Success of program linking data sources to monitor H1N1 vaccine safety points to potential for even broader safety surveillance

Health Affairs

Volumn 31, Issue 11, 2012, Pages 2518-2527

  Salmon, Daniel ^a   Yih, W Katherine ^b   Lee, Grace ^b   Rosofsky, Robert ^c   Brown, Jeffrey ^b   Vannice, Kirsten ^a   Tokars, Jerome ^d   Roddy, James ^e   Ball, Robert ^f   Gellin, Bruce ^g   Lurie, Nicole ^h   Koh, Howard ^h   Platt, Richard ^b   Lieu, Tracy ⁱ   Greene, Sharon ^b   Rett, Melisa ^b   Balsbaugh, Carolyn ^b   Gay, Charlene ^b   Jin, Robert ^b   Li, Renny ^b   Vilk, Yury ^b   Yin, Ruihua ^b   Zhu, Shao ^b   Fahey, Kevin ^j   Grosso, Lauren ^j   Lardy, Barbara ^j   Pescatello, Sara ^j   Rhee, Victor ^j   Destefano, Frank ^d   Gee, Julianne ^d   Skillen, Elizabeth ^d   Vellozzi, Claudia ^d   Weintraub, Eric ^d   Wilson, Rickey ^k   Garman, Patrick ^h   Foltz, Daniel ^h   Ford, Aurelia ^h   Manson, John ^h   Van Dyke, Jim ^h   Tandon, Vik ^h   Brand, Bill ^l   Hinman, Alan ^l   Lowery, Elaine ^l   Hoyle, Therese ^l   Wild, Ellen ^l   Fernandes, Joaquim ^h   Liu, Yihai ^h   Spettell, Claire ^h   Walraven, Cheryl N McMahill ^h   Bunz, Thomas ^h   Carmody, Daniel ^h   Connor, Therese ^h   Cooper, Jason ^h   Nguyen, Ha ^h   Regine, Mark ^h   Stambaugh, Thomas ^h   Sumner, Anthony ^h   Cannon, Alex ^h   Cuff, Diane ^h   Daniel, Greg ^h   Fang, Christy ^h   Hetrick, Chris ^h   Li, Jenny ^h   Meyers, Lori ^h   Wahl, Peter ^h   Wilson, Marcus ^h   Keshishian, Marc ^h   Ball, Amy ^h   Nau, David ^h   Stacy, Jane ^h   Xu, Yihua ^h   Young Xu, Yinong ^h   more..

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c Health Information Systems Consulting   (United States)

^d CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^e CSC   (United States)

^f CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^g U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

^h Department of Health and Human Services ^*  (United States)

ⁱ DIVISION OF RESEARCH   (United States)

^j America's Health Insurance Plans   (United States)

^k CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^l Public Health Informatics Institute   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

INFLUENZA VACCINE;

ARTICLE; DATA ANALYSIS; DRUG APPROVAL; DRUG MONITORING; DRUG SAFETY; HEALTH PROGRAM; HUMAN; INFLUENZA A (H1N1); INFLUENZA VACCINATION; INFLUENZA VIRUS A H1N1; INFORMATION PROCESSING; INFORMATION RETRIEVAL; OUTCOME ASSESSMENT; POSTMARKETING SURVEILLANCE; REGISTER; UNITED STATES; UNSPECIFIED SIDE EFFECT;

DATABASES, FACTUAL; FEMALE; HUMANS; IMMUNIZATION PROGRAMS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MASS VACCINATION; MONITORING, PHYSIOLOGIC; PANDEMICS; PATIENT SAFETY; PRODUCT SURVEILLANCE, POSTMARKETING; PROGRAM EVALUATION; PUBLIC HEALTH; UNITED STATES; UNITED STATES DEPT. OF HEALTH AND HUMAN SERVICES;

EID: 84871882908     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2012.0104     Document Type: Article

References (21)

