Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015
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. Metho...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2018-08-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2018.1456598 |
| _version_ | 1797677492595589120 |
|---|---|
| author | Elaine R. Miller Paige Lewis Tom T. Shimabukuro John Su Pedro Moro Emily Jane Woo Christopher Jankosky Maria Cano |
| author_facet | Elaine R. Miller Paige Lewis Tom T. Shimabukuro John Su Pedro Moro Emily Jane Woo Christopher Jankosky Maria Cano |
| author_sort | Elaine R. Miller |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T22:45:56Z |
| format | Article |
| id | doaj.art-a245ce01b8d94c07ab83b87e79560d05 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:45:56Z |
| publishDate | 2018-08-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-a245ce01b8d94c07ab83b87e79560d052023-09-22T08:38:21ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2018-08-011481963196910.1080/21645515.2018.14565981456598Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015Elaine R. Miller0Paige Lewis1Tom T. Shimabukuro2John Su3Pedro Moro4Emily Jane Woo5Christopher Jankosky6Maria Cano7Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionOffice of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationOffice of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and PreventionBackground: 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.http://dx.doi.org/10.1080/21645515.2018.1456598adverse eventherpes zosterimmunizationshinglesvaccine adverse event reporting system (vaers)vaccine safetyvaccinevaricella |
| spellingShingle | Elaine R. Miller Paige Lewis Tom T. Shimabukuro John Su Pedro Moro Emily Jane Woo Christopher Jankosky Maria Cano Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015 Human Vaccines & Immunotherapeutics adverse event herpes zoster immunization shingles vaccine adverse event reporting system (vaers) vaccine safety vaccine varicella |
| title | Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015 |
| title_full | Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015 |
| title_fullStr | Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015 |
| title_full_unstemmed | Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015 |
| title_short | Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006–2015 |
| title_sort | post licensure safety surveillance of zoster vaccine live zostavax r in the united states vaccine adverse event reporting system vaers 2006 2015 |
| topic | adverse event herpes zoster immunization shingles vaccine adverse event reporting system (vaers) vaccine safety vaccine varicella |
| url | http://dx.doi.org/10.1080/21645515.2018.1456598 |
| work_keys_str_mv | AT elainermiller postlicensuresafetysurveillanceofzostervaccinelivezostavaxintheunitedstatesvaccineadverseeventreportingsystemvaers20062015 AT paigelewis postlicensuresafetysurveillanceofzostervaccinelivezostavaxintheunitedstatesvaccineadverseeventreportingsystemvaers20062015 AT tomtshimabukuro postlicensuresafetysurveillanceofzostervaccinelivezostavaxintheunitedstatesvaccineadverseeventreportingsystemvaers20062015 AT johnsu postlicensuresafetysurveillanceofzostervaccinelivezostavaxintheunitedstatesvaccineadverseeventreportingsystemvaers20062015 AT pedromoro postlicensuresafetysurveillanceofzostervaccinelivezostavaxintheunitedstatesvaccineadverseeventreportingsystemvaers20062015 AT emilyjanewoo postlicensuresafetysurveillanceofzostervaccinelivezostavaxintheunitedstatesvaccineadverseeventreportingsystemvaers20062015 AT christopherjankosky postlicensuresafetysurveillanceofzostervaccinelivezostavaxintheunitedstatesvaccineadverseeventreportingsystemvaers20062015 AT mariacano postlicensuresafetysurveillanceofzostervaccinelivezostavaxintheunitedstatesvaccineadverseeventreportingsystemvaers20062015 |