Post00262b VACCINES & IMMUNIZATION NEWS 29 June 2000 CONTENTS 1. GAVI NEWS 2. VACCINE NEWS 3. DISEASE CONTROL NEWS 4. TRAVEL IMMUNIZATION 1. GAVI NEWS ___________________________________________________________________________ "Kenya Signs Vaccines Treaty" Kenya Daily Nation Online (http://www.nationaudio.com) (06/28/00) Kenya has become one of the first African nations to sign on with the Global Alliance for Vaccines and Immunizations' campaign to immunize all children worldwide. Public Health Minister Sam Ongeri signed the document. The five-year campaign, called The Children's Challenge, will help countries with little purchasing power to buy vaccines and syringes. Ongeri said the program should reduce the infant and childhood mortality rates in Kenya. GAVI will help by addressing the need of under-immunized children and new vaccines for hepatitis B, yellow fever, and haemophilus influenzae type B. --- "Norway Pledges Funds at Global Immunization Seminar" Associated Press (http://www.ap.org) (06/13/00) Norway has pledged $115 million over five years for the Global Alliance for Vaccines and Immunization (GAVI). At a seminar of vaccination in Oslo on Tuesday, Prime Minister Jens Stoltenberg noted that six children die every minute of preventable diseases. --- "WHO Chief Urges Fight Against Diseases" Reuters (http://www.reuters.com) (06/13/00) Gro Harlem Brundtland, director-general of the World Health Organization, has called for more action to fight such diseases as measles, malaria, tuberculosis, and AIDS, which kill 14 million people a year. Brundtland, who spoke Tuesday at a board meeting of the Global Alliance of Vaccines and Immunization (GAVI) in Oslo, noted that vaccines could have saved 3 million of those lives, as almost 1 million children die of measles alone each year. GAVI's Global Fund for Children's Vaccines expects to begin disbursements next month, aided by a $750 million grant from the Bill and Melinda Gates Foundation. --- "The Introduction of New Vaccines Into Developing Countries" Vaccine Online (http://www.elsevier.com:80/inca/publications/store/3/0/5/2/1) (06/01/00) Vol. 18, No. 24, P. 2625; Mahoney, Richard T.; Ramachandran, S.; Xu, Zhi-Yi Developing new vaccines for childhood diseases is necessary to control disease and save lives, but the cost of such vaccines is problematic for developing nations. Researchers from the International Vaccine Institute in South Korea discuss the allocation of funds like the William H. Gates Foundation's Global Fund for Children's Vaccines. They recommend a Vaccine Procurement Baseline, which would have a minimum of 0.01 percent of gross national product as a sum that each developing nation would set aside for its own vaccine purchases. The so-called Global Funds would be used to make up the difference in funding. Based on the Global Funds requirements for hepatitis B and Haemophilus influenzae type B (Hib) vaccines, the researchers conclude that, after an initial starting period, developing nations would need about $62 million for hepatitis B and $282 million for Hib at today's prices. --- "New Vaccines for the Poor" New York Times (http://www.nytimes.com) (03/14/00) P. A28 President Clinton's new budget includes a plan that would encourage pharmaceutical companies to develop vaccines for poor nations, note the editors of the New York Times. Millions of people die every year from AIDS, malaria, and tuberculosis; the majority of these individuals are poor and cannot pay for drug treatments. Under Clinton's proposal, drug companies would receive a targeted tax credit as an incentive for vaccine research. The companies would be given one dollar of credit for each dollar of sales of new vaccines they make to nonprofit groups in poor nations. The plan should cost $1 billion for nine years and would be restricted to new vaccines for malaria and infectious diseases that kill over 1 million people a year. --- "UNICEF: Universal Child Immunization" M2 Presswire (03/03/00) UNICEF Executive Director Carol Bellamy has praised President Clinton for helping the global effort to immunize children, as his leadership sparked a meeting at the White house. Bellamy also thanked the pharmaceuticals industry for giving funds for research into vaccines for poor countries; however, she noted that corporate donations represent little of the required resources. Bellamy said that vaccine groups should still focus on the challenges of giving children the "basic six" shots and on investing in vaccines for HIV, malaria, and tuberculosis. UNICEF is the world's largest buyer of vaccines for developing nations, spending over $100 million a year on vaccines and safe injection equipment. ---- "Merck & Co. Will Pledge $100 Million of Vaccines to World's Poorest Children" Wall Street Journal (http://www.wsj.com) (03/02/00) P. B2; Harris, Gardiner; Waldholz, Michael The chairman of Merck, Raymond Gilmartin, is to announce today at a meeting with President Clinton and leaders of three other top pharmaceutical companies that Merck will donate $100 million worth of vaccines to be used by children in the poorest nations of the world. While Merck's donation, which will be used to vaccinate against hepatitis B in sub-Saharan Africa, will probably be the largest, American Home Products, SmithKline Beecham, and Aventis Pharma will also donate vaccines for the prevention of meningitis, malaria, elephantiasis, and polio. Other efforts on part of the four companies to treat disease with vaccines include pledges to conduct additional vaccine research, especially work in the area of AIDS, and the joining of a group of government, healthcare, and nonprofit institutions interested in increased research for vaccines. American Home is expected to donate 10 million doses of a meningitis and pneumonia vaccine valued at $40 million retail, Aventis is expected to contribute 50 million doses of a polio vaccine, and SmithKline is expected to announce increased child trials for its malaria vaccine. --- Drug Companies Donate Vaccines 01:37 PM ET 03/02/00 By TERENCE HUNT= AP White House Correspondent= WASHINGTON (AP) _ Heeding a White House call, four major drug companies donated millions of doses of vaccines to combat malaria, hepatitis B, polio and other dreaded diseases in Africa and other troubled