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REPORT Volume VII, Number 2 Sabin Vaccine Fall 2004 The newsletter of the Albert B. Sabin Vaccine Institute — dedicated to disease prevention www.sabin.org Experts Say Global Vaccine Policy for Pandemic Influenza Is Needed Sabin Vaccine Institute’s Annual Vaccine Policy Colloquium Hammers Home Need for Vaccine Plan Health experts convened by the Sabin The colloquium, an annual meeting on “ W h e n Vaccine Institute at Cold Spring Harbor, vaccine policy, took place as H5N1 these win- New York, in October took steps to for- avian flu surveillance is on high alert and dows open, mulate recommendations for vaccine within fresh recollection of the 2003 as is now policy planning in the event of a pan- outbreak of sudden acute respiratory the case for demic flu outbreak. The group sounded syndrome, or SARS, that so quickly tra- influenza, a warning that an influenza pandemic, versed the globe from Asia to North m a x i m u m which many experts consider overdue, America. This year’s colloquium was efforts must would overshadow routine annual influ- titled Pandemic Disease Threats: Can be made to Meeting co-chairs Dr. Albert enza epidemics. The looming event could We Develop a Global Vaccine Policy? address the Osterhaus, left, and Dr. David be a calamity striking down millions The 35 meeting participants repre- problem at Heymann. across the globe. sented the World Health Organization, hand and Amid the discussion during the two- Pan American Health Organization, also increase resources in public health day colloquium, at least two practical rec- UNICEF, U.S. Department of Health in general.” ommendations sur- and Human Services, Na- A global flu outbreak—flu pandemic— faced. On the interna- tional Institutes of Health, strikes approximately three or four times tional cooperation front, Centers for Disease Control in a century, when humans come into the numbers of influenza and Prevention, and interna- contact with a new strain of influenza disease surveillance tional organizations from virus for which they have little or no prior sites should be ex- Brazil, Canada, India, Ko- immunity. The pandemic flu of 1918 panded. In terms of pub- rea, the Netherlands, killed 40 million people, which constituted lic health prevention, in- Singapore, Taiwan, and the more deaths than all casualties of World creased global vaccine United Kingdom. Repre- War I. John M. Barry, author of The manufacturing capacity Colloquium cochairs Lewis Miller, sentatives from several in- Great Influenza: The Epic Story of the is needed. left, and David Heymann, MD. fluenza vaccine manufac- Deadliest Plague in History, related turers attended. anecdotes and statistics from his book “Certainly the threat of on the 1918 pandemic at I nside pandemic influenza is one the opening of the collo- of the preoccupations of quium. A global vaccine ViewPoint .................................................... 2 the scientific community strategy with advanced President’s Message ..................................... 3 and (the World Health Or- planning and government Human Hookworm Vaccine Team in Brazil 5 ganization) at present,” said and industry commit- Cancer Vaccine Consortium News ................ 6 David L. Heymann, MD, ments is imperative to Book Corner ............................................... 8 executive director, Com- avoid a similar outcome Rotavirus Vaccine Progress .......................... 9 municable Diseases, World from the next pandemic. Sabin Board Expands by Two .................... 11 Health Organization Fresh ideas generated Calendar ................................................... 12 (WHO), who co-chaired Dr. Louis Cooper, Columbia Uni- at the meeting include the colloquium. “Public versity, and Michael Osterholm, broadening the base of SVI Celebrates Election of Institute health is all about windows University of Minnesota,discuss vaccine production by in- of Medicine Members, p 10. of opportunity,” he said. pandemic outbreak scenarios. Continued on page 7 2 FALL 2004 SABIN VACCINE REPORT The Sabin Vaccine Report VIEW is published by the POINT Albert B. Sabin Vaccine Institute Subscriptions are free Influenza and Our National Vaccine Shortage: Please direct inquiries to: Looking to the Legacy of Dr. Vannevar Bush SABIN VACCINE REPORT —by Frank Cilluffo and Peter J. Hotez, MD, PhD 161 Cherry Street THIS COMMENTARY FIRST APPEARED IN THE ASBURY PARK PRESS ON OCT. 15, 2004 New Canaan, CT 06840-4818 phone: 203.972.7907/fax: 203.966.4763 The shortage of influenza vaccine for the 2004-05 flu season portends a potentially serious www.sabin.org health crisis for the United States. Influenza is the single greatest cause of death from infec- email: email@example.com tious disease in the U.S., far exceeding deaths from HIV-AIDS, West Nile fever, and other infectious causes. During the 1990s, an average of 36,000 deaths from influenza occurred EDITOR Raymond MacDougall annually, with as many as 200,000 annual hospitalizations during a severe season. ASSOCIATE EDITOR COPY EDITOR Effective and appropriate use of an influenza vaccine could prevent up to 50% or more of Veronica Korn David Bedell the deaths caused by influenza. However, manufacture of the vaccine is a complicated pro- OFFICERS OF THE SVI BOARD OF TRUSTEES cess and business. Because of the changing antigenic properties of the influenza virus it is H. R. Shepherd, DSc, Chairman necessary to produce new vaccines annually. As a result, only a small window of time is William R. Berkley, Co-Chairman available for the two major manufacturers of influenza vaccine, Aventis Pasteur and Chiron, to Michael E. Whitham, Esq., Secretary/ produce sufficient vaccine in time for flu season. The manufacturing process relies on an old Treasurer method of growing the virus in embryonated hens’ eggs. This method was used to produce SVI STAFF the first influenza vaccines in the 1940s and has not been significantly modified in the last 50 Dean D. Mason, President/CEO years. Unfortunately, it is not uncommon for environmental bacteria and fungi to colonize the Fran G. Sonkin, Executive Vice President eggs resulting in unintentional contamination during manufacture. Ciro de Quadros, MD, MPH, Director, If this winter’s flu season is severe, it is possible that hundreds if not thousands of Americans International Programs Raymond MacDougall, Director of will die because they were not vaccinated. Sadly, the latest problem with our influenza vaccine Communications shortage could possibly have been prevented if funds were available to support the develop- David Bedell, Director, Educational ment of a new-generation influenza vaccine. Bacterial contamination such as the type that Programs occurred at Chiron’s plant in the U.K. is not unexpected. Although newer methods to produce Kari Stoever, CCRP, Program Manager, Human Hookworm Vaccine Initiative influenza vaccine using mammalian cell substrates would reduce the likelihood of contami- Jean Mitchell, Development Officer nation, this requires the construction of new plants, which are prohibitively