Vaccine Safety Controversies and the Future of Vaccination Programs

In the years following the hepatitis B vaccination/multiple sclerosis controversy, a number of new issues regarding vaccine safety have been raised, in some cases leading to more debate and confusion. Against this background, an international group of experts was convened to review the current points of view concerning the use of thimerosal as a preservative and its potential risks; the suggested link between thimerosal-containing vaccines and acute lymphoblastic leukemia; the alleged association between aluminum-containing vaccines/macrophagic myofasciitis and general systemic complaints; a possible link between vaccination and autoimmune pathology; and a hypothetical link between measles-mumps-rubella vaccination and autism. At present, there are no data to conclude that childhood vaccines, and in particular hepatitis B vaccine, pose a serious health risk or justify a change in current immunization practice. However, vaccine “scares” continue to have an international impact on immunization coverage. Creating a positive environment for immunization can be achieved by repositioning the value of vaccines and vaccination, supported by evidence-based information. The role of international organizations, the media, and the industry in the implementation of communication strategies was discussed and the impact of litigation issues on vaccination was evaluated. The Viral Hepatitis Prevention Board confirms its commitment to current recommendations for universal and risk group hepatitis B vaccination and further encourages the conduct of vaccine safety studies and the dissemination of their results.

[1]  T. Jefferson,et al.  Methodological issues arising from systematic reviews of the evidence of safety of vaccines. , 2004, Vaccine.

[2]  P. Lambert,et al.  Autoimmunity through infection or immunization? , 2001, Nature Immunology.

[3]  S Suissa,et al.  Vaccinations and the risk of relapse in multiple sclerosis. Vaccines in Multiple Sclerosis Study Group. , 2001, The New England journal of medicine.

[4]  B. Trollfors,et al.  Unexpectedly high incidence of persistent itching nodules and delayed hypersensitivity to aluminium in children after the use of adsorbed vaccines from a single manufacturer. , 2003, Vaccine.

[5]  Gupta,et al.  Aluminum compounds as vaccine adjuvants. , 1998, Advanced drug delivery reviews.

[6]  F. Destefano,et al.  Epidemiology of autoimmune reactions induced by vaccination. , 2001, Journal of autoimmunity.

[7]  D. Geier,et al.  A review of hepatitis B vaccination , 2003, Expert opinion on drug safety.

[8]  N. Andrews,et al.  Statistical assessment of the association between vaccination and rare adverse events post-licensure. , 2001, Vaccine.

[9]  F. André,et al.  Is there a causal link between hepatitis B vaccination and multiple sclerosis? , 2000, Vaccine.

[10]  Robert T. Chen,et al.  A retrospective cohort study of the association of varicella vaccine failure with asthma, steroid use, age at vaccination, and measles-mumps-rubella vaccination. , 2003, Pediatrics.

[11]  Withdrawal of rotavirus vaccine recommendation. , 1999, MMWR. Morbidity and mortality weekly report.

[12]  W. Thompson,et al.  Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan atlanta. , 2004, Pediatrics.

[13]  H. Peltola,et al.  Serious adverse events after measles-mumps-rubella vaccination during a fourteen-year prospective follow-up. , 2000, The Pediatric infectious disease journal.

[14]  J. Leask,et al.  Vaccination and risk communication: Summary of a workshop, Arlington Virginia, USA, 5–6 October 2000 , 2002, Journal of paediatrics and child health.

[15]  P. Duclos.  Safety of immunization and adverse events following vaccination against hepatitis B. , 2003, Journal of hepatology.

[16]  S. Ceccatelli,et al.  Neurotoxicity and molecular effects of methylmercury , 2001, Brain Research Bulletin.

[17]  Diane Simpson,et al.  Autism and thimerosal-containing vaccines: lack of consistent evidence for an association. , 2003, American journal of preventive medicine.

[18]  Man-Fung Yuen,et al.  Viral hepatitis B , 2003, The Lancet.

[19]  C. Quach,et al.  National Advisory Committee on Immunization (NACI). , 1989, Canada diseases weekly report = Rapport hebdomadaire des maladies au Canada.

[20]  T W Clarkson,et al.  Methylmercury poisoning in Iraq. , 1973, Science.

[21]  E. Merelli,et al.  Prognostic factors in multiple sclerosis: role of intercurrent infections and vaccinations against influenza and hepatitis B , 2000, Neurological Sciences.

[22]  P. Grandjean,et al.  Methylmercury neurotoxicity in Amazonian children downstream from gold mining. , 1999, Environmental health perspectives.

[23]  C P Farrington,et al.  Control without separate controls: evaluation of vaccine safety using case-only methods. , 2004, Vaccine.

[24]  M. McCormick,et al.  Immunization Safety Review: Multiple Immunizations and Immune Dysfunction , 2002 .

[25]  H. Bedford,et al.  Concerns about immunisation , 2000, BMJ : British Medical Journal.

