Volume V, Number 3 Sabin Winter 2002/2003 EPORT The newsletter of the Albert B. Sabin Vaccine InstituteR —dedicated to disease prevention www.sabin.org

Supply of Tops Agenda at 2002 Sabin Vaccine Policy Colloquium Ninth Sabin Colloquium Dubs Vaccines “Weapons of Mass Protection”

Vaccine supply issues took center the colloquium participants and deliver The colloquium focused on four strat- stage at the Sabin Vaccine Institute’s their charge. egies to resolve the current vaccine sup- Ninth Annual Colloquium convened at Two keynote addresses set the stage ply problem in the U.S. and in develop- Banbury Center, Cold Spring Harbor for the meeting: Kevin Reilly, past pres- ing countries. Laboratory, New York, October 23 to ident of Wyeth Vaccines, framed the do- • Achieving a fair rate of return on in- 25. Public health experts, domestic and mestic vaccine supply situation, while vestment for manufacturers; international health economists, industry Carol Bellamy, executive director of • Making vaccines/prevention of dis- representatives and immunization advo- UNICEF and chair of the Global Alli- ease a national and international pri- cates participated in the three-day col- ance for Vaccines and Immunization ority; loquium titled, “Global Vaccine Shortage: (GAVI), commented on vaccine short- The Threat to Children and What to Do Continued on page 6 About It,” that urged action to address current shortages of key vaccines and to improve the stability of future sup- plies. This year’s focus on vaccine supply issues was determined by broad concern for the security of the vaccine supply along with recent supply problems. Dur- ing the past year, the United States could not meet demand for five vaccines that prevent eight childhood diseases. For the past two years, there were shortages of the flu vaccine and until recently there Colloquium participants considered key issues that impact vaccine supply during roundtable discussions. was a shortage of the tetanus vaccine. From left, Karen Midthun, Jan Heinrich, Jose Ignacio Santos, Natalie Smith, and Julie Fischer share In developing countries, the reduced perspectives in exercise aimed at uncovering pathways to solutions to vaccine supply problems. number of qualified manufacturers has Photo by Miriam Chua, CSH Laboratory. led to serious risks of vaccine shortages ages in the developing world. (See side- for four basic vaccines that prevent six bars on page 7.) I nside childhood diseases including measles and “Vaccine security—the sustained, un- Chairman’s Message ...... 2 whooping cough. interrupted supply of affordable vac- Keep Vaccines Off “Endangered List” ...... 3 Underscoring the importance of the cines—is at risk,” said Carol Bellamy. PAHO turns 100! ...... 4 vaccine supply issue, Sabin Vaccine In- “While there is a growing divide be- President’s Smallpox Vaccination Plan ...... 5 Cold Spring Harbor Colloquium ...... 6 stitute Chairman H.R. Shepherd com- tween vaccines given to children in de- Keynotes Urge Secure Vaccine Supply ...... 7 mented, “Vaccines are a critical line of veloping and developed countries, short- Danish Study Dismisses MMR/Autism Link ..8 defence against infectious diseases. ages affect both. A key factor is that Panama Honors SVI Scientist ...... 11 Stops and starts in the supply of any vac- there are fewer manufacturers, espe- GAVI Partners Convene in Senegal ...... 12 cine can have dire consequences.” cially of basic vaccines where profitabil- Book Review: The Hidden Campaign ...... 14 Dr. Shepherd was on hand to welcome ity is lower.” CHOP Videos Answer FAQs about Vaccines 15 2 WINTER 2002/2003 SABIN VACCINE REPORT

The Sabin Vaccine Report Vaccines Offer Security on the Home Front is published by the A Message from the Chairman Albert B. Sabin Vaccine Institute Vaccines, tracing conditions prevented by Subscriptions are free back to Edward vaccines. Such an exer- Please direct inquiries to: Jenner’s time, still com- cise of remembrance SABIN VACCINE REPORT mand attention because would benefit each of 58 Pine Street us. New Canaan, CT 06840-5408 of their enormous con- phone: 203.972.7907 tribution to public health. We can be encour- fax: 203.972.4763 Popular media and sci- aged by news of vac- www.sabin.org entific press find ample cines for the future too. email: [email protected] material for their publi- An announcement last EDITOR cations and broadcasts month reported an ef- H.R. Shepherd, Chairman Raymond MacDougall fective vaccine to fight ASSOCIATE EDITOR COPY EDITOR focusing on the benefits Veronica Korn David Bedell of vaccines, their future potential, as well human papillomavirus, OFFICERS OF THE SVI BOARD OF TRUSTEES as any controversies surrounding spe- and more promising vaccines to treat H. R. Shepherd, Chairman cific vaccines, vaccine legislation or vac- diseases are in various stages of pre- William R. Berkley, Co-Chairman liminary and clinical trials. Michael E. Whitham, Esq., Secretary/ cine policy. Treasurer New attention is being paid to the The protective public benefit of cur- rently licensed vaccines is enormous and SVI STAFF everpresent threat of infectious diseases, Fran G. Sonkin, Executive Vice President particularly post 9/11. As a result of in- has contributed significantly to the ad- Paul J. Vilk, RPh, RAC, Vice President, creased awareness of biological weap- vancement of contemporary society. Program Management and Regulatory The Sabin Vaccine Report attempts to Affairs, Initiative ons, we recognize that one disease Raymond MacDougall, Director of thought to be eradicated might be an ex- provide the public with information on Communications tant threat—smallpox. health gains achieved in our time with Veronica Korn, Research Associate Fortunately, our nation’s experts, in- the help of vaccines. We perceive this David Bedell, Executive Assistant to dissemination of information to be es- the Chairman cluding SVI founding president and Vanessa Santiago, Assistant to the board member Philip Russell, arrived at pecially time critical, as there needs to Executive Vice President a clear vaccine policy based on the best be an increased realization and appre- Gboku Lumbila, Executive Assistant, available scientific data. The nation has ciation of the complexities of vaccine de- Hookworm Vaccine Initiative velopment and production. Jean-Serge Valcourt, Accounting been assured that ample supplies of Christel Lane, Receptionist/Staff Assistant smallpox vaccine are stockpiled and that The Sabin Vaccine Institute is encour- Martha Fleischer, Information/Database new initiatives will bring an improved aged in the role played by our colloquia Coordinator vaccine into use in the foreseeable fu- to provide an avenue for all sectors to SVI ADVISORS ture that will provide protection for im- come to a consensus of how to better Philip K. Russell, MD, Senior Advisor to serve national and global public health the Chairman munosuppressed segments of our popu- needs. Contributing to collaboration Peter J. Hotez, MD, PhD, Senior Fellow lation. & Chair, Scientific Advisory Council The outstanding success of immuni- among the partners who enable vaccine William Muraskin, PhD, Sabin Fellow zation efforts, however, has created a and immunization programs is a critical Patricia Thomas, Sabin Fellow role and the Institute is pleased to be a Nancy Gardner Hargrave, Development national mindset of complacency about part of this process. Counsel diseases staved off by immunization. Smallpox is but one of the dangerous in- fectious diseases for which modern sci- With all good wishes for a peaceful, ence has found an effective vaccine. healthy and productive year ahead. Our collective memory may have to stretch back to recall the suffering re- sulting from polio, diptheria, or congeni- Chairman tal rubella syndrome, just a few of the Sabin Vaccine Institute dedicated to disease prevention www.sabin.org 3

