruption ofindigenous measles transmission in theAmericas.

Venturing to South Africa in March,de Quadros lectured on rubella controlin Johannesburg. The country will be

Sabin Institute Pursues Commitment to International HealthCiro de Quadros Criss-crosses the Globe to Represent Sabin Vaccine Institute Commitment to International Health

considering introduction of rubella-con-taining vaccine in its national immuniza-tion program, which would make SouthAfrica the first African country to starta rubella control program.

The Sabin Vaccine Institute, incollaboration with the Centers forDisease Control, the World HealthOrganization, the American Red Cross,and the March of Dimes, organized ameeting in Geneva, Switzerland in April.The meeting focused on aerosol measlesvaccine development and addressed thepotential of a non-injectable measlesvaccine technology. Later in the month,

he presented a paper on WesternHemisphere polio eradication at a forumof European and Latin AmericanCountries in Recife, Brazil. He alsolectured at the Eighth VaccinologyCourse held by the AutonomousUniversity of Barcelona, Spain.

In May, Dr. de Quadros visited in Fin-land, Angola, Ethiopia and Egypt, amongother stops. He presented a paper en-titled “Eradication of Measles: Suc-cesses and Challenges” at the meetingof the European Society for PediatricInfectious Disease in Finland. He par-ticipated in the Technical AdvisoryGroup on Polio Eradication in Egypt andchaired the advisory groups for Angolaand Ethiopia (see story on page 13).

The Sabin Vaccine Institute was wellrepresented at the Global Vaccine Re-search Forum in Montreux, Switzerland.Dr. de Quadros, SVI President and CEODean Mason, and SVI Scientific Advi-sory Council Chair Peter Hotez, MD,PhD, attended. The forum is hostedjointly by the WHO’s Initiative for Vac-cine Research (WHO/IVR) and the Glo-bal Alliance for Vaccines and Immuni-zation (GAVI), and brings together topresearchers and scientists. Maria ElenaBottazzi, PhD, George Washington Uni-versity researcher and Human Hook-worm Vaccine Initiative project manager,also attended the forum.

Kenya and Uganda were among thestops de Quadros made in June, as amember of the International AIDS Vac-cines Initiative (IAVI), followed by areturn to Switzerland. He will visit Ja-pan in July to lecture at the Seminar onEradication of Vaccine Preventable Dis-eases.

New Book on Vaccines PublishedExperts Convene to Announce the Latest Research in Print

Continued from page 11

Only a Hepatitis B vaccine has beendeveloped so far, but with more fund-ing we have hopes for new vaccinesfor malaria, tuberculosis, hookworm,and others.”

One major problem, Hotez said, isthat the vaccine industry is not healthy.Low profits have dropped the num-ber of manufacturers from 20 to only4 in the U.S. and Europe. We havebegun seeing shortages of vaccinesand this is a signal that something isvery wrong.

PAHO was established in 1902 andworks to improve the health and thequality of life of people of the Ameri-cas. It also serves as the Regional Of-fice for the Americas of the WorldHealth Organization (WHO). PAHOmember states today include all 35countries in the Americas. France, theKingdom of the Netherlands, and theUnited Kingdom are participatingstates. Portugal and Spain maintainobserver status, and Puerto Rico is anassociate member.

Would you like to readWould you like to readWould you like to readWould you like to readWould you like to readthe the the the the Sabin VSabin VSabin VSabin VSabin VaccineaccineaccineaccineaccineReportReportReportReportReport online? Our online? Our online? Our online? Our online? Our

newsletter is availablenewsletter is availablenewsletter is availablenewsletter is availablenewsletter is availablein a PDF format atin a PDF format atin a PDF format atin a PDF format atin a PDF format atwww.sabin.orgwww.sabin.orgwww.sabin.orgwww.sabin.orgwww.sabin.org.....

13dedicated to disease prevention www.sabin.org

The Sabin Vaccine Institute is a new part-ner in the World Health Organization’s Glo-bal Polio Eradication Initiative. Ciro deQuadros, director of International Pro-grams, serves on the Technical AdvisoryGroups (TAG) on Polio Eradication, whichtook him to Angola, Egypt and Ethiopia inMay this year.