expensive for most vaccine manufacturers. SVI ADVISORS We could have, and should have, had new-generation influenza vaccines in our nation’s Philip K. Russell, MD, Senior Advisor to stockpile for more than a decade. One reason for the delay is that research, development, the Chairman Peter J. Hotez, MD, PhD, Senior Fellow manufacture and clinical testing for new vaccines occur at a snail’s pace relative to other & Chair, Scientific Advisory Council pharmaceutical products. The major vaccine producers in North America and Europe have Anne Gershon, MD, Co-chair, Scientific not had the incentive or the right business model to develop new products. Vaccines tradi- Advisory Council tionally provide a return on investment that pales in scale and scope compared to block- Hugh E. Evans, MD, Sabin Fellow William Muraskin, PhD, Sabin Fellow buster drugs. In some cases, vaccines must be sold for pennies a dose. As a result, while the Patricia Thomas, Sabin Fellow rest of the pharmaceutical industry is thriving, the leading vaccine manufacturing divisions of Nancy Gardner Hargrave, Development larger companies are barely hanging on. This simple fact likely explains why we have only Counsel four major pediatric vaccine manufacturers left to serve North America (Merck, Wyeth, GlaxoSmithKline and Aventis Pasteur) and this number might easily dwindle to three, or even two, in the coming years. Today, our nation’s vaccine supply is extremely fragile and there is no redundancy in the system, so that often we have a sole source supplier for a single vaccine. In recent years, this has resulted in acute shortages of vaccines for diphtheria-pertussis- tetanus, measles-mumps-rubella, chickenpox, and pneumococcal meningitis. Though stock- piles are now being built for the more common childhood vaccines, any shortage of signifi- cant duration could result in national shortages even for those products. The current shortage in influenza vaccine is a wake-up call that something is very wrong with the way we develop, manufacture, and procure our nation’s vaccines. To begin seeking answers we might look to similarities between our current vaccine crisis and the state of the defense industry at the beginning of World War II. During the War years and in the years that followed Dr. Vannevar Bush led a charge that reshaped the defense industry and laid the Continued on page 12 dedicated to disease prevention www.sabin.org 3 What the American Public Should Know About the Influenza Vaccine Crisis Message from the President Influenza kills approximately 36,000 people in the United States in transferring it to each other before it is an “average year.” In 1957, the Asian flu killed about 70,000 Ameri- sold to the public. Of course, with each cans and about 34,000 died from complications from the Hong Kong transfer costs are added. flu in 1968. The consequences of influenza are abundantly clear— The tragedy is that the problem, while the mode of prevention by vaccination is understood as well. long talked about and known to be solv- The announcement this fall that a manufacturing problem would able, has never been acted upon. result again this year in a national influenza vaccine shortage should 1. The United States must attract other serve as a wake-up call to the American public and our elected offi- influenza vaccine manufacturers to cials. In the U.S., only twice in the past six years has the influenza this market, both domestic and inter- vaccine supply been both sufficient and delivered in a timely manner. national companies. To do so we must The sad truth is that influenza vaccine supply disruptions and inad- address those problems that are sig- equacies are now the norm and not the exception. Steps must be nificant to industry including two re- Dean D. Mason taken to establish confidence in the production, supply and admin- current U.S. problems: regulatory is- istration of influenza vaccines on a national scale every year. sues and frivolous litigation. It is unfortunate that the wealthiest, most powerful and most influ- 2. Government must offer incentives that are sufficient to motivate ential country in the world cannot solve the problem of assuring the industry to participate. protection of its citizenry against a disease that is usually preventable 3. The federal government must dedicate additional resources, in- through vaccination. If influenza disease were declared a threat to cluding more money and personnel, to the year-to-year manage- our national security, would the response of our government leaders ment of the influenza vaccine supply and to the stockpiling of anti- be different? Does this problem inspire confidence that we could viral drugs. This might include federal sponsorship of scientists react in a meaningful way to the threat of a new influenza disease working more directly with industry. strain that might result in a pandemic outbreak? 4. Communication links between regulators, industry and public Here are some key facts that the American public should know health authorities must be improved, especially when manufactur- about the production of influenza vaccine: ing problems have the potential to disrupt vaccine supply. 1. The production of influenza vaccine is complicated because it is 5. The U.S. government must be given authority to direct vaccine essentially a new vaccine every year and there are no guarantees supply during periods of national crisis. concerning the yield or amount of vaccine that will be produced 6. Consideration should be given to the federal purchase of all influ- by the manufacturer. enza vaccine or at least to the purchase of a guaranteed amount. 2. The turn around time between the identification of the circulating 7. Stockpiling influenza vaccine, including surplus kept in manufac- strains to be included in the trivalent vaccine and actual vaccine turing storage from the previous year, should be considered. The production is less than six months. stockpiled vaccine might be of use even if there is not an exact 3. There are only two major companies now producing influenza strain match because it could modify the illness, reduce infectivity, vaccine for the U.S. market compared to four manufacturers only and the period of infection. five years ago. 8. More long-term strategies include the need for new technologies 4. Influenza vaccine production requires the use of thousands of for more efficient and timely production of vaccine in the neces- embryonated eggs, a technology that dates back over 50 years. sary quantities. The problem extends far beyond the 40 to 50% national shortage The influenza vaccine manufacturing problems facing the United we will experience this year. When there are shortages, the govern- States are fundamentally economic. Involved is a commodity vaccine ment has almost no control over the dispersement of the vaccine. that is undervalued and represents a relatively low profit for manu- National guidelines for influenza vaccine use are strictly voluntary. facturers. Adding to the problem is the fact that market demand is Though concerted efforts are