regions of the world. ``Today we're beginning a partnership to eradicate the leading infectious killers of our time,'' President Clinton said after meeting with leaders of pharmaceutical and biotechnology companies, public health foundations and international organizations in the Cabinet Room. The donations, valued at more than $150 million, aimed to accelerate the development of vaccines for troubled countries in Africa, Asia, the Caribbean and elsewhere. Clinton said meeting participants agreed to emphasize ``speeding the delivery of existing vaccines'' and to address the ``lack of incentive for private industry to invest in new vaccines for people who simply can't afford to buy them.'' The four companies also pledged to step up research and development on vaccines for HIV/AIDS and malaria. Clinton has proposed a $1 billion tax credit over 10 years to encourage the development of such vaccines. Infectious diseases kill more than 8 million children worldwide and orphan millions more annually. In Africa, 10 times as many people died from AIDS last year as were killed in wars. UNICEF executive director Carol Bellamy said last month that AIDS is turning parts of Africa into ``a killing field,'' leaving 11 million orphans, a figure expected to rise to 13 million within the year. The pledges to be announced today, according to an official familiar with the program, were: Merck will donate 1 million doses a year of RECOMBIVAX _HB, a vaccine to prevent hepatitis B, for five years. The vaccine is valued at $100 million. American Home Products Corp. will donate 10 million doses of Haemophilus influenza type-B conjugate vaccine to UNICEF. Officials said it should protect more than 3 million children in developing countries from one of the leading causes of pneumonia and meningitis. SmithKline Beecham will expand its malaria vaccine program and begin vaccine trials in Africa for children, starting in Gambia as early as next fall. Aventis will donate 50 million doses of polio vaccine in Africa to support the World Health Organization- and UNICEF-led campaign to eliminate polio in five war-torn African nations. Clinton was to direct Health and Human Services Secretary Donna Shalala to convene a meeting of representatives from industry, government and the academic world to address obstacles to vaccine development and to strengthen public-private partnerships. The president has asked Congress for $150 million for vaccine research and prevention programs in Africa, where about 2.2 million people died from AIDS in 1998. In today's meeting, Clinton was to recognize the $750 million contribution of the Bill and Melinda Gates Foundation to the vaccine purchase fund of the Global Alliance for Vaccines and Immunization. The president also was to acknowledge public-private partnerships such as the International AIDS Vaccine Initiative, which is investing more than $10 million this year to triple the number of AIDS vaccine candidates it is moving toward trials. ---- "Consortium Aims to Kick-Start TB Research" Nature (http://www.nature.com) (02/17/00) Vol. 403, No. 6771, P. 692; Butler, Declan The Global Alliance for TB Drug Development has announced plans to have a draft a scientific blueprint by June 2000. The alliance recently convened for the first time, at a meeting in Cape Town, South Africa, organized by the Rockefeller Foundation and co-sponsored by the U.S. National Institutes of Health, the Bill and Melinda Gates Foundation, the Wellcome Trust, the World Health Organization (WHO), the World Bank, and the U.S. Centers for Disease Control and Prevention, among others. The newly formed consortium of scientists, donor agencies, and drug companies hopes to reach a consensus on tuberculosis (TB) research priorities and on funding for member institutions. The alliance also plans to prepare a pharmaco- economics report later this year to assess both the market size for TB drugs and gaps in corporate research and development. --- "Gates Children's Vaccine Program and Partners Fight Misinformation on Web" PRNewswire (02/23/00) A new "web ring" called the Allied Vaccine Group has been established to improve access to reliable, science-based data about immunization and vaccines. The site, located at http://www.vaccine.org, offers up-to-date information about vaccines for a variety of users, including teenagers, parents, medical practitioners, and policymakers. The members of the Allied Vaccine Group are the Bill and Melinda Gates Children's Vaccine Program at PATH, the International Vaccine Institute in Seoul, Korea, the National Network for Immunization Information, and the Vaccine Page. The group was formed in response to the many Web sites that offer unreliable information about vaccines, which can confuse parents and result in delays in children receiving necessary shots. ---- "Immunization Focus" GAVI Special Announcement (05/16/00) The Global Alliance for Vaccines and Immunization (GAVI) has launched a new quarterly publication called Immunization Focus. The objective of the periodical, which will be sent via email for free, is to keep health and immunization policymakers up-to-date on the latest issues in the news and in vaccine development, emphasizing policy and research that is relevant to developing nations. To subscribe to Immunization Focus, which will require Adobe Acrobat Reader to view, send an email to [[email protected]][email protected][/email] with "subscribe gavi" in the first line of the message. The journal will also be posted on GAVI's Web site, located at http://www.vaccinealliance.org. Members of GAVI--a newly formed coalition of public and private organizations working toward the goal of universal childhood immunization--include United Nations agencies, the World Bank Group, national governments, and the Bill and Melinda Gates Children's Vaccine Program. --- MSNBC: 18 May 2000 WORLD BANK: Bill & Melinda Gates Foundation announces new global health grant to eradicate Guinea worm disease; Grant to be channeled through World Bank Trust Fund GENEVA The Bill & Melinda Gates Foundation today announced a global health grant of US$28.5 million to accelerate the eradication of Guinea worm disease, a painful and debilitating disease caused by an infection from contaminated drinking water. The grant, announced here