How effective is herpes zoster (shingles) vaccine in the real-world setting?

Regulatory approval of recombinant zoster vaccine (RZV; brand name Shingrix) was based on safety and efficacy data from clinical trials, which reported a two-dose effectiveness of at least 90% over a four-year period. An interim analysis of a long-term study among participants in the original clinical trials found that RSV effectiveness did not decline substantially during at least seven years of follow-up. However, the long-term effectiveness of RZV has not been extensively studied in “real-world” settings.To examine real-world efficacy, a prospective cohort study evaluated the effectiveness of one and two doses of RZV overall and by time since vaccination. The study also assessed whether two-dose vaccine efficacy varied by age at vaccination, by immunocompromise status at vaccination (i.e., used corticosteroids during the 3-month period before the first or second RZV dose), and by whether the second dose was received later than recommended (i.e., > 6 months after the first dose).This study was conducted from January 2018 through December 2022. The investigators used data from the Vaccine Safety Datalink, a collaboration between the US Centers for Disease Control and Prevention and nine integrated healthcare delivery systems with comprehensive electronic medical records that include data on immunizations, diagnoses and prescriptions. Results showed the following: The study included nearly two million persons 50 years of age or older who contributed 7.6 million person-years of follow-up.After adjustment for covariates, vaccine effectiveness was 64% with one dose and 76% after two doses. After one dose only, vaccine effectiveness was 70% during the first year, 45% during the second year, 48% during the third year, and 52% after the third year.After two doses, vaccine effectiveness was 79% during the first year, 75% during the second year, and 73% during the third and fourth years. Among fully vaccinated persons, vaccine effectiveness was higher in those who were vaccinated before age 65 years (81%) than in those vaccinated at age 65 years or older (74%). Vaccine effectiveness was lower in persons who were immunocompromised (defined on the basis of corticosteroid use) when they were vaccinated (65%) compared with those who were not immunocompromised when they were vaccinated (77%).Vaccine effectiveness was similar in persons who received the second dose later than recommended—76% when the interval between doses was within the recommended six months, 78% when it was more than six months to less than one year, and 75% when it was one or more years.The investigators conclude that two doses of RZV are highly effective in the real-world setting, although less effective than reported in previous clinical trials. Two-dose effectiveness waned very little during the four years of follow-up. However, single-dose effectiveness waned substantially after one year, highlighting the importance of getting the second dose. Vaccine effectiveness increased after the second dose regardless of whether it was administered within the recommended six months after the first dose. This finding provides reassurance about the effectiveness of the second dose even if administration is delayed due to vaccine shortage or other factors. The finding of substantial vaccine effectiveness among corticosteroid recipients underscores the value of vaccination for these persons, who are at increased risk for herpes zoster.Reference1. Zerbo O, Bartlett J, Fireman B, et al. Effectiveness of recombinant zoster vaccine against herpes zoster in a real-world setting. Ann Intern Med. Published online January 9, 2024. (accessed January 16, 2024).

How effective is herpes zoster (shingles) vaccine in the real-world setting?

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