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Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013.
Vaccine. 2014 Nov 12; 32(48):6499-504.V

Abstract

BACKGROUND

Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults.

METHODS

We searched Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged ≥ 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season.

RESULTS

During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n=207, 17%), headache (n=192, 16%), and fever (n=133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n=40, 39%), cardiovascular (n=14, 14%), and other non-infectious conditions (n=20, 19%). We noted a higher proportion of Guillain-Barré syndrome (GBS) and cardiovascular reports in the Department of Defense (DoD) population compared to the civilian population. Data mining detected disproportional reporting of ataxia (n=15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS.

CONCLUSIONS

Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in the DoD population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications.

Authors+Show Affiliations

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA. Electronic address: pyh0@cdc.gov.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA.Safety and Evaluation Division, Military Vaccine Agency (MILVAX), Falls Church, VA 22042, USA.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30333, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25258101

Citation

Haber, Penina, et al. "Post-licensure Surveillance of Trivalent Live Attenuated Influenza Vaccine in Adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013." Vaccine, vol. 32, no. 48, 2014, pp. 6499-504.
Haber P, Moro PL, McNeil MM, et al. Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013. Vaccine. 2014;32(48):6499-504.
Haber, P., Moro, P. L., McNeil, M. M., Lewis, P., Woo, E. J., Hughes, H., & Shimabukuro, T. T. (2014). Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013. Vaccine, 32(48), 6499-504. https://doi.org/10.1016/j.vaccine.2014.09.018
Haber P, et al. Post-licensure Surveillance of Trivalent Live Attenuated Influenza Vaccine in Adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013. Vaccine. 2014 Nov 12;32(48):6499-504. PubMed PMID: 25258101.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013. AU - Haber,Penina, AU - Moro,Pedro L, AU - McNeil,Michael M, AU - Lewis,Paige, AU - Woo,Emily Jane, AU - Hughes,Hayley, AU - Shimabukuro,Tom T, Y1 - 2014/09/22/ PY - 2014/07/23/received PY - 2014/09/09/revised PY - 2014/09/11/accepted PY - 2014/9/27/entrez PY - 2014/9/27/pubmed PY - 2015/6/16/medline KW - Live attenuated influenza vaccine KW - Post-licensure surveillance KW - Vaccine safety SP - 6499 EP - 504 JF - Vaccine JO - Vaccine VL - 32 IS - 48 N2 - BACKGROUND: Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults. METHODS: We searched Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged ≥ 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season. RESULTS: During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n=207, 17%), headache (n=192, 16%), and fever (n=133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n=40, 39%), cardiovascular (n=14, 14%), and other non-infectious conditions (n=20, 19%). We noted a higher proportion of Guillain-Barré syndrome (GBS) and cardiovascular reports in the Department of Defense (DoD) population compared to the civilian population. Data mining detected disproportional reporting of ataxia (n=15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS. CONCLUSIONS: Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in the DoD population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25258101/Post_licensure_surveillance_of_trivalent_live_attenuated_influenza_vaccine_in_adults_United_States_Vaccine_Adverse_Event_Reporting_System__VAERS__July_2005_June_2013_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(14)01277-8 DB - PRIME DP - Unbound Medicine ER -