at the 53rd World Health Assembly-the highest governing body meeting of the World Health Organization (WHO)-will go to several organizations that are leading the eradication effort. "This grant will help accelerate the incredible effort of four organizations that are winning the war on Guinea worm," said Bill Foege, Senior Health Advisor to the Global Health Program at the Foundation. "Guinea worm disease can be defeated, and I look forward to the day when the last case is certified." "The Bill & Melinda Gates Foundation once again has demonstrated an extraordinary commitment to improving health in the developing world," said former US President Jimmy Carter, Chairman of the non-profit Carter Center. "This grant will go a long way toward the final assault on Guinea worm disease, which has caused immense suffering among millions of people for thousands of years. I am extremely grateful to the Bill & Melinda Gates Foundation and look forward to working with our partner organizations and with the governments of endemic countries, who must remain committed to making this disease just a painful memory." The campaign to eradicate dracunculiasis (Guinea worm disease) has been spearheaded by the Global 2000 Program of The Carter Center and the Centers for Disease Control and Prevention, in close collaboration with WHO and UNICEF. The "Grand Coalition" also includes the World Bank, numerous bilateral and multilateral assistance agencies, private corporations, and foundations, all in support of village-based volunteer health workers. The campaign has already reduced the number of reported cases of the disease by 97 percent, from an estimated 3.2 million in 1986 to less than 100,000 cases in 1999. The number of affected countries has also been reduced from 20 to 13. Asia is now completely free of the parasite. The remaining endemic countries, all in Sub-Saharan Africa, are: Benin, Burkina Faso, Central African Republic, C'te d'Ivoire, Ethiopia, Ghana, Mali, Mauritania, Niger, Nigeria, Sudan, Togo and Uganda. People become infected when they drink water contaminated with tiny water fleas carrying Guinea worm larvae. Inside the body, the larvae mature and grow to as long as three feet. After about a year, the threadlike worm emerges slowly through a painful blister in the skin, most commonly on the foot. Many victims immerse the affected area in water to soothe the pain, causing the female worm to release more larvae and beginning the cycle again. Although Guinea worm disease cannot be cured, it can be prevented by teaching infected persons not to contaminate drinking water sources, by straining drinking water through a cloth filter, treating ponds with a chemical that kills the larvae, or providing water wells. The US$28.5 million grant will be channelled through the World Bank Trust Fund established to support this comprehensive eradication campaign. The designated recipients follow: -- The Carter Center - US$15 million The Carter Center (http://www.cartercenter.org) has primary responsibility among the external partners to assist the remaining endemic countries in eradicating this disease. The Carter Center is also designated as the coordinating non- governmental organization for Guinea worm disease eradication activities in the coalition of humanitarian groups working in southern Sudan. -- The World Bank - US$8.5 million The World Bank (http://www.worldbank.org) will manage this portion of the World Bank Trust Fund, by consensus agreement of the World Bank, The Carter Center, WHO, and UNICEF, to provide support for participation in this initiative by the Centers for Disease Control and Prevention, and the US Peace Corps, for contingencies; and for other expenditures pertaining to Guinea worm eradication. -- The World Health Organization - US$5 million WHO (http://www.who.int) will be responsible for eradication certification. WHO will also assume primary responsibility for assistance to countries in pre-certification stage, including still-endemic countries that report 100 cases or less during a calendar year. Pre-certification countries currently include Cameroon, Central African Republic, Chad, Kenya, Senegal and Yemen. WHO will also facilitate convening a program managers' meeting annually in March and Program Reviews for smaller groups of countries in the latter part of each year, in close cooperation with the other major partners. -- UNICEF - To be determined UNICEF (http://www.unicef.org) will have primary responsibility among the external partners for helping all national programs to bring the water supply sector to bear in endemic villages as quickly and effectively as possible. This includes helping programs to coordinate provision of new water supplies and rehabilitation of existing ones by all parties in endemic communities. Priority will be given to the highest endemic countries, especially Nigeria and Ghana. UNICEF will continue to support health education and social mobilization activities in all endemic countries. CONTACT: Subrata S. Dhar Tel: +1 202 458 8345 e-mail: [[email protected]][email protected][/email] ____________________________________*______________________________________ 2. VACCINE NEWS ___________________________________________________________________________ "Britain Boosts Vaccine Compensation Scheme" Reuters (http://www.reuters.com) (06/27/00) The British government will extend compensation for people who have been disabled by vaccines. In the past 30 years, hundreds of children have experienced brain damage as the result of government vaccination programs for diseases like whooping cough, polio, and measles. The payment threshold will increase from 40,000 pounds to 100,000 pounds (about $150). Social Security Secretary Alistair Darling stated the changes in policy will cost 60 million pounds in all. --- Vaccine disabled payments boost (ITN 27/06/2000) Cash payments to children disabled by vaccines given on the NHS are to be more than doubled to ?100,000, the Government has announced. MPs cheered in the Commons as Social Security Secretary Alistair Darling unveiled the ?60 million package and said he would extend the time limit for claims. In a statement, welcomed by the Opposition, Mr Darling said the disablement threshold would also be cut to make it easier for injured