made by industry to direct the available uncertain, there are high regulatory burdens and associated costs, vaccine to healthcare providers and organizations that serve those and manufacturers bear substantial risks. The combined effects have most at risk, the reality is that supermarkets often receive the vaccine been to drive several firms out of the market. Government interven- before primary care providers. Also, advance-sell contracts, pre- tion is needed to save domestic vaccine manufacturing and to diver- ferred by industry, can legally obligate the pre-commitment of per- sify the manufacturing base. haps 30% or more of the vaccine. Less well known is that a few mid- level distributors set price based on the knowledge that the demand exceeds the supply, leading to significant and widely varying prices for the vaccine. Even worse, influenza vaccine in times of shortages Dean D. Mason can be treated as a commodity with two, three, or four wholesalers President and Chief Executive Officer 4 FALL 2004 SABIN VACCINE REPORT Hookworm Disease Weighs Heavily on the Developing World Poor New England Journal of Medicine Article Illuminates Latest Findings on Bloodthirsty Parasite An article published in the August fects childhood memory, reasoning abil- The authors of the article are Dr. 19, 2004 New England Journal of ity and reading comprehension. Hotez, Jeffrey M. Bethony, PhD and Medicine calls attention to the enor- The current method of hookworm re- Maria Elena Bottazzi, PhD, from The mous impact of parasitic hookworm moval is a single dose treatment with George Washington University, Wash- infection on the developing world poor. anti-helminthic drugs. However, in highly ington, DC; Simon Brooker, PhD, Lon- The authors of “Current Concepts: endemic areas, hookworm infection of- don School of Hygiene and Tropical Hookworm Infection” have studied the ten reoccurs within just a few months. Medicine, London; Alex Loukas, PhD, parasite over many years and describe This, compounded by growing con- Institute of Medical Research, the disturbing effects of mild infection cerns about emerging drug resistance, Brisbane, Australia; and Shuhua Xiao, as well as the devastating disease has prompted efforts to identify new MD, Chinese Center for Disease Con- state that results from heavy hook- tools for hookworm control, including trol and Prevention, Shanghai, China. worm infection. a vaccine. According to Peter J. Hotez, MD, PhD, the article’s lead author, hookworm Hookworm is one of the most common infections in humans is one of the most common infections in with an estimated 740 million cases in areas of rural poverty in humans with an estimated 740 million the tropics and subtropics.— Hotez cases in areas of rural poverty in the tropics and subtropics. In China alone, approximately 190 million people are in- Hookworm Vaccine Initiative Names New Program Manager fected. Measured against other diseases, Stoever Steps into Role for Clinical Trials of Hookworm Vaccine hookworm outranks African trypanoso- miasis, dengue, Chagas disease, schis- The Human Hookworm thalmology, oncology, and tosomiasis, and leprosy in its impact on Vaccine Initiative (HHVI) infectious diseases. individuals and society. welcomed Kari Stoever, Stoever previously Hookworm infection plagues vast ar- CCRP, as program man- served as clinical research eas of Asia, Africa, and Latin America ager in November 2004. manager for the Retina and was once prevalent in the United Stoever, whose offices are Group of Washington, States. Here it was surmounted by sani- at the SVI’s Bethesda, where she developed and tation improvements that accompanied Maryland site, will play a implemented a clinical trial 20th century economic development. key role in managing vac- program and managed Ultimately, poverty reduction and eco- cine clinical trials soon to seven clinical studies for nomic development has done the most begin at HHVI. the practice. She was a to eliminate hookworm in industrial- Stoever was most re- Kari Stoever, CCRP consultant for Berlex ized nations, but for those living in cently a clinical research Laboratories and man- poor endemic areas around the world, coordinator, study monitor, and protocol aged the quality assurance program of such socioeconomic reforms are a development team member for Anthrax Midwest Cancer Research Group. distant prospect. Vaccine Clinical Studies at the U.S. There, she served as a site coordinator The term “hookworm disease” refers Army Medical Research Institute of In- for a multi-hospital hematology and on- to the iron deficiency anemia that re- fectious Diseases, Fort Detrick, Mary- cology research program and was clini- sults from moderate and heavy infec- land. There, she coordinated clinical re- cal trials coordinator for phase II and tions. Worms fasten onto the inner layers search studies, including development of phase III pharmaceutical studies. of the small intestine and cause blood clinical study protocols, and was a vot- Stoever currently is enrolled in The loss. According to the authors, each ing member on the Human Use Com- George Washington University School hookworm can grow to one centimeter mittee, Institutional Review Board. She of Medicine and Health Sciences Clini- and cause up to 0.2 cc of blood loss per has experience as principal point of con- cal Research Program. She has been day, and chronic intestinal blood loss re- tact for regulatory affairs, quality assur- certified as a clinical research profes- sults from heavy infections. Because ance and clinical monitoring issues, re- sional with the Society of Clinical Re- women and young children have the low- views, audits and reports. search Associates (SOCRA) since 2001 est iron stores, they are the ones most With extensive experience as a study and is a member of the Drug Informa- vulnerable to chronic hookworm blood coordinator and institution contact, tion Association (DIA) and Regulatory loss. Hookworm infection adversely af- Stoever has worked on studies in oph- Affairs Professionals (RAPs). dedicated to disease prevention www.sabin.org 5 SVI to Team with Brazilians on Human Hookworm Vaccine Trials Agreement Signed in Rio de Janeiro Clears Hurdle on Vaccine Production Brazil is the fifth largest country in the international collaboration I’ve ever had world by area and population. This land in 20 years of work in tropical medi- of famed beauty and diversity is also cine.” Hotez is professor and chair of home to hookworm. SVI Human Hook- the Department of Microbiology and worm Vaccine Initiative representatives Tropical Medicine at the GW Medical traveled to Brazil in September to sign a Center and senior fellow at the Sabin memorandum of understanding for pro- Institute. He has spent more than 20 spective hookworm vaccine production years studying hookworm disease and in Brazil that could alleviate the distress devising a vaccine to prevent infection. that hookworm disease causes among His team met with Brazilian scientists a segment of the population there. at the Oswaldo Cruz Foundation, a re- SVI sponsors the research funded