VIEW POINT We Must Keep All Vaccines off the “Endangered” List Securing Vaccine Supply is Global Health Priority

U.S. policy makers, physicians, and the general public are Vaccines offer their greatest reward to the most vulnerable now debating how vaccines can be used most effectively to among us — children. Childhood vaccines form the bedrock thwart the evil intent of bioterrorists. Such debate focuses of global and domestic public health strategy and have largely on the theoretical, however, and the nation must not unquestionably demonstrated their value and effectiveness lose sight of a real need that is much more pressing: the over decades. Smallpox killed more people in the twentieth need to ensure that every child is immunized against diseases century than did all wars of the same period, and its that are serious, confirmed threats today. eradication through a mass vaccination campaign was an The past several years have been marked by gaps in outstanding accomplishment. Measles still kills 800,000 vaccine supply that have left children vulnerable to debilitating children each year in countries where the vaccine is not and life threatening . Diseases that have become universally administered. The value of vaccines is clear and rare in developed countries such as the United States due to incontrovertible. our past successes in vaccination, continue to proliferate Children are not the only beneficiaries of vaccines. globally and are easily imported by jet travel. The one Preventive vaccines for hepatitis B, pneumococcal , exception to this threat is smallpox, which has been and flu offer both children and adults protective immunity. eliminated globally (for now, at least). It is a calamity that at least 38,000 American adults die At an October meeting organized by the Sabin Vaccine from complications of these infectious diseases every year. Institute, held to focus on resolving vaccine shortages, experts While supplies of flu vaccine are plentiful this year, they from diverse sectors — academic, scientific, public health have not been in recent years, and there is no guarantee policy, nonprofit and industry — agreed on one underlying they will remain plentiful in the future. In fact, there is no tenet: unless there is a greater appreciation of the value of guarantee that any existing vaccine will remain in strong vaccines for the individual and for society, they will continue supply. Without concerted collaboration among government, to be underfunded, underused, and more likely to suffer industry and consumer groups, the availability of vaccines production shortfalls. Vaccines have been the reliable remains vulnerable to market economics and production foundation of public health. Consequently, they tend to be difficulties. It is incumbent on all stakeholders to address taken for granted and are undervalued. the realities of vaccine economics and manufacturing Do vaccines make a significant difference in preventing complexities, both nationally and internationally. It is vital disease, disability and death? Without doubt. But public for the public health community to persist in its efforts to perception has placed a higher value on one week’s supply communicate the value of vaccines and to remind the public of an anti-cholesterol drug or an anti-impotence pill than on of the lurking dangers of preventable diseases. one shot of measles-mumps-rubella vaccine that prevents Let us not forget that vaccines unquestionably are the congenital malformations and possible death in the infant of most humane and cost-effective medical intervention against a pregnant woman. As a result of our unwillingness to give preventable infectious diseases. Can civilized society allow vaccines their social and economic due, the number of vaccine such wondrous tools in the battle against disease to languish, manufacturers has decreased, and shortages of some or even be lost, because we haven’t taken care to nurture necessary vaccines have increased. them? Vaccines’ perceived value unquestionably lies at the root of the supply question. Vaccine supply will be undermined Lance K. Gordon, PhD until parents recognize immunization as an essential part of Chief Executive Officer, VaxGen, Inc. preventive healthcare. Vaccine supply will not be secure until pediatricians and primary care practitioners take every Lewis A. Miller opportunity to ensure their patients are immunized with the Corporate Editorial Director, Dowden Health Media complete recommended schedule of vaccines. Vaccine Chairman, Intermedica, Inc. supply will remain a low priority until legislators are motivated by the welfare of their constituents to encourage vaccine The authors co-chaired the 9th Annual Sabin production and additional investments in research and Vaccine Institute Colloquium on Vaccine Policy development. this past October. 4 WINTER 2002/2003 SABIN VACCINE REPORT Pan-American Health Organization Celebrates 100 Years with Vaccine Conference , MD, PhD Addresses PAHO Vaccine Conference on Hookworm Vaccine Development PAHO’s 100th anniversary celebra- tive of health technologies—vaccines,” New Goals Enliven PAHO’s tion included the Conference on Vac- he said. “It is also a celebration of the cines, Prevention and Public Health: vibrancy of the Pan American spirit and 100-Year Commitment to A Vision for the Future, held Novem- the ideal--a celebration of things done Public Health ber 25-27. The three days of talks fol- together, for let us not forget that the One of PAHO’s most notable successes lowed a forward-looking theme for vac- success of immunization in the Ameri- in controlling vaccine-preventable dis- cines, from the present status of polio cas is a triumph of partnerships.” ease was the eradication of smallpox from and measles eradication efforts, to the The conference featured presenters the Americas in 1973, a triumph that led newest epidemiological information, to whose expertise and scope reflected the five years later to global eradication of the the future and quest pinnacle of re- disease. In 1994, PAHO assisted in the for vaccines on the THE WORLD OF search on vac- elimination of polio from the Americas. horizon. PUBLIC HEALTH cines. Among the Polio eradication is now a global goal for As part of the ses- roster of speakers 2005, and PAHO has set a new target of sions, Peter Hotez, MD, PhD, Sabin were Ciro de Quadros, MD, former di- eliminating measles from the hemisphere. Scientific Advisory Council chairman rector of the PAHO Division of Vac- In November, PAHO’s member countries and chairman of Microbiology and Tropi- cines and Immunization, who presented fully endorsed the Integrated Management cal Medicine at The George Washing- a sweeping perspective of the past 100 of Childhood Illnesses (IMCI) strategy. ton University, provided a presentation years of vaccines and immunization in The Organization is working to reduce by on Parasitic Diseases and discussed the the Americas as well as a discussion half the more than 200,000 preventable value and promise of a vaccine to im- regarding measles and the feasibility of deaths among children under five years. munize against . He global eradication. Louis Cooper, MD, The initiative is called Healthy Children: past president of the Ameri- Goal 2002, based on the IMCI strategy. can Academy of Pediatrics, Acute respiratory infections, diarrheal presented the status of ru- diseases, and malnutrition are the three bella and congenital rubella leading causes of illness and death in this syndrome, including com- age group. These diseases and others, pelling cases from his pedi- such as those caused by vaccine-prevent- atric practice and research. able diseases and malaria, are the primary Noted public health expert reasons for medical consultation and hos- D.A. Henderson, MD, di- pitalization in the Americas. rector of the U.S. Depart- “Children are being evaluated for ment of Health and Human cough, diarrhea, and fever; health work- Services Office of Public ers are verifying the vaccination status of Health Preparedness, dis- children, and children are being weighed cussed the heightened and families given preventive advice and awareness of bioterrorism an appointment for the next consultation,” threats and the strategies said Christopher Drasbek, PAHO’s regional Peter Hotez, MD, PhD delivers talk on parasitic disesaes at PAHO for renewed smallpox vac- technical advisor in IMCI. “PAHO is con- cination. Many other vac- headquarters in Washington,D.C. at event marking 100th anniver- vinced that this strategy should be the sary of the public health institution. To his left are former director of cine experts provided a col- PAHO’s Division of Vaccines and Immunization Ciro de Quadros, lective picture of the dy- principal intervention of primary health MD, MPH; and Stanley Plotkin, MD, Aventis Pasteur medical and namic research taking place care to reduce mortality from infectious scientific advisor. to carry out vaccine pro- diseases in children under five.” discussed approaches and progress of grams and develop new vaccine prod- his team’s efforts in development of a ucts. Would you like to read hookworm vaccine. As one of the culminating events of the Sabin Vaccine A welcome to the conference was PAHO’s centenary celebration, the vac- Report online? Our delivered by Sir George A. O. Alleyne, cine conference demonstrated the con- newsletter is available director of PAHO. “This celebration is tribution of vaccines to public health ef- in a PDF format at not only about the conquest of the forts in the Americas and around the www.sabin.org. world’s diseases with that most effec- globe. dedicated to disease prevention www.sabin.org 5 President Bush Announces Smallpox Vaccination Plan New Threat of Bioterrorism Prompts Policy, Nation to Revisit Inoculations Against Smallpox President George W. Bush announced that terrorists may have access to the sociated with the vaccine. a plan on December 13 to better pro- virus and attempt to use it against the HHS is in the process of establishing tect the American people against the American public. Immediately after an orderly process to make unlicensed threat of smallpox attack by hostile these attacks, HHS began working, in vaccine available to those adult mem- groups or governments. The announce- cooperation with state and local govern- bers of the general public without medi- ment laid out a plan to resume smallpox ments, to strengthen our preparedness cal contraindications who insist on be- vaccination, which was declared suc- for bioterror attacks by expanding the ing vaccinated either in 2003, with an cessfully eradicated by the World Health national stockpile of smallpox vaccine. unlicensed vaccine, or in 2004, with a Organization in 1980. With new The United States currently has suffi- licensed vaccine. (A member of the gen- bioterrorism threats, the President has cient quantities of the vaccine to vacci- eral public may also be eligible to volun- deemed it appropriate to begin a tiered nate every single person in the country teer for an ongoing clinical trial for next administration of the vaccine. in an emergency. generation vaccines). The smallpox vaccine, which was rou- Smallpox Response Teams tinely administered to Americans until Preparing Military and Overseas Under the plan, the Department of 1972, is a highly effective protection Personnel Health and Human Services (HHS) will against the disease when given before The President also announced that DOD work with state and local governments or shortly after exposure to the virus. will take steps immediately to reinstitute to form volunteer Smallpox Response Pre-attack vaccination of Smallpox Re- vaccination of certain military and civil- Teams who can provide critical services sponse Teams will allow them, in the ian personnel. Those personnel who are to their fellow Americans in the event event of a smallpox attack, to immedi- deployed or who may deploy to certain of a smallpox attack. ately administer the vaccine to others high threat areas will be vaccinated. The To ensure that Smallpox Response and care for victims. State Department will also offer vacci- Teams can mobilize immediately in an HHS is working with states to iden- nation to certain overseas personnel. emergency, health care workers and tify health care workers and first re- Although the vaccine is effective if other critical personnel will be asked to sponders to serve on Smallpox Response administered shortly after exposure, it volunteer to receive the smallpox vac- Teams. Pre-attack vaccination of these may not be feasible during an emer- cine. Smallpox Response Teams will allow gency to vaccinate overseas troops and The federal government is not recom- them to better protect the American civilian personnel. Pre-attack vaccina- mending vaccination for the general pub- public against smallpox attack. tion is therefore warranted. Vaccina- lic at this time. There may be some The federal government is not recom- tion of military personnel was con- members of the general public who in- mending that members of the general ducted during WWI and WWII and sist on being vaccinated now. Public public be vaccinated at this point. Our routinely from the 1940s until 1984. health agencies will work to accommo- government has no information that a Between 1984 and 1990, vaccinations date them, but that is not the federal rec- biological attack is imminent, and there were provided to many recruits enter- ommendation at this time. are significant side effects and risks as- ing basic training.

