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Vaccine Development and Safety

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Vaccinophobia and Vaccine Controversies of the 21st Century

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Abstract

Vaccines are considered one of the most effective public health achievements of the twentieth century. In the USA the incidence of most childhood vaccine-preventable diseases (VPDs) is at historic lows, while the number of diseases prevented by vaccines has increased steadily in the past few years. Development of vaccines is a complex, multistep process requiring the collaboration of multiple partners from basic science research through vaccine delivery and outcome monitoring. Advances in new sciences such as genomics, structural biology, novel adjuvant formulations, live vector vaccines, and computational studies have led to more detailed understanding of microbes and the host immune response. These advances offer great promise in the design of future generation of effective and safe vaccines against a host of infectious diseases. In addition, development of nontraditional vaccines against cancer, autoimmune disorders, and chronic diseases of ageing are currently being explored. Vaccine safety remains an integral component of the US immunization system involving several federal agencies such as the US Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and other federal agencies working in close partnerships with vaccine resources in the public and private sectors. Despite significant advances, there are many scientific, implementation, and policy challenges to modern vaccine development. Educating the public about vaccines and vaccine preventable diseases is crucial to improve vaccine acceptance and use. A trusting relationship between patients, parents, and health care providers is a must to effectively communicate vaccine risk–benefit issues.

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References

  1. Shann F, Steinhoff MC. Vaccines for children in rich and poor countries. Lancet. 1999;354(Suppl II):7–11.

    Google Scholar 

  2. Fenner F et al. Smallpox and its eradication. Geneva: World Health Organization; 1988.

    Google Scholar 

  3. Cochi SL, Linkins RW. The final phase of polio eradication: new vaccines and complex choices. J Infect Dis. 2012;205:169–71.

    PubMed  CAS  Google Scholar 

  4. Roush SW et al. Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States. JAMA. 2007;298:2155–63.

    PubMed  CAS  Google Scholar 

  5. Omer SB, Salmon DA, Orenstein WA, et al. Vaccine refusal, mandatory immunization, and the risks of vaccine-preventable diseases. N Engl J Med. 2009;360:1981–8.

    PubMed  CAS  Google Scholar 

  6. Omer SB, Pan WKY, Halsey NA, et al. Nonmedical exemptions to school immunization requirements: secular trends and association of state policies with pertussis incidence. JAMA. 2006;296:1757–63.

    PubMed  CAS  Google Scholar 

  7. Feikin DR, Lezotte DC, Hamman RF, et al. Individual and community risks of measles and pertussis associated with personal exemptions to immunization. JAMA. 2000;284:3145–50.

    PubMed  CAS  Google Scholar 

  8. Gust DA, Darling N, Kennedy A, et al. Parents with doubts about vaccines: which vaccines and reasons why. Pediatrics. 2008;122:718–25.

    PubMed  Google Scholar 

  9. Hammer LD, Curry ES, Harlor AD, et al. Increasing immunization coverage. Pediatrics. 2010;125:1295–304.

    PubMed  Google Scholar 

  10. Institute of Medicine of the National Academies. Adverse effects of vaccines: evidence and causality. http://www.iom.edu/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx (2011). Accessed 22 Mar 2012.

  11. Healy CM, Pickering LK. How to communicate with vaccine-hesitant parents. Pediatrics. 2011;127 Suppl 1:S127–33.

    PubMed  Google Scholar 

  12. Leroux-Roels G, Bonanni P, Tantawichien T, Zepp F. Vaccine development. In: Garcon N, Stern PL, Cunningham AL, Stanberry LR, editors. Understanding modern vaccines: perspectives in vaccinology. Missouri: Elsevier BV; 2011.

    Google Scholar 

  13. Stanberry LR, Barrett ABT. Vaccine development pathway. In: Barrett ADT, Stanberry LR, editors. Vaccines for biodefense and emerging and neglected diseases. London: Saunders Elsevier; 2009.

    Google Scholar 

  14. Curlin G, Landry S, Bernstein J, et al. Integrating vaccine safety and efficacy evaluation throughout vaccine research and development. Pediatrics. 2011;127 Suppl 1:S9–15.

    PubMed  Google Scholar 

  15. Salmon DA, Pavia A, Gellin B. Vaccine safety throughout the product life cycle. Pediatrics. 2011;127 Suppl 1:S1–4.

    PubMed  Google Scholar 

  16. Kanesa-thasan N, Shaw A, Stoddard JJ, Vernon TM. Ensuring the optimal safety of licensed vaccines: a perspective of the vaccine research, development, and manufacturing companies. Pediatrics. 2011;127 Suppl 1:S16–22.

    PubMed  Google Scholar 

  17. Marshall V, Baylor NW. Food and drug administration regulation and evaluation of vaccines. Pediatrics. 2011;127 Suppl 1:S23–30.

    PubMed  Google Scholar 

  18. Miller E, Battern B, Hampton L, et al. Tracking vaccine-safety inquiries to detect signals and monitor public concerns. Pediatrics. 2011;127 Suppl 1:S87–91.

    PubMed  Google Scholar 

  19. Kennedy A, Basket M, Sheedy K. Vaccine attitudes, concerns, and information sources reported by parents of young children: results from the 2009 HealthStyles survey. Pediatrics. 2011;127 Suppl 1:S92–9.

    PubMed  Google Scholar 

  20. Levine MM, Levine OS. Influence of disease burden, public perception, and other factors on new vaccine development, implementation, and continued use. Lancet. 1997;350:1386–92.