by search arm of the Brazilian Ministry of the Bill & Melinda Gates Foundation on Health, and with researchers at the Dean Mason, SVI president, signs memoran- a newly developed vaccine to prevent Butantan Institute, both of which oper- dum of understanding on behalf of the Sabin human hookworm disease. The memo- ate vaccine-manufacturing plants. Of- Vaccine Institute. randum of understanding with federal ficials from each group signed the memo and state vaccine production facilities in of understanding. stitute. He and Hotez participated in the Brazil is for clinical development of the According to Hotez, Brazil is like only visit along with Ciro de Quadros, MD, vaccine, including clinical trials and vac- a few countries in the world having both MPH, director of Sabin’s International cine manufacture. high endemic incidence of hookworm Programs, Maria Elena Bottazzi, PhD, Representatives from both the Sabin and pockets of extreme poverty, along project manager and GW assistant pro- Institute and The George Washington with a high technology capacity and abil- fessor of microbiology and tropical medi- University (GW) were greeted by Bra- ity to develop biological products. “These cine, and Jeffrey Bethony, PhD, project zilian officials hopeful that the new vac- features would also describe such middle clinical director. cine will prevent an ages-old disease income countries as China, Mexico, In- “What is remarkable is the openness endemic in Brazil that is caused by the dia and South Africa,” he said. “Brazil and cooperation of the government of devastating intestinal parasite. Fieldwork is one of the few countries with the Brazil at the highest levels,” said Ma- research on the hookworm vaccine is technical capacity and intrinsic interest son, who signed the agreement on be- underway already and Brazilian officials in the problem because hookworm is a half of the Sabin Institute. “This is a offered visits to research and produc- public health threat in their nation.” country where they are willing to get the tion plants affiliated with the government The trip was arranged in order to gar- vaccine to the needy. The whole idea, if of Brazil. ner the support of the Brazilian govern- the vaccine field trials prove successful, Elated with the success of the trip, lead ment for their commitment to produce is to make the hookworm vaccine avail- scientist Peter J. Hotez, MD, PhD, said, the hookworm vaccine, says Dean Ma- able for those afflicted and the poorest “This is the best and most substantive son, president of the Sabin Vaccine In- of the poor. No one is looking to make a commercial profit, but instead we are doing this for the best of reasons … ne- cessity.” The hookworm vaccine developed by Hotez will soon undergo clinical trials, so a team of a dozen workers led by Bethony is now assembling baseline data. The team is based in Belo Horizonte, Brazil, near the rural area impacted by hookworm disease. In just more than a year, that data and data from safety and tolerability trials in the United States will serve as required groundwork for a wider clinical trial to Brazilian officials welcome SVI and GW representatives at Castelo Mourisco, headquarters of ascertain the efficacy and safety of the the Oswaldo Cruz Foundation in Rio de Janeiro, Brazil. new vaccine. 6 FALL 2004 SABIN VACCINE REPORT Cancer Vaccine Consortium Joins Forces with International Partner Cancer Society Report from the Fourth Meeting of the Cancer Vaccine Consortium Participants at the Fourth Semi-An- the Consortium and the International breakout session to kick off each of the nual Meeting of the Cancer Vaccine Society for Biological Therapy of Can- workstreams. Consortium were told to “memorize the cer took place, and a joint initiative was The project has an ambitious work moment” because in years to come, the agreed to in principle. Members of the schedule. It will include many telecon- meeting may be known as the birthplace iSBTc are joining forces with the CVC ference calls, a spring meeting of of several important steps in the devel- to create a Cancer Vaccine Clinical Tri- workstream leaders to prepare a pre- opment of cancer vaccines. als Working Group (CVCTWG). The liminary document for wider circulation, Although not formally announced, sev- working group aims to write a scientific ultimately culminating in an important eral meetings between the leadership of paper describing the “state of the art” workshop at the iSBTc meeting in Al- of clinical development of cancer vac- exandria, Virginia, in November of 2005. cines and combination immunothera- Many experts will have the opportunity Correction of Fact in the pies. There is active liaison with the to contribute to this comprehensive work. History of Polio Vaccines FDA, and hopes are high that the pub- Keynote speakers at this year’s CVC The path of scientific discovery, in- lication could contribute to a future FDA meeting November 7-8 in San Francisco cluding vaccine discovery, is often guidance document. included Dr. Drew Pardoll (Johns complex and evolves from the contri- Chairpersons of the CVCTWG in- Hopkins Medical School) whose talk on butions of many. Such has been the clude Dr. Axel Hoos from Antigenics, “Regulatory Barriers for Cancer Vac- case with the discovery of vaccines to Dr. Geoffrey Nichol from Medarex, Dr. cine Development” engendered good- prevent poliomyelitis. In the Summer Giorgio Parmiani from the Istituto dei humored debate with the second 2004 issue of The Sabin Vaccine Re- Tumori in Milan, Italy, and Dr. Mario speaker, Dr. Steven Hirschfeld from the port we published a letter celebrating Sznol from Yale University. The group FDA. His presentation, “Clinical Trial the 50th anniversary of the launching of has divided the work into four Endpoints for Biologics Developments a mass vaccination trial with a polio workstreams. Each workstream is co- in Oncology,” drew much interest from vaccine developed by Jonas Salk, MD. chaired by a member of the CVC and the audience. Also of keen interest was The letter referred in error to the 1954 the iSBTc and includes broader repre- the third speaker’s subject. Dr. Holden landmark mass vaccination campaign sentation from the CVC, iSBTc, indus- Maecker (BD Biosciences) talked about with the Salk vaccine as the “first-ever try, academia, and regulatory agencies. “Standardization of Cellular Immune polio vaccination.” In fact, earlier vac- Drs. Hoos and Nichol were in attendance Monitoring Assays and What They Can cination trials had occurred. at the CVC meeting and co-chaired the Tell Us.” All attendees received a com- The Salk vaccine was later replaced morning’s activities, which included a plete meeting presentation package. on the immunization schedule by the Your gift is no small drop. oral polio vaccine developed by Albert B. Sabin, MD. Neither the vaccine developed by Salk nor that developed by Sabin was used in the “first-ever polio Your donation goes a long way in support of the Sabin Vaccine Institute. vaccination.” A polio vaccine developed by Hilary Koprowski, MD was As a partner with us, your