[26]  The role of editorial peer review in the evaluation of vaccine safety. , 2004, Vaccine.

[27]  M. Cabana,et al.  Hepatitis B vaccination practices in hospital newborn nurseries before and after changes in vaccination recommendations. , 2001, Archives of pediatrics & adolescent medicine.

[28]  Donna A. Almario,et al.  Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy , 2003 .

[29]  A. Sadovnick,et al.  School-based hepatitis B vaccination programme and adolescent multiple sclerosis , 2000, The Lancet.

[30]  P. Duclos.  Safety of immunisation and adverse events following vaccination against hepatitis B , 2003, Expert opinion on drug safety.

[31]  R. Tardif,et al.  Childhood urine mercury excretion: dental amalgam and fish consumption as exposure factors. , 2004, Environmental research.

[32]  Causality assessment of adverse events following immunization. , 2001, Releve epidemiologique hebdomadaire.

[33]  H. Margolis,et al.  Hepatitis B vaccine and central nervous system demyelinating diseases. Viral Hepatitis Prevention Board. , 1999, The Pediatric infectious disease journal.

[34]  M. Goldman,et al.  For Personal Use. Only Reproduce with Permission from the Lancet Publishing Group. Vaccination and Autoimmune Disease: What Is the Evidence? , 2022 .

[35]  A. Sabrá,et al.  Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children , 1998, The Lancet.

[36]  C. J. Clements,et al.  The evidence for the safety of thiomersal in newborn and infant vaccines. , 2004, Vaccine.

[37]  D. Lauderdale,et al.  Impact of recommendations to suspend the birth dose of hepatitis B virus vaccine. , 2001, JAMA.

[38]  E. Fombonne,et al.  No evidence for a new variant of measles-mumps-rubella-induced autism. , 2001, Pediatrics.

[39]  N. Andrews,et al.  Measles, mumps, and rubella vaccination and bowel problems or developmental regression in children with autism: population study , 2002, BMJ : British Medical Journal.

[40]  T. Jefferson,et al.  Hepatitis B vaccination: Risk‐benefit profile and the role of systematic reviews in the assessment of causality of adverse events following immunisation , 2002, Journal of medical virology.

[41]  Amy,et al.  VACCINATIONS AND THE RISK OF RELAPSE IN MULTIPLE SCLEROSIS , 2022 .

[42]  Thimerosal in vaccines: a joint statement of the American Academy of Pediatrics and the Public Health Service. , 1999, The Annals of pharmacotherapy.

[43]  H. Peltola,et al.  Neurologic disorders after measles-mumps-rubella vaccination. , 2002, Pediatrics.

[44]  R. M. Wolfe,et al.  Content and design attributes of antivaccination web sites. , 2002, JAMA.

[45]  D. Geier,et al.  Pediatric MMR Vaccination Safety , 2003 .

[46]  M. Hernán,et al.  Recombinant hepatitis B vaccine and the risk of multiple sclerosis , 2004, Neurology.

[47]  K. Nelson,et al.  Thimerosal and autism? , 2003, Pediatrics.

[48]  J. Lopreiato,et al.  For personal use. Only reproduce with permission from The Lancet Publishing Group. Effect of sunlight and season on serotonin turnover in the brain , 2002 .

[49]  H. Tokuomi,et al.  [Minamata disease]. , 1968, Naika. Internal medicine.

[50]  Robert L Davis,et al.  Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases. , 2003, Pediatrics.

[51]  H Jick,et al.  Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis , 2001, BMJ : British Medical Journal.

[52]  A. Hall,et al.  Multiple sclerosis and hepatitis B vaccine? , 1999, Vaccine.

[53]  C. Gillberg,et al.  MMR and Autism , 1998 .

[54]  U. Heininger.  The success of immunization-shovelling its own grave? , 2004, Vaccine.

[55]  T. Clarkson.  The three modern faces of mercury. , 2002, Environmental health perspectives.

[56]  R. Spier,et al.  Perception of risk of vaccine adverse events: a historical perspective. , 2001, Vaccine.

[57]  A. Bostrom,et al.  Risky Business: Challenges in Vaccine Risk Communication , 1998, Pediatrics.

[58]  P. Offit,et al.  Addressing parents' concerns: do vaccines cause allergic or autoimmune diseases? , 2003, Pediatrics.

[59]  Didier Pittet,et al.  Guideline for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HIPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. , 2002, American journal of infection control.

[60]  C P Farrington,et al.  MMR and autism: further evidence against a causal association. , 2001, Vaccine.

[61]  I. Chabot,et al.  The societal value of universal childhood vaccination. , 2004, Vaccine.

[62]  Mogens Vestergaard,et al.  A population-based study of measles, mumps, and rubella vaccination and autism. , 2002, The New England journal of medicine.

[63]  Benjamin Schwartz,et al.  General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). , 2002, MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports.

[64]  Immunization Safety Review : Vaccines and Autism , 2004 .

