Advanced search
Publication Cover
Expert Review of Vaccines Volume 2, 2003 - Issue 1
Submit an article Journal homepage
100
Views
34
CrossRef citations to date
0
Altmetric
Review

Vaccine safety surveillance using large linked databases: opportunities, hazards and proposed guidelines

Thomas Verstraeten GlaxoSmithKline Biologicals, Rue de l’Institut 89, 1330 Rixensart, Beligum
,
Frank DeStefano Centers for Disease Control and Prevention, Atlanta, GA, USA
,
Robert T Chen Centers for Disease Control and Prevention, Atlanta, GA, USA
&
Elizabeth Miller Elizabeth Miller, MBBS, Public Health Laboratory Service, London, UK
Pages 21-29 | Published online: 09 Jan 2014

References

  • Chen RT, DeStefano F, Pless R, Mootrey G, Kramarz P, Hibbs B. Challenges and controversies in immunization safety. Infect. Dis. Clin. North. Am. 15(1), 21–39 (2001).
  • Ellenberg SS, Braun MM. Monitoring the safety of vaccines: assessing the risks. Drug. 5r25(3), 145–152 (2002).
  • Salisbury DM, Beverley PC, Miller E. Vaccine programmes and policies. Br. Med. Bull 62(1), 201–211 (2002).
  • Ellenberg SS. Safety considerations for new vaccine development. Pharmacoepidemiol Drug. Sal 10(5), 411–415 (2001).
  • Chen RE Vaccine risks: real, perceived and unknown. Vaccine 17, S41—S46 (1999).
  • Strom BL, Carson JL. Use of automated databases for pharmacoepidemiology research. 431demiol. Rev 12,87–107 (1990).
  • ••Comprehensive and still actual review ofLLDBs used in pharmacoepidemiology and potential issues involved.
  • Ray WA, Griffin MR. Use of Medicaid data for pharmacoepidemiology. Am J. 431demiol. 129(4), 837–849 (1989).
  • Gerstman BB, Lundin FE, Stadel BF, Faich GA. A method of pharmacoepidemiologic analysis that uses computerized Medicaid. Clin. 431demiol 43(12), 1387–1393 (1990).
  • Strom BL, Carson JL, Morse ML, LeRoy AA. The computerized on-line Medicaid pharmaceutical analysis and surveillance system: a new resource for postmarketing drug surveillance. Clin. Pharmacol Ther. 38(4), 359–364 (1985).
  • Miller E, Waight P, Farrington P Safety assessment post-licensure. Dev Biol. Stand 95,235–243 (1998).
  • •Good review of methods used in drug safety surveillance.
  • Shapiro S. The role of automated record linkage in the postmarketing surveillance of drug safety: a critique. Clin. Pharmacol Ther. 46(4), 371–386 (1989).
  • Strom BL. Data validity issues in using claims data. Pharmacoepidemiol Drug Sal 10(5), 389–392 (2001).
  • Jick H, Jick SS, Derby L. Validation of information recorded on general practitioner based computerized data resource in the United Kingdom. Br. Med. J. 302,766–768 (1991).
  • van Staa TP, Abenheim L. The quality of information recorded on an UK database of primary care records: A study of hospitalizations due to hypoglycaemia and other conditions. Pharmacoepidemiol Drug 5.i(3, 15–21 (1994).
  • Farmer PDT, Lawrenson RA, Thompson CR, Kennedy JG, Hambleton JR. Population-based study of risk of venous thromboembolism associated with various oral contraceptives. Lancet 349,83–88 (1997).
  • Jick H, Vasikalis-Scaramozza C, Jick SS. Live attenuated polio vaccine and the risk of intussusception. Brj Clin. Pharmacol 52(4), 451–453 (2001).
  • Miller E. Studies of exposure to thiomersal (thimerosal) containing vaccines in UK children and developmental outcome. Testimony submitted to the House Committee on Government Reform Hearing on the Status of Research in Vaccine Safety and Autism, June 16 (2002).
  • Kaye JA, del Mar Melero-Montes M, Jick H. Mumps, measles and rubella vaccine and the incidence of autism recorded by general practitioners: A time trend analysis. Br. Med. 322,460-463 (2001).
  • Nash JQ, Chandrakumar M, Farrington CP, Williamson S, Miller E. Feasibility study for identifying adverse events attributable to vaccination by record linkage. 431demiol Infect. 114,475-480 (1995).
  • Farrington P, Pugh S, Colville A etal. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 345(8949), 567–569 (1995).
  • Miller E, VVaight P, Farrington CP, Andrews N, Stowe J, Taylor B. Idiopathic thrombocytopenic purpura and MMR vaccine (short report). Arch. Dis. Child. 84, 227–229 (2001).
