Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccination

Pediatric Infectious Disease Journal

Volumn 32, Issue 2, 2013, Pages 163-168

  Pahud, Barbara A ^a   Williams, S Elizabeth ^b   Dekker, Cornelia L ^a   Halsey, Neal ^c   Larussa, Philip ^d   Baxter, Roger P ^e   Klein, Nicola P ^e   Marchant, Colin D ^f   Sparks, Robert C ^b   Jakob, Kathleen ^d   Aukes, Laurie ^e   Swope, Susan ^a   Barnett, Elizabeth ^j   Lewis, Paige ^g   Berger, Melvin ^h   Dreskin, Stephen C ⁱ   Donofrio, Peter D ^b   Sejvar, James J ^g   Slade, Barbara A ^g   Gidudu, Jane ^g   Vellozzi, Claudia ^g   Edwards, Kathryn M ^b   more..

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

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

^d College of Physicians and Surgeons ^*  (United States)

^e Vaccine Study Center   (United States)

^f BOSTON MEDICAL CENTER   (United States)

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

^h CSL Behring LLC   (United States)

ⁱ UNIVERSITY OF COLORADO   (United States)

^j NONE

more..

Author keywords

adverse event following immunization; children and adolescents; influenza vaccine safety; monovalent 2009 H1N1 influenza vaccine

Indexed keywords

INFLUENZA VACCINE;

ADOLESCENT; ANGIONEUROTIC EDEMA; APHASIA; ARTICLE; ASEPTIC MENINGITIS; ATAXIA; BRAIN TUMOR; BRONCHIOLITIS; CHILD; CLINICAL ASSESSMENT; CRANIAL NEUROPATHY; DRUG HYPERSENSITIVITY; DYSPNEA; DYSTONIA; ENCEPHALOMYELITIS; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; HEMIPARESIS; HUMAN; INFANT; INFLUENZA A; MAJOR CLINICAL STUDY; MALE; MYELITIS; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SEIZURE; SINUSITIS; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; WEAKNESS;

ADOLESCENT; ADVERSE DRUG REACTION REPORTING SYSTEMS; CENTERS FOR DISEASE CONTROL AND PREVENTION (U.S.); CHILD; CHILD, PRESCHOOL; DRUG TOXICITY; FEMALE; HUMANS; INFANT; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; MALE; MASS VACCINATION; UNITED STATES;

EID: 84873024056     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e318271b90a     Document Type: Article

References (40)

