Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015.
Hum Vaccin Immunother
; 14(8): 1963-1969, 2018.
Article
in En
| MEDLINE
| ID: mdl-29580194
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Product Surveillance, Postmarketing
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Adverse Drug Reaction Reporting Systems
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Herpesvirus 3, Human
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Herpes Zoster Vaccine
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Herpes Zoster
Type of study:
Etiology_studies
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Prognostic_studies
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Screening_studies
Limits:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
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Pregnancy
Country/Region as subject:
America do norte
Language:
En
Journal:
Hum Vaccin Immunother
Year:
2018
Document type:
Article
Affiliation country: