Herpes zoster vaccine provides long-lasting protection for adults 50 and older

Interim analysis of the follow-up phase of two phase III trials show that recombinant adjuvanted zoster vaccine protects against herpes zoster for at least 10 years overall after initial vaccination. In Switzerland, the costs for the vaccination are covered by the compulsory health insurance.

The recombinant vaccine Shingrix® has been licensed (SL) in Switzerland since Feb. 1, 2022, and provides adults 50 years of age and older with long-lasting, effective protection against herpes zoster and herpes zoster neuralgia [1–4]. Shingrix® induces anti-varicella immunity through delivery of the viral surface protein glycoprotein E and has been shown to be a highly effective vaccine [1,2].

New interim results from extension study are convincing

In ZOSTER-049 (ZOE-LTFU), an extension of two phase III clinical trials, ZOE-50 and ZOE-70 (box), vaccine efficacy over a follow-up period of approximately four years was 97% in adults aged 50 years and older and 91% in those aged 70 years and older [2,5,6].

Overall, clinical benefit after vaccination in the ≥50-year age group was maintained over the current follow-up period of up to ten years [7].
Regarding the primary endpoint, preliminary data showed an overall efficacy of more than 80% over the follow-up period of approximately six to ten years after initial vaccination [7].
No new safety concerns were identified during the follow-up period [7].

In the ZOE-LTFU study, participants in the ZOE-50 and ZOE-70 clinical trials will be followed for an additional six years to further evaluate the longer-term efficacy, immunogenicity and safety of the vaccine.

Shingrix® proves sustainable clinical benefit

Shingles is caused by reactivation of the varicella-zoster virus, the same virus that causes chickenpox [5,8,9]. With age, the immune system loses the ability to develop a strong and effective immune response, increasing the risk for reactivation of the herpes zoster virus [8–10]. Dr. Javier Díez-Domingo, Principal Investigator, Valencia (Spain), commented on the encouraging interim results of the extension study ZOSTER-049 (ZOE-LTFU) as follows. [2,8]: “Shingles is a painful disease that one in three adults will develop during their lifetime. We can now confirm for the first time that the overall clinical benefit of the recombinant zoster vaccine lasts for at least 10 years after vaccination, giving patients and their healthcare professionals certainty about the duration of protection against shingles.” And Sabine Luik, Chief Medical Officer, GlaxoSmithKline, said [2], “We are pleased with the continued longevity of protection from our shingles vaccine. The ZOE-LTFU results show that the vaccine can protect for a decade against the pain, debilitating effects and potentially serious complications that shingles can cause in people over 50 years of age. These data are an important addition to the existing evidence of the vaccine’s long-term benefits, and we look forward to additional results from this ongoing study.”

Vaccination against shingles with the Shingrix® vaccine (two doses at intervals of 1 to 2 months) is recommended in Switzerland for the following groups of people [11]:
18 years of age or older or 50 years of age or older, depending on the type of risk factors (severe immunodeficiency, current or planned immunosuppressive treatment).
65 years of age and older regardless of individual history of varicella

Both the risk of contracting shingles and the risk of a severe course and of complications such as post-zoster neuralgia increase with age [8,11]. In some cases, post-herpetic neuralgia lasts for months or even years after the shingles rash has resolved [8,11].

Source: GlaxoSmithKline

Literature:

Swissmedic: Medicinal Product Information, www.swissmedicinfo.ch, (04.11.2022)
“New data show Shingrix can protect against shingles for at least 10 years in adults 50 years and older,” GlaxoSmithKline, Muenchenbuchsee, Oct. 20, 2022.
Cunningham AL, et al: Vaccine profile of herpes zoster (HZ/su) subunit vaccine. Expert Review of Vaccines 2017; 16(7): 661-670.
The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.
Lal H, et al: Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med 2015; 372: 2087-2096.
Cunningham AL, et al: Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med 2016; 375: 1019-1032.
Strezova A, et al: Long-term protection against herpes zoster (HZ) by the adjuvanted recombinant zoster vaccine (RZV): interim efficacy, immune and safety results at approximately 10 years after initial vaccination [abstract]. In: IDWeek 2022, 19-23 October 2022; Washington, DC, USA.
Harpaz R, et al: Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008; 57(RR-5): 1-30.
Mueller NH, et al: Varicella zoster virus infection: clinical features, molecular pathogenesis of disease and latency.Neurologic Clinics 2008; 26; 675-697.
Bricout H, et al: Herpes zoster-associated mortality in Europe: a systematic review. BMC Public Health 2015; 15: 466.
Infovac: Shingles (Herpes zoster), www.infovac.ch/de/impfunge/nach-krankheiten-geordnet/guertelrose-herpes-zoster, (last accessed Nov. 04, 2022).