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. 2023 Nov 8:383:e076321.
doi: 10.1136/bmj-2023-076321.

Effectiveness of the live zoster vaccine during the 10 years following vaccination: real world cohort study using electronic health records

Nicola P Klein  1 , Joan Bartlett  1 , Bruce Fireman  1 , Morgan A Marks  2 , John Hansen  1 , Edwin Lewis  1 , Laurie Aukes  1 , Patricia Saddier  2
Affiliations

Effectiveness of the live zoster vaccine during the 10 years following vaccination: real world cohort study using electronic health records

Nicola P Klein et al. BMJ. .

Abstract

Objectives: To assess the effectiveness of live zoster vaccine during more than 10 years after vaccination; and to describe methods for ascertaining vaccine effectiveness in the context of waning.

Design: Real world cohort study using electronic health records.

Setting: Kaiser Permanente Northern California, an integrated healthcare delivery system in the US, 1 January 2007 to 31 December 2018.

Population: More than 1.5 million people aged 50 years and older followed for almost 9.4 million person years.

Main outcome measure: Vaccine effectiveness in preventing herpes zoster, postherpetic neuralgia, herpes zoster ophthalmicus, and admission to hospital for herpes zoster was assessed. Change in vaccine effectiveness by time since vaccination was examined using Cox regression with a calendar timeline. Time varying indicators were specified for each interval of time since vaccination (30 days to less than one year, one to less than two years, etc) and adjusted for covariates.

Results: Of 1 505 647 people, 507 444 (34%) were vaccinated with live zoster vaccine. Among 75 135 incident herpes zoster cases, 4982 (7%) developed postherpetic neuralgia, 4439 (6%) had herpes zoster ophthalmicus, and 556 (0.7%) were admitted to hospital for herpes zoster. For each outcome, vaccine effectiveness was highest in the first year after vaccination and decreased substantially over time. Against herpes zoster, vaccine effectiveness waned from 67% (95% confidence interval 65% to 69%) in the first year to 15% (5% to 24%) after 10 years. Against postherpetic neuralgia, vaccine effectiveness waned from 83% (78% to 87%) to 41% (17% to 59%) after 10 years. Against herpes zoster ophthalmicus, vaccine effectiveness waned from 71% (63% to 76%) to 29% (18% to 39%) during five to less than eight years. Against admission to hospital for herpes zoster, vaccine effectiveness waned from 90% (67% to 97%) to 53% (25% to 70%) during five to less than eight years. Across all follow-up time, overall vaccine effectiveness was 46% (45% to 47%) against herpes zoster, 62% (59% to 65%) against postherpetic neuralgia, 45% (40% to 49%) against herpes zoster ophthalmicus, and 66% (55% to 74%) against admission to hospital for herpes zoster.

Conclusions: Live zoster vaccine was effective initially. Vaccine effectiveness waned substantially yet some protection remained 10 years after vaccination. After 10 years, protection was low against herpes zoster but higher against postherpetic neuralgia.

Trial registration: ClinicalTrials.gov number NCT01600079; EU PAS register number EUPAS17502.

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Conflict of interest statement

Competing Interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/ and declare: PS is an employee of Merck Sharp and Dohme LLC, the manufacturer of the vaccine and sponsor of the study. MAM was an employee of Merck Sharp and Dohme LLC during the study and now is an employee of Moderna Inc. The study was conducted and analysed at Kaiser Permanente, where all the other authors have been employed. NPK has received research grant support for unrelated studies from GlaxoSmithKline, Sanofi Pasteur, Pfizer, and the US Centers for Disease Control and Prevention.

Figures

Fig 1
Fig 1
Live zoster vaccine coverage in the study population by age group, 2007-18. Coverage is the proportion of the study population who had received the vaccine by midpoint of each year
See this image and copyright information in PMC

Comment in

References

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