Active Postlicensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data
© The Author(s) 2022. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:192 |
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| Enthalten in: |
American journal of epidemiology - 192(2023), 2 vom: 01. Feb., Seite 205-216 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Nelson, Jennifer C [VerfasserIn] |
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| Links: |
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| Themen: |
Herpes Zoster Vaccine |
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| Anmerkungen: |
Date Completed 06.02.2023 Date Revised 26.02.2023 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/aje/kwac170 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM347093108 |
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| 520 | |a © The Author(s) 2022. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Belongia, Edward A |e verfasserin |4 aut | |
| 700 | 1 | |a Daley, Matthew F |e verfasserin |4 aut | |
| 700 | 1 | |a Harpaz, Rafael |e verfasserin |4 aut | |
| 700 | 1 | |a Kharbanda, Elyse O |e verfasserin |4 aut | |
| 700 | 1 | |a Klein, Nicola P |e verfasserin |4 aut | |
| 700 | 1 | |a Naleway, Allison L |e verfasserin |4 aut | |
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| 700 | 1 | |a Yih, W Katherine |e verfasserin |4 aut | |
| 700 | 1 | |a Jackson, Lisa A |e verfasserin |4 aut | |
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