1. Centers for Disease Control and Prevention. MMWR Swine infuenza A (H1N1) Infection in Two Children-Southern California, March-April 2009. 2009. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5815a5.htm. Accessed March 24, 2011.
2. World Health Organization. Infuenza A(H1N1) 2009; Statement by WHO Director-General, Dr Margaret Chan Available at: http://www.who. int/mediacentre/news/statements/2009/h1n1-20090429/en/index.html. Accessed March 24, 2011.
3. Libster R, Bugna J, Coviello S, et al. Pediatric hospitalizations associated with 2009 pandemic infuenza A (H1N1) in Argentina. N Engl J Med. 2010;362:45-55.
4. Centers for Disease Control and Prevention. MMWR: Update: Infuenza activity-United States, 2009-2010 season. 2010. Available at: http://www.cdc. gov/mmwr/preview/mmwrhtml/mm5929a2.htm. Accessed March 24, 2011.
5. Centers for Disease Control and Prevention. MMWR: Use of infuenza A (H1N1) 2009 monovalent vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. 2009. Available at: http://www.cdc.gov/ mmwr/preview/mmwrhtml/rr5810a1.htm?s- cid=rr5810a1-e. Accessed March 24, 2011.
6. Salmon DA, Akhtar A, Mergler MJ, et al. Immunization-safety monitoring systems for the 2009 H1N1 monovalent infuenza vaccination program. Pediatrics. 2011:127(suppl 1):S78-S86.
7. Federal Immunization Safety Task Force. Federal plans to monitor immunization safety for the pandemic 2009 H1N1 infuenza vaccination program. 2009. Available at: http://www.fu.gov/professional/federal/monitor-immu- nization-safety.html#cur. Accessed March 24, 2011.
8. LaRussa PS, Edwards KM, Dekker CL, et al. Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network. Pediatrics. 2011;127(suppl 1):S65-S73.
9. Williams SE, Klein N P, Halsey N, et al. Overview of the clinical consult case review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004-2009. Vaccine. 2011;29: 6920-6927.
10. Vellozzi C, Broder KR, Haber P, et al. Adverse events following infuenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009-January 31, 2010. Vaccine. 2010;28:7248-7255.
11. Varricchio F, Iskander J, Destefano F, et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2004;23:287-294.
12. Food and Drug Administration. Code of Federal Regulations; Postmarket-ing reporting of adverse drug experiences. 2010. Available at: http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.80. Accessed November 24, 2010.
13. Haber P, Iskander J, Walton K, et al. Internet-based reporting to the vaccine adverse event reporting system: a more timely and complete way for providers to support vaccine safety. Pediatrics. 2011;127(suppl 1):S39-S44.
14. Williams SE, Pahud BA, Vellozzi C, et al. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination. Vaccine. 2011;29:8302-8308.
15. Sejvar JJ, Kohl KS, Gidudu J, et al.; Brighton Collaboration GBS Working Group. Guillain-Barré syndrome and Fisher syndrome: case defnitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2011;29:599-612.
16. Rosenberg M, Sparks R, McMahon A, et al. Serious adverse events rarely reported after trivalent inactivated infuenza vaccine (TIV) in children 6-23 months of age. Vaccine. 2009;27:4278-4283.
17. Centers for Disease Control and Prevention. Interim results: infuenza A (H1N1) 2009 monovalent vaccination coverage-United States, October-December 2009. 2010. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm59e0115a1. htm. Accessed March 24, 2011.
18. Centers for Disease Control and Prevention. Interim results: state-specifc infuenza A (H1N1) 2009 monovalent vaccination coverage-United States, October 2009-January 2010. 2010. Available at: http://www.cdc.gov/mmwr/ preview/mmwrhtml/mm5912a2.htm. Accessed March 24, 2011.
19. Centers for Disease Control and Prevention. Safety of infuenza A (H1N1) 2009 monovalent vaccines-United States, October 1-November 24, 2009. MMWR Morb Mortal Wkly Rep. 2009;58:1351-1356.
20. Wu J, Xu F, Lu L, et al. Safety and effectiveness of a 2009 H1N1 vaccine in Beijing. N Engl J Med. 2010;363:2416-2423.
21. Liang XF, Li L, Liu DW, et al. Safety of infuenza A (H1N1) vaccine in postmarketing surveillance in China. N Engl J Med. 2011;364:638-647.
22. Vajo Z, Tamas F, Sinka L, et al. Safety and immunogenicity of a 2009 pandemic infuenza A H1N1 vaccine when administered alone or simultaneously with the seasonal infuenza vaccine for the 2009-10 infuenza season: a multicentre, randomised controlled trial. Lancet. 2010;375:49-55.
23. Lu C Y, Shao PL, Chang LY, et al. Immunogenicity and safety of a mono-valent vaccine for the 2009 pandemic infuenza virus A (H1N1) in children and adolescents. Vaccine. 2010;28:5864-5870.
24. Mallory RM, Malkin E, Ambrose CS, et al. Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 infu-enza vaccine to children and adults in two randomized controlled trials. PLoS One. 2010;5:e13755.
25. Nolan T, McVernon J, Skeljo M, et al. Immunogenicity of a monovalent 2009 infuenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010;303:37-46.
26. Oh CE, Lee J, Kang JH, et al. Safety and immunogenicity of an inactivated split-virus infuenza A/H1N1 vaccine in healthy children from 6 months to <18 years of age: a prospective, open-label, multi-center trial. Vaccine. 2010;28:5857-5863.
27. Wijnans L, De Bie S, Dieleman J, et al. Safety of pandemic H1N1 vaccines in children and adolescents. Vaccine. 2011;29:7559-7571.
28. Verity C, Stellitano L, Winstone AM, et al. Guillain-Barré syndrome and H1N1 infuenza vaccine in UK children. Lancet. 2011;378:1545-1546.
29. Liang XF, Wang HQ, Wang JZ, et al. Safety and immunogenicity of 2009 pandemic infuenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2010;375:56-66.
30. Dieleman J, Romio S, Johansen K, et al. Guillain-Barre syndrome and adjuvanted pandemic infuenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ. 2011;343:d3908.
31. Deeks SL, Lim GH, Simpson MA, et al. Estimating background rates of Guillain-Barré Syndrome in Ontario in order to respond to safety concerns during pandemic H1N1/09 immunization campaign. BMC Public Health. 2011;11:329.
32. Choe YJ, Cho H, Bae GR, et al. Guillain-Barre syndrome following receipt of infuenza A (H1N1) 2009 monovalent vaccine in Korea with an emphasis on Brighton Collaboration case defnition. Vaccine. 2011;29: 2066-2070.
33. Nakada H, Narimatsu H, Tsubokura M, et al. Risk of fatal adverse events after H1N1 infuenza vaccination. Clin Infect Dis. 2010;50:1548-1549.
34. McNeil MM, Broder KR, Vellozzi C, et al. Risk of fatal adverse events after H1N1 infuenza vaccine: limitations of passive surveillance data. Clin Infect Dis. 2010;51:871-872; author reply 872-873.
35. Mahajan D, Roomiani I, Gold MS, et al. Annual report: surveillance of adverse events following immunisation in Australia, 2009. Commun Dis Intell. 2010;34:259-276.
36. Lawrence G, Menzies R, Burgess M, et al. Surveillance of adverse events following immunisation: Australia, 2000-2002. Commun Dis Intell. 2003;27:307-323.
37. Western Pacifc Regional Offce. Immunization Safety Surveillance: Guidelines for Managers of Immunization Programmes on Reporting and Investigating Adverse Events Following Immunization Geneva, Switzerland: World Health Organization; 1999.
38. Halsey NA. The science of evaluation of adverse events associated with vaccination. Semin Pediatr Infect Dis. 2002;13:205-214.
39. Armstrong PK, Dowse GK, Effer P V, et al. Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated infuenza vaccine. BMJ Open. 2011;1:e000016.
40. Kelly HA, Skowronski DM, De Serres G, et al. Adverse events associated with 2010 CSL and other inactivated infuenza vaccines. Med J Aust. 2011;195:318-320.