1. Ellenberg SS. Safety considerations for new vaccine development. Pharmacoepidemiol Drug Saf. 2001; 10(5):411-5.
2. Chen RT, Glasser JW, Rhodes PH, Davis RL, Barlow WE, Thompson RS, et al. Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team. Pediatrics. 1997;99(6): 765-73.
3. Cooper LZ, Larson HJ, Katz SL. Protecting public trust in immunization. Pediatrics. 2008;122(1): 149-53.
4. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 12th ed. Atlanta (GA): CDC; 2011 Apr.
5. Davis RL, Kolczak M, Lewis E, Nordin J, Goodman M, Shay DK, et al. Active surveillance of vaccine safety: a system to detect early signs of adverse events. Epidemiology. 2005;16(3):336-41.
6. Kulldorff M, Davis R, Kolczak M, Lewis E, Lieu T, Platt R. A maximized probability ratio test for drug and vaccine safety surveillance. Unpublished manuscript.
7. Food and Drug Administration. Regulatory information: Food and Drug Administration Amendments Act (FDAAA) of 2007 [Internet]. Silver Spring (MD): FDA; [last updated 2011 Dec 2; cited 2012 Oct 12]. Available from: http://www.fda.gov/ RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticAct FDCAct/SignificantAmendmentsto theFDCAct/FoodandDrug AdministrationAmendmentsActof 2007/default.htm
8. Salmon DA, Akhtar A, Mergler MJ, Vannice KS, Izurieta H, Ball R, et al. Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program. Pediatrics. 2011;127(Suppl 1): S78-86.
9. HHS.gov. National Vaccine Advisory Committee: report on 2009 H1N1 vaccine safety risk assessment [Internet]. Washington (DC): Department of Health and Human Services; [cited 2012 Oct 12]. Available from: http://www.hhs.gov/nvpo/nvac/ reports/vsrawg_repot_may2010.html
10. Flu.gov. Federal plans to monitor immunization safety for the pandemic 2009 H1N1 influenza vaccination program [Internet]. Washington (DC): Department of Health and Human Services; [cited 2012 Oct 12]. Available from: http:// www.flu.gov/professional/federal/ monitor_immunization_safety.html
11. Velentgas P, Bohn RL, Brown JS, Chan KA, Gladowski P, Holick CN, et al. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study. Pharmacoepidemiol Drug Saf. 2008;17(12):1226-34.
12. Yih WK, Lee GM, Lieu TA, Ball R, Kuldorff M, Rett M, et al. Surveillance for adverse events following receipt of pandemic 2009 H1N1 vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (H1N1 PRISM) System, 2009-2010. Am J Epidemiol. 2012;175(11); 1120-8.
13. Maro JC, Platt R, Holmes JH, Strom BL, Hennessy S, Lazarus R, et al. Design of a national distributed health data network. Ann Intern Med. 2009;151(5):341-4.
14. Brown JS, Holmes JH, Shah K, Hall K, Lazarus R, Platt R. Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care. Med Care. 2010;48(6 Suppl): S45-51.
15. To access the Appendix, click on the Appendix link in the box to the right of the article online
16. Lee GM, Greene SK, Weintraub ES, Baggs J, Kulldorff M, Fireman BH, et al. H1N1 and seasonal influenza vaccine safety in the Vaccine Safety Datalink Project. Am J Prev Med. 2011;41(2):121-8.
17. Centers for Disease Control and Prevention. Seasonal influenza (flu): final estimates for 2009-10 seasonal influenza and influenza A (H1N1) 2009 monovalent vaccination coverage- United States, August 2009 through May, 2010 [Internet]. Atlanta (GA): CDC; [last updated 2011 May 13; cited 2012 Oct 12]. Available from: http://www.cdc.gov/ flu/professionals/vaccination/ coverage_0910estimates.htm
18. Burwen DR, Sandhu SK, Macurdy TE, Kelman JA, Gibbs JM, Garcia B, et al. Surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2009-2010. Am J Public Health. 2012;102(10):1921-7.
19. Platt R, Carnahan RM, Brown JS, Chrischilles E, Curtis LH, Hennessy S, et al. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf. 2012; 21(Suppl 1):1-8.
20. Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt R. Developing the Sentinel System-a national resource for evidence development. N Engl J Med. 2011; 364(6):498-9.
21. 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.