children to qualify. The move follows a two year review of the vaccine damage payment scheme, set up in 1979 and criticised by campaigners in recent years as wholly inadequate. "Nothing can make up for what has happened to these children," Mr Darling said. "But we have a clear duty to support them and their families." Ministers have been under cross party pressure to speed up the review of payments. Announcing the results, Mr Darling said the six-year limit on making claims was too short and should be raised to any time up to the age of 21. He said the "disability threshold" which people must cross before getting payments will be lowered from 80 percent to 60 per cent. Both measures would require legislation, which would be introduced at the earliest available opportunity."The Government recognises that caring for people who have suffered damage puts a considerable burden on their families and carers," he said. In 1998 the payment per child had been raised from ?30,000 to ?40,000. "That is too low. So I propose that the sum payable to each individual should be raised to ?100,000 for all new cases." Those who had already received lump sum payments would get "top up" payments to put them on an equal footing with new claimants. "These payments for the 900 existing recipients will range from ?58,000 to ?67, 000." Shadow Social Security Secretary David Willetts welcomed the changes, saying: "We do recognise the need for a generous and sensible settlement for this grievance." But he criticised the time taken to complete the review, asking: "After so much delay and so many promised reviews, will you legislate before the next election?" Mr Willetts promised that the Tories would co-operate with any legislation brought forward by the Government, giving it a "full and fair passage". Mr Darling told him: "When you consider the children we are dealing with here, I do not think it is the stuff of knock about politics." He said the pharmaceutical industry had not been very "enthusiastic" about part funding a payment scheme. Rather than take several years to resolve the matter, ministers had decided it would be far better to press ahead with their own improvements to the scheme. Ian Stewart, Labour MP for Eccles, who has led the campaign on behalf of vaccine-damaged children, congratulated the Minister for his statement. "The first thing we have to say is that the vaccine programme has been a great success." Mr Stewart: "This statement will be welcomed by the parent groups and the families. This isn't just about the individual who has been damaged, it is a whole family issue and these proposals go a long way towards meeting the `immediate help those families need. "The issue is not finished here. This is about the payments scheme only. The issue of compensation now needs to be addressed." Welcome to ITN Online, Britain's leading multimedia news site. If you are a first time visitor you will find up to the minute coverage of breaking sports stories and today's other news stories from ITN's reporters in Britain and around the world: click here. Also visit Desktop News to receive your own personalised news and video to your email address at the time you want. --- "Vaccine Injuries Have Cost Gov't $1 Bil in Compensation So Far" Investor's Business Daily (http://www.investors.com) (05/30/00) P. A2 A new report from FedBuzz indicates that some 1,700 of the 11,000 vaccine side effects reported every year are deemed serious. FedBuzz has listed the government's database of all reported adverse reactions to vaccines on its Web site, http://www.fedbuzz.com. The report also indicates that the government's Vaccine Injury Compensation Program has paid out $1 billion since 1998. --- "A Brief History of Polio Vaccines" Science (http://www.sciencemag.org) (06/02/00) Vol. 288, No. 5471, P. 1593; Blume, Stuart; Geesink, Ingrid The global goal to eradicate polio was set in 1988, decades after Jonas Salk and Albert Sabin created the first polio vaccines. While the future holds the promise of being polio-free, the history of polio vaccine development should not be forgotten. One reason for this is the recent hypothesis that HIV developed from a simian virus that tainted early stocks of polio vaccine being tested in the Congo during the 1950s. As a result, it has been suggested that the last few batches of the original polio supplies used in those studies be tested for HIV. Another reason to highlight the polio vaccine's history is that the U.S. Advisory Committee for Immunization Practices recommended that, starting this January, American children should be given Salk's inactivated polio vaccine instead of the oral polio vaccine that Sabin developed and which has been used in this country for the past several decades. During the 1950s, it was argued that only a live-attenuated vaccine could provide long-term protection. Sabin's vaccine was labeled as more effective and easy to administer through a sugar cube. However, instances have show that the oral, live vaccine could lead to cases of the disease rather than protect from it. Even so, by 1968, Salk's vaccine was no longer in use in America, while the Netherlands continued to use it exclusively. Starting in the mid-1960s, health experts started to debate the benefits of the live vaccine compared to the small risks of it. The cost of switching back to Salk's vaccine was also a consideration, and public confidence needed to be upheld. The Netherlands insisted on using the Salk vaccine and began to improve it, shipping it today to the United States. The improvements in the Salk vaccine came from a Dutch commitment to maintaining their immunization schedule and techniques that reduced their reliance on monkeys for testing the vaccine. --- "Spud-Based Vaccine May Prevent the Runs" Reuters Health Information Services (http://www.reutershealth.com) (05/29/00) A study by Dr. Charles Arntzen of the Boyce Thompson Institute for Plant Research in Ithaca and colleagues shows that potatoes modified with the Norwalk virus can protect humans against most cases of diarrhea. Bioengineered potatoes may hold an answer to an oral vaccine that can prevent diarrhea. Arntzen reported at the recent annual meeting of the American Society for Microbiology that 19 of 20 volunteers who ate the modified potatoes