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Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data
Recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to prevent herpes zoster (shingles) and its complications in older adults. In this prospective, postlicensure Vaccine Safety Datalink study using el...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9896469/ https://www.ncbi.nlm.nih.gov/pubmed/36193854 http://dx.doi.org/10.1093/aje/kwac170 |
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author | Nelson, Jennifer C Ulloa-Pérez, Ernesto Yu, Onchee Cook, Andrea J Jackson, Michael L Belongia, Edward A Daley, Matthew F Harpaz, Rafael Kharbanda, Elyse O Klein, Nicola P Naleway, Allison L Tseng, Hung-Fu Weintraub, Eric S Duffy, Jonathan Yih, W Katherine Jackson, Lisa A |
author_facet | Nelson, Jennifer C Ulloa-Pérez, Ernesto Yu, Onchee Cook, Andrea J Jackson, Michael L Belongia, Edward A Daley, Matthew F Harpaz, Rafael Kharbanda, Elyse O Klein, Nicola P Naleway, Allison L Tseng, Hung-Fu Weintraub, Eric S Duffy, Jonathan Yih, W Katherine Jackson, Lisa A |
author_sort | Nelson, Jennifer C |
collection | PubMed |
description | Recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to prevent herpes zoster (shingles) and its complications in older adults. In this prospective, postlicensure Vaccine Safety Datalink study using electronic health records, we sequentially monitored a real-world population of adults aged ≥50 years who received care in multiple US Vaccine Safety Datalink health systems to identify potentially increased risks of 10 prespecified health outcomes, including stroke, anaphylaxis, and Guillain-Barré syndrome (GBS). Among 647,833 RZV doses administered from January 2018 through December 2019, we did not detect a sustained increased risk of any monitored outcome for RZV recipients relative to either historical (2013–2017) recipients of zoster vaccine live, a live attenuated virus vaccine (Zostavax; Merck & Co., Inc., Kenilworth, New Jersey), or contemporary non-RZV vaccine recipients who had an annual well-person visit during the 2018–2019 study period. We confirmed prelicensure trial findings of increased risks of systemic and local reactions following RZV. Our study provides additional reassurance about the overall safety of RZV. Despite a large sample, uncertainty remains regarding potential associations with GBS due to the limited number of confirmed GBS cases that were observed. |
format | Online Article Text |
id | pubmed-9896469 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-98964692023-02-06 Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data Nelson, Jennifer C Ulloa-Pérez, Ernesto Yu, Onchee Cook, Andrea J Jackson, Michael L Belongia, Edward A Daley, Matthew F Harpaz, Rafael Kharbanda, Elyse O Klein, Nicola P Naleway, Allison L Tseng, Hung-Fu Weintraub, Eric S Duffy, Jonathan Yih, W Katherine Jackson, Lisa A Am J Epidemiol Original Contribution Recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to prevent herpes zoster (shingles) and its complications in older adults. In this prospective, postlicensure Vaccine Safety Datalink study using electronic health records, we sequentially monitored a real-world population of adults aged ≥50 years who received care in multiple US Vaccine Safety Datalink health systems to identify potentially increased risks of 10 prespecified health outcomes, including stroke, anaphylaxis, and Guillain-Barré syndrome (GBS). Among 647,833 RZV doses administered from January 2018 through December 2019, we did not detect a sustained increased risk of any monitored outcome for RZV recipients relative to either historical (2013–2017) recipients of zoster vaccine live, a live attenuated virus vaccine (Zostavax; Merck & Co., Inc., Kenilworth, New Jersey), or contemporary non-RZV vaccine recipients who had an annual well-person visit during the 2018–2019 study period. We confirmed prelicensure trial findings of increased risks of systemic and local reactions following RZV. Our study provides additional reassurance about the overall safety of RZV. Despite a large sample, uncertainty remains regarding potential associations with GBS due to the limited number of confirmed GBS cases that were observed. Oxford University Press 2022-10-04 /pmc/articles/PMC9896469/ /pubmed/36193854 http://dx.doi.org/10.1093/aje/kwac170 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Original Contribution Nelson, Jennifer C Ulloa-Pérez, Ernesto Yu, Onchee Cook, Andrea J Jackson, Michael L Belongia, Edward A Daley, Matthew F Harpaz, Rafael Kharbanda, Elyse O Klein, Nicola P Naleway, Allison L Tseng, Hung-Fu Weintraub, Eric S Duffy, Jonathan Yih, W Katherine Jackson, Lisa A Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data |
title | Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data |
title_full | Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data |
title_fullStr | Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data |
title_full_unstemmed | Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data |
title_short | Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data |
title_sort | active postlicensure safety surveillance for recombinant zoster vaccine using electronic health record data |
topic | Original Contribution |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9896469/ https://www.ncbi.nlm.nih.gov/pubmed/36193854 http://dx.doi.org/10.1093/aje/kwac170 |
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