    PubMed  CAS  Google Scholar 

  21. Rappuoli R, Black S, Lambert PH. Vaccine discovery and translation of new vaccine technology. Lancet. 2011;378:360–8.

    PubMed  Google Scholar 

  22. Levine OS, Bloom DE, Cherian T, et al. The future of immunization policy, implementation, and financing. Lancet. 2011;378:439–48.

    PubMed  Google Scholar 

  23. Smith J, Lipsitch M, Almond JW. Vaccine production, distribution, access, and uptake. Lancet. 2011;378:428–38.

    PubMed  Google Scholar 

  24. Rees H, Madhi SA. Will the decade of vaccines mean business as usual? Lancet. 2011;378:382–4.

    PubMed  Google Scholar 

  25. GAVI alliance. Innovative financing. http://fr.gavialliance.org/vision/in_financing/index.php(2012). Accessed 6 Feb 2012.

  26. Lim SS, Stein DB, Charrow A, Murray CJ. Tracking progress towards universal childhood immunization and the impact of global initiatives: a systematic analysis of three-dose diphtheria, tetanus, and pertussis immunization coverage. Lancet. 2008;372:2031–46.

    PubMed  Google Scholar 

  27. Lob-Levyt J. Vaccine coverage and the GAVI Alliance Immunization Services Support initiative. Lancet. 2009;373:209.

    PubMed  Google Scholar 

  28. Lieu TA, McGuire TG, Hinman AR. Overcoming economic barriers to the optimal use of vaccines. Health Aff (Millwood). 2005;24:666–79.

    Google Scholar 

  29. Eskola J, Kilpi T. Public-private collaboration in vaccine research. Lancet. 2011;378:385–6.

    PubMed  Google Scholar 

  30. Hargreaves JR, Greenwood B, Clift C, et al. Making new vaccines affordable: a comparison of financing processes used to develop and deploy new meningococcal and pneumococcal conjugate vaccines. Lancet. 2011;378:1885–93.

    PubMed  Google Scholar 

  31. Orenstein WA, Douglas RG, Rodewald LE, Hinam AR. Immunizations in the United States: success, structure, and stress. Health Aff. 2005;24:599–610.

    Google Scholar 

  32. Glass RI et al. The epidemiology of rotavirus diarrhea in the United States; surveillance and estimates of disease burden. J Infect Dis. 1996;174 Suppl 1:S5–11.

    PubMed  Google Scholar 

  33. Dasbach EJ, Haddix AC, Corso PS. Prevention effectiveness. New York: Oxford University Press; 1996.

    Google Scholar 

  34. Ray T, Whitney C, Fireman BH, Ciuryla V, Black SB. Cost-effectivness of pneumococcal conjugate vaccine: evidence from the first 5 years of life in the United States incorporating herd effect. Pediatr Infect Dis J. 2006;25:494–501.

    PubMed  Google Scholar 

  35. Mahmoud A. A global road map is necessary for vaccine research, development, and deployment. Health Aff. 2011;30:6.

    Google Scholar 

  36. Folkers GK, Fauci AS. The role of U.S. government agencies in vaccine research and development. Nat Med. 1998;4 Suppl 5:491–4.

    PubMed  CAS  Google Scholar 

  37. Hoft DF, Brusic V, Sakala IG. Optimizing vaccine development. Cell Microbiol. 2011;13:934–42.

    PubMed  CAS  Google Scholar 

  38. Plotkin SA. Immunological correlates of protection induced by vaccination. Pediatr Infect Dis J. 2001;20:63–75.

    PubMed  CAS  Google Scholar 

  39. Qin L, Gilbert PB, Corey L, McElrath MJ, Self SG. A framework for assessing immunological correlates of protection in vaccine trials. J Infect Dis. 2007;196:1304–12.

    PubMed  Google Scholar 

  40. O’Shea JJ, Paul WE. Mechanisms underlying lineage commitment and plasticity of helper CD4 + T cells. Science. 2010;327:1098–102.

    PubMed  Google Scholar 

  41. Knickelbein JE, Khanna KM, Yee MB, et al. Noncytotoxic lytic granule-mediated CD8+ T cell inhibition of HSV-1 reactivation from neuronal latency. Science. 2008;322:268–71.

    PubMed  CAS  Google Scholar 

  42. Zhou L, Chong MM, Littman DR. Plasticity of CD4+ T cell lineage differentiation. Immunity. 2009;30:646–55.

    PubMed  CAS  Google Scholar 

  43. Zhu J, Yamane H, Paul WE. Differentiation of effector CD4 T cell populations. Annu Rev Immunol. 2010;28:445–89.

    PubMed  CAS  Google Scholar 

  44. Willinger T, Freeman T, Hasegawa H, McMichael AJ, Callan MF. Molecular signatures distinguish human central memory from effector memory CD8 T cell subsets. J Immunol. 2005;175:5895–903.

    PubMed  CAS  Google Scholar 

  45. Bluestone JA, Abbas AK. Natural versus adaptive regulatory T cells. Nat Rev Immunol. 2003;3:253–7.

    PubMed  CAS  Google Scholar 

  46. Coffman RL, Sher A, Seder RA. Vaccine adjuvants: putting innate immunity to work. Immunity. 2010;33:492–503.

    PubMed  CAS  Google Scholar 

  47. Wei CJ, Boyington JC, McTamney PM, et al. Induction of broadly neutralizing H1N1 influenza antibodies by vaccination. Science. 2010;329:1060–4.