generated serum and mucosal antibodies to the Norwalk virus. The researchers hope to conduct another U.S. trial, and if that is successful, they may launch a test in which volunteers would be challenged with the virus. --- "Veggie Vaccines vs Cholera in the Offing, Researcher Says" Jerusalem Post (http://www.jpost.com) (05/18/00) P. 5; Siegel, Judy Charles Arntzen, a genetic engineering expert at Cornell University, spoke at a symposium for the Hebrew University's 75th anniversary about work on edible vaccines. He stated that genetically modified potatoes could be the answer for a cheap vaccine against diarrheal diseases. Tests in Baltimore indicated that the specially engineered potatoes boosted children's antibodies against enteric diseases and may reduce the diseases' impact. Arntzen is currently working on vaccines against cholera and Norwalk virus, and he noted that bananas may ultimately serve as the most useful plant- based vaccine, but more research is needed. --- "Vaccine Delivered by Fork, Not Needle" New York Times (http://www.nytimes.com) (05/14/00) P. 26; Pollack, Andrew The edible vaccine underwent some of its first clinical trials last year in Baltimore. Scientists are seeking ways to deliver vaccines through eating bananas, tomato paste, or crackers. John Howard, chief executive of ProdiGene, is working on an edible vaccine in corn, which would be useful in developing countries. Dr. Hilary Koprowski of Thomas Jefferson University and scientists in Poland have made a hepatitis B vaccine found in lettuce. It is important the foods chosen be eaten raw, and scientists hope to create an edible vaccine that requires no refrigeration. The edible vaccine would also make it easier on children who refuse needles. ---- "Chickenpox Raises Risk of Dangerous Strep Infection" Reuters Health Information Services (05/02/00) A study published in the online version of the journal Pediatrics suggests that the chickenpox vaccine could prevent as much as 15 percent of cases of a possibly fatal streptococcal infection, and the authors call for universal chickenpox vaccination for children. The researchers, who studied the medical records of 2.5 million children and 8.5 million adults in Ontario over the course of five years, concluded that vaccination against the chickenpox could substantially reduce the number of group A streptococcal (GAS) infections, which occur in many children who have chickenpox. GAS can cause conditions like necrotizing fasciitis and streptococcal toxic shock syndrome (STSS). The researchers from the Universities of Calgary and Toronto in Canada and the Centers for Disease Control and Prevention also found that children had lower rates of STSS and death from chickenpox than adults. --- "Health Consequences of Exemptions From Immunization Laws" Journal of the American Medical Association (http://www.jama.com) (03/01/00) Vol. 283, No. 9, P. 1141; Salmon, Daniel A.; Gangarosa, Eugene J.; Chen, Robert T. In response to two letters to the editor regarding a 1999 Journal of the American Medical Association article on the health consequences of religious and philosophical exemptions from vaccination laws, the authors of the article, led by Daniel A. Salmon of Johns Hopkins University, explain their position. Salmon et al. note that while some parents feel their decision is in the best interest of the child, their research revealed a 35 times greater risk of measles to exemptors compared with nonexemptors, and a higher risk to the community. Furthermore, they point out that the "success of immunization programs in preventing disease has been well demonstrated worldwide, as has the consequent resurgent disease when too few are immunized." In conclusion, the authors write that their previous recommendation that "public health surveillance for [vaccine- preventable diseases] should routinely monitor exemption status among new VPD cases," is intended to help safeguard the public by showing the consequences of not being vaccinated. --- Study Confirms New Vaccine Effective Against Invasive Pneumococcal Disease And Ear Infections PHILADELPHIA, March 16 /PRNewswire/ via NewsEdge Corporation - A study published in this month's issue of The Pediatric Infectious Disease Journal confirms that a newly approved vaccine is at least 90% effective in preventing invasive pneumococcal disease in young children. The study also shows that the vaccine, Prevnar(TM), reduced common ear infections by 7%, multiple ear infections by 23%, and the need for ear tubes by 20%. Invasive pneumococcal disease includes bacteremia (bloodstream infection) and bacterial meningitis, a potentially fatal infection in the brain or spinal cord. Children who survive meningitis can be left with life-long disabilities such as deafness, impaired vision, seizures and mental retardation. The pneumococcus bacteria, also known as Streptococcus pneumoniae, is also a major cause of bacterial pneumonia, sinusitis, and otitis media (ear infection). In the United States, infants and young children are at greatest risk for invasive pneumococcal disease, with more than 16,000 cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis reported annually in children under five. There are more than 5 million cases of otitis media in young children every year, resulting in 27 million doctor visits. Annually, pneumococcal disease in children costs the healthcare system an estimated $1.5 billion. "These study results are great news for children, parents and pediatricians," said George McCracken, Jr., M.D., Professor of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, and editor of The Pediatric Infectious Disease Journal. "The results indicate that we can now prevent nearly all invasive pneumococcal disease in children and a substantial number of ear infections as well. That's important because many of these infections are becoming resistant to the antibiotics we have traditionally used to treat them." The three-year, Phase III clinical trial involved nearly 38,000 children at 23 Kaiser Permanente sites throughout Northern California. It was conducted by Steven Black, M.D., and Henry Shinefield, M.D., co-directors of the Kaiser Permanente Vaccine Study Center. Prevnar(TM), a seven-valent pneumococcal conjugate vaccine, targets the seven serotypes (strains) of