In Luanda, Angola, the expertgroup noted the last wild poliovi-rus in Angola was isolated morethan three years ago, and currentindicators suggest that endemicpolio transmission is interrupted.The experts remain concerned,however, that Angola is at signifi-cant risk for importation of poliovirus, given the persistently lowroutine immunization coverageand increased transmission of thevirus in the African region. Theyrecommended that Angola con-

Sixth International Symposium on Rotavirus ConvenedSabin Vaccine Institute, with WHO, PAHO, CDC and NIH Convenes Rotavirus Meeting in Mexico City

Ciro de Quadros, left, and the Speaker of the Ethiopian House ofthe Parliament Dawit Yohannes, discussed the convening of Afri-can parliamentarians to support immunization in Africa.

With vaccines against the killer dis-ease of rotavirus almost in hand, gov-ernment representatives, scientists, pub-lic health professionals and vaccine in-dustry representatives met in MexicoCity to review progress toward safe,effective rotavirus vaccines and addressthe question of how to make sure theyget to the world’s poorest children. Newdata on the extent and burden of the dis-ease in developing countries, and insightsinto its biology and pathology were alsoreported at the Sixth International Sym-posium on Rotavirus, from July 7-9.

Rotavirus can cause severe diarrheaand vomiting, resulting in dehydration thatkills 500,000 children a year, 85 percentin developing countries. Nearly everychild in the world gets it by the the ageof five. Countries in Latin America arelikely to be the first to introduce a ro-tavirus vaccine into routine childhoodimmunization.

The Symposium tackled pressing sci-entific, social, and economic issues con-fronting rotavirus prevention, such as:

How can rotavirus vaccines be madeavailable to the world’s poorest nations?How safe and effective will the nextgeneration of rotavirus vaccines be?

Experts present at the conference in-cluded the discoverer of the virus, RuthBishop, and rotavirus vaccine inventorAlbert Kapikian. Ciro de Quadros, SabinVaccine Institute director of Interna-tional Programs, welcomed the partici-pants during the opening of the meet-ing. SVI, together with the Pan Ameri-can Health Organization, the WorldHealth Organization, the Centers forDisease Control and the National Insti-tutes of Health convened the meeting.The previous symposium was held in1995, prior to the introduction of the firstrotavirus vaccine, which subsequentlywas withdrawn.

Attending were leading scientists andhealth ministers from throughout Cen-tral and South America; vaccine indus-try representatives involved in rotavirusvaccines development; and experts fromleading public health and donor organi-

tinue to carry out at least two annual roundsof very high quality nationwide immuniza-tion activities to sustain its polio-free status.

In Addis Ababa, Ethiopia they noted thatthe last wild poliovirus case there was inJanuary 2001 and that the polio eradicationinitiative remains a high priority of the min-

zations, including the World Health Or-ganization, the Global Alliance for Vac-cines and Immunization, and the Rotavi-rus Vaccine Program.

The Minister of Health of Mexicoaddressed the question “What Is Rotavi-rus and Why Do We Need Vaccines?”Reports will be made on the results ofnew rotavirus vaccine studies and mov-ing toward implementation of these prod-ucts. The audience were be policy mak-ers, national public health and financialauthorities, national immunization pro-gram managers, pediatric and infectiousdisease societies, scientists, researchers,bilateral and multilateral developmentand financial agencies, and other immu-nization program partners.

Mexico City was chosen as the venuebecause Latin America is the first re-gion of the developing world to partici-pate in the testing of the next generationof rotavirus vaccines. It will likely be thefirst region to introduce rotavirus vac-cines into the routine program of child-hood immunization.

Advisory Groups Evaluate Progress in Polio Fightistry of health and partner agencies in Ethio-pia. Remaining challenges to polio eradi-cation include an acute funding gap, de-clining surveillance quality, difficult terrain,poor infrastructure and increasing risk ofwild polio virus importations. Ethiopia con-tinues to have very large numbers of sus-

ceptible children as a result ofthe sub-optimal performanceof routine immunization andscaled down geographicalpolio immunization coveragesince 2002. The advisorygroup recommended that it isurgent for population immu-nity in Ethiopia to be boostedby high quality nationwide im-munization.