    PubMed  CAS  Google Scholar 

  48. Buonaguro L, Pulendran B. Immunogenomics and systems biology of vaccines. Immunol Rev. 2011;239:197–208.

    PubMed  CAS  Google Scholar 

  49. Stevens CE, Taylor PE, Tong MJ, et al. Yeast-recombinant hepatitis b vaccine (1987). JAMA. 1987;257:2612–6.

    PubMed  CAS  Google Scholar 

  50. Black S, Shinefield HR, Hiatt RA, Fireman BH. Efficacy of Haemophilus influenzae type b capsular polysaccharide vaccine. Pediatr Infect Dis J. 1988;7:149–55.

    PubMed  CAS  Google Scholar 

  51. Wenger J. Epidemiology of Haemophilus influenzae type b disease and impact of Haemophilus influenzae type b conjugate vaccines in the United States and Canada. Pediatr Infect Dis J. 1998;17:132–6.

    Google Scholar 

  52. Kaplan SL, Mason EO, Wald ER, et al. Decrease of invasive pneumococcal infections in children among 8 children’s hospitals in the United States after the introduction of 7-valent pneumococcal conjugate vaccine. Pediatrics. 2004;113:443–9.

    PubMed  Google Scholar 

  53. Balmer P, Borrow R, Miller E. Impact of meningococcal conjugate C vaccine in the United Kingdom. J Med Microbiol. 2002;51:717–22.

    PubMed  CAS  Google Scholar 

  54. Kirkwood BR, Gove S, Rogers S, et al. Potential interventions for prevention of childhood pneumonia in developing countries: a systematic review. Bull World Health Organ. 1995;73:793–8.

    PubMed  CAS  Google Scholar 

  55. Stanberry LR, Strugnell R. Vaccines of the future. In: Garcon N, Stern PL, Cunningham AL, Stanberry LR, editors. Understanding modern vaccines: perspectives in vaccinology. Missouri: Elsevier BV; 2011.

    Google Scholar 

  56. Rogers LJ, Eva LJ, Luesley DM. Vaccines against cervical cancer. Curr Opin Oncol. 2008;20:570–4.

    PubMed  Google Scholar 

  57. Harandi AM, Medaglini D, Shattock RJ. Vaccine adjuvants: a priority for vaccine research. Vaccine. 2010;28:2363–6.

    PubMed  Google Scholar 

  58. Lindblad EB. Aluminium compounds for use in vaccines. Immunol Cell Biol. 2004;82:497–505.

    PubMed  CAS  Google Scholar 

  59. Reed SG, Bertholet S, Coler RN, Friede M. New horizons in adjuvants for vaccine development. Trends Immunol. 2009;30:23–32.

    PubMed  CAS  Google Scholar 

  60. Guy B. The perfect mix: recent progress in adjuvant research. Nat Rev Microbiol. 2007;5:505–17.

    PubMed  CAS  Google Scholar 

  61. Mosca F, Tritto E, Muzzi A, et al. Molecular and cellular signatures of human vaccine adjuvants. Proc Natl Acad Sci USA. 2008;105:10501–6.

    PubMed  CAS  Google Scholar 

  62. Didierlaurent AM, Morel S, Lockman L, et al. AS04, an aluminum salt- and TLR4 agonist-based adjuvant system, induces a transient localized innate immune response leading to enhanced adaptive immunity. J Immunol. 2009;183:6186–97.

    PubMed  CAS  Google Scholar 

  63. Minutello M, Senatore F, Cecchinelli G, et al. Safety and immunogenicity of an inactivated subunit influenza vaccine combined with MF59 adjuvant emulsion in elderly subjects, immunized for three consecutive influenza seasons. Vaccine. 1999;17:99–104.

    PubMed  CAS  Google Scholar 

  64. Neutra MR, Kozlowski PA. Mucosal vaccines: the promise and the challenge. Nat Rev Immunol. 2006;6:148–58.

    PubMed  CAS  Google Scholar 

  65. Medaglini D, Olesen OF, Rappuoli R. The European effort towards the development of mucosal vaccines for poverty-related diseases. Vaccine. 2009;27:2641–8.

    PubMed  Google Scholar 

  66. Kate L, Seib KL, Dougan G, Rappuoli R. The key role of genomics in modern vaccine and drug design for emerging infectious diseases. PLoS Genet. 2009;5(10):e1000612.

    Google Scholar 

  67. Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine development. Vaccine. 2001;19:2688–91.

    PubMed  CAS  Google Scholar 

  68. Sette A, Rappuoli R. Reverse vaccinology: developing vaccines in the era of genomics. Immunity. 2010;33:530–41.

    PubMed  CAS  Google Scholar 

  69. Serruto D, Rappuoli R. Post-genomic vaccine development. FEBS Lett. 2006;580:2985–92.

    PubMed  CAS  Google Scholar 

  70. Sirskyj D, Diaz-Mitoma F, Golshani A, et al. Innovative bioinformatic approaches for developing peptide-based vaccines against hypervariable viruses. Immunol Cell Biol. 2011;89:81–9.

    PubMed  CAS  Google Scholar 

  71. Zepp F. Principles of vaccine design—lessons from nature. Vaccine. 2010;28 Suppl 3:14–24.

    Google Scholar 

  72. Plotkin SA. Vaccines, the fourth century. Clin Vaccine Immunol. 2009;16:1709–19.

    PubMed  CAS  Google Scholar 

  73. Ferraro B, Morrow MP, Hutnick NA, et al. Clinical applications of DNA vaccines: current progress. Clin Infect Dis. 2011;53:296–302.

    PubMed  CAS  Google Scholar 

  74. Oberg AL, Kennedy RB, Li P, et al. Systems biology approaches to new vaccine development. Curr Opin Immunol. 2011;23:436–43.