Department of Defense and State Department Personnel The President also announced that the Sources of Smallpox Vaccine Information Department of Defense (DOD) will The Centers for Disease control and Prevention has made the information provided above vaccinate certain military and civilian available and also recommends the following web pages for further information: personnel who are or may be deployed in high threat areas. Some United States • To read more on the disease, visit www.bt.cdc.gov/agent/smallpox personnel assigned to certain overseas • To read more on the vaccine, visit www.bt.cdc.gov/agent/smallpox/vaccination/ embassies will also be offered vaccina- facts.asp tion. Although there is no reason to believe • To read more on medical conditions that make pre-vaccination unadvisable, visit · that smallpox presents an imminent www.bt.cdc.gov/agent/smallpox/vaccination/contraindications-public.asp threat, the attacks of September and • Persons interested in participating in an ongoing clinical trial can obtain October, 2001 have heightened concern additional information at www.clinicaltrials.gov 6 WINTER 2002/2003 SABIN VACCINE REPORT Ninth Sabin Colloquium Explores Pathways to Secure Vaccine Supply Vaccine Supply Issue Commands Front-and-Center Status at Three-Day Meeting Continued from page 1

• Harmonizing the regulatory process to arrive at global standards for safety, efficacy and good manufacturing practices; • Securing adequate vaccine capacity. “The world is a far safer place for us and our children because of the advent and advances made on the vaccine front,” said Lance Gordon, CEO of Vax- Gen and colloquium co-chair. “ It is im- perative to achieve a steady and secure supply of existing vaccines as we press forward to achieve vaccine break- throughs of the future.” The Sabin Vaccine Institute received Participants in the Ninth Sabin Vaccine Institute Colloquium at Cold Spring Harbor are, from funding support for the colloquium from left, front row: Carol Nacy, Walter Vandersmissen, Stephen Landry, Jose Ignacio Santos, the Bill and Melinda Gates Foundation. Jan Heinrich, Chris Grant, Piers Whitehead, Mary Ann Chaffee, John Zapp; second row: Support was also received from Barbara Mulach, Litjen Tan, Karen Midthun, Veronica Korn, Lance Gordon; third row: Erica UNICEF, a major funding source for Kochi, Diane Simpson, Diane Peterson, Julie Milstien, Louis Cooper, Richard Skolnik, Eileen Dolich, Anthony Robbins, Natalie Smith, Raymond MacDougall; back row: Steven Bice, vaccination programs worldwide. Damian Braga, Julie Fischer, Rosemary Chalk, Stephen Jarrett, Nancy Tomich, and Sharon Hammer. Missing from photo: Geno Germano, Heidi Larson, Kevin Reilly.

Select Recommendations Made by Colloquium Participants On Communication • Create greater communication among all stakeholders including private and public sectors. • Advocate the value of vaccines as an international priority. • Improve understanding of industry to the public health sector. • Translate the concern over bioterrorism into an opportunity for advocacy of immunization’s value to a country’s security. On Capacity • Determine the feasibility of stockpiles. • Explore tax incentives in the U.S. and EU to expand manufacturing capacity for developing countries. • Improve long-term demand forecasting. Lance Gordon, co-chair of the colloquium, engaged • Track supply versus demand and improve planning at the country level. in discussion, above, with Chris Grant, Aventis Pas- • Create incentives for industry to continue long-term and innovative vaccine development through grant programs. teur, and, below, with Jan Heinrich, Government Ac- On Regulatory Issues counting Office, and Damian Braga, Aventis Pasteur. • Develop a strategy to manage the uncertainty of liability exposure. • Promote predictability and stability through greater transparency in the timelines, costs and licensure in a development of a vaccine. • Globalize vaccine markets by focusing on regulatory harmonization. • Look at the pros and cons of standardization of vaccine products. On Financing • Translate value of vaccines into political terms to ensure long-term funds. • Set up GAVI and UNICEF as a revolving fund to ensure long-term funding. • Improve capacity and infrastructure of developing countries to purchase vaccines through a series of incentives/aid from the U.S. • Identify mechanisms between Ministries of Health and Donors to ensure long-term financial reliability . • Create a public and private sector discussion on procurement, factoring the role of competition, the importance of international forecasts, and supply. dedicated to disease prevention www.sabin.org 7 Colloquium Keynotes Address Domestic and Global Vaccine Supply Context

CAROL BELLAMY PRESENTS A GLOBAL market, leaving just four World Health Organization- VACCINE PURCHASER’S PERSPECTIVE approved manufacturers of basic pediatric vaccines. Carol Bellamy, executive director of the Unit- Also, tiered pricing is less ed Nations Children’s Fund (UNICEF) and viable when developed chair of the Global Alliance for Vaccines and countries buy different vac- Immunization, delivered opening keynote cines than poor countries. remarks at the October colloquium. UNICEF Further, the shift to a sin- is the single largest buyer of vaccines for chil- gle-dose preference dren, purchasing 40% of the global volume among high-income coun- Kevin Reilly, right, newly retired president of Wyeth Vaccines of vaccines, worth $261 million. try buyers and the required and Nutrition, talks with Geno Germano, executive vice presi- dent and general manager of Wyeth Global Vaccines. “Twenty years ago, children in both devel- removal of the preservative oped and developing countries received the thimerosal has placed greater demand for vaccines recognizes the need for enhanced same basic vaccines and their availability was capacity in the manufacturing infrastructure. accuracy in long-term forecasting of demand; more than adequate.” she explained. “To- She noted that domestic and international working closely with governments to arrange day, capacity is a growing source of worry. manufacturers and buyers face common is- for firm multi-year funding commitments, and While a number of new vaccines have been sues regarding the need for long-term plan- solid future vaccine-supply contracts with developed, there are fewer vaccine manufac- ning and commitments, as well as better com- multiple manufacturers. turers. There is also a growing divide between munication between regulatory bodies, man- The challenges remaining include over- vaccines given to children in developing and ufacturers and buyers. The long lead times coming inaccurate forecasting despite under- developed countries. Children in developing involved in vaccine production and capacity developed health delivery and public health countries still receive the same basic vaccines increases make forward planning especially systems, ensuring functional public-private that children around the world used to get, critical. partnership for immunization, and mobiliz- but those in industrialized countries are now Touching upon the thematic issues to be ing producers to make decisions that are receiving a new, considerably more expen- addressed by the participants at the collo- driven not only by short-term market gains, sive battery of vaccines.” quium, Ms. Bellamy pointed to remedies to but also by long-term concerns for human Ms. Bellamy described disconcerting the vaccine market in appropriate returns for security. changes over the past decade in the global suppliers; open, collaborative relationships; Ms. Bellamy presented a clear and com- vaccine market. With the introduction of new and credible and predictable demand. pelling picture of the challenges facing se- vaccine products, less profitable older ones UNICEF’s principal strategy for ensuring a cure global vaccine supplies. become progressively devalued. In this envi- sustained, uninterrupted supply of affordable ronment, vaccine producers have exited the KEVIN REILLY PRESENTS A VACCINE MANUFACTURING PERSPECTIVE Kevin Reilly is past president of Wyeth Vaccines & Nutrition and his career in the industry spans 35 years, with exposure to both the North American and international markets during that time. He provided a second keynote talk drawing from experiences in run- ning a vaccine business. His remarks looked at economic issues, problems created by the interaction between demand and supply, and the driving forces on the supply side. He described that people are genuinely committed to the value of immunization and vaccines, including the business people run- ning the vaccine operations. Their level of dedication is very high, and as a result vaccines and immunization in the 20th century have made an enormous contribution to public health. Another aspect Carol Bellamy, UNICEF executive director, discusses international of the vaccine manufacturing picture is economics, inclusive of health statistics with Sabin Vaccine Institute Chairman H.R. Shepherd. Continued on page 16 8 WINTER 2002/2003 SABIN VACCINE REPORT Danish Team Explores MMR Data, Finds No Link with Autism Article Appearing in November Issue of New England Journal of Medicine Reassures Pediatricians and Parents identical twins there is about a 3% con- Findings of an eight-year study of half a million children in Denmark cordance rate. The risk of autism in sib- provided added evidence of the safety of the measles, mumps, and ru- lings ranges from 2 to 6 percent. And in bella vaccine (MMR). The study was reported in the November 7 issue of families with autism, there are often oth- The New England Journal of Medicine. er developmental problems as well, such Many studies suggesting a link between MMR vaccination and autism as language delays or learning disabili- were based on case-series, cross-sectional studies rather than a popula- ties. The inheritance pattern is complex tion-based cohort design. Danish epidemiologists, however, designed a and suggests that a number of genes are follow-up study of all children born in Denmark between 1991 and 1998. involved. Autism also tends to occur A unique administrative system in that country provided the researchers more frequently than expected in indi- with extensive civil registries including birth and hospital records. Through viduals with certain other medical con- the use of personal identification numbers, they were able to trace those ditions, such as Fragile X syndrome, tu- children born during this time who were vaccinated against MMR and berous sclerosis, congenital rubella syn- those who remained unvaccinated. The Danish team then looked at the drome and untreated phenylketonuria cohort for incidences of autism between the two groups. (PKU). Some harmful substances tak- Three strong arguments against a link between MMR vaccination and en in pregnancy also have been associ- autism emerged from the study. First, the risk of autism was similar be- ated with an increased risk for autism, tween the two groups, second there were no temporal clusters of autism specifically the prescription drug, thali- after immunization and third, neither autistic disorders nor any other domide. We do know that parents do not related disorders were associated with MMR. cause ASDs in their children. In the US, Lead author of the Danish research team responsible for this work, the Children’s Health Act of 2000 di- Dr. Kreesten Madsen, provided the following interview with the Sabin rected CDC to establish regional cen- Vaccine Report to further comment on the study and its implications. ters of excellence for ASD and other developmental disabilities.