SUMMER 2004 SABIN VACCINE REPORT14

Sabin Headquarters Relocates in New Canaan, ConnecticutSame Town, New Address at 161 Cherry Street

After seven years at 58Pine Street in New Canaan,Connecticut, the Sabin Vac-cine Institute’s headquartersmoved to a new location. Notfar from the old address, theheadquarters now is at 161Cherry Street, New Canaan06840-4818. Telephone num-bers and e-mail addressesremain the same.

Sabin Institute Chairmanand New Canaan resident of40 years, H.R. Shepherd says“Our move to a newer andlarger facility reflects thecommitment of SVI to ex-

pand and grow in the comingyears. Our new facilities willenhance the futureprogramatic efforts of the In-stitute.”

The Hookworm VaccineInitiative offices of the SabinVaccine Institute also relo-cated in Maryland, fromRockville to Bethesda. Thenew address is 7500 OldGeorgetown Road, Suite 800,Bethesda, Maryland, 20814-6804. The new phone num-ber for the Hookworm Vac-cine Initiative program officeis 301-547-2961.

The new New Canaan SVI headquarters at 161 Cherry Street.

ies consistently showed no associationbetween the MMR vaccine and autism.The committee also reviewed five stud-ies that reported links between thimero-sal and autism and two that indicated aconnection between the MMR vaccineand the disorder. However, limitationsin how these studies were conductedand how the data were analyzed led thecommittee to conclude that they did notprovide evidence supporting an associa-tion between vaccines and autism.

The committee also reviewed evidencerelated to possible biological mechanismsby which immunizations might triggerautism. For example, it has been hypoth-esized that the measles virus in theMMR vaccine might lodge in the intes-tines and trigger the release of toxinsthat lead to autism. Another hypothesissuggests that the MMR vaccine mightstimulate the release of immune factorsthat damage the central nervous system,resulting in autism. It also has been sug-gested that thimerosal may interfere

with biochemical systems in the brain,leading to the disorder.

However, no evidence has yet beenfound that the immune system or its ac-tivation play a direct role in causing au-tism, the report notes. Autism also hasnever been documented as a conse-quence of exposure to high doses ofmercury. While the committee agreedthat the studies exploring these hypothesesraise interesting questions, they do not ad-dress the specifics of how autism couldresult. Therefore, evidence for any bio-logical mechanism linking vaccines withautism can only be considered theoretical.

Autism is not a single condition, butrather a complex set of severe develop-mental disorders — also referred to asautistic spectrum disorders — charac-terized by sustained impairments in so-cial interaction and communication abili-ties, as well as restricted or repetitivepatterns of behaviors and interests. It isunclear how many cases of autism thereare, but two reviews of published stud-ies put the prevalence at one case for

every 1,000 children. While some infor-mation suggests that autism rates maybe rising, it is not clear whether the ob-served increase is real or due to factorssuch as heightened awareness of thedisorder or the use of a broader diag-nostic definition.

Thimerosal is an organic mercury com-pound that is still used as a preservativein some adult vaccines. It began to beremoved from vaccines for children in1999, and as of mid-2000, vaccines thatare recommended for universal use ininfants and young children are availablein forms that have no or only traceamounts of thimerosal.

This study is the eighth and final in aseries on vaccine safety sponsored bythe Centers for Disease Control andPrevention and the National Institute ofAllergy and Infectious Diseases. TheInstitute of Medicine is a private, non-profit institution that provides healthpolicy advice under a congressionalcharter granted to the National Acad-emy of Sciences.

Institute of Medicine Announces Conclusive Recommendation on Safety of VaccinesMMR Vaccine and Thimerosal-Containing Vaccines Not Associated with Autism

Continued from page 8

Sabin Institute in the NewsRecent News Reports Feature Sabin Activities

The Board of Trustees of the AlbertB. Sabin Vaccine Institute announcedthe election of their newest board mem-ber, Walter Orenstein, MD. Recentlyrecruited as Professor of Medicine andPediatrics at Emory University Schoolof Medicine, Dr. Orenstein’s posts atEmory will include director of the Pro-gram for Vaccine Policy and Develop-ment and associate director of the Vac-cine Center. Dr. Orenstein is former di-rector of the Centers for Disease Con-trol and Prevention’s National Immuni-zation Program (NIP).