pneumococci that cause approximately 80% of the pneumococcal disease in U.S. children. In the study, half of the infants received Prevnar(TM) and half received a control vaccine. Each child was followed for up to three years. Fifty-two cases of invasive disease caused by vaccine strains were reported. All cases but three were in the control group. Prevnar(TM) was approved by the U.S. Food and Drug Administration in February and is now available in physicians' offices. Full text of the article is available at (http://www.pidj.com) The Pediatric Infectious Disease Journal is the official publication of the Pediatric Infectious Disease Society and the European Society for Paediatric Infectious Disease. Published monthly by Lippincott Williams & Wilkins, the Journal's has a circulation of more than 16,000. Philadelphia-based Lippincott Williams & Wilkins is a leading publisher of health information for physicians, nurses, clinicians and students. SOURCE Lippincott Williams & Wilkins CONTACT: Connie Hofmann of Lippincott Williams & Wilkins, 215-521-8511 Web site: http://www.lrpub.com Web site: http://www.pidj.com Copyright ? 2000, Individual.com, Inc.TM This content is for your personal use only, subject to Terms and Conditions. No redistribution allowed. --- "American Home's Vaccine Prevnar Too Expensive, Study Says" Bloomberg News Service (03/14/00) Researchers from Harvard Pilgrim Health Care report that the Prevnar vaccine, a vaccine developed by American Home Products to protect children against pneumococcal bacteria, would have to cost less than $46 a dose to generate net savings. The study, published in the Journal of the American Medical Association, was based on medical costs and non-medical costs like lost work time; however, it did not include the pain and emotional cost of the illnesses prevented by the vaccine. While Prevnar was more expensive to develop and costs more to make than older vaccines, which cost roughly $10 to $20, the $58 price for Prevnar is more expensive even than recently introduced products like Merck's chickenpox vaccine. ---- "Combination Vaccines More Than a One-Shot Deal" American Medical News Online (http://www.ama-assn.org/sci-pubs/amnews) (03/20/00); Shelton, Deborah L. New childhood vaccines aim to combine shots for three to five diseases into one injection. Children receive up to 16 separate injections in the first year of life. Combination vaccines are an alternative to multiple shots that could make things easier. Currently, three are in use, to fight measles-mumps-rubella, diphtheria-pertussis-tetanus, and three strains of polio. Dr. Margaret Rennels of the Center for Vaccine Development at the University of Maryland School of Medicine says combination vaccines are "phenomenal advances in medicine" that are the future for inoculation. Children who receive fewer shots will be more likely to get all necessary vaccinations and in fewer sittings. However, a combination vaccine is not simply adding five shots together, but each element must be reviewed for interference with others. Constant testing of vaccines for optimal protection will continue, as manufacturers learn to cope with a loss in revenue stream from fewer doses and doctors must charge less for giving fewer injections. --- "Vaccine's Price Drives a Debate About Its Use" Wall Street Journal (02/16/00) P. B1; Harris, Gardiner The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices faces a difficult trade-off: recommending the use of Prevenar, a vaccine that prevents meningitis, pneumonia, blood poisoning, and ear infections in children, or withholding a recommendation due to its $232 price tag, a cost as high as all other childhood vaccines combined. After having voted in October to give the vaccine to all children under the age of five years, the Advisory Committee may change its decision today to reflect concerns over the rising cost of health care, voting to vaccinate only the most at-risk group: children under two years of age. The debate is a volatile one, as the decision to reduce the number of vaccinated children for an economic reason is relatively unpopular, yet as drug companies develop more vaccines for less deadly diseases, the government has begun to look at the issue of cost versus risk. The vaccine, which fights pneumococcal bacteria that cause the diseases listed above, is expected to be approved by the FDA this week; however, it is the CDC which concerns itself with recommendations for use, not the FDA, which only verifies effectiveness and safety. --- ATLANTA (AP)February 17, 2000 - In a sign that cost is becoming a factor in making immunization policy, a government advisory committee has changed its initial recommendation and will require fewer children to receive an expensive vaccine. The Center for Disease Control and Prevention's Advisory Committee on Immunization Policy recommended that the vaccine Prevenar be administered to all children under 2 and those under 5 who are at high risk of contracting illnesses such as meningitis. The committee voted in October to recommend Prevenar, which costs $232 per four-dose series, for all children under 5. Wednesday's 7-4 vote in favor of changing the recommendation came after a lengthy discussion of cost implications that included a presentation from a representative of health insurance companies. --- "Vaccine's High Price Prompts About-Face" New York Times (http://www.nytimes.com) (02/17/00) P. A16 As expected, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has reversed its earlier recommendation for use of the Prevnar vaccine in all children under the age of five years. Spurred by the extremely high cost of the vaccine, the panel voted Wednesday to change its suggestion for the vaccine to children under two years of age, with only those at high risk being inoculated up to the age of five years. Prevnar, which costs $232 per four-dose series, helps to prevent streptococcus pneumoniae, a bacteria which causes pneumonia, meningitis, and ear infections, reducing the number of ear infections by 9 percent and doctor visits by chronic ear infection sufferers by 20 percent. This is just the second time the recommendation of the use of a vaccine has been affected by cost, but the issue is likely to become more and more commonplace as vaccines