donation promotes disease prevention through administered in a trial four years earlier immunization, effective vaccine policy, and vaccine research and devel- to 20 subjects and was reported in March 1952 at a meeting of the opment. We hope you will consider a tax-deductible contribution to the National Foundation for Infantile Sabin Vaccine Institute. Readers may enclose a check in the envelope (no Paralysis in Hershey, Pennsylvania. There were at least two previous postage is necessary if mailed in the U.S.). If vaccine candidates tested in the 1930s you are reading this online, our address is that were not proven safe and effective and were abandoned. The editor 161 Cherry Street, New Canaan, CT 06840. Photo: Marcel Crozet/WHO thanks Dr. Koprowski for taking time to You may also phone 203-972-7907, or visit inform the readers of The Sabin Vaccine Report of his groundbreaking our website to arrange your contribution. discovery. We regret the error. Thank you! dedicated to disease prevention www.sabin.org 7 11th Annual Vaccine Policy Colloquium on Pandemic Influenza Vaccine Sabin Vaccine Institute—“New, Important and Credible Participant” in Worldwide Influenza Partnership Continued from page 1 be done. This meeting cluding developing country manufactur- identified some impor- ers in the discussions—two developing tant gaps in the plan- country manufacturers of quality as- ning.” The number of sured vaccine were present at the meet- people who would ing. According to Heymann, they are need to be vaccinated now committed to explore the possibil- greatly exceeds the ity of technology transfer between com- number of vaccine panies to increase influenza vaccine pro- doses that can be duction and to promote discussions with manufactured today. other developing country The time it would take manufacturers. “The pandemic influ- to make the vaccine enza meeting could be a launch point available using existing Pictured with author John Barry, signing book, are from left, Lewis A. for a new way of working on influenza technologies and plan- Miller, SVI trustee; David L. Heymann, WHO; Barry; and Dean Mason, SVI vaccines internationally if particular rec- ning for the use of anti- president. Berry’s book, titled, The Great Influenza, chronicles the 1918 ommendations are followed up,” viral drugs are other pandemic. Photo by M. Chua, CSH Laboratory. Heymann said. areas where contin- including AIDS, TB, malaria, childhood “This meeting can serve as a catalyst gent planning is needed. diarrheal diseases, and pneumonias— among participants from around the A further goal of pandemic disease are the target for research to develop globe,” said organizer Dean Mason, preparedness beyond strengthening the vaccines or improve coverage and ef- president of the Sabin Vaccine Institute. global vaccine manufacturing enterprise fectiveness of existing products. Accord- “Though a number of countries and re- would be development of new vaccine ing to WHO’s Heymann, “The meeting gional organizations have drafted plans technologies to prevent other killer dis- will have direct positive impact on to address pandemic influenza, there is eases. Each year approximately 15 mil- WHO’s activities in influenza pandemic still much coordination and planning to lion people in the world die of infectious planning and adds a new, important and diseases and most of these diseases— credible participant to the worldwide in- fluenza partnership.” It also adds to the international coalitions working to bet- ter assure that influenza vaccine will be made available to all countries. The colloquium, held at the Banbury Conference Center, Cold Spring Har- bor Laboratory, New York, was co- chaired by Heymann, with Lewis A. Miller, principal of WentzMiller & As- sociates and Sabin trustee, and Albert Osterhaus, DVM, PhD, head of virol- ogy at Erasmus Medical Center in Rotterdam, Netherlands. Also serving on the expert committee for the collo- quium was Ciro de Quadros, MD, MPH, director, International Programs, at the Sabin Vaccine Institute. It was the 11th annual vaccine policy colloquium in an Colloquium participants gathered at the Banbury Conference Center at Cold Spring Harbor ongoing series sponsored by the Bill & Laboratory are, from left, front row: Helen Garey, Chun Kang, Dean Mason, David Heymann, Lew Melinda Gates Foundation. Miller, Albert Osterhaus, Theresa Tam; 2nd row: Conny Mason, Isaias Raw, James Matthews, Veronica The proceedings of the colloquium is Korn, Sharon Hammer, and Suresh Jadhav; 3rd row: Sarah Landry, John Barry, Michael Osterholm, being prepared for publication in Janu- Lance Gordon, Diane Simpson, Karen Nielsen, Richard Knox, and Louis Cooper; back row: David ary 2004. The document will be pub- Salisbury, Mary Ann Chaffee, Shanelle Hall, Otavio Oliva, James LeDuc, Benjamin Schwartz, Mark Miller, Clem Lewin, John Woodall, Klaus Stohr, and Raymond MacDougall. lished in print and made available online at www.sabin.org. 8 FALL 2004 SABIN VACCINE REPORT BOOK CORNER Vaccine Shortages Examined, Prescription Formulated in SVI Release Public Health Experts Provide Guidance to Vaccine Supply Problem in Meeting Proceedings Recent highly publicized vac- zation. Each is- “The complexities and pitfalls chal- cine shortages have cast a sue received lenging the stability of vaccine supply are shadow over the otherwise thorough consid- much better understood following the in- enormous success of vaccines eration by the depth analysis and guidance shared by as a tool for disease prevention group of global this group,” said H.R. Shepherd, chair- around the world. Vaccines experts repre- man of the Sabin Vaccine Institute. Ed- have been the cornerstone of senting the ited by Gloria Parkinson, Feasible So- public health for the past 50 medical and lutions to Global Vaccine Shortages years and shortages have public health is the latest in a series of colloquium pro- shaken public confidence and communities, ceedings that the Sabin Vaccine Insti- exposed real vulnerabilities in U.S. and interna- tute has published in order to generate the current system of vaccines tional govern- discussion on critical topics related to production. A new publication of ments, interna- vaccines. the Sabin Vaccine Institute tional agencies, Review copies of this proceedings pub- (SVI), Feasible Solutions to non-governmen- lication are available upon request to Global Vaccine Shortages, addresses tal organizations, academia, and the firstname.lastname@example.org. A pdf version may a set of issues that may hold the key to manufacturing sector. be downloaded from www.sabin.org. remedying the threats of vaccine short- ages. A precipitous decline in the number Spanish Edition of Vaccines Available of manufacturers in the 1990s was am- plified by sudden regulatory decisions, PAHO Offers Spanish Edition of Centennial Commemorative Volume heightened liability concerns, and a rela- In the previous issue of The Sabin sues, ranging from improving the im- tively low return on investment for vac- Vaccine Report we ran a review of a pact of immunization programs using cine producers. SVI convened the 10th recent publication release from the Pan existing vaccines to the frontiers of Annual Vaccine Colloquium at Cold American Health Organization vaccine research. The text consists Spring Harbor in the fall of 2003 to bring (PAHO), which has since been pub- of 48 chapters written by 76 authors, together key players to address key re- lished in the Spanish language. most of whom are among the top in- lated issues, namely stockpiling, financ- To reiterate a brief description, dur- ternational authorities in their fields. ing, advocacy, and regulatory harmoni- ing 2002, the centennial year of PAHO, a meeting was held to review the ac- complishments of vaccines and vacci- Visit the PAHO web page for order nation programs—both within the Re- information: publications.paho.org gion of the Americas and throughout or call 301-617-7806. the world—and challenges for the Fu- ture. Over 250 scientists, health care English Edition and public health officials participated. 