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Post-Licensure Surveillance of Trivalent Live-Attenuated Influenza Vaccine in Children Aged 2-18 Years, Vaccine Adverse Event Reporting System, United States, July 2005-June 2012.
J Pediatric Infect Dis Soc. 2015 Sep; 4(3):205-13.JP

Abstract

BACKGROUND

The first trivalent live-attenuated influenza vaccine (LAIV3) was licensed in 2003 for use in healthy persons 5-49 years of age. In 2007, the US Food and Drug Administration expanded its indication to healthy children 2-4 years of age.

METHODS

We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 from July 1, 2005 to June 30, 2012 in children aged 2-18 years. Medical records were requested for nonmanufacturer reports coded as serious (ie, death, hospitalization, prolonged hospitalization, life-threatening illness, disability). We characterized electronic data and clinically reviewed all serious reports and reports of special interest. Empirical Bayesian data mining was used to identify new or unexpected adverse events (AEs).

RESULTS

During the study period, VAERS received 2619 US LAIV3 reports for children aged 2-18 years; 197 (7.5%) reports were serious, including 5 deaths. The 2 most frequent nonfatal serious reports involved neurological and respiratory systems, with 56 (29.2%) and 43 (22.4%) reports, respectively. The most frequent neurological diagnoses were seizures and Guillain-Barré Syndrome, and the most frequent respiratory conditions were pneumonia and asthma or reactive airway disease. Data mining showed increased proportions for reports of medication errors, most commonly vaccine administration errors not associated with an AE.

CONCLUSIONS

In this VAERS analysis of reports following LAIV3, we found no new or unexpected AEs patterns. Reports of LAIV3 administration to persons, for whom it is not recommended, including children with a history of asthma or reactive airway disease or wheezing, indicate that ongoing monitoring and education in vaccine indications are needed.

Authors+Show Affiliations

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26407428

Citation

Haber, Penina, et al. "Post-Licensure Surveillance of Trivalent Live-Attenuated Influenza Vaccine in Children Aged 2-18 Years, Vaccine Adverse Event Reporting System, United States, July 2005-June 2012." Journal of the Pediatric Infectious Diseases Society, vol. 4, no. 3, 2015, pp. 205-13.
Haber P, Moro PL, Cano M, et al. Post-Licensure Surveillance of Trivalent Live-Attenuated Influenza Vaccine in Children Aged 2-18 Years, Vaccine Adverse Event Reporting System, United States, July 2005-June 2012. J Pediatric Infect Dis Soc. 2015;4(3):205-13.
Haber, P., Moro, P. L., Cano, M., Vellozzi, C., Lewis, P., Woo, E. J., & Broder, K. (2015). Post-Licensure Surveillance of Trivalent Live-Attenuated Influenza Vaccine in Children Aged 2-18 Years, Vaccine Adverse Event Reporting System, United States, July 2005-June 2012. Journal of the Pediatric Infectious Diseases Society, 4(3), 205-13. https://doi.org/10.1093/jpids/piu034
Haber P, et al. Post-Licensure Surveillance of Trivalent Live-Attenuated Influenza Vaccine in Children Aged 2-18 Years, Vaccine Adverse Event Reporting System, United States, July 2005-June 2012. J Pediatric Infect Dis Soc. 2015;4(3):205-13. PubMed PMID: 26407428.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-Licensure Surveillance of Trivalent Live-Attenuated Influenza Vaccine in Children Aged 2-18 Years, Vaccine Adverse Event Reporting System, United States, July 2005-June 2012. AU - Haber,Penina, AU - Moro,Pedro L, AU - Cano,Maria, AU - Vellozzi,Claudia, AU - Lewis,Paige, AU - Woo,Emily Jane, AU - Broder,Karen, Y1 - 2014/05/07/ PY - 2013/12/04/received PY - 2014/03/19/accepted PY - 2015/9/26/entrez PY - 2015/9/26/pubmed PY - 2017/8/22/medline KW - live-attenuated influenza KW - postmarketing surveillance KW - vaccine KW - vaccine safety SP - 205 EP - 13 JF - Journal of the Pediatric Infectious Diseases Society JO - J Pediatric Infect Dis Soc VL - 4 IS - 3 N2 - BACKGROUND: The first trivalent live-attenuated influenza vaccine (LAIV3) was licensed in 2003 for use in healthy persons 5-49 years of age. In 2007, the US Food and Drug Administration expanded its indication to healthy children 2-4 years of age. METHODS: We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 from July 1, 2005 to June 30, 2012 in children aged 2-18 years. Medical records were requested for nonmanufacturer reports coded as serious (ie, death, hospitalization, prolonged hospitalization, life-threatening illness, disability). We characterized electronic data and clinically reviewed all serious reports and reports of special interest. Empirical Bayesian data mining was used to identify new or unexpected adverse events (AEs). RESULTS: During the study period, VAERS received 2619 US LAIV3 reports for children aged 2-18 years; 197 (7.5%) reports were serious, including 5 deaths. The 2 most frequent nonfatal serious reports involved neurological and respiratory systems, with 56 (29.2%) and 43 (22.4%) reports, respectively. The most frequent neurological diagnoses were seizures and Guillain-Barré Syndrome, and the most frequent respiratory conditions were pneumonia and asthma or reactive airway disease. Data mining showed increased proportions for reports of medication errors, most commonly vaccine administration errors not associated with an AE. CONCLUSIONS: In this VAERS analysis of reports following LAIV3, we found no new or unexpected AEs patterns. Reports of LAIV3 administration to persons, for whom it is not recommended, including children with a history of asthma or reactive airway disease or wheezing, indicate that ongoing monitoring and education in vaccine indications are needed. SN - 2048-7207 UR - https://www.unboundmedicine.com/medline/citation/26407428/Post_Licensure_Surveillance_of_Trivalent_Live_Attenuated_Influenza_Vaccine_in_Children_Aged_2_18_Years_Vaccine_Adverse_Event_Reporting_System_United_States_July_2005_June_2012_ L2 - https://academic.oup.com/jpids/article-lookup/doi/10.1093/jpids/piu034 DB - PRIME DP - Unbound Medicine ER -