SVR When does autism begin and SVR For those of our readers who SVR Do we yet know the causes of what are the first signs of autism? are trying to appreciate this issue, can autism? KM Children with ASDs develop dif- you help us define a few things? For KM No one knows exactly what ferently from other children, but it is of- instance, “autism”? causes ASDs, but scientists think that ten difficult to see signs of an ASD dur- KM The condition we call “autism” both genetic and environmental factors is actually a group of developmental dis- may play a role. abilities called the autism spectrum dis- Family studies orders (ASDs) that are caused by ab- have shed the normalites in the brain. ASDs include au- most light on the tistic disorder, pervasive developmental genetic contri- disorder - not otherwise specified (PDD- bution to autism. NOS), and Asperger’s disorder. These Studies of twins three conditions all have some of the have shown that same symptoms and share unusual so- in identical cial development as a common feature; twins there is but they differ in terms of when the about a 75% symptoms start, how fast they appear, concordance how severe they are, and their exact rate (that is, if nature. ASDs begin during childhood and one twin has last throughout a person’s life; howev- autism 75% per- er, some individuals may participate in cent of the time typical community activities as adults. the other twin also has autism), while in non- Kreesten Maadsen is the Danish study’s lead author. dedicated to disease prevention www.sabin.org 9 Eight Years of Records Reveal No Cause for MMR Concern An Interview with Dr. Kreesten Madsen ing the first year of a child’s life. Chil- 12-15 months of age because vaccina- tion, new outbreaks of the disease be- dren without disabilities develop at about tion before 12 months does not gener- come more and more unlikely. A cover- the same rate across areas of develop- ate sufficient immunity to protect against age rate of 80-90% may in some cases ment such as motor, language, cognitive, infection. Delaying vaccination unnec- suffice to eradicate the disease. Hence, and social skills. Children with ASDs essarily leaves children at risk for these by vaccinating you are not only protect- develop at different rates in different vaccine preventable diseases. ing your own child, but even adding to areas of growth. They may have large the protection of the population at large. delays in language, social, and cognitive SVR What record of safety does the I think, that we in this debate have for- skills, while their motor skills may be MMR vaccine have? gotten how serious a disease Measles about the same as other children their KM The MMR vaccine has an ex- is. Measles causes pneumonia (1 in 20), age. Most children with autism have cellent safety record. It does commonly encephalitis (1 in 2,000) and death (1 in delayed development from birth, such as cause minor reactions, and rarely more 3,000 in industrialized countries - as much delays in developing language skills or serious reactions. Most reactions result as 1 in 5 in outbreaks developing coun- an inability to interact with other people, from vaccine virus infection, 6-12 days tries). I certainly won’t hesitate to vac- but maybe a third of children with au- after immunization. The measles vac- cinate my children. tism seem to regress, that is develop cine virus infection causes fever, rash normally then lose skills. and/or conjunctivitis, and affects 5-15% SVR What is the logic that is used of the children vaccinated. The rubella to draw a hypothetical link between SVR Is autism on the rise? vaccine may cause the same local re- MMR vaccine and autism? KM Few researchers have been able actions on the injection site as mumps KM In general terms, the hypothe- to look at autism trends over time be- and measles. Mild systemic reactions sis states that MMR-vaccination leads cause they haven’t been able to moni- may also occur with the use of rubella to a nonspecific intestinal injury that tor the number of people with autism in vaccine. Those vaccinated sometimes leads to the absorption of certain mole- a specific area on an ongoing basis. But, develop a mild case of the disease that cules produced in the gut, which then in Europe, including Denmark, and else- includes fever, rash, lymphadenopathy, leads to damage to the brain and causes where outside the US, the more recent sore throat and headache. Also rubella autism and other serious developmental prevalence rates suggest a higher rate may be associated with joint symptoms. disorders. of autism then previously thought. We However, such adverse reactions are don’t know how much of these higher very rare in children receiving MMR SVR Did you set out to test this rates are due to a real increase in au- vaccine (less than 1%). When combi- hypothesis? tism or due to other factors related to nation vaccines (MMR) are used, both KM A number of scientific studies identifying children with autism. We do mild and severe reactions are similar to have looked at the MMR vaccine and not know if ASDs are becoming more those described above. autism but none have found evidence to common in the United States. We do support the idea that MMR vaccine know that more children are being iden- SVR What are the benefits of the causes autism. However, because of tified as having an ASD. MMR vaccine? some limitations in these other studies, KM Vaccines are the best possible the seriousness of autism, and the great SVR Now can you describe the protection against measles, mumps and public concern, we decided to carry out MMR vaccine? rubella. In an outbreak, the unvaccinat- our study. The public concern follows KM The MMR is a combination vac- ed child runs a much higher risk of dis- from two sources: first, there have been cine that protects children from getting ease than those who are already vacci- case reports of patients with inflamma- measles, mumps and rubella. The Dan- nated. This risk of disease vastly over- tory bowel conditions and regressive ish vaccination program recommends shadows the small inconvenience and developmental disorders, mostly autism, that the first dose is given between 12 extremely small risks associated with that appeared to begin after MMR vac- and 15 months of age and the second the vaccination. As it takes several days cination. Because the first signs of au- dose is given at 12 years. The type of to achieve the protective effect from a tism are often noticed by parents around MMR vaccine in Denmark used during vaccination, it may be too late to immu- the same time that the MMR vaccine is the study period is the same as the vac- nize when the first cases of a disease given, this may make parents worry that cine used in the United States. Vacci- occur in your environment. Besides, with the MMR vaccine caused autism. Sec- nation with MMR is recommended at high vaccination coverage in a popula- Continued on page 10 10 WINTER 2002/2003 SABIN VACCINE REPORT

