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Vaccine Controversies 23 March 2010 University of Wisconsin School of Medicine and Public Health Synopsis Background on vaccines U.S. Smallpox program - 2002 Cost Effectiveness Thimerosal – Neurodevelopmental issues MMR – Autism Fetal Tissue Vaccine Controversies Background on Vaccines US Birth Cohort ~ 4,000,000 children / year General vaccine coverage ~ 90% doses per vaccine per year = 3,600,000 Financial Implications: $10 vaccine with universal recommendation $36,000,000 per year $108 vaccine with 4 dose $1,555,200,000 per year Global total profit from vaccines Less than profit from a single cholesterol drug HPV Number of Immunizations Tdap Meningococcal from Birth to Age 18 Influenza Hep A 55 Pneumococcal Varicella 50 MMR 45 Rota Cumulative Number IPV 40 Hib DTaP 35 Hep B 30 25 20 15 10 5 0 2-M 4-M 6-M 3 4 5 6 7 8 9 Birth 10 11 12 13 14 15 16 17 18 12-M 18-M Age HPV Cost of Immunizations Tdap Meningococcal from Birth to Age 18 Influenza Hep A 2000 Pneumococcal $541 Varicella Cummunlative Cost (US$) 1750 MMR Rota IPV $223 1500 Hib DTaP 1250 Hep B 1000 $1060 750 500 250 0 Birth 2-M 4-M 6-M 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 12-M 18-M Age Prevalence, Mortality and Cost recommended childhood and adolescent vaccines Case Fatality Rate (per 1000 cases) 1000 100 $300 10 $100 1 0.1 $50 0.01 0.001 0.1 1 10 100 1000 10000 100000 Pre-vaccine Prevalence (cases/100,000) Comparative Costs to fully Immunize all American Children (77.9 million children: ages 0 – 18) 800 700 Billions of Dollars 600 713 500 400 300 200 100 134 0 Childhood Immunization Iraq War (as of 3/22/10) Sources of population and cost information: http://www.census.gov; http://www.costofwar.com Vaccine Controversies Smallpox (Variola major) Smallpox: Overview 1949 - Last U.S. case 1972 - End of routine childhood vaccination 1980 - Global eradication U.S. and Russia maintain cultures of Variola History of weaponization Efficient person-to-person aerosol/contact transmission CDC: Electron micrograph of Up to 30% mortality Variola major Smallpox Vaccine Immunity not life-long old vaccine available Made from live Vaccinia 14 million doses 1:5 dilution = 70 million Smallpox Vaccine Complications Eczema vaccinatum. Photo courtesy of John M. Leedom, M.D. Rates of Complication from Vaccinia Vaccine Autoinnoculation 529.2 Generalized Vaccinia 241.5 Eczema Vaccinatum 38.5 Encphalitis 12.3 Vaccinia Necrosum 1.5 Death 1.1 WCP 5.25 OPV 0.4 0 100 200 300 400 500 600 Events per 1,000,000 doses Lane et al, J Infect Dis 1970: 122:303-9 Number of Smallpox citations reported on MEDLINE per month ( January 1999 -February 2004 ) 80 “End of hostilities” No. MEDLINE citations 70 Start of Iraq war 60 50 Start of civilian vaccination 40 30 Anthrax Attacks 20 September 11th, 2001 10 0 | 1999 | 2000 | 2001 | 2002 | 2003 | Vaccine Controversies Human Papillomavirus vaccine Source: http://rhino.bocklabs.wisc.edu/cgi-bin/virusworld/ictv8gallery.pl HPV School-entry mandates are essential to provide vaccine to traditionally under-immunized individuals and populations Compulsory Vaccination can violate personal values Status of HPV School-entry Mandates National Conference of State Legislatures http://www.ncsl.org/programs/health/HPVvaccine.htm Passed Introduced Conflict Withdrawn Now… for boys as well HPV Questions What is the role of cost effectiveness in shaping vaccine policy? Is there a cost per life or cost per QALY that is too expensive? Who should pay for vaccines What are the ethics of a sex-based recommendation for HPV? Vaccine Controversies Thimerosal Thimerosal History Thiomersal or sodium ethylmercurithiosalicylate, is commonly known in the United States as thimerosal. Organomercury compound (approximately 49% mercury by weight) used as an antiseptic and antifungal agent Developed and registered under the trade name Merthiolate in 1928 by Eli Lilly and Company Used as a preservative in vaccines, immunoglobulin preparations, skin test antigens, antivenins, ophthalmic and nasal products, and tattoo inks In the U.S., E.U., and a few other affluent countries, the compound is being phased out from vaccines routinely given to children. Packaging the vaccines in single-dose vials eliminates the need for bacteriostatics such as thiomersal Policy Effect - 1999 The American Academy of Family Physicians (AAFP), American Academy