  • Andrews N, Miller E, Waight P etal. Does oral polio vaccine cause intussusception in infants? Evidence from a sequence of three self controlled case series studies in the UK. Eur I Epidemiol 17,701–706 (2001).
  • Miller E, Andrews N, Waight P, Taylor B. Bacterial infections, immune overload and MMR vaccination. Alrh. Dis. Child. (In Press).
  • Andrews NJ. Statistical assessment of the association between vaccination and rare adverse events post-licensure. Vaccine 20, S49—S53 (2001).
  • Taylor B, Miller E, Lingam R, Andrews N, Simmons A, Stowe J. Measles, mumps and rubella vaccination and bowel problems or developmental regression in children with autism: population study. Br. Med. 234, 393–396 (2002).
  • Andrews N, Miller E, Taylor B, Lingam R, Simmons A, Stowe J. Recall bias and the MMR—autism hypothesis. Arch. Dis. Child (2002).
  • 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 43idemiol. 110(2), 105–123 (1979).
  • Walker AM, Jick H, Perera DR, Knauss TA, Thompson RS. Neurologic events following diphtheria—tetanus—pertussis immunization. Pediatrics81(3), 345–349 (1988).
  • Walker AM, Jick H, Perera DR, Thompson RS, Knauss TA. Diphtheria—tetanus—pertussis immunization and sudden infant death syndrome. Am. J. Public Health 77(8), 945–951 (1987).
  • Griffin MR, Ray WA, Mortimer EA, Fenichel GM, Schaffner W Risk of seizures and encephalopathy after immunization with the diphtheria—tetanus—pertussis vaccine. JANIA 263(12), 1641–1645 (1990).
  • Howson CP, Howe CF, Fineberg HV. Adverse effects of Pertussis and Rubella vaccines: A report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. National Academy Press, Washington, DC, USA (1991).
  • Chen RT, Glasser JW, Rhodes PH et al Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team. Pediatrics 99(6), 765–773 (1997).
  • •Good description of the Vaccine Safety Datalink.
  • Chen RI, DeStefano F, Davis RL etal. The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA. Bull Pibrld Health Organ. 78(2), 186–194 (2000).
  • DeStefano F. The Vaccine Safety Datalink project. Pharmacoepidemiol Drug. Sal 10(5), 403–406 (2001).
  • Stratton KR, Howe CJ, Johnston RB Jr. Adverse events associated with childhood vaccines other than pertussis and rubella. Summary of a report from the Institute of Medicine. JA/V/A 271(20), 1602–1605 (1994).
  • Kramarz P, France EK, DeStefano F etal. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect. Dis. 20(4), 410–416 (2001).
  • Niu MT, Rhodes P, Salive M et al. 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. 43idemiol. 51(6), 503–510 (1998).
  • Davis RL, Marcuse E, Black S etal. MIVIR2 immunization at 4 to 5 years and 10 to 12 years of age: a comparison of adverse clinical events after immunization in the Vaccine Safety Datalink project. The Vaccine Safety Datalink Team. Pediatrics 100(5), 767–771 (1997).
  • Vadheim CM, Greenberg DP, Marcy SM, Froeschle J, Ward JI. Safety evaluation of PPP-D liaemophilus intluenzae type b conjugate vaccine in children immunized at 18 months of age and older: follow-up study of 30,000 children. Pediatr Infect. Dis. I 9(8), 555–561 (1990).
  • Barlow WE, Davis RL, Glasser JW etal. The risk of seizures after receipt of whole-cell pertussis or measles, mumps and rubella vaccine. N Engl. J. Med. 2001 345(9), 656–661 (2001).
  • •Example of excellent vaccine safety research using LLDBs.
  • Davis RL, Kramarz P, Bohlke K etal. Measles—mumps—rubella and other measles-containing vaccines do not increase the risk for inflammatory bowel disease: a case-control study from the Vaccine Safety Datalink project. Arrh. Pediatr Adolesc. 155(3), 354–359 (2001).
  • DeStefano F, Mullooly JP, Okoro CA et al Childhood vaccinations, vaccination timing and risk of Type 1 diabetes mellitus. Pediatrics 108 (6), E112 (2001).
  • DeStefano F, Verstraeten T, Jackson LA et al Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch. Neural. (In Press).
  • Kramarz P, DeStefano F, Gargiullo PM etal. Does influenza vaccination prevent asthma exacerbations in children? J. Pediatr 138(3), 306–310 (2001).
