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Sequential Data-Mining for Adverse Events after Recombinant Herpes Zoster Vaccination Using the Tree-Based Scan Statistic
In this study, the binomial tree-based scan statistic was applied sequentially to detect adverse events in Days 1-28 compared with Days 29-56 after recombinant herpes zoster (RZV) vaccination, with 5 looks at the data and formal adjustment for the repeated analyses over time. IBM Marketscan data on commercially insured persons 50+ years of age receiving RZV during January 1, 2018-May 5, 2020 were used. With 999,876 doses of RZV included, statistically significant signals were detected only for unspecified adverse effects/complications following immunization, with attributable risks as low as 2 excess cases per 100,000 vacc...
Source: Am J Epidemiol - October 13, 2022 Category: Epidemiology Authors: W Katherine Yih Martin Kulldorff Inna Dashevsky Judith C Maro Source Type: research

Active Post-Licensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data
Am J Epidemiol. 2022 Oct 4:kwac170. doi: 10.1093/aje/kwac170. Online ahead of print.ABSTRACTRecombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to prevent herpes zoster and its complications in older adults. In this prospective, post-licensure Vaccine Safety Datalink (VSD) study using electronic health records, we sequentially monitored a real-world population of adults aged 50 years and older who received care at multiple VSD health systems in the United States to identify potential increased risks of 10 pre-specified prior...
Source: Am J Epidemiol - October 4, 2022 Category: Epidemiology Authors: Jennifer C Nelson Ernesto Ulloa-P érez Onchee Yu Andrea J Cook Michael L Jackson Edward A Belongia Matthew F Daley Rafael Harpaz Elyse O Kharbanda Nicola P Klein Allison L Naleway Hung-Fu Tseng Eric S Weintraub Jonathan Duffy W Katherine Yih Lisa A Jacks Source Type: research

A Broad Safety Assessment of the Recombinant Herpes Zoster Vaccine
Am J Epidemiol. 2022 Feb 12:kwac030. doi: 10.1093/aje/kwac030. Online ahead of print.ABSTRACTThe recombinant herpes zoster vaccine (RZV), approved as a 2-dose series in the U.S. in October 2017, has proven highly effective and generally safe. However, a small risk of Guillain-Barré syndrome (GBS) after vaccination was identified post-approval, and questions remain about other possible adverse events. This data-mining study assessed RZV safety in the U.S. using the self-controlled tree-temporal scan statistic, scanning data on thousands of diagnoses recorded during follow-up to detect any statistically unusual temporal clu...
Source: Am J Epidemiol - February 13, 2022 Category: Epidemiology Authors: W Katherine Yih Martin Kulldorff Inna Dashevsky Judith C Maro Source Type: research

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022
This report updates previous ACIP recommendations for the prevention of herpes zoster (1,3).PMID:35051134 | DOI:10.15585/mmwr.mm7103a2
Source: MMWR Morb Mortal Wkl... - January 20, 2022 Category: Epidemiology Authors: Tara C Anderson Nina B Masters Angela Guo Leah Shepersky Andrew J Leidner Grace M Lee Camille N Kotton Kathleen L Dooling Source Type: research

Safety and reactogenicity of the adjuvanted recombinant zoster vaccine: experience from clinical trials and post-marketing surveillance
Ther Adv Vaccines Immunother. 2021 Nov 30;9:25151355211057479. doi: 10.1177/25151355211057479. eCollection 2021.ABSTRACTAn adjuvanted recombinant zoster vaccine (RZV) is licensed for the prevention of herpes zoster. This paper reviews its safety and reactogenicity. A pooled analysis of two pivotal randomized Phase-3 trials (NCT01165177, NCT01165229) in adults ⩾50 years found that more solicited adverse events (AEs) were reported with RZV than placebo. Injection site pain was the most common solicited AE (RZV: 78.0% participants; placebo: 10.9%). Grade-3 pain occurred in 6.4% of RZV and 0.3% of placebo recipients. Myalgia...
Source: Adv Data - January 10, 2022 Category: Epidemiology Authors: Joseph Fiore Maribel Miranda Co-van der Mee Andr és Maldonado Lisa Glasser Phil Watson Source Type: research

QuickStats: Percentage* of Adults Aged ≥50 Years Who Ever Received a Shingles Vaccination, < sup > † < /sup > by Race and Hispanic Origin < sup > § < /sup > and Sex - National Health Interview Survey, United States, 2019 < sup > ¶ < /sup >
MMWR Morb Mortal Wkly Rep. 2021 Jun 18;70(24):901. doi: 10.15585/mmwr.mm7024a5.NO ABSTRACTPMID:34138832 | DOI:10.15585/mmwr.mm7024a5
Source: MMWR Morb Mortal Wkl... - June 17, 2021 Category: Epidemiology Source Type: research

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