Vaccine safety datalink project

A new tool for improving vaccine safety monitoring in the United States

Robert T. Chen, John W. Glasser, Philip H. Rhodes, Robert Davis, William E. Barlow, Robert S. Thompson, John P. Mullooly, Steve B. Black, Henry R. Shinefield, Connie M. Vadheim, S. Michael Marcy, Joel I. Ward, Robert P. Wise, Steven G. Wassilak, Stephen C. Hadler, Emmett Swint, Janet R. Hardy, Thomas Payne, Virginia Immanuel, Patti Benson & 13 others Julie Draket, Lois Drew, Barbara Mendius, Paula Ray, Ned Lewis, Bruce H. Fireman, Jennie Jing, Michael Wulfsohn, Marlene M. Lugg, Patricia Osborne, Suresh Rastogi, Peter Patriarca, Vito Caserta

Research output: Contribution to journalArticle

238 Citations (Scopus)

Abstract

Objective. To fill the large 'gaps and limitations' in current scientific knowledge of rare vaccine adverse events identified in recent reviews of the Institute of Medicine. Methods. Computerized information on immunization, medical outcomes, and potential confounders on more than 500 000 children 0 to 6 years of age is linked annually at several health maintenance organizations to create a large cohort for multiple epidemiologic studies of vaccine safety. Results. Analysis of 3 years of follow-up data shows that 549 488 doses of diphtheria-tetanus-pertussis (DTP) and 310618 doses of measles-mumps-rubella (MMR) vaccines have been administered to children in the study cohort. Analyses for associations between vaccines and 34 medical outcomes are underway. Screening of automated data shows that seizures are associated with receipt of DTP on the same day (relative risk [RR], 2.1; 95% confidence interval [CI], 1.1 to 4.0) and 8 to 14 days after receipt of MMR (RR, 3.0; 95% CI, 2.1 to 4.2). The diversity of vaccination exposures in this large cohort permits us to show that an apparent association of seizures 8 to 14 days after Haemophilus influenzae type b vaccine (RR, 1.6; 95% CI, 1.2 to 2.1) was attributable to confounding by simultaneous MMR vaccination; the association disappears with appropriate adjustment (RR, 1.0; 95% CI, 0.7 to 1.4). Conclusion. Preliminary design, data collection, and analytic capability of the Vaccine Safety Datalink project has been validated by replication of previous known associations between seizures and DTP and MMR vaccines. The diversity in vaccine administration schedules permits potential disentangling of effects of simultaneous and combined vaccinations. The project provides a model of public health-managed care collaborations in addition to an excellent infrastructure for safety and other studies of vaccines.

Original languageEnglish (US)
Pages (from-to)765-773
Number of pages9
JournalPediatrics
Volume99
Issue number6
DOIs
StatePublished - Jun 1 1997

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Vaccines
Safety
Diphtheria
Whooping Cough
Tetanus
Measles-Mumps-Rubella Vaccine
Confidence Intervals
Mumps
Vaccination
Seizures
Rubella
Measles
Haemophilus Vaccines
Haemophilus influenzae type b
National Academies of Science, Engineering, and Medicine (U.S.) Health and Medicine Division
Health Maintenance Organizations
Managed Care Programs
Epidemiologic Studies
Immunization
Appointments and Schedules

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

Cite this

Chen, R. T., Glasser, J. W., Rhodes, P. H., Davis, R., Barlow, W. E., Thompson, R. S., ... Caserta, V. (1997). Vaccine safety datalink project: A new tool for improving vaccine safety monitoring in the United States. Pediatrics, 99(6), 765-773. https://doi.org/10.1542/peds.99.6.765

Vaccine safety datalink project : A new tool for improving vaccine safety monitoring in the United States. / Chen, Robert T.; Glasser, John W.; Rhodes, Philip H.; Davis, Robert; Barlow, William E.; Thompson, Robert S.; Mullooly, John P.; Black, Steve B.; Shinefield, Henry R.; Vadheim, Connie M.; Michael Marcy, S.; Ward, Joel I.; Wise, Robert P.; Wassilak, Steven G.; Hadler, Stephen C.; Swint, Emmett; Hardy, Janet R.; Payne, Thomas; Immanuel, Virginia; Benson, Patti; Draket, Julie; Drew, Lois; Mendius, Barbara; Ray, Paula; Lewis, Ned; Fireman, Bruce H.; Jing, Jennie; Wulfsohn, Michael; Lugg, Marlene M.; Osborne, Patricia; Rastogi, Suresh; Patriarca, Peter; Caserta, Vito.

In: Pediatrics, Vol. 99, No. 6, 01.06.1997, p. 765-773.