study still had an unvaccinated group of SVR How common is autism in Den- Continued from page 9 almost 100,000 children. This made it mark? possible to compare vaccinated and un- KM The prevalence of autism in ond, it has been suggested that the ap- vaccinated children, which was not pos- Denmark is around 3 /1,000 children in parent rise in autism coincides with a sible in previous studies in which very eight year olds. That means that when rise in MMR vaccine coverage. few children were unvaccinated. children are eight years old 3 out of 1,000 will be diagnosed with autism. SVR Have other studies been done SVR Could there still be some chil- on MMR vaccine and autism? dren who could be harmed by the vac- SVR What message do you have KM Some epidemiological studies cine? for parents of children of vaccine- have tried to evaluate the connection KM In general the Danish study has age? For doctors, pediatricians and between MMR vaccination and autism. shown that MMR vaccination does not health care providers of children of None of the studies support an associa- increase the risk of autism. However, it vaccine-age? tion. has been speculated whether a small KM The Danish study of about a half vulnerable subgroup could exist. In the million children showed that MMR vac- SVR How is your study different/ Danish study, the fact that the risks for cination did not increase the risk for au- better than the previous studies? autism were the same between the vac- tism. The current scientific evidence, KM The Danish study is by far the cinated and unvaccinated children, re- based on this study and others, does not biggest study performed so far. It includ- gardless of the different ways that it was support the hypothesis that measles- ed about a half million children and more looked at, and that the study was very mumps-rubella (MMR) vaccine, or any than 700 autistic children. It thus had large, does not support the idea that a combination of vaccines, causes the sufficient power to examine a possible subgroup of vulnerable children exists. development of autism, including regres- connection between MMR vaccination However, further studies into the caus- sive forms of autism. and autism. Furthermore, the Danish es of autism, like what we are doing here The question about a possible link be- study used a population-based cohort and what is being done in the U.S., will tween MMR vaccine and autism has design. That type of design is superior help answer some of these important been extensively reviewed by indepen- to the designs that have been used to questions. dent groups of experts in the U.S. in- evaluate the hypothesis so far. In this cluding the National Academy of Sci- study all children born in Denmark from SVR How do you explain the on- ences, Institute of Medicine (IOM). January 1991 through December 1998 set of symptoms of autism at the same These reviews have concluded that the all were included. time that the MMR vaccine is given? available epidemiologic evidence does KM Although most children with not support a causal link between MMR SVR Why was Denmark a good autism have delayed development from vaccine and autism. The IOM commit- place to do this study? birth, it is often difficult to see signs of tee also did not suggest any need to KM In Denmark it is possible to do an ASD during the first year of a child’s change the current U.S. vaccination very large studies based on the whole life. The development of normal social schedule for MMR. However, because population. This is due to the extensive and communication skills and normal of some gaps in the scientific evidence, use of administrative registries that con- behaviors in infants and children is a the IOM committee also recommends tain information on all citizens through- complex process and takes place over further research because of the serious- out their lives, including information on a long period of time. As the skills that ness of the diseases prevented by the health and illness, medical care and life parents expect their young children to vaccine and the seriousness of autism. styles. These different registries can have become more complex, such as The Danish study aimed at providing also be linked very accurately with the beginning to say simple words around a some of that lacking scientific evidence. use of a unique personal identification year or so of age, then the problems that number that is used by all the registries. autistic children have may become more SVR Who paid for your study? So, by linking information on thousands, obvious to their parents. These first signs KM We received grants from the or millions, of people over time makes it of autism are often noticed by parents Danish National Research Foundation, possible to do large studies even of rel- around the same time that the MMR the National Vaccine Program Office atively rare health conditions such as vaccine is given. and National Immunization Program in autism. Another reason why Denmark the US, and the National Alliance for was a good place for this study was that SVR How many children were in- Autism Research, a private organization the vaccination coverage in Denmark cluded in your study? also in the U.S. has been rising in recent years but our KM About 500,000 (537,303 to be exact) SVR Thank you Dr. Madsen. dedicated to disease prevention www.sabin.org 11 Sabin Vaccine Institute Scientist Recognized with Top Panamanian Honor Award Presented in Appreciation for Collaboration on Tropical Medicine Center Dr. Allan L. Goldstein of the Sabin gional University of Veraguas, the Uni- the award. Dignitaries at the ceremony Vaccine Institute, headquartered in New versity of Panama and the Gorgas Med- included Dr. Fernando Gracias, Pana- Canaan, Connecticut, received Pana- ical Center in developing this new cen- ma’s Minister of Health, and Panama ma’s highest national honor during a visit ter for geographic medicine in Panama. Special Ambassador Dr. Adán Rios. The to that country earlier this month. The The international collaboration that es- honor given Dr. Goldstein carries the ti- decoration as “Commander” in the Or- tablished the center has the strong sup- tle Knight-Commander, is named for the der of Vasco Nuñez de Balboa was pre- port of Panamanian President Mireya Spanish explorer who trekked through sented to Dr. Goldstein at an awards Moscoso, who is committed to improve the jungles of what is now Panama in ceremony on December 6 in Santiago, the health of the citizens of Panama. A 1513 to become the first European to Panama. goal of the partnership is to create the see the eastern shore of the Pacific Dr. Goldstein is a board member of premier center for the study of tropical Ocean. The award has been given since the institute and also is chairman of Bio- diseases. 1941 to citizens and friends of Panama chemistry and Molecular Biology at The Dr. Jose Miguel Alemán, Panama’s who have made significant scientific or George Washington University (GW) in Minister of Foreign Affairs, presented artistic contributions to the country. Washington, D.C. The Panamanian gov- ernment cited Dr. Goldstein’s valuable contributions and personal dedication in the performance of his profession direct- ed to the preservation of human life throughout the world. The medal was presented at the inau- gural scientific meeting of the President Mireya Moscoso Center for Geograph- ic Medicine and Emerging Tropical Dis- eases, which is a collaborative project of Panamanian and U.S. institutions. The international center is directed by Peter Hotez, MD, PhD, Sabin Scientific Advisory Council chairman and chair- man of Microbiology and Tropical Med- icine at GW. “I am humbled by the great honor you have given me today,” said Dr. Goldstein. He dedicated the award to the thousands of young students and scientists from In Santiago, Panama, at the presentation ceremony are, from left, Dr. Fernando Gracia, both countries whose health research Panama’s Minister of Health, Dr. Allan L. Goldstein, recipient of the Order of Vasco Nuñez efforts do not gain such attention. de Balboa, and Dr. Jose Miguel Alemán, Panama’s Minister of Foreign Affairs. “These young people are my heroes and our future and I am hopeful that the sci- entific and medical center we are de- veloping here in Panama will make a difference in the training and education of these young scientists and clinicians and help them to do their work,” he said. Drs. Goldstein and Hotez are work- ing with U.S. colleagues from GW, Uni- versity of Texas Medical Branch, Tex- as Children’s Hospital, and Case West- ern Reserve University School of Med- icine, along with those of Panama’s Chicho Fabria Hospital, the Central Re- 12 WINTER 2002/2003 SABIN VACCINE REPORT Second Partners’ Meeting of GAVI Convenes in Senegal GAVI Calls Attention to Financing of Vaccine Programs for Developing World Nations Dakar, Senegal, was the venue for the world can make. “Vaccines are among watched a film documenting his 15-day, Second Partners’ Meeting of the Global the most cost-effective public health 560-kilometer trek across this small Hi- Alliance for Vaccines and Immunization interventions. Today, no child should die malayan kingdom to raise awareness of (GAVI) on November 20-22. Represen- from a vaccine-preventable disease. We immunization and public health and to tatives from international organizations, need to invest more—and more promote the Bhutan Health Trust Fund. developing country governments, indus- rationally—in vaccine coverage and He collected two million dollars in dona- try, research institutions, and philanthropy research, and ensure access in all tions, mainly from domestic sources in gathered to review strategies and lay corners of the globe.” this cash-strapped country. Dr. Ngedup plans for their shared assault on global Representatives of participating Min- emphasized that even aside from the diseases. istries of Health and Ministries of Fi- money raised, his walk impacted thou- GAVI was formed two years ago as a nance signed the Dakar Declaration, a sands of people’s lives with messages public-private partnership to address statement committing their countries to as simple as the value of hand-washing. worldwide concerns in disease control. the implementation of Financial He believes that even a country with a GAVI and its financial arm, the Vaccine Sustainability Plans for immunization, and small gross national product can achieve Fund, invited the world’s 75 poorest calling upon all governments to recog- a large “gross national happiness.” countries to submit proposals for immu- nize that “immunization and the But every country faces unique chal- nization financing. sustainability of immunization is a national lenges. Afghanistan provides a case in Of these, 55 countries have already priority, a global concern and a shared point. Dr. Suhaila Siddiq, the new Health received vaccines or cash support with responsibility.” Minister of Afghanistan, brought two a total value of $130 million, while oth- Advocacy was stressed as a key com- urgent requests to the GAVI leadership: ers have proposals pending. GAVI’s ponent of a minister’s job. Ministers of First, she explained that her country, award commitments total $900 million to Health shared tips with each other on while already approved for assistance in date. The Vaccine Fund was established how to lobby for immunization financing the “basic six” vaccines and approach- with $750 million from the Bill & Melinda within their governments, and Ministers ing the 50% immunization benchmark, Gates Foundation, supplemented by of Finance responded with their perspec- is suffering an epidemic of hepatitis B. grants from the governments of the tives on what kind of “sales job” it takes She therefore asked for accelerated ap- United States, the Netherlands, Norway, to loosen government purse-strings. proval for hep B vaccination support. the United Kingdom, Canada, Denmark, Social mobilization is equally important. A second problem is the administra- and Sweden, as well as private donors. An unusual example was seen in the tion of GAVI funds in a war-torn coun- The first priority identified by GAVI is efforts of Bhutan’s Minister of Health, try like hers. Currently, GAVI investment for every country to boost immunization Dr. Lyonpo Sangay Ngedup. Participants in Afghanistan is channeled through UN rates of the “basic six” vaccines: diphtheria, tetanus, pertussis, polio, measles, and BCG. Once a country has achieved 50% cover- age rates with these vaccines, it is eligible to apply for assistance with other vaccines such as yellow fever, hepatitis B, and Hib. During the Dakar meeting, UNICEF executive director and GAVI chair Carol Bellamy argued that expanding immuni- zation coverage is the Ministers of Health and of Finance, along with other delegates convened for the Second Partners’ Meeting of the best investment the Global Alliance for Vaccines and Immunization (GAVI) in Dakar, Senegal. dedicated to disease prevention www.sabin.org 13 UNICEF’s Bellamy Calls Immunization Best Investment World Health Ministers Tasked with Role of Immunization Advocacy agencies. Dr. Siddiqi felt that vaccines and received close scrutiny could be delivered with lower adminis- at the meeting. Delegates trative costs if the assistance were chan- debated whether it would neled directly to the Health Ministry. In ever be feasible to stop po- reply, GAVI executive secretary Dr. lio immunization, and how Tore Godal said that GAVI would con- the campaign infrastructure sider her request, but a non-governmen- could be applied to a tal organization such as UNICEF would stepped-up measles control still be needed to reach populations liv- initiative. Some delegates ing in rebel-held zones outside the argued that the emphasis on government’s control. polio eradication had come The worldwide polio eradication cam- at the expense of more paign has been central to GAVI efforts pressing disease problems in their countries and argued for more flexible ap- proaches. There were impassioned pleas for more research to- ward malaria and AIDS vaccines. The prospects for future vaccines were dis- cussed in a breakout ses- sion, while other sessions examined issues such as the regulatory process for new vaccines and logistical prob- lems in vaccine delivery. Also released at the meeting was the tion and presents the remaining chal- report State of the World’s Vaccines lenges of the access gaps and emerging and Immunization, a joint publication of and neglected diseases. It also outlines the World Health Organization, UNICEF the vaccines research agenda for the and the World Bank. This is a long- 21st century, including the expanding awaited update of the first edition pub- role of alliances between the public lished in 1996. The report examines the and private sectors. It is available free progress made in the field of immuniza- of charge from UNICEF in English, French, or Spanish; ISBN: 92 4 154578 X. Email requests to [email protected]. It also can be be down- loaded from www.unicef.org.

