Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

López-Fauqued, Marta; Cámpora, Laura; Delannois, Frédérique; Idrissi, Mohamed El; Oostvogels, Lidia; Looze, Ferdinandus J. de; Díez-Domingo, Javier; Heineman, Thomas C.; Lal, Himal; McElhaney, Janet E.; McNeil, Shelly; Yeo, W. W.; Silva, Fernanda Tavares Da; Ahonen, Anitta; Avelino‐Silva, Thiago Junqueira; Barba‐Gómez, José Fernando; Berglund, Johan; Cuixart, Carlos Brotons; Caso, Covadonga; Chlíbek, Roman; Choi, Won Suk; Cunningham, Anthony L.; Desole, Maria Guiseppina; Eizenberg, Peter; Esen, Meral; Espié, Emmanuelle; Gervais, Pierre; Ghesquière, Wayne; Godeaux, Olivier; Gorfinkel, Iris; Hui, David Shu Cheong; Hwang, Shinn‐Jang; Korhonen, Tiina; Kovac, Martina; Ledent, Edouard; Leung, Edward M. F.; Levin, Myron J.; Pérez, Silvia Narejos; Neto, José Luiz Costa; Pauksens, Karlis; Põder, Airi; Pinta, María Luisa Rodriguez de la; Rombo, Lars; Schwarz, Tino F.; Smetana, Jan; Staniscia, Tommaso; Tinoco, Juan Carlos; Toma, Aurel; Vastiau, Ilse; Vesikari, Timo; Volpi, Antonio; Watanabe, Daisuke; Weckx, Lily Yin; Zahaf, Toufik

doi:10.1016/j.vaccine.2019.03.043

Cited by 43 publications

(66 citation statements)

References 24 publications

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“…The two large pivotal phase III clinical trials, ZOSTER-006/ZOE-50 (NCT01165177) and −022/ZOE-70 (NCT01165229), that involved a total of 29 305 subjects ≥50 years of age who received at least one dose of RZV (n=14 645) or placebo (n=14 660) were designed to assess the efficacy and safety of the RZV vaccine, but not to statistically assess a potential risk of gout among RZV recipients 2–4…”

mentioning

confidence: 99%

Clarification regarding the statement of the association between the recombinant zoster vaccine (RZV) and gout flares

Didierlaurent¹,

Desssart²,

Cunningham

2019

Ann Rheum Dis

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mentioning

confidence: 99%

Clarification regarding the statement of the association between the recombinant zoster vaccine (RZV) and gout flares

Didierlaurent¹,

Desssart²,

Cunningham

2019

Ann Rheum Dis

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“…Similarly, the occurrence of fatal adverse reactions such as neoplasms, cardiac failure, and myocardial infarction were comparable between the two groups (4.3% in the RZV group and 4.6% in the placebo group). Of these, only one was considered to be vaccinerelated and occurred in a previously thrombocytopenic 90-year-old patient [37]. 3.…”

Section: ) Rzv Shingrix ®mentioning

confidence: 99%

Recombinant zoster vaccine (Shingrix^®): a new option for the prevention of herpes zoster and postherpetic neuralgia

et al. 2020

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“…It is administered intramuscularly as two doses given 2-6 months apart. RZV has demonstrated over 90% efficacy against HZ across all age groups studied over 4 years of follow-up [5] and has a favourable benefit-risk profile [6][7][8].…”

Section: Introductionmentioning

confidence: 99%

Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology

et al. 2020

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A diligent, systematic, regular review of aggregate safety data is essential, particularly early after vaccine introduction, as this is when safety signals not identified during clinical development may emerge. In October 2017, the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommended the adjuvanted recombinant zoster vaccine (RZV; Shingrix, GSK) as the preferred vaccine for preventing herpes zoster (HZ) and related complications in immunocompetent adults aged ≥ 50 years. Subsequently, GSK experienced an unprecedented high demand for RZV. In this methodology paper, we summarize the enhanced measures undertaken to assess RZV safety during its early post-marketing experience in the USA, Canada and Germany. In addition to the routine signal-detection methods already in place for all vaccines, GSK established tailored and enhanced safety monitoring for RZV based on aggregate data of spontaneous reports and manufacturing data. Proactive, near real-time detection and evaluation of signals was a key objective. A dedicated in-house signal-detection tool customized for RZV was employed on a weekly (rather than the routine monthly) basis, allowing for a centralized, more frequent review of data on a single web-based platform. We also identified the background incidence rates of preselected medical events of interest in the first countries to introduce RZV (USA, Canada and Germany) to perform observed-to-expected analyses. This approach may offer a solution to the challenges associated with the assessment and monitoring of vaccine safety in an efficient and timely manner in the context of high vaccine uptake.

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Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Cited by 43 publications

References 24 publications

Clarification regarding the statement of the association between the recombinant zoster vaccine (RZV) and gout flares

Clarification regarding the statement of the association between the recombinant zoster vaccine (RZV) and gout flares

Recombinant zoster vaccine (Shingrix^®): a new option for the prevention of herpes zoster and postherpetic neuralgia

Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology

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Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Cited by 43 publications

References 24 publications

Clarification regarding the statement of the association between the recombinant zoster vaccine (RZV) and gout flares

Clarification regarding the statement of the association between the recombinant zoster vaccine (RZV) and gout flares

Recombinant zoster vaccine (Shingrix®): a new option for the prevention of herpes zoster and postherpetic neuralgia

Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology

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Product

Resources

About

Recombinant zoster vaccine (Shingrix^®): a new option for the prevention of herpes zoster and postherpetic neuralgia