Drug Safety

, Volume 25, Issue 3, pp 145–152 | Cite as

Monitoring the Safety of Vaccines

Assessing the Risks
Leading Article

Abstract

The safety of vaccines, particularly the most widely used vaccines to which most children are exposed as infants and toddlers, has always been an extremely high priority for vaccine manufacturers and government agencies. Products intended for healthy people must be held to a high standard of safety assurance. In addition to the intense safety assessments conducted prior to licensure, post-marketing surveillance programmes are essential to identify and study possible risks that occur too rarely to have been identified in pre-licensure studies or that occur in populations not studied in pre-licensure studies. Studying rare risks of vaccines is more complex than for therapeutic products because the exposure is virtually universal for many vaccines, ensuring occurrence simply by chance of many adverse outcomes in temporal association with vaccination. In the US the Vaccine Safety Datalink (VSD), a consortium of managed care organisations, has been established to study more rigourously possible vaccine-associated risks. These risks may be identified through reports to the Vaccine Adverse Event Reporting System (VAERS), the nationwide passive surveillance programme, as well as other sources. The combination of passive surveillance and more structured case-control or cohort studies possible in the VSD has helped to both identify new vaccine risks and to provide reassuring evidence of lack of risk in other situations where concerns have been raised.

References

  1. 1.
    Howson CP, Howe CJ, Fineberg HV, editors. Adverse effects of pertussis and rubella vaccines. Washington, DC: National Academy Press, 1991Google Scholar
  2. 2.
    Stratton KR, Howe CJ, Johnston RB, editors. Adverse events associated with childhood vaccines: evidence bearing on causality. Washington, DC: National Academy Press, 1994Google Scholar
  3. 3.
    Stratton KR, Howe CJ, Johnston RB, editors. DPT vaccine and chronic nervous system dysfunction: a new analysis. Washington, DC: National Academy Press, 1994Google Scholar
  4. 4.
    Stratton K, Gable A, Shetty P, et al., editors. Immunization safety review: measles-mumps-rubella vaccine and autism. Washington, DC: National Academy Press, 2001Google Scholar
  5. 5.
    Adverse events: surveillance systems for adverse events and medical errors. Testimony before the Subcommittees on Health and Environment, and Oversight and Investigations, Committee on Commerce and Subcommittee on Health, Committee on Veterans’ Affairs, House of Representatives. GA0/T-HEHS-00-61, (2000)Google Scholar
  6. 6.
    Gangarosa EJ, Galazka AM, Wolfe CR, et al. Impact of antivaccine movements on pertussis control: the untold story. Lancet 1998 Jan 31; 335(9099): 356–61CrossRefGoogle Scholar
  7. 7.
    Medical Dictionary for Regulatory Activities (MedDRA) [online]. Available from URL: http://www.meddramsso.com [Accessed 2002 Mar 4]
  8. 8.
    COSTART: Coding symbols for thesaurus of adverse reaction terms. 5th ed. Food and Drug Administration, Rockville MD 1995Google Scholar
  9. 9.
    Baum C, Kweder S, Anello C. The spontaneous reporting system in the United States. In: Strom BL, editor. Pharmacoepidemiology. 2nd ed. Chichester: John Wiley and Sons, 1994: 125–37Google Scholar
  10. 10.
    Ellenberg SS, Chen RT. The complicated task of monitoring vaccine safety. Public Health Rep 1997 Jan/Feb; 112: 101–9Google Scholar
  11. 11.
    Parkman PD, Hardegree MC. Regulation and testing of vaccines. In: Plotkin SA, Orenstein WA, editors. Vaccines. 3rd ed. Philadelphia (PA): Saunders, 1999: 1131–43Google Scholar
  12. 12.
    Ellenberg SS. Safety considerations for new vaccine development. Pharmacoepidemiol Drug Saf 2001; 10: 411–5PubMedCrossRefGoogle Scholar
  13. 13.
    Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994; 12: 542–50PubMedCrossRefGoogle Scholar
  14. 14.
    Intussusception among recipients of rotavirus vaccine. United States, 1998–1999. MMWR Morb Mortal Wkly Rep 1999; 48: 577–81Google Scholar
  15. 15.