of Pediatrics (AAP), and the Public Health Service (PHS) in consultation with the Advisory Committee on Immunization Practices (ACIP) established a goal to remove or greatly reduce thimerosal from vaccines as soon as possible for the following reasons: removal or substantial reduction of thimerosal is feasible progress in removal to date is substantial discussions between the FDA and the vaccine manufacturers in removing thimerosal are ongoing public concern about the use of mercury of any sort remains high Thimerosal & Autism “Fact Box” A typical flu shot contains 25 micrograms - or 50,000 parts per billion - of mercury. The EPA classifies a liquid with 200 parts per billion of mercury as hazardous waste. The limit for drinking water is 2 parts per billion. Using the standards set for the kind of mercury in fish, an average 130-pound person getting the flu shot would exceed the daily limit by more than four times. A 22-pound baby would get more than 25 times the amount of mercury considered safe. Doctors are recommending many babies and children get two flu shots this season. Source: RAQUEL RUTLEDGE Milwaukee Journal Sentinel Posted: Nov. 12, 2007 Flu-shot scare unjustified by either evidence or science By JONATHAN L. TEMTE Posted: Nov. 24, 2007 “Legitimizing extreme points of view, without critical evaluation, not only is wrong but can lead to flawed, and sometimes deadly, personal and policy decisions.” Suggestions for “Fair” Evaluations Make numbers understandable. Mixing parts per billion and microgram amounts encourages readers to equate influenza vaccines with hazardous waste. Make chemistry understandable. Two forms of mercury often are often confused. Thimerosal, the preservative used in a limited number of vaccines, contains ethyl mercury. Exposure warnings are based on methyl mercury. Make sources of information understandable. The article quoted a publication from the Journal of American Physicians and Surgeons. This journal, however, is not included in the 5,146 medical journals listed by the National Library of Medicine as a recognized source of legitimate medical information. Science vs. Dogma “The committee also concludes that the body of epidemiological evidence favors rejection of a causal relationship between thimerosal -containing vaccines and autism” “Evidence of Harm is a gripping investigation. Much like the 9/11 commission's report, it is an alarming page-turner. Keep your eye on California, where autism cases are closely tracked. If autism-related diagnoses decline over the next year or two following the introduction of thimerosal-free vaccines, the finding will further fuel this simmering controversy.” -- Newsday Prevalence of autism in children aged 2 to 12 years by year of birth from 1989 to 2003 Schechter, R. et al. Arch Gen Psychiatry 2008;65:19-24. Possible Consequences of Action On December 12, 2007 Merck & Co. announced that it was recalling 13 Lots containing 1.2 million doses of HIB vaccine (PedvaxHIB and the combination COMVAX containing HIB and hepatitis B vaccines) Possible contamination with the common bacterium called Bacillus cereus (B. cereus). Problem due to a piece of equipment in Merck's West Point, PA manufacturing facility which failed a sterility test and yielding the bacterium Increasing cases of Haemophilus influenzae Type B Mercury and Autism References Schechter R, Grether JK. Continuing increases in autism reported to California's developmental services system: mercury in retrograde. Arch Gen Psychiatry. 2008 Jan;65(1):19-24. Baker, JP Mercury, Vaccines, And Autism: One Controversy, Three Histories. Am J Public Health. 2008. Vol. 98 Novella S. The Anti-Vaccination Movement. Skeptical Inquirer 2007;31(6):25-31. Immunization Safety Review – Vaccines and Autism. Immunization Safety Review Committee, Board on Health Promotion and Disease Prevention, Institute of Medicine of the National Academies. 