  • DeStefano F, Gu D, Kramarz P et a/. Childhood vaccinations and risk of asthma. Pediatr Infect. Dis. I 21(6), 498–504 (2002).
  • Clayton D, Cuzick J. Multivariate generalizations of the proportional hazards model. R. .9at. Soc. 148(2), 82–117 (1985).
  • Vaida F, Xu R. Proportional hazards model with random effects. Stat. Med. 19 (24), 3309–3324 (2000).
  • Halloran ME, Longini IM Jr, Struchiner CJ. Estimability and interpretation of vaccine efficacy using frailty mixing models. Am J. 43idemiol 144(1), 83-97(1996).
  • Farrington a Relative incidence estimation from case series for vaccine safety evaluation. Biometths 51(1), 228–235 (1995).
  • •Primary reference for the case-series method.
  • Farrington CP, Nash J, Miller E. Case series analysis of adverse reactions to vaccines: a comparative evaluation. Am. J. Epidemiol 143,1165–1173 (1996).
  • Griffm MR, Ray WA, Livengood JR, Schaffner W Risk of sudden infant death syndrome after immunization with the diphtheria—tetanus—pertussis vaccine. N Engl Med. 319(10), 618–623 (1988).
  • Farrington CP, Miller E, Taylor B. MMR and autism: further evidence against a causal association. Vaccine 19,3632–3635 (2001).
  • Geier DA, Geier MR An analysis of the reactivity of vaccines administered in Texas from 1991 through 1999. TeX. Med. 98(7), 50–54 (2002).
  • Geier MR, Geier DA. Hepatitis B vaccination safety. Ann. Pharmacother. 36(3), 370–374 (2002).
  • Wang J, Donnan PT Propensity score methods in drug safety studies: practice, strengths and limitations. Phannacoepidemiol Drug Sal 10(4), 341–344 (2001).
  • Wang J, Donnan FT, Steinke D, MacDonald TM. The multiple propensity score for analysis of dose—response relationships in drug safety studies. Phannacoepidemiol Drug Si( 10(2), 105–111 (2001).
  • Rubin DB. Estimating causal effects from large data sets using propensity scores. Ann. Intern. Med. 127(8 Pt 2), 757–763 (1997).
  • Mullooly J, Drew L, DeStefano F et al Quality of HMO vaccination databases used to monitor childhood vaccine safety. Vaccine Safety DataLink Team. Am. 43idemiol. 149(2), 186–194 (1999).
  • ••Very good example of LLDB data qualityassessment.
  • Hull BP, McIntyre PB, Sayer GP. Factors associated with low uptake of measles and pertussis vaccines — an ecologic study based on the Australian Childhood Immunisation Register. Aust. N Z J. Public Health 25 (5), 405–410 (2001).
  • McIntyre E Hull B, Lester R In defence of the Australian Childhood Immunisation Register. Aust. NZ Public Health 25(4), 380 (2001).
  • Alonso JA, Gonzalez PJ, Carbonell JC. Analysis of factors influencing vaccine uptake: perspective from Spain. Vaccine 15(20), S13—S15 (2001).
  • Heijbel H, Jefferson T Vaccine safety — improving monitoring. Vaccine 19(17), 2457–2460 (2001).
  • Lober VVB, Karras BT Wagner MM et al Roundtable on bioterrorism detection: information system-based surveillance. jAm Med Inform Assoc 9(2), 105–115 (2002).
  • Black SB, Shinefield HR. Immunization with oligosaccharide conjugate Haemophilus intluenzaetype b (HbOC) vaccine on a large health maintenance organization population: extended follow-up and impact on Haemophilus influenzae disease epidemiology. The Kaiser Permanente Pediatric Vaccine Study Group. Pedlar': Infect Dis. J. 11(8), 610–613 (1992).
  • Black S, Shinefield H, Ray P et al Postmarketing evaluation of the safety and effectiveness of varicella vaccine. Pediatr Infect. Dis. 18(12), 1041–1046 (1999).
  • Miller E, Goldacre M, Pugh S et al Risk of aseptic meningitis after Measles, Mumps and Rubella vaccine in UK children. Lancet 341,979–982 (1993).
  • McCarthy LC, Davies KJ, Campbell DA. Pharmacogenetics in diverse ethnic populations — implications for drug discovery and development. Phannacogenomics 3 (4), 493–506 (2002).
  • Chen RE Evaluation of Vaccine Safety Post-9/11: Role of Cohort and Case-Control Studies. Vaccine (2002).

Websites

  • Guidelines for Data Sharing Proposals from External Researchers. www.cdc.govinip/ vacsafe/vsd/default.htm#Guidelines.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.