Research output: Contribution to journalArticle

Chen, RT, Glasser, JW, Rhodes, PH, Davis, R, Barlow, WE, Thompson, RS, Mullooly, JP, Black, SB, Shinefield, HR, Vadheim, CM, Michael Marcy, S, Ward, JI, Wise, RP, Wassilak, SG, Hadler, SC, Swint, E, Hardy, JR, Payne, T, Immanuel, V, Benson, P, Draket, J, Drew, L, Mendius, B, Ray, P, Lewis, N, Fireman, BH, Jing, J, Wulfsohn, M, Lugg, MM, Osborne, P, Rastogi, S, Patriarca, P & Caserta, V 1997, 'Vaccine safety datalink project: A new tool for improving vaccine safety monitoring in the United States', Pediatrics, vol. 99, no. 6, pp. 765-773. https://doi.org/10.1542/peds.99.6.765
Chen, Robert T. ; Glasser, John W. ; Rhodes, Philip H. ; Davis, Robert ; Barlow, William E. ; Thompson, Robert S. ; Mullooly, John P. ; Black, Steve B. ; Shinefield, Henry R. ; Vadheim, Connie M. ; Michael Marcy, S. ; Ward, Joel I. ; Wise, Robert P. ; Wassilak, Steven G. ; Hadler, Stephen C. ; Swint, Emmett ; Hardy, Janet R. ; Payne, Thomas ; Immanuel, Virginia ; Benson, Patti ; Draket, Julie ; Drew, Lois ; Mendius, Barbara ; Ray, Paula ; Lewis, Ned ; Fireman, Bruce H. ; Jing, Jennie ; Wulfsohn, Michael ; Lugg, Marlene M. ; Osborne, Patricia ; Rastogi, Suresh ; Patriarca, Peter ; Caserta, Vito. / Vaccine safety datalink project : A new tool for improving vaccine safety monitoring in the United States. In: Pediatrics. 1997 ; Vol. 99, No. 6. pp. 765-773.
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abstract = "Objective. To fill the large 'gaps and limitations' in current scientific knowledge of rare vaccine adverse events identified in recent reviews of the Institute of Medicine. Methods. Computerized information on immunization, medical outcomes, and potential confounders on more than 500 000 children 0 to 6 years of age is linked annually at several health maintenance organizations to create a large cohort for multiple epidemiologic studies of vaccine safety. Results. Analysis of 3 years of follow-up data shows that 549 488 doses of diphtheria-tetanus-pertussis (DTP) and 310618 doses of measles-mumps-rubella (MMR) vaccines have been administered to children in the study cohort. Analyses for associations between vaccines and 34 medical outcomes are underway. Screening of automated data shows that seizures are associated with receipt of DTP on the same day (relative risk [RR], 2.1; 95{\%} confidence interval [CI], 1.1 to 4.0) and 8 to 14 days after receipt of MMR (RR, 3.0; 95{\%} CI, 2.1 to 4.2). The diversity of vaccination exposures in this large cohort permits us to show that an apparent association of seizures 8 to 14 days after Haemophilus influenzae type b vaccine (RR, 1.6; 95{\%} CI, 1.2 to 2.1) was attributable to confounding by simultaneous MMR vaccination; the association disappears with appropriate adjustment (RR, 1.0; 95{\%} CI, 0.7 to 1.4). Conclusion. Preliminary design, data collection, and analytic capability of the Vaccine Safety Datalink project has been validated by replication of previous known associations between seizures and DTP and MMR vaccines. The diversity in vaccine administration schedules permits potential disentangling of effects of simultaneous and combined vaccinations. The project provides a model of public health-managed care collaborations in addition to an excellent infrastructure for safety and other studies of vaccines.",
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AU - Chen, Robert T.

AU - Glasser, John W.

AU - Rhodes, Philip H.

AU - Davis, Robert

AU - Barlow, William E.

AU - Thompson, Robert S.

AU - Mullooly, John P.

AU - Black, Steve B.

AU - Shinefield, Henry R.

AU - Vadheim, Connie M.

AU - Michael Marcy, S.

AU - Ward, Joel I.

AU - Wise, Robert P.

AU - Wassilak, Steven G.

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AU - Payne, Thomas

AU - Immanuel, Virginia

AU - Benson, Patti

AU - Draket, Julie

AU - Drew, Lois

AU - Mendius, Barbara

AU - Ray, Paula

AU - Lewis, Ned

AU - Fireman, Bruce H.

AU - Jing, Jennie

AU - Wulfsohn, Michael

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AU - Patriarca, Peter

AU - Caserta, Vito

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