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Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015.
Hum Vaccin Immunother. 2018; 14(8):1963-1969.HV

Abstract

BACKGROUND

Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged ≥50 years and recommended by the CDC for persons ≥60 years.

METHODS

We analyzed U.S. reports of adverse events (AEs) following ZVL submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system to monitor vaccine safety, for persons vaccinated May 1, 2006, through January 31, 2015. We conducted descriptive analysis, clinical reviews of reports with selected pre-specified conditions, and empirical Bayesian data mining.

RESULTS

VAERS received 23,092 reports following ZVL, of which 22,120 (96%) were classified as non-serious. Of reports where age was documented (n = 18,817), 83% were in persons aged ≥60 years. Reporting rates of AEs were 106 and 4.4 per 100,000 ZVL doses distributed for all reports and serious reports, respectively. When ZVL was administered alone among persons aged ≥50 years, injection site erythema (27%), HZ (17%), injection site swelling (17%), and rash (14%) were the most commonly reported symptoms among non-serious reports; HZ (29%), pain (18%), and rash (16%) were the most commonly reported symptoms among serious reports. Six reports included laboratory evidence of vaccine-strain varicella-zoster virus (Oka/Merck strain) infection; AEs included HZ, HZ- or varicella-like illness, and local reaction with vesicles. In our review of reports of death with sufficient information to determine cause (n = 46, median age 75 years), the most common causes were heart disease (n = 28), sepsis (n = 4), and stroke (n = 3). Empirical Bayesian data mining did not detect new or unexpected safety signals.

CONCLUSIONS

Findings from our safety review of ZVL are consistent with those from pre-licensure clinical trials and other post-licensure assessments. Transient injection-site reactions, HZ, and rashes were most frequently reported to VAERS following ZVL. Overall, our results are reassuring regarding the safety of ZVL.

Authors+Show Affiliations

a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.b Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.b Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29580194

Citation

Miller, Elaine R., et al. "Post-licensure Safety Surveillance of Zoster Vaccine Live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015." Human Vaccines & Immunotherapeutics, vol. 14, no. 8, 2018, pp. 1963-1969.
Miller ER, Lewis P, Shimabukuro TT, et al. Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015. Hum Vaccin Immunother. 2018;14(8):1963-1969.
Miller, E. R., Lewis, P., Shimabukuro, T. T., Su, J., Moro, P., Woo, E. J., Jankosky, C., & Cano, M. (2018). Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015. Human Vaccines & Immunotherapeutics, 14(8), 1963-1969. https://doi.org/10.1080/21645515.2018.1456598
Miller ER, et al. Post-licensure Safety Surveillance of Zoster Vaccine Live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015. Hum Vaccin Immunother. 2018;14(8):1963-1969. PubMed PMID: 29580194.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015. AU - Miller,Elaine R, AU - Lewis,Paige, AU - Shimabukuro,Tom T, AU - Su,John, AU - Moro,Pedro, AU - Woo,Emily Jane, AU - Jankosky,Christopher, AU - Cano,Maria, Y1 - 2018/05/18/ PY - 2018/3/28/pubmed PY - 2019/4/30/medline PY - 2018/3/28/entrez KW - Adverse event KW - Vaccine Adverse Event Reporting System (VAERS) KW - herpes zoster KW - immunization KW - shingles KW - vaccine KW - vaccine safety KW - varicella SP - 1963 EP - 1969 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 14 IS - 8 N2 - BACKGROUND: Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged ≥50 years and recommended by the CDC for persons ≥60 years. METHODS: We analyzed U.S. reports of adverse events (AEs) following ZVL submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system to monitor vaccine safety, for persons vaccinated May 1, 2006, through January 31, 2015. We conducted descriptive analysis, clinical reviews of reports with selected pre-specified conditions, and empirical Bayesian data mining. RESULTS: VAERS received 23,092 reports following ZVL, of which 22,120 (96%) were classified as non-serious. Of reports where age was documented (n = 18,817), 83% were in persons aged ≥60 years. Reporting rates of AEs were 106 and 4.4 per 100,000 ZVL doses distributed for all reports and serious reports, respectively. When ZVL was administered alone among persons aged ≥50 years, injection site erythema (27%), HZ (17%), injection site swelling (17%), and rash (14%) were the most commonly reported symptoms among non-serious reports; HZ (29%), pain (18%), and rash (16%) were the most commonly reported symptoms among serious reports. Six reports included laboratory evidence of vaccine-strain varicella-zoster virus (Oka/Merck strain) infection; AEs included HZ, HZ- or varicella-like illness, and local reaction with vesicles. In our review of reports of death with sufficient information to determine cause (n = 46, median age 75 years), the most common causes were heart disease (n = 28), sepsis (n = 4), and stroke (n = 3). Empirical Bayesian data mining did not detect new or unexpected safety signals. CONCLUSIONS: Findings from our safety review of ZVL are consistent with those from pre-licensure clinical trials and other post-licensure assessments. Transient injection-site reactions, HZ, and rashes were most frequently reported to VAERS following ZVL. Overall, our results are reassuring regarding the safety of ZVL. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/29580194/Post_licensure_safety_surveillance_of_zoster_vaccine_live__Zostavax®__in_the_United_States_Vaccine_Adverse_Event_Reporting_System__VAERS__2006_2015_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2018.1456598 DB - PRIME DP - Unbound Medicine ER -