• Ousseny Zerbo, Joan Bartlett, Bruce Fireman, Ned Lewis, Kristin Goddard, Kathleen Dooling, Jonathan Duffy, Jason Glanz, Allison Naleway, James G Donahue, and Nicola P Klein.
• Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California (O.Z., J.B., B.F., N.L., K.G., N.P.K.).
• Ann. Intern. Med. 2024 Feb 1; 177 (2): 189195189-195.

BackgroundA 2-dose series of recombinant zoster vaccine (RZV) was 97% effective against herpes zoster (HZ) in a pivotal clinical trial.ObjectiveTo evaluate real-world effectiveness of RZV against HZ.DesignProspective cohort study.SettingFour health care systems in the Vaccine Safety Datalink.ParticipantsPersons aged 50 years or older.MeasurementsThe 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.ResultsThe 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.LimitationHerpes zoster could not be identified as accurately in these observational data as in the previous clinical trials.ConclusionTwo 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 SourceCenters for Disease Control and Prevention.

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