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2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction
BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV, GSK), indicated for the prevention of herpes zoster (HZ) in adults ≥ 50 years of age, received its first marketing authorization in October 2017. We reviewed the post-marketing spontaneous adverse event (AE) reports submitted to GSK’s world...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Oxford University Press
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810355/ http://dx.doi.org/10.1093/ofid/ofz360.2453 |
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author | Tavares-Da-Silva, Fernanda Miranda Co, Maribel Dessart, Cristophe Hervé, Caroline López-Fauqued, Marta Mahaux, Olivia Van Holle, Lionel Stegmann, Jens-Ulrich |
author_facet | Tavares-Da-Silva, Fernanda Miranda Co, Maribel Dessart, Cristophe Hervé, Caroline López-Fauqued, Marta Mahaux, Olivia Van Holle, Lionel Stegmann, Jens-Ulrich |
author_sort | Tavares-Da-Silva, Fernanda |
collection | PubMed |
description | BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV, GSK), indicated for the prevention of herpes zoster (HZ) in adults ≥ 50 years of age, received its first marketing authorization in October 2017. We reviewed the post-marketing spontaneous adverse event (AE) reports submitted to GSK’s worldwide safety database since RZV introduction. METHODS: Descriptive analyses were conducted on all spontaneous reports involving RZV from October 13, 2017 to February 10, 2019. Observed-to-expected analyses were performed for the outcomes of interest: all-cause mortality and the 2 most commonly reported potential immune-mediated diseases, Guillain–Barré syndrome (GBS) and Bell’s palsy. Data mining was done to detect quantitative signals by identifying RZV-AE pairings with disproportionate reporting or evidence of an unexpected time-to-onset distribution. RESULTS: Most of the15,638 spontaneous reports received were medically verified (75.2%), originated from the United States (81.7%) and were non-serious (95.3%). Reports were mainly from individuals 50–69 years old (62.1%) and females (66.7%), when documented (Figure 1). Of all reports, 12,059 (77.1%) described signs/symptoms and 3,579 (22.9%) described vaccination errors, majority of which were without associated signs/symptoms (2,961; 82.7%). Overall, the most commonly reported signs/symptoms were consistent with vaccine reactogenicity (such as injection-site reactions, pyrexia, pain, chills, headache, fatigue), which were previously reported after RZV (Table 1). The observed reporting rates of outcomes of interest likely represent temporary associated events that are occurring as background incidence in the general population. No unexpected reporting patterns were detected overall. The proportion of RZV vaccination errors over time, by country, is shown in Figure 2. Overall, most reports described errors in vaccine preparation and reconstitution (29.7%) (Table 2). CONCLUSION: Overall, the safety profile of RZV, following the first year of post-marketing use, is reassuring and consistent with that observed in clinical trials. Ongoing surveillance will continue to monitor RZV safety, as it is an early stage in the implementation, when real-life data are limited. Funding: GlaxoSmithKline Biologicals SA. [Image: see text] [Image: see text] [Image: see text] [Image: see text] DISCLOSURES: All authors: No reported disclosures. |
format | Online Article Text |
id | pubmed-6810355 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-68103552019-10-28 2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction Tavares-Da-Silva, Fernanda Miranda Co, Maribel Dessart, Cristophe Hervé, Caroline López-Fauqued, Marta Mahaux, Olivia Van Holle, Lionel Stegmann, Jens-Ulrich Open Forum Infect Dis Abstracts BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV, GSK), indicated for the prevention of herpes zoster (HZ) in adults ≥ 50 years of age, received its first marketing authorization in October 2017. We reviewed the post-marketing spontaneous adverse event (AE) reports submitted to GSK’s worldwide safety database since RZV introduction. METHODS: Descriptive analyses were conducted on all spontaneous reports involving RZV from October 13, 2017 to February 10, 2019. Observed-to-expected analyses were performed for the outcomes of interest: all-cause mortality and the 2 most commonly reported potential immune-mediated diseases, Guillain–Barré syndrome (GBS) and Bell’s palsy. Data mining was done to detect quantitative signals by identifying RZV-AE pairings with disproportionate reporting or evidence of an unexpected time-to-onset distribution. RESULTS: Most of the15,638 spontaneous reports received were medically verified (75.2%), originated from the United States (81.7%) and were non-serious (95.3%). Reports were mainly from individuals 50–69 years old (62.1%) and females (66.7%), when documented (Figure 1). Of all reports, 12,059 (77.1%) described signs/symptoms and 3,579 (22.9%) described vaccination errors, majority of which were without associated signs/symptoms (2,961; 82.7%). Overall, the most commonly reported signs/symptoms were consistent with vaccine reactogenicity (such as injection-site reactions, pyrexia, pain, chills, headache, fatigue), which were previously reported after RZV (Table 1). The observed reporting rates of outcomes of interest likely represent temporary associated events that are occurring as background incidence in the general population. No unexpected reporting patterns were detected overall. The proportion of RZV vaccination errors over time, by country, is shown in Figure 2. Overall, most reports described errors in vaccine preparation and reconstitution (29.7%) (Table 2). CONCLUSION: Overall, the safety profile of RZV, following the first year of post-marketing use, is reassuring and consistent with that observed in clinical trials. Ongoing surveillance will continue to monitor RZV safety, as it is an early stage in the implementation, when real-life data are limited. Funding: GlaxoSmithKline Biologicals SA. [Image: see text] [Image: see text] [Image: see text] [Image: see text] DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2019-10-23 /pmc/articles/PMC6810355/ http://dx.doi.org/10.1093/ofid/ofz360.2453 Text en © The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Abstracts Tavares-Da-Silva, Fernanda Miranda Co, Maribel Dessart, Cristophe Hervé, Caroline López-Fauqued, Marta Mahaux, Olivia Van Holle, Lionel Stegmann, Jens-Ulrich 2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction |
title | 2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction |
title_full | 2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction |
title_fullStr | 2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction |
title_full_unstemmed | 2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction |
title_short | 2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction |
title_sort | 2776. post-marketing safety surveillance for the adjuvanted recombinant zoster vaccine: review of spontaneous reports since introduction |
topic | Abstracts |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810355/ http://dx.doi.org/10.1093/ofid/ofz360.2453 |
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