Effectiveness and safety of recombinant zoster vaccine: A review of real-world evidence

ABSTRACT

The recombinant zoster vaccine (RZV) was licensed in the US for prevention of herpes zoster (HZ) in 2017. We conducted a literature search (January 1, 2017–August 1, 2023) using PubMed, Embase, and Scopus to consolidate the real-world evidence related to RZV. Overall, RZV effectiveness against HZ was high across the studied populations in real-world settings, including adults aged ≥ 50 years and patients aged ≥ 18 years with immunodeficiency or immunosuppression. Effectiveness was higher with two doses versus one dose, especially in elderly people and immunocompromised individuals. The safety profile of RZV was broadly consistent with that established in clinical trials. RZV does not appear to increase the risk of disease flares in patients with immune-mediated diseases. Approximately two-thirds of individuals received a second RZV dose within 2–6 months after the first dose. Collectively, RZV effectiveness against HZ was high, and these real-world studies reaffirm its favorable benefit–risk profile.

Plain Language Summary

What is the context?

Herpes zoster is a common and painful rash that develops following reactivation of latent (meaning silent or dormant) varicella zoster virus, which is the virus that causes the common childhood illness chickenpox. The recombinant zoster vaccine (RZV) was first approved for the prevention of herpes zoster in the USA and Canada in 2017 and has since been approved in the European Union and various other countries. The approval was based on the results of large clinical trials. Since its launch over 5 years ago, evidence for RZV use in real-world settings has been collected; the benefits of real-world studies include large sample sizes, more diverse populations, and the ability to identify rare side effects.

What is new?

We provide a review of real-world studies, which have shown that RZV is effective across the studied populations, including in adults aged 50 years and above and in patients with immunodeficiencies (i.e., those who have a decreased ability to fight infections or other diseases) or receiving immunosuppressive therapies (treatments that lower the activity of the body’s immune system). The safety profile of RZV in real-world studies was generally consistent with that seen in clinical trials.

What is the impact?

These studies show the effectiveness and well-tolerated safety profile of RZV in real-world settings.

GRAPHICAL ABSTRACT