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A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus.

ABSTRACT: HZ/Su, branded as 'Shingrix', is one of the newest vaccines to be submitted for multi-national regulatory approval. It is targeted to prevent shingles, a global concern with aging populations. A live attenuated vaccine for shingles has been available for over a decade, however it is contraindicated in specific subgroups of people, and there are added concerns regarding long-term immunogenicity. HZ/Su is the first subunit vaccine developed to protect against shingles. This paper provides a critical appraisal of current evidence regarding HZ/Su.

SUBMITTER: Bharucha T

PROVIDER: S-EPMC5557227 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus.

Bharucha Tehmina T Ming Damien D Breuer Judith J

Human vaccines & immunotherapeutics 20170420 8

HZ/Su, branded as 'Shingrix', is one of the newest vaccines to be submitted for multi-national regulatory approval. It is targeted to prevent shingles, a global concern with aging populations. A live attenuated vaccine for shingles has been available for over a decade, however it is contraindicated in specific subgroups of people, and there are added concerns regarding long-term immunogenicity. HZ/Su is the first subunit vaccine developed to protect against shingles. This paper provides a critic ...[more]

PMID: 28426274

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Project description:ObjectivesTo examine the reported incidence and features of disseminated varicella zoster virus (VZV) infection following live attenuated herpes zoster vaccine live (ZVL: Zostavax, Merck) in immunocompromised people in Australia.Design and settingZVL was funded in 2016 in Australia for people aged 70 years, with a catch-up programme for those 71-79 years. From 2016 to 2020, three deaths due to disseminated vaccine-strain VZV infection occurred following inadvertent ZVL administration in individuals with varying levels of immunocompromise. This descriptive study examined 4 years of national surveillance data reported to the Therapeutic Goods Administration's Adverse Event Monitoring System (AEMS). Denominator data for rates were from doses recorded in the Australian Immunisation Register.ParticipantsIndividuals vaccinated between 1 November 2016 and 31 December 2020 who experienced adverse event(s) following immunisation (AEFI) after ZVL recorded in the AEMS.Primary and secondary outcome measuresRates and outcomes of confirmed (Oka strain positive) or probable disseminated VZV infection, and inadvertent administration of ZVL in immunocompromised individuals.Results854 AEFI were reported from 1 089 966 doses of ZVL administered (78.4 per 100 000 doses). Of those, 14 were classified as confirmed (n=6, 0.55 per 100 000) or probable (n=8) disseminated VZV infection. The confirmed cases were all hospitalised, and most (5/6) were immunocompromised; three cases died. Thirty-seven individuals were reported as vaccinated despite a contraindication due to immunocompromise (3.4 per 100 000), with 12/37 (32%) hospitalised.ConclusionsDisseminated VZV is potentially life-threatening and occurs mostly in those with severe immunocompromise. Inadvertent administration of ZVL to immunocompromised individuals has occurred despite initial provider guidance and education. Multiple additional strategies to assist providers to identify contraindications have been implemented to prevent adverse outcomes.

Dataset Information

A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus.

Publications

A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus.

Similar Datasets

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