2004,412p., From that meeting, has come Vaccines: ISBN 92 75 11596 6 Preventing Disease and Protecting Order code: SP 596 Health. The book, edited by Ciro de Spanish Edition Quadros, the major driving force be- 2004, 452 pp. hind many of PAHO’s successful im- ISBN 92 75 31596 5 4 munization initiatives, represents a Código: PC 596 comprehensive and easily readable Price/Precio: US$62.00 / US$46.00 in compilation of outstanding articles on Latin America and the Caribbean/ en a wide variety of immunization is- América Latina y el Caribe dedicated to disease prevention www.sabin.org 9 Rotavirus Vaccine: A Major Tool for Child Survival A Public Health Commentary by Ciro A. de Quadros, MD, MPH, and Jon Kim Andrus, MD The following Op Ed appeared in Latin American daily newspapers, including La Prensa in Managua, Nicaragua; O Globo in Rio de Janeiro, Brazil; La Tribuna in Tegucigalpa, Honduras; and Ultima Hora in Asuncion, Paraguay. Over the course of the last century, the of knowledge about rotavirus and efforts to sectors are essential to ensuring full access Americas have repeatedly led the world in combat it. The symposium marked a turning to life-saving vaccines. tackling killer diseases. It was the first re- point in the fight against rotavirus. It spot- Health officials from 16 Latin American gion to free itself from smallpox and then lighted recent efforts across Latin America, countries emphasized this point of view polio—two killers of global dominion. Africa and Asia to assess the burden of when they delivered a declaration under- Once again, this region has the opportunity rotavirus disease and produced new estimates scoring support for immunization, with the to pave the way in a vital public health effort: of global mortality, finding that rotavirus ac- highest political priority, as a public good increasing child survival through targeting counts for 39 percent of all diarrheal deaths, for the region. The representatives called rotavirus, the most common cause of se- up from the previous estimate of 22 percent. upon the Pan American Health Organiza- vere diarrhea in infants and toddlers. Ev- The symposium also noted the emergence tion and its Revolving Fund for Vaccine Pro- ery year this virus claims the lives of more of two vaccines, one developed by Merck & curement to work with collaborating agen- than 500,000 children worldwide. Co., the other by GlaxoSmithKline, and pre- cies, national and global health organiza- Severe rotavirus kills by inducing acute liminary data presented at the meeting indi- tions, and with vaccine manufacturers, “to diarrhea and vomiting that can quickly de- cate that both will be safe and effective. Each facilitate the introduction of vaccines against hydrate a small child. In such a dire emer- has been tested in more than 60,000 infants rotavirus at prices accessible to all coun- gency, children may need fluids delivered and children. The GlaxoSmithKline trials tries of the region as soon as they become intravenously if they are to survive. So, al- were based in Latin America, and carried out available.” The Pan American Health Orga- though nearly every child in the world will in cooperation with Ministries of Health and nization is committed to making this hap- become infected by rotavirus within their scientific investigators from many of the pen in a way that ensures vaccines are af- first years of life, children in poor countries region’s leading hospitals and research uni- fordable to all children, particularly those that lack adequate medical care suffer 85 versities. In fact, just days after the sympo- who need them most. This provides an- percent of rotavirus deaths. For these chil- sium, Mexican health authorities announced other opportunity to reduce inequities in dren, a preventive vaccine against rotavirus plans to offer this vaccine on Mexico’s immu- health services. would offer the best protection against this nization schedule next spring. In Latin America, rotavirus accounts for ubiquitous disease. What is striking, however, is not only the an estimated 75,000 hospitalizations annu- Until now, no such vaccines have been scientific triumph of developing safe, effec- ally, and the deaths of more than 15,000 available to the world’s children. This, how- tive vaccines against one of the largest killer children. Country-by-country, the burden ever, is about to change, and Latin Ameri- diseases of childhood, but also the deep com- varies. In Mexico, 2,000 children die of can countries are at the center of this trans- mitment evidenced by the public health com- diarrhea each year, and a vaccine could formation. munity and collaborating agencies to ensure cut those deaths by 40 percent. Each epi- This past July, 350 public health experts, that these, and any future vaccines against sode of diarrhea costs families an average scientists, clinicians and representatives of rotavirus, are made available to all children of US$100, which represents 85 percent of governments, the vaccine industry and the who need them. the monthly income for families living on multilateral, bilateral and NGO community Until now, vaccines have become available minimum wage. In a single outbreak ear- met in Mexico City to assess the current state first in developed industrialized countries, lier this year in Guatemala, more than 6,500 which are able to pay a premium price children were treated for rotavirus at hos- for the new products that typically cost pitals, and at least 50 children died. up to $800 million to develop. New vac- For all of these children, new vaccines cines such as those for hepatitis B and offer hope that rotavirus disease will no Haemophilus influenzae type b have longer be a rite of passage and test of sur- taken 10 to 15 years to “trickle down” to vival. developing countries. In this regard, the Ciro A. de Quadros, MD, MPH, is the Di- new rotavirus vaccines represent a turn- rector, International Programs at the around of business as usual. Vaccine Sabin Vaccine Institute. Jon Kim Andrus, accessibility is an equity issue, and part- MD, is Chief of the