—by David Bedell

David Bedell, Sabin Vaccine In- stitute, left, with Dr. Yankuba Kassama, Gambian Minister of Health. 14 WINTER 2002/2003 SABIN VACCINE REPORT FDR’s Hidden Campaign Study Sheds New Light on One of the Greatest Cover-Ups in U.S. History

An age in when the media uncovers mation, and a level of medical treatment BOOK more about politicians and government below what would have been provided officials than we may necessarily want another citizen,” Evans explains. “The REVIEW or need to know, when little goes unre- medical history of Roosevelt offers par- corded, unreported or unanalyzed, it’s adoxes, enigmas, and conflicts which eral population. Critics have always hard to imagine that the death of Frank- parallel, and are interwoven, with the charged that in 1944 the Democrats ran lin D. Roosevelt was a shock to a na- larger tapestry of his presidential ca- a dead man whose health undermined tion during one of the most pivotal mo- reer.” negotiations with the Soviets on the ments in U.S. history. Despite his iconic In this comprehensive study of one of postwar world order at Yalta in early status, President Roosevelt, at 62 years the most loved and iconoclastic leaders 1945, the year of the President’s death. old, was deathly ill – a fact that was care- of the 20th century, Evans points out the This volume makes it clear that FDR fully shielded from the American public extent to which modern medicine fails boasted excellent health at least during during the election of 1944. in the context of extraordinary celebrity his first two terms and that he generally In The Hidden Campaign, a study 10 and national need. Drawing on the med- enjoyed himself until the end, despite years in the making, Dr. Hugh Evans ical notes of the physician treating suffering from serious hypertension. explores the efforts to conceal the truth Roosevelt at the time, and in-depth in- Evans points out that both the presiden- about Roosevelt’s declining health from terviews with FDR’s cardiologist as well tial and vice-presidential candidates on the American public, the world—even as other key figures and confidants of the 1940 Republican ticket, seemingly from some of his own staff. Dr. Evans the World War II era, The Hidden Cam- in robust health, died in 1944. takes a medical ethics perspective of paign reveals fascinating new insights FDR’s 12 years in office, with a focus into one of the most successful cover- —review by Veronica Korn on the wartime pressures and politics ups in U.S. history. ISBN: 0-7656-0855-3 that pushed him into a fourth campaign, Evans goes on to explain the impact 2002, M.E. Sharpe, Inc., Armonk, NY compromised his health, and ultimately and relevance of FDR’s administration led to his death. today, calling into question the role of “There was ignorance, denial, a de- the White House physician, with an em- About The Author liberate campaign of misinfor- phasis on how full, timely disclo- sure by neutral, nongovernmen- Hugh Evans, M.D., author of The tal physicians is nothing short of Hidden Campaign, is a well- imperative in the nuclear era, known clinician, educator, re- particularly in light of recent searcher and administrator whose events. career spans four decades. He has “The scenario that played out published over 140 peer-reviewed across the nation and the world articles, a medical textbook, and sends a clear warning for the fu- numerous abstracts. As a grand ture,” says Evans. “The public’s rounds speaker, he has been an right to know the facts of high- associate director, director and risk illness in a chief executive chairman of academic depart- should be paramount, transcend- ments. Dr. Evans has served on ing the ‘privacy rights’ of the numerous regional and national president or presidential candi- committees, and has chaired a date. While events evolved fa- committee of The American Acad- vorably in 1944-45, the potential emy of Pediatrics. His research on consequences of future cover- the medical history of FDR, which ups are likely to be more devas- represents a decade of focused tating.” study, has been presented to nu- The Presidency is a “killing merous professional and commu- job” for its occupant. On aver- nity groups and noted on television. age, presidents die much earlier than their counterparts in the gen- dedicated to disease prevention www.sabin.org 15 CHOP Video Series Provides Immunization Guidance to Parents The Children’s Hospital of Philadelphia Introduces Parent Resource About Importance of Vaccines