    PubMed  CAS  Google Scholar 

  75. Bonanni P, Santos JI. Vaccine evolution. In: Garcon N, Stern PL, Cunningham AL, Stanberry LR, editors. Understanding modern vaccines: perspectives in vaccinology. Missouri: Elsevier BV; 2011.

    Google Scholar 

  76. Dormitzer PR, Ulmer JB, Rappuoli R. Structure-based antigen design: a strategy for next generation vaccines. Trends Biotechnol. 2008;26:659–67.

    PubMed  CAS  Google Scholar 

  77. Bowden TA, Crispin M, Jones EY, Stuart DI. Shared paramyxoviral glycoprotein architecture is adapted for diverse attachment strategies. Biochem Soc Trans. 2010;38:1349–55.

    PubMed  CAS  Google Scholar 

  78. Kantoff PW, Schuetz TJ, Blumenstein BA, et al. Overall survival analysis of a phase II randomized controlled trial of a poxviral-based PSA targeted immunotherapy in metastatic castration resistant prostate cancer. J Clin Oncol. 2010;28:1099–105.

    PubMed  CAS  Google Scholar 

  79. Limbach KJ, Richie TL. Viral vectors in malaria vaccine development. Parasite Immunol. 2009;31:501–19.

    PubMed  CAS  Google Scholar 

  80. Daudel D, Weidinger G, Spreng S. Use of attenuated bacteria as delivery vectors for DNA vaccines. Expert Rev Vaccines. 2007;6:97–110.

    PubMed  CAS  Google Scholar 

  81. Liniger M, Zuniga A, Naim HY. Use of viral vectors for the development of vaccines. Expert Rev Vaccines. 2007;6:255–66.

    PubMed  CAS  Google Scholar 

  82. Ramshaw IA, Ramsay AJ. The prime-boost strategy: exciting prospects for improved vaccination. Immunol Today. 2000;21:163–5.

    PubMed  CAS  Google Scholar 

  83. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009;361:2209–10.

    PubMed  CAS  Google Scholar 

  84. Belakova J, Horynova M, Krupka M, Weigl E, Raska M. DNA vaccines: are they still just a powerful tool for the future? Arch Immunol Ther Exp (Warsz). 2007;55:387–98.

    CAS  Google Scholar 

  85. Srivastava IK, Liu MA. Gene vaccines. Ann Intern Med. 2003;138:550–9.

    PubMed  CAS  Google Scholar 

  86. Okura Y, Matsumoto Y. Recent advance in immunotherapies for Alzheimer disease: with special reference to DNA vaccination. Hum Vaccin. 2009;5:373–80.

    PubMed  CAS  Google Scholar 

  87. Wang S, Kennedy JS, West K, et al. Cross- subtype antibody and cellular immune responses induced by a polyvalent DNA prime-protein boost HIV-1 vaccine in healthy human volunteers. Vaccine. 2008;26:3947–57.

    PubMed  CAS  Google Scholar 

  88. Dery M, Bausch DG. A DNA vaccine for the prevention of Ebola virus infection. Curr Opin Mol Ther. 2008;10:285–93.

    PubMed  CAS  Google Scholar 

  89. Martin JE, Pierson TC, Hubka S, et al. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis. 2007;196:1732–40.

    PubMed  Google Scholar 

  90. Bringmann A, Held SA, Heine A, Brossart P. RNA vaccines in cancer treatment. J Biomed Biotechnol. 2010;2010:623687.

    PubMed  Google Scholar 

  91. Plotkin SA, Plotkin SL. The development of vaccines: how the past led to the future. Nat Rev Microbiol. 2011;9:889–93.

    PubMed  CAS  Google Scholar 

  92. Kamath AT, Rochat AF, Christensen D, et al. A liposome-based mycobacterial vaccine induces potent adult and neonatal multifunctional T cells through the exquisite targeting of dendritic cells. PLoS One. 2009;4:e5771.

    PubMed  Google Scholar 

  93. Pulendran B, Li S, Nakaya HI. Systems vaccinology. Immunity. 2010;33:516–29.

    PubMed  CAS  Google Scholar 

  94. Pulendran B, Ahmed R. Immunological mechanisms of vaccination. Nat Immunol. 2011;131:509–17.

    Google Scholar 

  95. Querec TD, Akondy RS, Lee EK, et al. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nat Immunol. 2009;10:116–25.

    PubMed  CAS  Google Scholar 

  96. US Food and Drug Administration. Draft guidance for industry: considerations for reproductive toxicity studies for preventive vaccines for infectious disease indications. www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm092267.pdf (2012). Accessed Mar 2012.

  97. Marshall GS. The vaccine handbook: a practical guide for clinicians. 2nd ed. New York: Professional Communications Inc; 2008.

    Google Scholar 

  98. DiMassi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151–85.

    Google Scholar 

  99. Baylor NW, Midthun K. Regulation and testing of vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: Saunders Elsevier; 2008.

    Google Scholar 

  100. Douglas RG, Sadoff JC, Samant VB. The vaccine industry. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: Saunders Elsevier; 2008.