Immunization Unit at Benjamin, a one-year-old Chilean boy, almost died of nerships between the public and private the Pan American Health Organization. rotavirus, an infection that kills 500,000 children every year worldwide. (Photo: Victor Hugo Durán) 10 FALL 2004 SABIN VACCINE REPORT Ciro de Quadros Elected to Institute of Medicine Membership Also Elected Are SVI Trustee Osterholm, SVI Scientific Advisor Hoffman The Institute of Medicine (IOM) of the National Acad- “I am honored that the IOM emies announced in October the election of 65 new mem- membership elected me to join bers, including Sabin Vaccine Institute (SVI) Director of In- their distinguished ranks,” said de ternational Programs Ciro de Quadros, MD, MPH. New mem- Quadros, who joined the Sabin bers bringing the roster to 1,416 also included SVI trustee Vaccine Institute in early 2003 to Michael T. Osterholm, PhD and SVI Scientific Advisory Coun- direct several international advocacy cil member Stephen L. Hoffman, MD. projects. Beforehand, he was direc- According to IOM President Harvey V. Fineberg, mem- tor of the Division of Vaccines and bership is highly selective and recognizes people who have Immunization of the Pan American Michael Osterholm, PhD made major contributions to the advancement of the medical Health Organization in Washington, sciences, health care, and public health. “Election is consid- DC. He completed medical studies in ered one of the highest honors in Brazil in 1966 and received a Master of Public Health degree the fields of medicine and health,” from the National School of Public Health in Rio de Janeiro in he said. Current active members 1968. He is among the pioneers in developing strategies of sur- elect new members from candi- veillance and containment for smallpox eradication. He also di- dates nominated for their profes- rected the successful efforts of polio eradication from the West- sional achievement and commit- ern Hemisphere and efforts to eradicate measles from the re- ment to service. Members com- gion. mit volunteer time as members of Michael T. Osterholm is director of the Center for Infec- IOM committees, which engage tious Disease Research and Policy at the University of Min- Ciro de Quadros, MD, MPH in a broad range of studies on nesota, Minneapolis; Stephen L. Hoffman is chief executive health policy issues. and scientific officer of Sanaria The Institute of Medicine is a Inc., Rockville, Maryland. national resource for independent, scientifically informed For more information on the In- analysis and recommendations on issues related to human stitute of Medicine see health. Recent studies included the titles Immunization Safety www.iom.edu. Review: Vaccines and Autism, a report that closed the ques- SVI Chairman H.R. Shepherd tion of any such link; and Financing Vaccines in the 21st is a longstanding member of the Century: Assuring Access and Availability, which proposes National Academies Presidents’ new strategies for assuring access to vaccines and sustain- Circle, heading its Library Out- ing the supply of vaccines. Stephen Hoffman, MD reach Program. Weizmann Institute Recognizes Science’s Select H.R. Shepherd Honored During Weizmann Institute’s New York Event The American Committee for the “This event celebrated an exceptional sol cosmetics and medical technology in- Weizmann Institute of Science, New group of talented scientists,”Shepherd dustry. He is recognized as the devel- York Region, hosted its gala dinner, In said. “The Weizmann Institute is unpar- oper of the metered-dose inhaler used Celebration of Science, November 4, alleled in the research and discovery it broadly by asthmatics and others requir- 2004 at the Mandarin Oriental Hotel in promotes, so I am honored to have ing respiratory treatment. New York City. The focus of the hon- played a part in the celebration.” The For the past 11 years, Shepherd has ors were leading “Women of Weizmann Institute, located in Rehovot, served as founding chairman of the Vision”among a select group of others Israel, is a top-ranking multidisciplinary Sabin Vaccine Institute and established celebrated for their scientific contribu- research institution, noted for its wide- a reputation of excellence for the Insti- tions to humanity. Also honored at the ranging exploration of the sciences and tute within the scientific community event were a group of “Distinguished technology. worldwide promoting vaccines and im- Guests from the Scientific Community” The “book of honors” distributed at munization. including H.R. Shepherd, DSc, chairman the dinner mentioned Shepherd’s distin- of the Albert B. Sabin Vaccine Institute. guished career as a chemist in the aero- dedicated to disease prevention www.sabin.org 11 Pediatrician and Vaccine Executive Join Sabin Board of Trustees Louis Cooper, MD and Kevin Reilly Elected at October Board Meeting The Board of Trustees of the Albert Cooper was the founding co-chairman He began his career at Connaught B. Sabin Vaccine Institute announced of the Campaign for Healthy Children, Laboratories, Ltd. as a senior vice presi- the election of two new board which is best known dent in charge of Canadian and export members during its September for designing, advo- operations. 2004 meeting in New York cating, and facilitat- Reilly earned a bachelor of science City. Members of the board ing implementation of degree from the University of provide guidance and valued the Child Health Melbourne in 1963 and a master of busi- expertise on all of the Institute’s Plus Program, New ness administration degree from York programs. The election of York’s effort to guar- University, Toronto in 1973. Mr. Reilly Louis Z. Cooper, MD and antee health insur- is also a 1981 graduate of the Advanced Kevin Reilly to the SVI Board ance for every child Management Program at Harvard Busi- adds a depth of experience in in the state. Dr. Coo- ness School. vaccine research, immuniza- Louis Z. Cooper, MD per is a graduate of In announcing the election of the two tion advocacy, and vaccine Yale University and new board members, SVI Chairman manufacturing and economics. received his medical degree from Yale H.R. Shepherd said, “Lou Cooper has Dr. Louis Cooper is a retired profes- University School of Medicine. been an advocate with us since the be- sor of pediatrics at the College of Phy- Kevin Reilly has more than 20 years ginning of the Institute. He is respected sicians and Surgeons of Columbia Uni- experience in pharmaceutical manage- across the country and globally as a versity and a past president of the Ameri- ment and was president of Wyeth Vac- champion for immunization and can Academy of Pediatrics (2001-2002) cines and Nutrition, a division of Wyeth, children’s health.” Of Mr. Reilly, Shep- and Chairman of the Board of Direc- for five years. Prior to join- herd acknowledged the tors of its Center for Child Health Re- ing the vaccine division, insights into the chal- search. Reilly was president of lenges and economics of Since 1964, Cooper has been exten- Wyeth Nutrition Interna- the vaccine manufactur- sively involved in vaccine research. At