The Vaccine Education Center at the sured when they learn of the rigorous ies for $5 each; others may purchase Children’s Hospital of Philadelphia testing and evaluation involved in the the video for $5 by emailing (CHOP) has introduced a new parent development of the vaccines to make [email protected] or calling education resource entitled Vaccines them safe.” CHOP at 215-590-9990. and Your Baby, a 28-minute video de- According to Dr. Offit, a decision not signed to answer frequently asked ques- to have a child vaccinated presents tions about immunization. The video cov- much greater risks and therefore, Vac- ers common questions including how cines and Your Baby includes vignettes vaccines are made, how they protect about the adverse outcomes for fami- against disease and how they are regu- lies who did not have their kids immu- lated and tested for safety. A parent nized based on misperceptions about handbook accompanies the video and vaccine safety. outlines major childhood illnesses, which With many once-common childhood are now preventable through the mira- disease now virtually eliminated and cle of vaccines. widely unseen, substantial numbers of Paul A. Offit, MD, chief of Infectious parents today question whether particu- Diseases and director of the Vaccine lar vaccines are still necessary. Many Education Center at The Children’s times these doubts are fueled by inac- Hospital of Philadelphia, says “Well-doc- curate or scientifically questionable in- umented scientific evidence overwhelm- formation. ingly supports the protective qualities of The Children’s Hospital of Philadel- vaccines, yet some parents resist immu- phia founded the Vaccine Education nization for their children. For parents Center in 2000 to educate healthcare to make the best decisions about their professionals and the public by provid- children’s health, it is essential they un- ing complete, up-to-date, science-based derstand the nature of vaccines and how information about vaccines and the dis- they work, the diseases they prevent eases they prevent. Depicted is the first of two educational videos sand why it is so important to immunize Pediatricians may obtain their first two produced by CHOP on the importance of against diseases. Parents will be reas- copies at no charge and subsequent cop- immunization. Their latest in the series is titled “Vaccines and Your Baby.” Institute Volunteer Appreciation SAVE THE DATE Volunteers provide welcome assistance at the Vaccine Institute headquarters. Recent volunteers include: • Brett Wasserman, Port Chester, New York, who solved a number of computer problems and wired Wednesday, May 14, 2003 computer networks. • George Holland, Danbury, Sabin Vaccine Institute Connecticut who lent a hand to update the Library Files Database. Annual Awards Dinner Thank you Brett and George! Anyone interested in volunteering in the New Canaan office can contact Vanessa The Pierre Hotel Santiago at 203-972-7907 or New York City [email protected]. 16 WINTER 2002/2003 SABIN VACCINE REPORT

Vaccine Supply Colloquium SABIN Placed in Context CALENDAR Keynote Remarks from Kevin Reilly, from page 7 JANUARY 2003 [email protected] 7 – 13 Snowbird, Utah www.cdc.gov/nip/nic money for both producing vaccines and dis- Mechanisms of Immunologic covering new and improved vaccines. Tolerance and Its Breakdown 20 - 22 San Jose, California “Vaccines are difficult,” Reilly said. “Vac- Snowbird Resort 11th Infant Development Association cines have more production problems than (CME credit offered.) of California Conference any other category in any pharmaceutical or Phone: 800-253-0685 Fairmont Hotel [email protected] Phone: 916-453-8801 medical area. You are working with biologi- www.symposia.com www.idnofcal.org cal processes, not with chemical processes, and it is just a tougher activity to manage.” 25 - 30 Taos, New Mexico 28 - April 4 Banff, Alberta, Canada Mr. Reilly placed security of vaccine supply Tuberculosis: Integrating Host and 2003 Fellows and New Investigators and price in the context of the past 30 years. Pathogen Biology Workshop on HIV-(Concurrent with Business decisions in the industry have dur- Sagebrush Inn and Conference Center 2003 Keystone Symposia, Twenty ing that time been governed according to www.symposia.com Years of HIV Research and HIV three thresholds: an operating level, a capital [email protected] Vaccine Development) level, and a discovery level. Fairmont Banff Springs Hotel To illustrate this point, he suggested that FEBRUARY 2003 National Institute of Allergy and 13-16 Lorne, Victoria, Australia Infectious Diseases/ the threshold for operating a vaccine manu- 15th Lorne Cancer Conference National Institutes of Health facturing operation at a given capacity of pro- Erskine on the Beach, Lorne, Phone: 800-253-0685 / 970-262-1230 duction might not be exceeded under cir- Phone: 61 3 9496 3548 Fax: 970-262-1525 cumstances as normal production and per- Fax: 61 3 9496 3577 [email protected] haps with tiered pricing. However, if called [email protected] www.symposia.com upon to invest in new facilities or to make www.ludwig.edu/lorne expensive innovations, the threshold could APRIL 2003 be exceeded. Far more market return would MARCH 2003 7-9 Montreal, Canada be warranted if capital investment would be 5-8 Walker’s Cay, Bahamas World Vaccine Conference Montreal required to increase capacity or for mandat- 5th Annual Sabin Colloquium on Hilton Montreal Bonaventure Cancer Vaccines and Immunotherapy www.pharma-rd.net/2003/wvc_CA/ ed regulatory requirements. Such thresholds [email protected] govern the vaccine manufacturing business www.sabin.org/pub_cancer.htm 30 - May 2 Bethesda, MD and guide business decisions. Ninth National Symposium: Basic With a measure of reassurance, Reilly ex- 17-20 Chicago, Illinois Aspects of Vaccines plained that every company confronting a de- The 37th Annual National wrair-www.army.mil/News&Events/ cision whether or not to discontinue a prod- Immunization Conference 9symposia/dmbsym.htm uct, be it a pharmaceutical or a vaccine, will Sheraton Chicago Hotel and Towers [email protected] assess if there is a medical need that will be Contact: Suzanne Johnson-DeLeon left unmet. “If you have a marketplace for Phone: 404-639-8225 vaccines that is not huge, I am not sure you can expect to see three or four suppliers in NON-PROFIT ORG. there, all fighting for a share of that,” Reilly U.S. POSTAGE said. “So, in a way, with old product it is not PAID very surprising to see a reducing number of MONTROSE, PA suppliers.” PERMIT NO. 2 Reilly suggests that despite consolidations 58 Pine Street RETURN SERVICE REQUESTED among the vaccine manufacturers supplying New Canaan, CT 06840 the global market, a core of companies that U.S.A. are committed to vaccines have kept most production facilities operational. These com- panies, however, are dealing with economics and dynamics of manufacturing vaccines that have changed.