At the National Immunization Pro-gram, Dr. Orenstein is credited with at-taining the highest immunization levelsever in U.S. children; eliminating indig-enous transmission of measles; introduc-tion of hepatitis B, Hib, rotavirus, vari-cella, and pneumococcal conjugate vac-cines; and involving the CDC in the glo-bal polio eradication initiative. “WalterOrenstein is recognized nationally andinternationally for successful efforts toimprove immunization rates and intro-duce new life-saving vaccines to thepublic,” said H.R. Shepherd, chairmanof the Sabin Vaccine Institute board.“We are proud to welcome him to theboard and to an affiliation with the SabinVaccine Institute following our associa-tion through the years on the sharedconcern for disease prevention throughvaccines.”

Dr. Orenstein has served in leader-ship roles within the CDC’s immuniza-tion program since 1982, and since 1993has been Director of the National Im-munization Program. He has served asa consultant to the World Health Orga-nization and to the Pan American HealthOrganization (PAHO) for programs inpolio eradication, measles control, andsmallpox eradication in India, Brazil,Argentina, and Peru.

“I am pleased to have the opportunityto engage in the programs of the SabinVaccine Institute as a member of itsboard and look forward to advancing the

Former CDC Immunization Program Director Joins Sabin Board of TrusteesDr. Walter Orenstein Named to Board of Vaccine Think Tank

Walter Orenstein, MD

15dedicated to disease prevention www.sabin.org

Institute’s mission,” said Dr. Orenstein.“The Institute has a unique role to playin advocating for research and educa-tion about vaccines and the vital benefitfor public health that immunization of-fers. I have made this an ongoing goalin my life’s work and it will be satisfyingto contribute to the Institute as a mem-ber of its board.”

Dr. Orenstein has served as anAssistant Surgeon General of the U.S.Public Health Service, and he currentlyserves as chairman of the World HealthOrganization’s Technical ConsultativeGroup on the Global Eradication of Po-liomyelitis, and as a member of the In-ternational Editorial Board for the jour-nal, Vaccine. He has been the CDC li-aison member to the National VaccineAdvisory Committee (NVAC) from1988 to 2004 and is a past member andrapporteur of the PAHO’s TechnicalAdvisory Group on Vaccines and Immu-nization. He served as an adjunct pro-fessor at Emory University’s RollinsSchool of Public Health from 1992 until2004. He is a fellow of the AmericanAcademy of Pediatrics, the InfectiousDiseases Society of America, and thePediatric Infectious Diseases Society.

Dr. Orenstein’s many honors andawards include the CommendationMedal and the Meritorious ServiceMedal from the U.S. Public Health Ser-vice; the Surgeon General’s ExemplaryService Medal; the Excellence in PublicHealth Award of the Association ofState and Territorial Health Officials, theDistinguished Service Award from thePediatric Infectious Diseases Society;and in 2003, the Excellence in PublicService Award of the American Acad-emy of Pediatrics.

The Sabin Vaccine Institute is recognizedas a source for reliable information aboutvaccines, and vaccine research and policy.Recent news coverage has provided an ex-tended reach for our communications efforts.

The Stamford Advocate’s Richard Lee in-terviewed new SVI President Dean Mason fora May 12 article titled “Hookworm Vaccineon the Horizon.” The article reviewed a num-ber of events taking place at SVI and exploredthe Institute’s signature research project, theHuman Hookworm Vaccine Initiative.

An article written by William Hathaway ofThe Hartford Courant titled “Untwisting thePuzzle of Hookworms” was printed in thatnewspaper on June 10 and subsequently car-ried in other newspapers around the coun-

try. The story followed recent progress in theSabin Institute and Bill and Melinda GatesFoundation-supported Human HookwormVaccine Initiative.

Peter Hotez, MD, PhD was profiled inBioTechniques I by reporter LynneLederman, in volume 36, no. 6, 2004.

The New Canaan Advertiser and The NewCanaan News-Review closely covered recentevents at the Institute, with articles on the Can-cer Vaccine Consortium, the annual gala, andthe appointment of Dr. Walter Orenstein tothe Board of Trustees.

