Safety of inadvertent administration of live zoster vaccine to immunosuppressed individuals in a UK-based observational cohort analysis

Daniel J. Grint, Helen I. McDonald, Jemma L. Walker, Gayatri Amirthalingam, Nick Andrews, Sara Thomas

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Abstract

Objectives: To investigate the safety of live attenuated varicella zoster vaccination when administered to immunosuppressed individuals. Design: Prospective observational cohort study. Setting: The study used anonymised data from the Clinical Practice Research Datalink (CPRD), comprising a representative sample of routinely collected primary care data in England between 2013 and 2017 and and linked Hospital Episode Statistics data. Participants: 168 767 individuals age-eligible for varicella zoster vaccination registered at a general practice in England contributing data to CPRD. Main outcome measures: Electronic health records indicating immunosuppression, zoster vaccination, diagnoses of specific varicella-zoster virus (VZV)-related disease and non-specific rash/encephalitis compatible with VZV-related disease. Results: Between 1 September 2013 and 31 August 2017, a period of immunosuppression was identified for 9093/168 767 (5.4%; 95% CI: 5.3%-5.5%) individuals age-eligible for zoster vaccination. The overall rate of vaccination while immunosuppressed was 1742/5251 (33.2 per 100 adjusted person years at risk; 95% CI: 31.9%-34.5%). Follow-up of the 1742 individuals who were inadvertently vaccinated while immunosuppressed identified only two cases of VZV-related disease within 8 weeks of vaccination (0.1%; 95% CI: 0.01%-0.4%), both primary care diagnoses of 'shingles', neither with a related hospital admission. Conclusions: Despite evidence of inadvertent vaccination of immunosuppressed individuals with live zoster vaccination, there is a lack of evidence of severe consequences including hospitalisation. This should reassure primary care staff and encourage vaccination of mildly immunosuppressed individuals who do not meet current thresholds for contraindication. These findings support a review of the extent to which live zoster vaccination is contraindicated among the immunosuppressed.

Original languageEnglish
Article numbere034886
JournalBMJ Open
Volume10
Issue number1
DOIs
Publication statusPublished - 29 Jan 2020
Externally publishedYes

Bibliographical note

Funding Information:
Competing interests DJG, JLW, NA and SLT had financial support from the National Institute for Health Research (NIHR) Health Protection Research Unit (HPRU) in Immunisation for the submitted work; the Public Health England Immunisation Department has provided vaccine manufacturers with post-marketing surveillance reports on pneumococcal and meningococcal infection which the companies are required to submit to the UK Licensing Authority in compliance with their Risk Management Strategy, and a cost recovery charge is made for these reports.

Funding Information:
Funding The research was funded by the National Institute for Health Research (NIHR) Health Protection Research Unit (HPRU) in Immunisation at the London School of Hygiene and Tropical Medicine in partnership with Public Health England (PHE).

Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Keywords

  • adverse events
  • geriatric dermatology
  • immunology
  • infectious diseases and infestations
  • public health

ASJC Scopus subject areas

  • Medicine(all)

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