    Google Scholar 

  101. RotaTeq [package insert]. Whitehouse Station, NJ: Merck & Co, Inc; December 2010.

    Google Scholar 

  102. Rotarix [package insert]. Rixensart. Belgium: GlaxoSmithKline Biologicals; 2010

    Google Scholar 

  103. Code of Federal Regulations, 21 CFR parts 600–680 (2010).

    Google Scholar 

  104. Code of Federal Regulations, 21 CFR parts 210 and 211 (2010).

    Google Scholar 

  105. Prescription Drug User Fee Act, Pub L No.102-571 (1992).

    Google Scholar 

  106. Food and Drug Administration Modernization Act of 1997, Pub L No. 105–115 (1997).

    Google Scholar 

  107. Best Pharmaceuticals for Children Act, Pub L No. 107–109 (2002)

    Google Scholar 

  108. Food and Drug Administration Amendments Act of 2007, Pub L No. 110–85 (2007).

    Google Scholar 

  109. Pediatric Research Equity Act, Pub L No. 108–155 (2003).

    Google Scholar 

  110. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH tripartite guideline. Pharmaceutical Quality System Q10. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf. Accessed Mar 2012.

  111. Duclos P, Delo A, Aguado T, et al. Immunization safety priority project at the World Health Organization. Semin Pediatr Infect Dis. 2003;14:233–9.

    PubMed  Google Scholar 

  112. Advisory Committee on Immunization Practices. http://www.cdc.gov/vaccines/recs/acip/default.htm (2012). Accessed 28 Mar 2012

  113. Advisory Committee on Immunization Practices. Recommended adult immunization schedules—United States, 2012. Ann Intern Med. 2012;156:211–7.

    Google Scholar 

  114. American Academy of Pediatrics Committee on Infectious Diseases. Recommended immunization schedules for children and adolescents—United States, 2012. Pediatrics. 2012;129:385–6.

    Google Scholar 

  115. Committee on the Evaluation of Vaccine Purchase Financing in the United States. Financing vaccines in the 21st century: assuring access and availability. Legislative history of vaccine policy. Washington, DC: National Academies Press; 2004.

    Google Scholar 

  116. Halsey NA. The science of evaluation of adverse events associated with vaccination. Semin Pediatr Infect Dis. 2002;13:205–14.

    PubMed  Google Scholar 

  117. Jacobson RM, Zabel KS, Poland GA. The challenge of vaccine safety. Semin Pediatr Infect Dis. 2002;13:215–20.

    PubMed  Google Scholar 

  118. Inter-Agency Vaccine Group, Department of Defense and Veterans Affairs. A comprehensive review of federal vaccine safety activities. http://www.hhs.gov/nvpo/nvac/documents/vaccine-safety-review.pdf (2008). Accessed 28 Mar 2012

  119. Ball R, Horne D, Izurieta H, et al. Statistical, epidemiologic, and risk assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration. Pediatrics. 2011;127 Suppl 1:S31–8.

    PubMed  Google Scholar 

  120. Haber P, Iskander J, Walton K, et al. Internet-based reporting to the Vaccine Adverse Event Reporting System: a more timely and complete way for providers to support vaccine safety. Pediatrics. 2011;127 Suppl 1:S39–44.

    PubMed  Google Scholar 

  121. Baggs J, Gee J, Lewis E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety. Pediatrics. 2011;127 Suppl 1:S45–53.

    PubMed  Google Scholar 

  122. Yih WK, Kulldorf M, Fireman BH, et al. Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project. Pediatrics. 2011;127 Suppl 1:S54–64.

    PubMed  Google Scholar 

  123. LaRussa PS, Edwards KM, Dekker CL, et al. Understanding the role of human variation in vaccine adverse events: the clinical immunization safety assessment network. Pediatrics. 2011;127 Suppl 1:S65–73.

    PubMed  Google Scholar 

  124. Nguyen M, Ball R, Midthun K, Lieu TA. The Food and Drug Administration’s Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:291–7.

    PubMed  Google Scholar 

  125. Chen RT, DeStefano F, Pless R, et al. Challenges and controversies in immunization safety. Infect Dis Clin North Am. 2001;15:21–39.

    PubMed  CAS  Google Scholar 

  126. Hilleman MR. Vaccines in historic evolution and perspective: a narrative of vaccine discoveries. Vaccine. 2000;18:1436–47.

    PubMed  CAS  Google Scholar 

  127. Rauh L, Schmidt R. Measles immunization with killed virus vaccine. Am J Dis Child. 1965;109:232–7.

    PubMed  CAS  Google Scholar 

  128. Lane JM, Goldstein J. Evaluation of 21st century risks of smallpox vaccination and policy options. Ann Intern Med. 2003;138:488–93.

    PubMed  Google Scholar 

  129. Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, et al. Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976–1977. Am J Epidemiol. 1979;110:105–23.

    PubMed  CAS  Google Scholar 

  130. Centers for Disease Control and Prevention. Intussusception among recipients of rotavirus vaccine: United States, 1998–1999. MMWR Morb Mortal Wkly Rep. 1999;48:577–81.

    Google Scholar 

  131. Centers for Disease Control and Prevention. In: Atkinson W, Wolfe S, Hamborsky J, McIntyre L, editors. Epidemiology and Prevention of Vaccine-Preventable Diseases. 11th ed. Washington, DC: Public Health Foundation; 2009.

    Google Scholar 

  132. Varricchio F, Iskander J, DeStefano F, et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2004;23:287–94.

    PubMed  Google Scholar 

  133. Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine. 1994;12:542–50.

    PubMed  CAS  Google Scholar 

  134. Woo J, Ball R, Burwen DR, Braun MM. Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS). Drug Saf. 2008;31:667–74.

    PubMed  Google Scholar 

  135. Centers for Disease Control and Prevention. Guillain–Barre syndrome among recipients of Menactra meningococcal conjugate vaccine—United States, June–July 2005. MMWR Morb Mortal Wkly Rep. 2005;54:1023–5.

