H1N1 and Seasonal Influenza Vaccine Safety in the Vaccine Safety Datalink Project

被引：107

作者：

Lee, Grace M. ^{[1
,2
]}

Greene, Sharon K. ^{[1
]}

Weintraub, Eric S. ^{[4
]}

Baggs, James ^{[4
]}

Kulldorff, Martin ^{[1
]}

Fireman, Bruce H. ^{[5
]}

Baxter, Roger ^{[5
]}

Jacobsen, Steven J. ^{[6
]}

Irving, Stephanie ^{[7
]}

Daley, Matthew F. ^{[8
]}

Yin, Ruihua ^{[1
]}

Naleway, Allison ^{[9
]}

Nordin, James D. ^{[10
]}

Li, Lingling ^{[1
]}

McCarthy, Natalie ^{[4
]}

Vellozzi, Claudia ^{[4
]}

DeStefano, Frank ^{[4
]}

Lieu, Tracy A. ^{[1
,3
]}

机构：

[1] Harvard Pilgrim Hlth Care Inst, Dept Populat Med, Ctr Child Hlth Care Studies, Boston, MA 02215 USA

[2] Childrens Hosp, Dept Lab Med, Boston, MA 02115 USA

[3] Childrens Hosp, Div Gen Pediat, Boston, MA 02115 USA

[4] CDC, Immunizat Safety Off, Div Healthcare Qual & Promot, Atlanta, GA 30333 USA

[5] Kaiser Permanente Vaccine Study Ctr, Oakland, CA USA

[6] Kaiser Permanente So Calif, Pasadena, CA USA

[7] Marshfield Clin Res Fdn, Marshfield, WI USA

[8] Univ Colorado Denver, Dept Pediat, Denver, CO USA

[9] Kaiser Permanente NW, Portland, OR USA

[10] HealthPartners Res Fdn, Minneapolis, MN USA

来源：

AMERICAN JOURNAL OF PREVENTIVE MEDICINE | 2011年 / 41卷 / 02期

关键词：

GUILLAIN-BARRE-SYNDROME; EVENT REPORTING SYSTEM; PROBABILITY RATIO TEST; BELLS-PALSY; UNITED-STATES; ADVERSE EVENTS; CHILDREN; SURVEILLANCE; ADULTS; ANAPHYLAXIS;

D O I：

10.1016/j.amepre.2011.04.004

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Background: The emergence of pandemic H1N1 influenza virus in early 2009 prompted the rapid licensure and use of H1N1 monovalent inactivated (MIV) and live, attenuated (LAMV) vaccines separate from seasonal trivalent inactivated (TIV) and live, attenuated (LAIV) influenza vaccines. A robust influenza immunization program in the U. S. requires ongoing monitoring of potential adverse events associated with vaccination. Purpose: To prospectively conduct safety monitoring of H1N1 and seasonal influenza vaccines during the 2009-2010 season. Methods: The Vaccine Safety Datalink (VSD) Project monitors similar to 9.2 million members in eight U. S. medical care organizations. Electronic data on vaccines and pre-specified adverse events were updated and analyzed weekly for signal detection from November 2009 to April 2010 using either a self-controlled design or a current versus historical comparison. Statistical signals were further evaluated using alternative approaches to identify temporal clusters and to control for time-varying confounders. Results: As of May 1, 2010, a total of 1,345,663 MIV, 267,715 LAMV, 2,741,150 TIV, and 157,838 LAIV doses were administered in VSD. No significant associations were noted during sequential analyses for Guillain-Barre syndrome, most other neurologic outcomes, and allergic and cardiac events. For MIV, a statistical signal was observed for Bell's palsy for adults aged >= 25 years on March 31, 2010, using the self-controlled approach. Subsequent analyses revealed no significant temporal cluster. Case-centered logistic regression adjusting for seasonality demonstrated an OR for Bell's palsy of 1.26 (95% CI=0.97, 1.63). Conclusions: No major safety problems following H1N1 or seasonal influenza vaccines were detected in the 2009-2010 season in weekly sequential analyses. Seasonality likely contributed to the Bell's palsy signal following MIV. Prospective safety monitoring followed by rigorous signal refinement is critical to inform decision-making by regulatory and public health agencies. (Am J Prev Med 2011;41(2):121-128) (C) 2011 American Journal of Preventive Medicine

引用

页码：121 / 128

页数：8

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