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Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project.
Am J Epidemiol. 2010 Jan 15; 171(2):177-88.AJ

Abstract

The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent inactivated influenza vaccine during the 2005/06-2007/08 influenza seasons. In self-controlled case series analysis, the risk of adverse events in a prespecified exposure period following vaccination was compared with the risk in 1 control period for the same individual either before or after vaccination. In difference-in-difference analysis, the relative risk in exposed versus control periods each season was compared with the relative risk in previous seasons since 2000/01. The authors used Poisson-based analysis to compare the risk of Guillain-Barré syndrome following vaccination in each season with that in previous seasons. Maximized sequential probability ratio tests were used to adjust for repeated analyses on weekly data. With administration of 1,195,552 doses to children under age 18 years and 4,773,956 doses to adults, no elevated risk of adverse events was identified. Near real-time surveillance for selected adverse events can be implemented prospectively to rapidly assess seasonal and pandemic influenza vaccine safety.

Authors+Show Affiliations

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim HealthCare Institute, 133 Brookline Avenue, Boston, MA 02215-3920, USA. sharon_greene@harvardpilgrim.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

19965887

Citation

Greene, Sharon K., et al. "Near Real-time Surveillance for Influenza Vaccine Safety: Proof-of-concept in the Vaccine Safety Datalink Project." American Journal of Epidemiology, vol. 171, no. 2, 2010, pp. 177-88.
Greene SK, Kulldorff M, Lewis EM, et al. Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project. Am J Epidemiol. 2010;171(2):177-88.
Greene, S. K., Kulldorff, M., Lewis, E. M., Li, R., Yin, R., Weintraub, E. S., Fireman, B. H., Lieu, T. A., Nordin, J. D., Glanz, J. M., Baxter, R., Jacobsen, S. J., Broder, K. R., & Lee, G. M. (2010). Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project. American Journal of Epidemiology, 171(2), 177-88. https://doi.org/10.1093/aje/kwp345
Greene SK, et al. Near Real-time Surveillance for Influenza Vaccine Safety: Proof-of-concept in the Vaccine Safety Datalink Project. Am J Epidemiol. 2010 Jan 15;171(2):177-88. PubMed PMID: 19965887.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project. AU - Greene,Sharon K, AU - Kulldorff,Martin, AU - Lewis,Edwin M, AU - Li,Rong, AU - Yin,Ruihua, AU - Weintraub,Eric S, AU - Fireman,Bruce H, AU - Lieu,Tracy A, AU - Nordin,James D, AU - Glanz,Jason M, AU - Baxter,Roger, AU - Jacobsen,Steven J, AU - Broder,Karen R, AU - Lee,Grace M, Y1 - 2009/12/04/ PY - 2009/12/8/entrez PY - 2009/12/8/pubmed PY - 2010/2/17/medline SP - 177 EP - 88 JF - American journal of epidemiology JO - Am J Epidemiol VL - 171 IS - 2 N2 - The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent inactivated influenza vaccine during the 2005/06-2007/08 influenza seasons. In self-controlled case series analysis, the risk of adverse events in a prespecified exposure period following vaccination was compared with the risk in 1 control period for the same individual either before or after vaccination. In difference-in-difference analysis, the relative risk in exposed versus control periods each season was compared with the relative risk in previous seasons since 2000/01. The authors used Poisson-based analysis to compare the risk of Guillain-Barré syndrome following vaccination in each season with that in previous seasons. Maximized sequential probability ratio tests were used to adjust for repeated analyses on weekly data. With administration of 1,195,552 doses to children under age 18 years and 4,773,956 doses to adults, no elevated risk of adverse events was identified. Near real-time surveillance for selected adverse events can be implemented prospectively to rapidly assess seasonal and pandemic influenza vaccine safety. SN - 1476-6256 UR - https://www.unboundmedicine.com/medline/citation/19965887/Near_real_time_surveillance_for_influenza_vaccine_safety:_proof_of_concept_in_the_Vaccine_Safety_Datalink_Project_ L2 - https://academic.oup.com/aje/article-lookup/doi/10.1093/aje/kwp345 DB - PRIME DP - Unbound Medicine ER -