    Google Scholar 

  136. Centers for Disease Control and Prevention. Postmarketing monitoring of intussusception after RotaTeq vaccination—United States, February 1, 2006—February 15, 2007. MMWR Morb Mortal Wkly Rep. 2007;56:218–22.

    Google Scholar 

  137. Food and Drug Administration. Fluzone vaccine safety: FDA and CDC update on fluzone influenza vaccine and VAERS reports of febrile seizures in children. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm240037.htm. January 2011. Accessed 19 Apr 2012.

  138. Centers and for Disease Control Prevention. Syncope after vaccination—United States, January 2005–July 2007. MMWR Morb Mortal Wkly Rep. 2008;57:457–60.

    Google Scholar 

  139. Centers for Disease Control and Prevention. Rapid assessment of influenza vaccination coverage among HMO members: northern California influenza seasons, 2001–02 through 2004–05. MMWR Morb Mortal Wkly Rep. 2005;54:676–8.

    Google Scholar 

  140. Jackson LA, Neuzil KM, Baggs J, et al. Compliance with the recommendations for 2 doses of trivalent inactivated influenza vaccine in children less than 9 years of age receiving influenza vaccine for the first time: a Vaccine Safety Datalink study. Pediatrics. 2006;118:2032–7.

    PubMed  Google Scholar 

  141. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. Rotavirus vaccination coverage and adherence to the Advisory Committee on Immunization Practices (ACIP)-recommended vaccination schedule: United States, February 2006–May 2007. MMWR Morb Mortal Wkly Rep. 2008;57:398–401.

    Google Scholar 

  142. Lin ND, Kleinman K, Chan KA, et al. Vaccine Safety Datalink Team. Variation in hepatitis B immunization coverage rates associated with provider practices after the temporary suspension of the birth dose. BMC Pediatr. 2006;6:31.

    PubMed  Google Scholar 

  143. Lin ND, Kleinman K, Chan KA, et al. Vaccine Safety Datalink Group. Impact of the introduction of pneumococcal conjugate vaccine on immunization coverage among infants. BMC Pediatr. 2005;5:43.

    PubMed  Google Scholar 

  144. Belay ED, Holman RC, Clarke MJ, et al. The incidence of Kawasaki syndrome in West Coast health maintenance organizations. Pediatr Infect Dis J. 2000;19:828–32.

    PubMed  CAS  Google Scholar 

  145. Parashar UD, Holman RC, Bresee JS, et al. Epidemiology of diarrheal disease among children enrolled in four West Coast health maintenance organizations. Vaccine Safety Datalink Team. Pediatr Infect Dis J. 1998;17:605–11.

    PubMed  CAS  Google Scholar 

  146. Averhoff F, Zucker J, Vellozzi C, et al. Adequacy of surveillance to detect endemic rubella transmission in the United States. Clin Infect Dis. 2006;43 Suppl 3:S151–7.

    PubMed  Google Scholar 

  147. Mullooly JP, Bridges CB, Thompson WW, Vaccine Safety Datalink Adult Working Group, et al. Influenza- and RSV-associated hospitalizations among adults. Vaccine. 2007;25:846–55.

    PubMed  Google Scholar 

  148. Bohlke K, Davis RL, DeStefano F, Marcy SM, Braun MM, Thompson RS. Epidemiology of anaphylaxis among children and adolescents enrolled in a health maintenance organization. J Allergy Clin Immunol. 2004;113:536–42.

    PubMed  Google Scholar 

  149. Mullooly JP, Riedlinger K, Chun C, Weinmann S, Houston H. Incidence of herpes zoster, 1997–2002. Epidemiol Infect. 2005;133:245–53.

    PubMed  CAS  Google Scholar 

  150. Izurieta HS, Thompson WW, Kramarz P, et al. Influenza and the rates of hospitalization for respiratory disease among infants and young children. N Engl J Med. 2000;342:232–9.

    PubMed  CAS  Google Scholar 

  151. O’Brien MA, Uyeki TM, Shay DK, et al. Incidence of outpatient visits and hospitalizations related to influenza in infants and young children. Pediatrics. 2004;113(3 pt 1):585–93.

    PubMed  Google Scholar 

  152. McClure DL, Glanz JM, Xu S, Hambidge SJ, Mullooly JP, Baggs J. Comparison of epidemiologic methods for active surveillance of vaccine safety. Vaccine. 2008;26:3341–5.

    PubMed  Google Scholar 

  153. Lieu TA, Black SB, Ray GT, Martin KE, Shinefield HR, Weniger BG. The hidden costs of infant vaccination. Vaccine. 2000;19:33–41.

    PubMed  CAS  Google Scholar 

  154. Prosser LA, Bridges CB, Uyeki TM, et al. Values for preventing influenza-related morbidity and vaccine adverse events in children. Health Qual Life Outcomes. 2005;3:18.

    PubMed  Google Scholar 

  155. Prosser LA, Bridges CB, Uyeki TM, et al. Health benefits, risks, and cost-effectiveness of influenza vaccination of children. Emerg Infect Dis. 2006;12:1548–58.

    PubMed  Google Scholar 

  156. Hinrichsen VL, Kruskal B, O’Brien MA, Lieu TA, Platt R. Using electronic medical records to enhance detection and reporting of vaccine adverse events. J Am Med Inform Assoc. 2007;14:731–5.

    PubMed  Google Scholar 

  157. DeStefano F, Vaccine Safety Datalink Research Group. The Vaccine Safety Datalink project. Pharmacoepidemiol Drug Saf. 2001;10:403–6.