are developed for diseases that are less life- threatening or affect a smaller percentage of the population at a higher cost. ---- February 17, 2000 FDA APPROVES FIRST PNEUMOCOCCAL VACCINE FOR INFANTS AND TODDLERS The United States Food and Drug Administration (FDA) approved the first vaccine to prevent invasive pneumococcal diseases in infants and toddlers on February 17, 2000. The full text of the press release from the United States Department of Health and Human Services reads as follows: FIRST PNEUMOCOCCAL VACCINE APPROVED FOR INFANTS AND TODDLERS FDA today approved the first vaccine to prevent invasive pneumococcal diseases in infants and toddlers -- diseases which can cause brain damage and, in rare cases, death. The vaccine prevents invasive diseases caused by the organism Streptococcus pneumoniae (also known as pneumococcus) including bacteremia (an infection of the bloodstream) and meningitis, an infection of the lining of the brain or spinal cord. The vaccine -- Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197Protein) -- will be marketed as Prevnar by a unit of Wyeth-Ayerst Laboratories, a Division of American Home Products Corporation in Philadelphia, Pennsylvania. Infants can receive the vaccine as a series of four inoculations administered at 2, 4, 6, and 12-15 months of age. For children who cannot receive the vaccine starting at age two months, it is recommended that parents see their health care provider for alternative schedules. Prevnar is the first multivalent conjugate pneumococcal vaccine for children under the age of two. It targets the most common seven strains of pneumococcus that account for approximately 80 percent of invasive disease in infants. It is manufactured by attaching the polysaccharides (purified surface components of the different strains) to a genetically modified nontoxic form of the diphtheria toxin protein called CRM197. "This new vaccine is great news for parents and their children because now, for the first time, we have a highly effective way to prevent a major cause of meningitis and serious blood infections in the most susceptible children -- those under two years of age," said Dr. Jane Henney, Commissioner of Food and Drugs. "When we prevent these infections, we are also preventing brain damage and mortality from pneumococcal diseases." It is estimated that each year in the U.S. there are about 16,000 cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis among children under age five. Children under the age of two are at highest risk for infection. In up to half the cases of meningitis, brain damage and hearing loss occurs and about 10 percent die. Clinical trials included a large multicenter safety and efficacy study conducted at Northern California Kaiser Permanente in Oakland, California. The controlled, double-blind trial enrolled approximately 38,000 children, about half of whom received Prevnar. The vaccine was given at 2, 4, 6 and 12-15 months of age along with routinely recommended vaccines. In this trial, the vaccine was 100 percent effective in preventing invasive pneumococcal disease caused by the seven strains of pneumococcus in the vaccine. The vaccine was approximately 90 percent effective in preventing invasive disease for illnesses caused by all pneumococcal subtypes. This vaccine is not indicated for use in adults or as a substitute for other approved pneumococcal polysaccharide vaccines approved for high risk children over the age of two. Side-effects in the trials were generally mild and included local injection site reactions, irritability, drowsiness and decreased appetite. Approximately 21 percent of the children had fevers over 100.3 compared to about 14 percent in the control group not receiving Prevnar. The vaccine's effectiveness in preventing ear infections, another infection caused by pneumococcus, has not been evaluated by FDA. Meningitis is usually caused by a viral or bacterial infection. There are different types of bacterial meningitis. Before the approval of the first Haemophilus influenza type b (Hib) conjugate vaccine in 1990 for infants, Hib was the leading cause of bacterial meningitis, but today Streptococcus pneumoniae is one of the leading causes of bacterial meningitis. To obtain a copy of this FDA press release online, go to: http://www.fda.gov/bbs/topics/NEWS/NEW00716.html ____________________________________*______________________________________ 3. DISEASE CONTROL NEWS ___________________________________________________________________________ "Anti-Measles Campaign Starts in Dry Southern Ethiopia" PANA Wire Service (http://www.africanews.org/PANA) (06/23/00) A month-long anti-measles campaign was started Friday in southern Ethiopia, where 2.16 million children are said to be at risk for the disease. The World Health Organization (WHO) and UNICEF are working to protect the children from the disease, working with the Ethiopian health ministry. As part of the vaccination effort, which will initially target children in 18 areas of the drought-stricken country, the children will also receive vitamin A. The WHO's Dr. Michel Jancloes noted that water and food are desperately needed, but children weakened by hunger also need to be protected against diseases like measles because they have lower resistance to them. ---- "Congo Republic Measles Epidemic Kills 23 Children" Fox News Online (http://www.foxnews.com) (03/04/00) A spokesman for the government of the Congo Republic announced Saturday that 23 children under the age of five have died from the measles. The outbreak, located in the Okoyo district, has also resulted in the hospitalization of 40 other patients. --- "500,000 Children Miss Their TB Jabs" UK Telegraph Online (02/15/00); Hall, Celia An ongoing shortage of vaccine has forced 500,000 British schoolchildren to go without their tuberculosis (TB) shots, according to TB Alert. The charity noted that the supply problem could extend for another year, in which case nearly 1 million children would have missed their vaccinations. The Department of Health halted the school TB program in late 1999, after Medeva Pharma, the only licensed source of the BCG vaccine in Britain, reported manufacturing problems. The disruption of the program has some concerned because the number of TB cases in England has