[65]  R. Jacobson,et al.  Understanding those who do not understand: a brief review of the anti-vaccine movement. , 2001, Vaccine.

[66]  S. Dittmann.  Vaccine safety: risk communication--a global perspective. , 2001, Vaccine.

[67]  M. McCormick,et al.  Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism , 2001 .

[68]  P. Duclos.  How to improve communication on vaccine safety at international level? , 2001, Vaccine.

[69]  S. Black,et al.  Perspectives on the design and analysis of prelicensure trials: bridging the gap to postlicensure studies. , 2001, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[70]  L. Dales,et al.  Time trends in autism and in MMR immunization coverage in California. , 2001, Journal of the American Medical Association (JAMA).

[71]  M. McCormick,et al.  Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders , 2001 .

[72]  L. Ball,et al.  An assessment of thimerosal use in childhood vaccines. , 2001, Pediatrics.

[73]  Donna A. Almario,et al.  Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer , 2003 .

[74]  A M Walker,et al.  Hepatitis B vaccination and the risk of multiple sclerosis. , 2001, The New England journal of medicine.

[75]  J. Grabenstein,et al.  Are Vaccines Safe? Risk Communication Applied to Vaccination , 1999 .

[76]  Donna A. Almario,et al.  Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders , 2002 .

[77]  K Reesten M Eldgaard,et al.  A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism , 2002 .

[78]  M. Tosti,et al.  Multiple sclerosis and vaccination against hepatitis B: analysis of risk benefit profile. , 1999, Italian journal of gastroenterology and hepatology.

[79]  H. Feldman,et al.  Causes of Alzheimer's disease. , 2000, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[80]  R.E Spier.  Ethical aspects of the methods used to evaluate the safety of vaccines. , 2004, Vaccine.

[81]  P. Offit.  The power of ‘box a’ , 2003, Expert review of vaccines.

[82]  Robert T. Chen.  Evaluation of vaccine safety after the events of 11 September 2001: role of cohort and case-control studies. , 2004, Vaccine.

[83]  P. Duclos.  A global perspective on vaccine safety. , 2004, Vaccine.

[84]  S. Hem,et al.  Mechanism of adsorption of hepatitis B surface antigen by aluminum hydroxide adjuvant. , 2004, Vaccine.

[85]  A. Hall,et al.  Multiple sclerosis and hepatitis B vaccine? Meeting report , 1999 .

[86]  M. McCormick,et al.  Immunization Safety Review: Influenza Vaccines and Neurological Complications , 2004 .

[87]  P. Duclos,et al.  Immunization safety: a global priority. , 2000, Bulletin of the World Health Organization.

[88]  S. Coffin,et al.  Communicating science to the public: MMR vaccine and autism. , 2003, Vaccine.

[89]  C. Macintyre,et al.  Immunization myths and realities: Responding to arguments against immunization , 2003, Journal of paediatrics and child health.

[90]  A. Cross,et al.  Does the hepatitis B vaccine cause multiple sclerosis? , 2004, Neurology.

[91]  L. Magos.  Review on the toxicity of ethylmercury, including its presence as a preservative in biological and pharmaceutical products , 2001, Journal of applied toxicology : JAT.

[92]  N. Okabe,et al.  An epidemiological study on Japanese autism concerning routine childhood immunization history. , 2003, Japanese journal of infectious diseases.

[93]  Jun Li,et al.  Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association , 1999, The Lancet.

[94]  N. Cox,et al.  Thiomersal allergy and vaccination reactions , 1988, Contact dermatitis.

[95]  D. Cook,et al.  Do children who become autistic consult more often after MMR vaccination? , 2001, The British journal of general practice : the journal of the Royal College of General Practitioners.

[96]  P. Leinikki,et al.  No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study , 1998, The Lancet.

[97]  J. Hawker,et al.  Material deprivation, hospitalisation and adverse events temporally associated with immunisation. , 2004, Vaccine.

[98]  David A Geier,et al.  A comparative evaluation of the effects of MMR immunization and mercury doses from thimerosal-containing childhood vaccines on the population prevalence of autism. , 2004, Medical science monitor : international medical journal of experimental and clinical research.

[99]  A. Dhillon,et al.  Retraction of an interpretation , 2004, The Lancet.

[100]  R. M. Wolfe,et al.  Anti-vaccinationists past and present , 2002, BMJ : British Medical Journal.

[101]  S. Chapman,et al.  Antivaccination activists on the world wide web , 2002, Archives of disease in childhood.

[102]  Recommendations regarding the use of vaccines that contain thimerosal as a preservative. , 1999, MMWR. Morbidity and mortality weekly report.

[103]  T. Kilpi,et al.  Use of vaccine surveillance data in the evaluation of safety of vaccines. , 2004, Vaccine.

[104]  Robert T. Chen,et al.  The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI). , 2002, Vaccine.

[105]  A. Tozzi.  Field evaluation of vaccine safety. , 2004, Vaccine.