In addition, the international press, includ-ing such papers as Barcelona’s DiarioMedico, covered the Institute’s representationat International meetings.

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July 7 - 9 Mexico City, Mexico6th International Rotavirus Symposiumwww.internationalrotavirus.com

July 11 - 16 Bangkok, ThailandXV International AIDS Conferencewww.aids2004.org

July 18 - 23 Montreal, Quebec, Canada12th International Congress ofImmunology and 4th Annual Conferenceof FOCIS (Federation of ClinicalImmunology Societies)www.immuno2004.org

Aug. 30 - Sept. 1 Lausanne, SwitzerlandAIDS Vaccine 2004www.aidsvaccine04.org

Sept. 10 - 11Rotorua, New ZealandNew Zealand Immunisation Conference2004www.imac.auckland.ac.nz

Sept. 15 - 17 Prague, Czech RepublicMVAF 2004 - Modern Vaccine/AdjuvantFormulationwww.meetingsmanagement.com/mvaf_2004

Sept. 20 - 22 Norfolk, Virginia6th National Conference onImmunization Coalitionswww.cme.hsc.usf.edu/coph/immcoal Sept. 28 - Oct. 1 St. Paul, MinnesotaASTHO 2004 Annual Meeting www.astho.org

Oct. 5 - 6 Washington, DCNational Vaccine Advisory Committeewww.hhs.gov/nvpo/nvac.html

Oct. 11 - 13 Lyon, FranceWorld Vaccine Congress Lyon 2004www.lifescienceworld.com/2004/wvcl_FR

Oct. 18 - 20 Atlanta, Georgia5th Immunization Registry Conferencewww.cdc.gov/nip/registry/irc Oct. 21 - 23 Princeton, New JerseyThe 10th Conference on CancerTherapy with Antibodies &Immunoconjugateswww.imedex.com/announcements/goldenberg04.html

Oct. 24 – 26 Cold Spring Harbor, NY11th Annual Sabin Vaccine ColloquiumE-mail: veronica.korn@sabin.orgwww.sabin.org/programs_cold_spring.htm

Nov. 2 - 5 Cambridge, MassachusettsPhacilitate Vaccine Forum Fall 2004www.phacilitate.co.uk/pages/fall_vac2004

Nov. 4 - 7 San Francisco, CaliforniaInternational Society for BiologicalTherapy of Cancer 19th Annual Meetingwww.isbtc.org

Nov. 7 - 8 San Francisco, CaliforniaCancer Vaccine Consortium Meetingwww.sabin.org/cv_consortium.htm

16

almost all of the cases occur in just six statesor provinces of these nations.

The Global Polio Eradication Initiative,spearheaded by national governments, theWHO, Rotary International, the CDC, andUNICEF, has the ambition to interrupttransmission by wild poliovirus by the end ofthis year.

Tremendous progress has been made inthe global fight against polio since 1988, whenthe World Health Assembly resolved toeradicate the disease. From 1988 to today,the number of worldwide polio cases hasdecreased from 350,000 to just a fewhundred.

The WHO and its Director of the EradicationInitiative, Dr. David Heymann, have arguedpersuasively that we have “a historic, one-time only opportunity” to stop poliotransmission forever.

Provided we act immediately, no parenthas to witness their child suffering frompolio’s crippling effects. Practically speakingthis means that every child under five wholives in the world’s remaining polio-endemicregions must receive the Sabin vaccine.

Through the same type of globalcooperation and “vaccine diplomacy” thatresulted in the taming of measles and thedevelopment of the polio vaccine, we are onthe verge of an equally extraordinary globalhealth goal.

That would be an extraordinarily fitting wayto wrap up fifty of the most exciting years ofhuman achievement, which brought scienceand politics together for a common and noblepurpose.Dr. Peter Hotez, MD, PhD is the Chair of theSVI Scientific Advisory Council, and Chairof Microbiology and Tropical Medicine, TheGeorge Washington University. H.R. Shep-herd, DSc, is Chairman of the Board of theSabin Vaccine Institute.

Continued from page 2

Fifty Years ofPolio Prevention

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