    Zanardi LR, Haber P, Mootrey GT, et al. Intussusception among recipients of rotavirus vaccine: reports to the Vaccine Adverse Event Reporting System. Pediatrics 2001; 107(6): E97PubMedCrossRefGoogle Scholar
  16. 16.
    Vaccine Adverse Event Reporting System (VAERS) [online]. Available from URL: http://www.vaers.org [Accessed 2002 Mar 4]
  17. 17.
    Rosenthal S, Chen RT. Reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: 1706–9PubMedCrossRefGoogle Scholar
  18. 18.
    DeStefano F. The Vaccine Safety Datalink project. Pharmacoepidemiol Drug Saf 2001; 10: 403–6PubMedCrossRefGoogle Scholar
  19. 19.
    Maclure M. The case-crossover design: a method for studying transient reactions associated with intermittent exposures. Am J Epidemiol 1991; 133: 144–53PubMedGoogle Scholar
  20. 20.
    Davis RL, Kramarz P, Bohlke K, et al. Measles-mumps-rubella and other measles-containing vaccines do not increase risk for bowel disease: a case-control study from the Vaccine Safety Datalink project. Arch Pediatr Adolesc Med 2001 Mar; 155(3): 354–9PubMedGoogle Scholar
  21. 21.
    Ray P, Black S, Shinefield H. Risk of chronic arthropathy among women after rubella vaccinations. JAMA 1997; 278: 551–6PubMedCrossRefGoogle Scholar
  22. 22.
    Kramarz P, Destefano F, Gargiullo PM, et al. Does influenza vaccination prevent asthma exacerbations in children? J Pediatr 2001 Mar; 138(3): 306–10PubMedCrossRefGoogle Scholar
  23. 23.
    Ascherio A, Zhang SM, Hernan MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med 2001; 344: 327–32PubMedCrossRefGoogle Scholar
  24. 24.
    Confavreux C, Suissa S, Saddier P, et al. Vaccinations and the risk of relapse of multiple sclerosis. N Engl J Med 2001; 344: 319–26PubMedCrossRefGoogle Scholar
  25. 25.
    Causality assessment of adverse events following immunization. Wkly Epidemiol Rec 2001 Mar; 76 (12): 8509Google Scholar
  26. 26.
    Dourado I, Cunha S, Teixeira MG, et al. Outbreak of aseptic meningitis associated with mass vaccination with a Urabecontaining measles-mumps-rubella vaccine: implications for immunization programs. Am J Epidemiol 2000 Mar 1; 151(5): 524–30PubMedCrossRefGoogle Scholar
  27. 27.
    Murphy TV, Margiullo PM, Mehran S, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001 Feb; 344(8): 564–72PubMedCrossRefGoogle Scholar
  28. 28.
    Rennels MB. The rotavirus vaccine story: a clinical investigator’s view. Pediatrics 2000; 106: 123–5PubMedCrossRefGoogle Scholar
  29. 29.
    Kramarz P, France EK, Destefano F, et al. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect Dis J 2001 Apr; 20(4): 410–6PubMedCrossRefGoogle Scholar
  30. 30.
    Wise RP, Kitonga PK, Salive ME. Hair loss after routine immunizations. JAMA 1997 Oct; 278(14): 1176–8PubMedCrossRefGoogle Scholar
  31. 31.
    Meyboom RHB, Hekster YA, Egberts ACG, et al. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 1997; 17: 374–89PubMedCrossRefGoogle Scholar
  32. 32.
    DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA Spontaneous Reporting System. Am Stat 1999; 53: 177–90Google Scholar
  33. 33.
    O’Neill RT, Szarfman A. Discussion: Bayesian data mining in large frequency tables, with an application to FDA Spontaneous Reporting System by William DuMouchel. Am Stat 1999; 53: 190–6Google Scholar
  34. 34.
    Niu MT, Erwin DE, Braun MM. Data mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination. Vaccine 2001; 19: 4627–34PubMedCrossRefGoogle Scholar
  35. 35.
    Niu MT, Davis DM, Ellenberg SS. Recombinant hepatitis B vaccination of neonates and infants: emerging safety data from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 1996 Oct; 15: 771–6PubMedCrossRefGoogle Scholar
  36. 36.
    Niu MT, Rhodes P, Salive ME. Comparative safety of two recombinant hepatitis B vaccines in children: data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD). J Clin Epidemiol 1998; 51(6): 503–10PubMedCrossRefGoogle Scholar

Copyright information

© Adis International Limited 2002

Authors and Affiliations

  1. 1.Center for Biologics Evaluation and ResearchUS Food and Drug AdministrationRockvilleUSA

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