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Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018.
Vaccine. 2019 03 07; 37(11):1516-1520.V

Abstract

BACKGROUND

Trivalent adjuvanted influenza vaccine (aIIV3; Fluad®) was approved in the United States (U.S.) in 2015 for adults aged ≥65 years and has been in use since the 2016-17 influenza season.

METHODS

We analyzed U.S. reports for aIIV3 submitted from July 1, 2016 through June 30, 2018 to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. Medical records were reviewed for serious reports. Among individuals ≥65 years of age, the relative frequency of the most commonly reported adverse events (AEs) after aIIV3 were compared with non-adjuvanted inactivated influenza vaccines given to adults aged ≥65 years, high-dose trivalent influenza vaccine (IIV3-HD) and trivalent or quadrivalent vaccines (IIV3/IIV4). Data mining analyses were undertaken to identify whether AEs for aIIV3 occurred disproportionately more than expected compared to all influenza vaccines.

RESULTS

VAERS received 630 reports after aIIV3, of which 521 (83%) were in adults aged ≥65 years; 79 (13%) in persons <65 years and in 30 (5%) reports age was missing; 19 (3%) reports were serious, including two deaths (0.4%) related to myocardial infarction and Sjogren's syndrome. The most common AEs reported in adults aged ≥65 years were injection site pain (21%) and erythema (18%), with similar proportions reported for IIV3-HD (17% and 19%, respectively) and for IIV3/IIV4 (15%, each). Except for reports related to vaccination of inappropriate age (n = 79) and syringe malfunction (n = 6), data mining did not identify other disproportionately reported AEs.

CONCLUSIONS

Although our review of aIIV3 in VAERS did not identify any unexpected health conditions of concern, we observed more than twice the expected number of reports with administration of the vaccine to persons outside of the age range for which the vaccine is approved in the U.S. Health care providers should be educated on the age groups for whom aIIV3 is recommended.

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, United States. Electronic address: phaber@cdc.gov.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

30739795

Citation

Haber, Penina, et al. "Post-licensure Surveillance of Trivalent Adjuvanted Influenza Vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018." Vaccine, vol. 37, no. 11, 2019, pp. 1516-1520.
Haber P, Moro PL, Ng C, et al. Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018. Vaccine. 2019;37(11):1516-1520.
Haber, P., Moro, P. L., Ng, C., Dores, G. M., Lewis, P., & Cano, M. (2019). Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018. Vaccine, 37(11), 1516-1520. https://doi.org/10.1016/j.vaccine.2019.01.052
Haber P, et al. Post-licensure Surveillance of Trivalent Adjuvanted Influenza Vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018. Vaccine. 2019 03 7;37(11):1516-1520. PubMed PMID: 30739795.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018. AU - Haber,Penina, AU - Moro,Pedro L, AU - Ng,Carmen, AU - Dores,Graça M, AU - Lewis,Paige, AU - Cano,Maria, Y1 - 2019/02/07/ PY - 2018/11/02/received PY - 2019/01/14/revised PY - 2019/01/17/accepted PY - 2019/2/12/pubmed PY - 2020/8/5/medline PY - 2019/2/12/entrez KW - Adjuvanted influenza vaccine MF59® (Fluad) KW - Attenuated influenza vaccine KW - Post-licensure surveillance KW - Vaccine adverse event reporting system KW - Vaccine safety SP - 1516 EP - 1520 JF - Vaccine JO - Vaccine VL - 37 IS - 11 N2 - BACKGROUND: Trivalent adjuvanted influenza vaccine (aIIV3; Fluad®) was approved in the United States (U.S.) in 2015 for adults aged ≥65 years and has been in use since the 2016-17 influenza season. METHODS: We analyzed U.S. reports for aIIV3 submitted from July 1, 2016 through June 30, 2018 to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. Medical records were reviewed for serious reports. Among individuals ≥65 years of age, the relative frequency of the most commonly reported adverse events (AEs) after aIIV3 were compared with non-adjuvanted inactivated influenza vaccines given to adults aged ≥65 years, high-dose trivalent influenza vaccine (IIV3-HD) and trivalent or quadrivalent vaccines (IIV3/IIV4). Data mining analyses were undertaken to identify whether AEs for aIIV3 occurred disproportionately more than expected compared to all influenza vaccines. RESULTS: VAERS received 630 reports after aIIV3, of which 521 (83%) were in adults aged ≥65 years; 79 (13%) in persons <65 years and in 30 (5%) reports age was missing; 19 (3%) reports were serious, including two deaths (0.4%) related to myocardial infarction and Sjogren's syndrome. The most common AEs reported in adults aged ≥65 years were injection site pain (21%) and erythema (18%), with similar proportions reported for IIV3-HD (17% and 19%, respectively) and for IIV3/IIV4 (15%, each). Except for reports related to vaccination of inappropriate age (n = 79) and syringe malfunction (n = 6), data mining did not identify other disproportionately reported AEs. CONCLUSIONS: Although our review of aIIV3 in VAERS did not identify any unexpected health conditions of concern, we observed more than twice the expected number of reports with administration of the vaccine to persons outside of the age range for which the vaccine is approved in the U.S. Health care providers should be educated on the age groups for whom aIIV3 is recommended. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/30739795/Post_licensure_surveillance_of_trivalent_adjuvanted_influenza_vaccine__aIIV3 L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(19)30128-8 DB - PRIME DP - Unbound Medicine ER -