    PubMed  CAS  Google Scholar 

  158. Lieu TA, Kulldorff M, Davis RL, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care. 2007;45(10 Suppl 2):S89–95.

    PubMed  Google Scholar 

  159. Mullooly J, Drew L, DeStefano F, et al. Quality assessments of HMO diagnosis databases used to monitor childhood vaccine safety. Methods Inf Med. 2004;43:163–70.

    PubMed  CAS  Google Scholar 

  160. Centers for Disease Control and Prevention. Guillain–Barre syndrome among recipients of Menactra meningococcal conjugate vaccine—United States, June–July 2005. MMWR Morb Mortal Wkly Rep. 2006;55:364–6.

    Google Scholar 

  161. Thompson WW, Price C, Goodson B, et al. Vaccine Safety Datalink Team. Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years. N Engl J Med. 2007;357:1281–92.

    PubMed  CAS  Google Scholar 

  162. Burwen DR, La Voie L, Braun MM, Houck P, Ball R. Evaluating adverse events after vaccination in the Medicare population. Pharmacoepidemiol Drug Saf. 2007;16:753–61.

    PubMed  Google Scholar 

  163. Burwen DR, Ball R, Bryan WW, et al. Evaluation of Guillain–Barre syndrome among recipients of influenza vaccine in 2000 and 2001. Am J Prev Med. 2010;39:296–304.

    PubMed  Google Scholar 

  164. Rubertone MV, Brundage JF. The Defense Medical Surveillance System and the Department of Defense serum repository: glimpses of the future of public health surveillance. Am J Public Health. 2002;92:1900–4.

    PubMed  Google Scholar 

  165. McNeil MM, Ma G, Aranas A, Payne DC, Rose CE. A comparative assessment of immunization records in the Defense Medical Surveillance System and the Vaccine Adverse Event Reporting System. Vaccine. 2007;25:3428–36.

    PubMed  Google Scholar 

  166. Grabenstein JD, Winkenwerder W. US military smallpox vaccination program experience. JAMA. 2003;289:3278–82.

    PubMed  Google Scholar 

  167. Salmon DA, Akhtar A, Mergler MJ, et al. Immunization-safety monitoring system for the 2009 H1N1 monovalent influenza vaccination program. Pediatrics. 2011;127 Suppl 1:S78–86.

    PubMed  Google Scholar 

  168. Williams SE, Klein NP, Halsey N, et al. Overview of the Clinical Consult Case Review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004–2009. Vaccine. 2011;29:6920–7.

    PubMed  Google Scholar 

  169. Muralles A, Ray P, Black S, et al. Active telephone surveillance to evaluate adverse events among civilian smallpox vaccine recipients. Vaccine. 2006;24:476–84.

    PubMed  Google Scholar 

  170. Rosenberg M, Sparks R, McMahon A, et al. Serious adverse events rarely reported after trivalent inactivated influenza vaccine (TIV) in children 6–23 months of age. Vaccine. 2009;27:4278–83.

    PubMed  Google Scholar 

  171. Qiang Y, Krishnan C, Kerr D, et al. Idiopathic acute transverse myelitis: comparison of patients with vs. without receipt of a vaccine within 30 days prior to onset. Presented at 24th international conference for pharmacoepidemiology and therapeutic risk management, Copenhagen, Denmark; 2008.

    Google Scholar 

  172. Klein N, Fireman B, Enright A, Ray P, Black S, Dekker C. A role for genetics in the immune response to the varicella vaccine. Pediatr Infect Dis J. 2007;26:300–5.

    PubMed  Google Scholar 

  173. The Brighton Collaboration. Setting standards in vaccine safety. http://www.brightoncollaboration.org (2012). Accessed Feb 15, 2012

  174. Kohl KS, Bonhoeffer J, Braun MM, et al. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine. 2007;25:5671–4.

    PubMed  CAS  Google Scholar 

  175. Bonhoeffer J, Kohl K, Chen R, et al. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunizations (AEFI). Vaccine. 2002;21:298–302.

    PubMed  Google Scholar 

  176. Ball R, Halsey N, Braun MM, VAERS Working Group, et al. Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the Vaccine Adverse Event Reporting System. J Clin Epidemiol. 2002;55:819–24.

    PubMed  Google Scholar 

  177. Rothstein E, Kohl KS, Ball L, Brighton Collaboration Local Reaction Working Group, et al. Nodule at injection site as an adverse event following immunization case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004;22:575–85.

    PubMed  Google Scholar 

  178. Bonhoeffer J, Menkes J, Gold MS, Brighton Collaboration Seizure Working Group, et al. Generalized convulsive seizure as an adverse event following imunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004;22:557–62.

    PubMed  Google Scholar 

  179. Graham PL, LaRussa PS, Kohl KS, Brighton Collaboration Vaccinia Virus Adverse Event Working Group for Robust Take. Robust take following exposure to vaccinia virus: case definition and guidelines of data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25:5763–5.

    PubMed  CAS  Google Scholar 

  180. Beigel J, Kohl K, Brinley F, Brighton Collaboration Vaccinia Virus Vaccine Adverse Event Working Group for Generalized Vaccinia, et al. Generalized vaccinia as an adverse event following exposure to vaccinia virus: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25:5745–53.

    PubMed  CAS  Google Scholar 

  181. Nell P, Kohl P, Graham P, Brighton Collaboration Vaccinia Virus Vaccine Adverse Event Working Group for Eczema Vaccinatum, et al. Eczema vaccinatum as an adverse event following exposure to vaccinia virus: case definition and guidelines of data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25:5725–34.

