Highly effective herpes zoster vaccine approved

The Federal Office of Public Health (FOPH) and the Swiss Federal Commission for Immunization Questions (EKIF) recommend vaccination against herpes zoster with the new recombinant inactivated vaccine consisting of the two active ingredient components glycoprotein E (virus subinit) and AS01B (adjuvant) for healthy persons aged 65 years and older and for patients with immunodeficiency aged 50 years and older or with severe immunodeficiency aged 18 years and older. This is now approved for cash and available in Switzerland.

With age, the number and functionality of immune cells that prevent reactivation of the varicella-zoster virus (VZV) decrease [2,6,7,9,10]. This leads to an increase in the incidence and severity of shingles. In Switzerland, there are between 17,000 to 30,000 cases of herpes zoster annually [2]. Approximately 99% of adults 50 years of age and older are infected with the shingles-causing virus, and in one in three individuals, latent VZV reactivates and causes shingles [2,3]. Certain pre-existing conditions such as rheumatoid arthritis, inflammatory bowel disease, diabetes, COPD, asthma, systemic lupus erythematosus, or depression also lead to an increased risk of herpes zoster. The risk of herpes zoster is highest in diseases that lead to severe immunodeficiency, such as lymphoma or myeloma, and the risk is increased 13-fold during chemotherapy [2,5,6,11,12].

Shingles and the potentially serious complications.

Shingles is a painful disease that can be associated with serious and long-lasting complications, which include postherpetic neuralgia (PHN) and zoster ophthalmicus [2]. PHN affects up to 30% of shingles patients and is characterized by nerve pain, sometimes lasting for years [2,4]. Zoster ophthalmicus affects about 20% of shingles patients. This can lead to ophthalmologic complications and, in rare cases, blindness [2,13]. The herpes zoster recurrence rate after eight years is estimated at 6.2% according to Yawn et al. Among them, recurrences were more frequent in individuals with pain lasting >30 d and in immunosuppressed individuals. Because of the relatively high recurrence rates, vaccination should also be offered to patients who have already suffered from herpes zoster [14].

Prevention through new recombinant inactivated vaccine

SHINGRIX® is the first and only shingles vaccine to induce a strong, sustained immune response using a combination of a recombinant antigen and an adjuvant system [1,15–19]. The antigen (glycoprotein E [gE]) triggers a specific immune response against VZV. gE is expressed on the surface of VZV-infected cells and is critical for virus replication. The adjuvant system (AS01B) causes an enhancement of the immune response to the vaccine antigen. It induces a strong, sustained antigE immune response. The unique combination of MPL and QS-21 enhances both humoral and cellular immune responses against gE* [1,17–22]. This property also makes it suitable for immunodeficient or immunosuppressed patients [1].

* VZV = varicella zoster virus; MPL: 3-O-desacyl-4′-monophosporyl lipid A of Salmonella minnesota; QS-21: saponin fraction QS-21 of soap bark tree.

Efficacy and safety profile

The adjuvanted subunit vaccine demonstrated greater than 90% efficacy in preventing shingles in all age groups 50 years and older, remaining at very high levels after more than seven years. Likewise, the risk of developing PHN is significantly reduced (Fig. 1) [1]. Safety has been extensively evaluated in two large-scale Phase 3 clinical trials. The majority of adverse events were mild to moderate in severity and included pain, redness, and swelling at the injection site. Patients may also suffer from muscle pain, fatigue, headache, chills, fever or upset stomach. In clinical trials, these adverse effects lasted a median of 2 to 3 days [1,8,17].

Vaccination recommendation BAG and EKIF

Vaccination against herpes zoster with two doses and a minimum interval of 1-2 months is given in two recommendation categories [25]: A Supplemental vaccination recommendation: vaccination is recommended for all immunocompetent individuals aged ≥65 years and older, regardless of their individual history of varicella and herpes zoster. Two doses are recommended with a minimum interval of two months.

B Vaccination recommendation for two defined risk groups:

B1: Vaccination is recommended for all patients aged ≥50 years with current or future (especially cellular) immunodeficiency associated with an increased risk of herpes zoster. Two doses are recommended with a minimum interval of two months.

B2: Vaccination is recommended for patients ≥18 years of age who are currently suffering from severe immunodeficiency or who are currently or will be receiving immunosuppressive treatment in the foreseeable future. The first dose should ideally be administered ≥4 weeks before an assumed, expected, or planned onset of severe immunosuppression. The second dose with a minimum interval of one to two months after the first dose or as soon as possible at a later time during or after therapy that is favorable from a medical point of view.

SHINGRIX® is intended exclusively for intramuscular injection and only for prophylactic use and not for the treatment of confirmed clinical disease. Vaccine may be administered concurrently with non-adjuvanted seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23), or diphtheria-tetanus acellular pertussis vaccine with reduced antigen content (dTpa) (different injection site). The immune response (2 doses) was not affected by prior vaccination with live attenuated HZ vaccine [1]. A minimum interval between COVID mRNA vaccination and the administration of other vaccines is not required, as with all other non-live vaccines [24].

Source: GlaxoSmithKline AG

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