2004; The National Academies Press; Washington, D.C. www.nap.edu Thimerosal Questions What is the role of alarmists and contrarians in vaccine policy? Are such cautions helpful or harmful? Do proponents of vaccine harm bear responsibility of vaccine related disease? Is the current system responsive to patients’ needs? Special Masters Ruling On Friday, March 12, special masters in the U.S. Court of Federal Claims ruled against the claims of parents of autistic children in three separate cases. The parents alleged that vaccines with thimerosal had triggered autism in their children, and they were seeking compensation from the National Vaccine Injury Compensation Program. The vaccine court was established to require a lower standard of proof than civil courts, so the forceful rejection of the vaccine-autism link is especially notable. Special Masters Ruling Special Master George Hastings wrote, for example, that "The overall weight of the evidence is overwhelming contrary to the petitioners' causation theories." Another ruling noted that many parents had "relied upon practitioners and researchers who peddled hope, not opinions grounded in science and medicine." The rulings follow the same court's judgment last year against claims that measles-mumps-rubella shots in combination with other thimerosal- containing vaccines cause autism. Vaccine Controversies MMR and Autism Autism Background Autism and autism spectrum disorders begin before the age of 3, and include a group of developmental disabilities marked by great difficulty in social interaction and communication. Difficulties on the spectrum range from mild to severe. The disorder is on the rise, with one in 150 children now diagnosed with autism spectrum disorders, according to the CDC. Suspicion of a vaccine link with autism has been ongoing at numerous advocacy groups MMR – Autism Timeline Apr – 2000 Jan – 2001 Rep. Dan Burton chairs British Press runs Congressional Panel Favorable articles on On MMR - Autism MMR-Autism Theory Feb – 1998 Mar – 2004 Wakefield publishes 10 of 11 co-authors MMR-Autism* Study retract the claim *Wakefield AJ et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. The Lancet, Volume 351, Number 9103 28 February 1998 MMR – Autism Timeline May – 2004 Institute of Medicine June - 2007 Sep - 2007 releases report Special Masters start Jenny McCarthey’s hearing test cases book blaming MMR for son’s autism June – 2004 featured on Oprah Rep. Dave Weldon derides IOM Report Feb – 2008 on MMR - Autism Wakefield accused of misconduct Feb – 2010 Lancet Retracts Wakefield paper The Lancet fully retracts paper Office of Special Masters Decision March 6, 2008 - Federal officials say a Georgia girl is entitled to compensation from a federal vaccine injury fund because she developed autism-like symptoms after receiving childhood vaccines Her father said, "we showed there was a plausible mechanism. We showed that an injury occurred shortly after her vaccination. Her growth curve went flat for months." officials concluded that the vaccines given to the girl aggravated a pre-existing condition -- a mitochondrial disorder -- that then manifested as a regressive neurological disease with some symptoms of autism spectrum disorder. Consequences of Action 13% reduction in MMR coverage in UK since 1998 Increasing cases of measles in England and Wales Consequences of Action Focused on Vaccines? January 16, 2009: Alison Singer, the executive vice president of communications and awareness at Autism Speaks, one of the nation's leading autism advocacy groups, announced her resignation, citing a difference of opinion over the organization's policy on vaccine research. "Dozens of credible scientific studies have exonerated vaccines as a cause of autism," she wrote in a statement. "I believe we must devote limited funding to more promising avenues of autism research." Singer, who has an 11-year-old daughter with autism, joined the organization when it launched in 2005. Singer praised Autism Speaks and its founders, Bob and Suzanne Wright, but said she could no longer work for a group that supports spending limited resources on vaccine research. Office of Special Masters Decision Feb. 12, 2009 - The Office of Special Masters of the U.S. Court of Federal Claims rejected claims that either the measles/mumps/rubella (MMR) vaccine or thimerosal in vaccines caused children's autism. The three cases addressed by the vaccine court were picked as test cases by a panel of lawyers representing all the families with vaccine-related autism claims. The main issue in all three test cases was whether thimerosal-containing vaccines and/or the MMR vaccine can cause autism. The ruling is a major setback for the more than 5,000 cases in which families claim that the mercury-based thimerosal -- a preservative no longer in wide use in vaccines -- or the MMR vaccine itself