Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster in a Real-World Setting.

BACKGROUND

A 2-dose series of recombinant zoster vaccine (RZV) was 97% effective against herpes zoster (HZ) in a pivotal clinical trial.

OBJECTIVE

To evaluate real-world effectiveness of RZV against HZ.

DESIGN

Prospective cohort study.

SETTING

Four health care systems in the Vaccine Safety Datalink.

PARTICIPANTS

Persons aged 50 years or older.

MEASUREMENTS

The outcome was incident HZ defined by a diagnosis with an antiviral prescription. Cox regression was used to estimate the hazard of HZ in vaccinated persons compared with unvaccinated persons, with adjustment for covariates. Vaccine effectiveness (VE) was calculated as 1 minus the adjusted hazard ratio and was estimated by time since the last RZV dose and by corticosteroid use.

RESULTS

The study included nearly 2.0 million persons who contributed 7.6 million person-years of follow-up. After adjustment, VE of 1 dose was 64% and VE of 2 doses was 76%. After 1 dose only, VE was 70% during the first year, 45% during the second year, 48% during the third year, and 52% after the third year. After 2 doses, VE was 79% during the first year, 75% during the second year, and 73% during the third and fourth years. Vaccine effectiveness was 65% in persons who received corticosteroids before vaccination and 77% in those who did not.

LIMITATION

Herpes zoster could not be identified as accurately in these observational data as in the previous clinical trials.

CONCLUSION

Two doses of RZV were highly effective, although less effective than in the previous clinical trials. Two-dose effectiveness waned very little during the 4 years of follow-up. However, 1-dose effectiveness waned substantially after 1 year, underscoring the importance of the second dose.

PRIMARY FUNDING SOURCE

Centers for Disease Control and Prevention.