    PubMed  CAS  Google Scholar 

  182. Nell P, Kohl K, Graham P, Brighton Collaboration Vaccinia Virus Vaccine Adverse Event Working Group for Progressive Vaccinia, et al. Progressive vaccinia as an adverse event following exposure to vaccinia virus: case definition and guidelines of data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5735–44.

    PubMed  CAS  Google Scholar 

  183. Wenger P, Oleske J, Kohl K, Brighton Collaboration Vaccinia Virus Adverse Event Working Group for Inadvertent Inoculation, et al. Inadvertent inoculation as an adverse event following exposure to vaccinia virus: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25:5754–62.

    PubMed  CAS  Google Scholar 

  184. Kohl KS, Magnus M, Ball R, Halsey N, Shadomy S, Farley TA. Applicability, reliability, sensitivity, and specificity of six Brighton Collaboration standardized case definitions for adverse events following immunization. Vaccine. 2008;26(50):6349–60.

    PubMed  Google Scholar 

  185. Cook KM, Evans G. The national vaccine injury compensation program. Pediatrics. 2011;127 Suppl 1:S75–7.

    Google Scholar 

  186. Smith MH. National Childhood Vaccine Injury Compensation Act. Pediatrics. 1988;82:264–9.

    PubMed  CAS  Google Scholar 

  187. Institute of Medicine. Adverse effects of pertussis and rubella vaccines. Washington, DC: National Academy Press; 1991.

    Google Scholar 

  188. Institute of Medicine. Adverse events associated with childhood vaccines. Washington, DC: National Academy Press; 1994.

    Google Scholar 

  189. National Vaccine Advisory Committee. Recommendations on 2009 H1N1 Influenza Vaccine Safety Monitoring. http://www.hhs.gov/nvpo/nvac/meetings/pastmeetings/h1n1subgrouprecommendationsvsmjuly2009.html (2009). Accessed 16 Mar 2012.

  190. National Vaccine Advisory Committee. Reports, Recommendations and Resolutions. http://www.hhs.gov/nvpo/nvac/reports/index.html (2012). Accessed 16 Mar 2012.

  191. Vaccine Safety Advisory Committee. Vaccine Safety. Wkly Epidemiol Rec. 1999;41:227–8.

    Google Scholar 

  192. Global Advisory Committee on Vaccine Safety. Causality assessment of adverse events following immunization. Wkly Epidemiol Rec. 2001;76:85–8.

    Google Scholar 

  193. Stephenson WP, Hauben M. Data mining for signals in spontaneous reporting databases: proceed with caution. Pharmacoepidemiol Drug Saf. 2007;16:359–65.

    PubMed  Google Scholar 

  194. Ball R, Bostis T. Can network analysis improve pattern recognition among adverse events following immunization reported to VAERS? Clin Pharmacol Ther. 2011;90:271–8.

    PubMed  CAS  Google Scholar 

  195. Lieu TA, Nguyen MD, Ball R, Martin DB. Health outcomes of interest for evaluation in the post-licensure Rapid Immunization Safety Monitoring Program. Vaccine. 2012;30:2824–30.

    PubMed  Google Scholar 

  196. Freed GL, Clark SJ, Butchart AT, Singer DC, Davis MM. Sources and perceived credibility of vaccine-safety information for parents. Pediatrics. 2011;127 Suppl 1:S107–12.

    PubMed  Google Scholar 

  197. Pineda D, Myers MG. Finding reliable information about vaccines. Pediatrics. 2011;127 Suppl 1:S134–7.

    PubMed  Google Scholar 

  198. Offit PA, Moser CA. Vaccines and your child: separating fact from fiction. New York: Columbia University Press; 2011.

    Google Scholar 

  199. Marshall S. Using media and Influencer Network Analysis to better understand how to most effectively communicate about vaccination and vaccine safety. Convergence 2010. National Conference on Health, Communication, Marketing and Media; 2010.

    Google Scholar 

  200. Oyston PC, Robinson K. The current challenges for vaccine development. J Med Microbiol. 2012;61(Pt 7):889–94.

    PubMed  Google Scholar 

  201. Berkley SF, Koff WC. Scientific and policy challenges to development of an AIDS vaccine. Lancet. 2007;374:94–101.

    Google Scholar 

  202. Buckland BC. The process development challenge for a new vaccine. Nat Med (Suppl). 2005;11:S16–9.

    CAS  Google Scholar 

  203. Usher AD. GAVI enters its second decade with massive funding gap. Lancet. 2010;375:791.

    PubMed  Google Scholar 

  204. Bethony JM, Cole RN, Guo X, et al. Vaccines to combat the neglected tropical diseases. Immunol Rev. 2011;239:237–70.

    PubMed  CAS  Google Scholar 

  205. Smith MJ, Marshall GS. Navigating parental vaccine hesitancy. Pediatr Ann. 2011;39:476–82.

    Google Scholar 

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Authors and Affiliations

  1. Department of Pediatrics, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27157, USA

    Avinash K. Shetty M.D.

  2. Division of Pediatric Infectious Diseases, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA

    Yvonne A. Maldonado M.D.

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Correspondence to Avinash K. Shetty M.D. .

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  1. , School of Medicine, Creighton University, North 30th Street,Suite 6814 601, Omaha, 68131, Nebraska, USA

    Archana Chatterjee

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Shetty, A.K., Maldonado, Y.A. (2013). Vaccine Development and Safety. In: Chatterjee, A. (eds) Vaccinophobia and Vaccine Controversies of the 21st Century. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7438-8_2

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