been rising, albeit slowly, since 1987. --- "No New Polio Cases in Europe in 19 Months, But Risk Still There: WHO" Agence France Presse (http://www.afp.com) (06/20/00) The World Health Organization's George Oblapenko, the agency's polio eradication coordinator for Europe, said Tuesday that even though no new cases of polio have been reported in Europe for 19 months, facilities maintaining specimens should be carefully supervised. Oblapenko, speaking at a two-day conference in Vienna on the eradication of polio, noted that remaining free of reported polio for three years is important, but "the ultimate task is containment of all specimens of wild polio currently in laboratories in the region." Participants at the meeting will discuss methods for containing virus specimens in laboratories and eventually destroying them. They will also decide whether to issue a certificate to Albania, Bosnia-Herzegovina, Moldova, and Macedonia stating that the countries are polio-free. --- "Outbreak of Measles Kills 300 in Month" Boston Globe Online (http://www.boston.com/globe) (06/18/00) P. A5 A measles outbreak has killed at least 300 people in the Central African Republic in the past month. According to health officials, most of the deaths have been among children and over 2,000 people have been infected. The Central African Republic, one of the world's most impoverished nations, has not had widespread vaccination. --- "Measles Cases Spur Vaccine Reminder; Disease Officials Hope that Four Local Incidents Will Prompt Parents" Los Angeles Times (http://www.latimes.com) (06/19/00) P. S1; Allen, Jane E. Four cases of measles in southern California have officials hoping there will be no outbreaks. The cases serve, however, as reminders of the need to vaccinate against measles. Statistics from the World Health Organization show that measles kills 1 million children a year in poor countries. Area health officials note there are vaccination gaps among residents who never developed natural immunity after contracting measles, who were never vaccinated, or who were among the rare few not protected by the vaccine. A total of 17 measles cases were reported in California last year, and there have been 12 reported already this year, including the three recent ones in Los Angeles County and one in Orange County. --- "Iraq Starts New Campaign Against Polio" Agence France Presse (http://www.afp.com) (06/17/00) Iraq's health ministry launched this weekend a new polio vaccination campaign. The five-day effort aims to vaccinate over 2 million children under five, according to Ahmed Hardan, director of the research center. The first phase began on Saturday, and the second phase will start in mid- August. --- "Man Exhibits Polio Symptoms" Daily Yomiuri (http://www.yomiuri.co.jp) (06/05/00); Shimbun, Yomiuri A 37-year-old man from Miyazaki Prefecture in Japan has been diagnosed with polio symptoms, the first patient in five years. The government believes the man contracted a secondary infection from his child, who was vaccinated in April with a weak strain of poliovirus. The man, who was hospitalized last month, is now recovering but remains paralyzed in the left leg. ____________________________________*______________________________________ 4. TRAVEL IMMUNIZATION ___________________________________________________________________________ "Travelers Need Hepatitis and Other Immunizations" Journal of the American Medical Association (http://www.jama.com) (05/03/00) Vol. 283, No. 17, P. 2226; Mitka, Mike It is important for travelers to receive the proper vaccinations before heading to a distant location. For example, the Centers for Disease Control and Prevention recommends vaccines for hepatitis A, Japanese encephalitis, rabies, typhoid, and boosters for measles and polio when traveling near Borneo. The hepatitis B virus (HBV)vaccine is recommended if exposure to blood may occur or if sexual contact is anticipated. However, the International Society of Travel Medicine (ISTM) believes the hepatitis B vaccine recommendation is too lax and should be given to anyone visiting a place with high HBV infection rates. The ISTM emphasizes that hepatitis A and B are common vaccine-preventable diseases and should be taken into account months before traveling. Acquiring hepatitis A when abroad can lead to months of illness, and hepatitis B infection can lead to liver damage and cancer. The injection schedule for hepatitis A and B can be combined into a few months if necessary. Also, the Food and Drug Administration is expected to soon approve a dual vaccine for hepatitis A and B, called Twinrix. --- A ProMED-mail post Date: 25 Feb 2000 From: Jack Woodall Source: CDR Weekly (UK), Vol. 10 / No. 7, February 18, 2000 Subject: International travel and health The January 2000 update of the World Health Organization's International Travel and Health has recently been published and is also available on WHO's website (1,2). The first chapter, printed on yellow paper, lists vaccination requirements by country with epidemiological information about malaria and recommended prophylaxis. The next chapter advises travellers on protecting their health abroad. A table of vaccinations recommended and advised by WHO gives information about the vaccines, lower age limits for their administration, and the time required for protection to develop and its duration. Also included is advice on immunization for HIV infected people and on the risk of tuberculosis transmission during air travel. International Travel and Health (ISBN 92 4 1 580259) is available in English and French. (SwFr17/US$15.30, in developing countries Sw.Fr11.90) from Marketing and Dissemination, WHO, 1211 Geneva 27, Switzerland; fax: +44 22 791 4857; email: . References: 1.WHO. International travel and health. Wkly Epidemiol Rec 2000; 75:58-9. 2.WHO International travel and health. Vaccination requirements and health advice - situation as on 1 January 2000. Geneva, WHO: 2000. Reported by Caroline Akehurst ([[email protected]][email protected][/email]), PHLS Communicable Disease Surveillance Centre, London, England. ____________________________________*________________________Selected news items reprinted under the fair use doctrine of international copyright law: http://www4.law.cornell.edu/uscode/17/107.html