caused their children's autism Office of Special Masters Decision The three separate decisions by the court's "special masters" were not close "To conclude that [autism] was the result of [this child's] MMR vaccine, an objective observer would have to emulate Lewis Carroll's White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast," wrote Special Master Denise K. Vowell. The vaccine court reviewed huge amounts of scientific evidence, including tens of thousands of pages of medical records and scientific literature and testimony from scores of medical experts. "I find that it is extremely unlikely that any of [this child's] disorders were in any way causally connected to her MMR vaccination, or any other vaccination," writes Special Master George L. Hastings, Jr. MMR-Autism Questions Why do certain claims receive wide acceptance and persist? What is the difference between scientific proof and preponderance of evidence? Will the special masters’ rulings have any effect on the priorities of autism interest groups? Vaccine Controversies Fetal Tissue Human Diploid Cell Lines Rubella vaccine produced using the WI-38 cell line derived from a 3-month female fetus UK - 1962 Varicella vaccine produced using the MRC-5 cell line derived from a 14-week male fetus US -1966 Religious objection [e-mail from a parent to Dr. Temte] “… has your group done any research on the manufacture of the Rubella and Varicella vaccines? I am concerned with the safety of both of these viruses knowing that they are propagated on medias of human fetal diploid fibroblasts (the source of these cell lines is aborted human babies). The Varicella vaccine insert directly states that a child who receives the shot will receive cell fragments including DNA and proteins (again, these are cell fragments from an aborted fetal tissue line that most parents have no idea is being injected into their child). As a parent I am concerned that not enough parents are educated about the contents and adverse events of vaccination.” Religious objection Pontifical Academy for Life at the Vatican Encourages manufacturers to seek alternative In the absence of alternative: Vaccines may be used “to avoid serious risk not only for one’s own children, but also, and more specifically, for the health conditions of the population as a whole – especially for pregnant women.” “the parents who did not accept the vaccination for their own children become responsible for the malformations in question.” Religious objection “Catholic parents who wish to consent to its use can be assured that there is no general obligation to refuse permission for the vaccination to be given. Consenting does not condone abortion, nor amount to encouraging further abortions for this vaccine. The substantial benefits of this vaccine, for which there is no substitute available, may be accepted” Bishop Budd – Chair of the Department for Christian Responsibility and Citizenship and of the Committee fro Family Life http://www.cdc.gov/vaccines/vac-gen/laws/rubella-cathnews.html Fetal Tissues Questions Is the ongoing use of human diploid cell culture justified for vaccine production? What are the potential effects of avoiding vaccines on religious grounds? Are there non-religious reasons for avoiding vaccination? Breaking news… Rotavirus vaccine Rotarix (GSK) ROTARIX is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P type. This strain is propagated on Vero cells Vero lineage isolated from kidney epithelial cells extracted from an African green monkey developed on 27 March 1962 independent U.S. academic research team found DNA from porcine circovirus 1 (PCV1) in Rotarix. PCV1 is not known to cause illness in humans or other animals PCV2 is associated with postweaning multisystemic wasting syndrome in pigs Rotavirus background Worldwide sales in 2009 = $440,000,000 US sales = 118,000,000 Rotavirus can cause vomiting and watery diarrhea in infants and children. Significant across the globe rotavirus causes 500,000 deaths a year Pre-vaccine in the US < 100 deaths per year ~ 50,000 pediatric hospitalizations annually Rotavirus Questions Is it appropriate to suspend distribution of an effective and safe rotavirus vaccine due to the finding of unexpected DNA? What are the benefits and costs of this suspension? What type of evidence is needed to re-enter the market?
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