tional and was responsible ing that Reilly has pro- Bellevue Hospital in New York, he cre- for management and direc- vided as an industry part- ated the Rubella Project, a vaccine re- tion of the business world- ner representative. “The search program, which evolved into a wide. During his rise value of having expertise multidisciplinary team dedicated to de- through Wyeth, Reilly held from the private sector fining and resolving the rubella problem. the positions of group vice is immeasurable. We This project enabled Cooper to trans- president and area vice look forward to expand- late scientific information into public president for the Pacific Kevin Reilly ing the programs of the policy, legislation and program building Rim Group, an area that en- Institute and drawing in health, education, and social services. compasses the Philippines, Australia, from the strength of leadership repre- Dr. Cooper served as chairman of the New Zealand, India and Pakistan. sented on our board of trustees.” Department of Pediatrics at St. Luke’s- Roosevelt Hospital Center for 25 years, CDC’s Uyeki and SVI’s Mason Present New Canaan Lecture becoming chair emeritus in 1998. He has The Sabin Vaccine Institute participated in the first Davidoff-Sabin Health Science served on numerous advisory bodies at Lecture held at the New Canaan Library in New Canaan, Connecticut on December 9, the federal, state, and city level, includ- 2004. Guest speaker for the lecture was Tim Uyeki, MD, MPH, Medical Epidemiologist, ing chairmanships of the Medical Soci- ety of the State of New York Commit- Influenza Branch, Centers for Disease Control and Pre- tee on Medicaid and the Public Policy vention, Atlanta, who along with SVI President and CEO Committee (PPC) of the Pediatric In- Dean Mason provided insight on influenza. fectious Disease Society. He is also a The free public lecture was titled Influenza Vaccine— member of the corresponding PPC of Missing the Point: Vaccine Shortages and the Larger the Infectious Diseases Society of Threat. The lecture provided an opportunity for the com- America. He recently chaired a Blue munity to become better informed about the impact of Ribbon Panel on Vaccine Safety for the influenza and the importance of a secure vaccine supply. Centers for Disease Control. Dr. Tim Uyeki 12 FALL 2004 SABIN VACCINE REPORT National Vaccine Shortage SABIN Continued from page 2 CALENDAR April 2 - 5 Copenhagen, Denmark groundwork for our present-day industrial- 15th European Congress of Clinical academic-military complex. In his capacity JANUARY-JUNE 2005 Microbiology and Infectious Diseases January 24 - 25 Washington,DC www.akm.ch/eccmid2005 as director of a newly created Office of Scien- tific Research and Development, Dr. Bush 2nd Workshop on Strengthening the April 9 - 15 Banff, Alberta coordinated the activities of some 6,000 lead- Supply of Vaccines in the U.S. HIV Vaccines: Current Challenges and www.hhs.gov/nvpo Future Prospects (X8) ing American scientists and engaged the de- February 8 - 9 Washington, DC www.keystonesymposia.org/Meetings fense industry, the U.S. military, and major National Vaccine Advisory Committee April 16 - 20 Anaheim, California research universities in an unprecedented Meeting www.hhs.gov/nvpo 96th Annual Meeting of the American dialogue and partnership, aided by federal February 10 – 11 Atlanta, Georgia Association for Cancer Research support. Our national military strengths are Advisory Committee on Immunization www.aacr.org partly a result of his vision and legacy. Practices (ACIP) www.cdc.gov/nip/acip April 19 - 20 Montreal, Canada Vaccines, whether for influenza, major February 17 - 22 Santa Fe, New Mexico World Vaccine Congress Montreal 2005 childhood illnesses, biodefense, or global www.lifescienceworld.com/2005/wvcm_CA Antibody-Based Therapeutics for Cancer health, have effectively become orphan drugs. www.keystonesymposia.org/Meetings April 24 - 30 U.S. Nationwide If we realistically expect a new generation of February 24 - 26 Hershey, Pennsylvania National Infant Immunization Week vaccines, we have to look at alternative busi- www.cdc.gov/nip/events/niiw 8th Annual Meeting of the Regional ness models to ensure their development and Cancer Center Consortium for the May 9 - 11 Baltimore, Maryland testing. We need to develop novel private- Biological Therapy of Cancer 8th Conference on Vaccine Research public partnerships between the remaining www.cancerbiologicaltherapy.org/ www.nfid.org/conferences vaccine manufacturers, research universities, symp.html May 10 Baltimore, Maryland the Department of Health and Human Ser- March 17 - 18 London, United Kingdom Albert B. Sabin Gold Medal Ceremony vices, and the U.S. military. In so doing, we DNA Vaccines Forum www.sabin.org/awards_gold.htm would create a critical vehicle to marshal and www.marcusevans.com/events/ May 23 - 25Amsterdam, The Netherlands mobilize the best and brightest American bio- CFEventinfo.asp?EventID=9175 Phacilitate Vaccine Forum Spring 2005 medical scientists into vaccine development. March 18 - 20 Madrid, Spain www.phacilitate.co.uk We need to develop new business models for Frontiers in Neonatal & Infant June 7 - 8 Washington, DC ensuring a steady pipeline for our nation’s Immunity www.themacraegroup.com National Vaccine Advisory Committee vaccine supply. We need also to attract vac- March 18 - 22 San Antonio, Texas Meeting www.hhs.gov/nvpo cine manufacturers from other countries to American Academy of Allergy, Asthma June 15 - 18 Lisbon, Portugal the U.S. market, support/subsidize research and Immunology 12th International Congress on and development, streamline our regulatory www.aaaai.org/members/annual_meeting Infectious Diseases (12th ICID) system, better protect against frivolous litiga- March 19 - 24 Keystone, Colorado www.isid.org tion and encourage competition among vac- Basic Aspects of Tumor Immunology June 21 - 24 Cold Spring Harbor, New York cine makers, giving consumers more choice. www.keystonesymposia.org/Meetings 7th Annual Sabin Colloquium on Cancer Some estimates suggest that vaccines saved March 21 - 24 Washington, DC Vaccines and Immunotherapy almost 200 million lives in the 20th century – 39th National Immunization Conference www.sabin.org/programs_walkers_cay.htm more lives saved than all lives lost in wars www.cdc.gov/nip/NIC over the same period. Almost all of these were produced by the vaccine industry. In this NON-PROFIT ORG. sense, our remaining vaccine manufacturers U.S. POSTAGE should be thought of as national and interna- PAID tional treasures. Because vaccines are our MONTROSE, PA greatest resources for disease prevention, PERMIT NO. 2 their manufacture and distribution are de- 161 Cherry Street RETURN SERVICE REQUESTED New Canaan, CT 06840-4818 serving of thoughtful support and leadership. U.S.A. Peter Hotez, MD, PhD is co-chair of the SVI Scientific Advisory Council and is chair of Microbiology and Tropical Medicine, The George Washington University (GW). Frank Cilluffo is vice president for Homeland Se- curity at GW.
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