Source – GSK
On 26 June 2023, GSK announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has given approval for an expanded use of Shingrix (Recombinant Zoster Vaccine, Adjuvanted – RZV). This vaccine is now approved for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are at a higher risk of developing the condition.
Previously, RZV, a non-live, recombinant subunit adjuvanted vaccine, was approved in Japan in 2018 for shingles prevention in adults aged 50 years and older. This recent approval marks a significant extension of RZV’s availability in Japan, encompassing all adults aged 18 and older who are considered to be at an increased risk of shingles according to their healthcare provider’s assessment.
The majority of older adults carry dormant VZV (varicella-zoster virus) in their nervous system, which can reactivate as they age. As the immune system weakens with age, the risk of developing shingles increases. Individuals with a compromised or suppressed immune system are also at a higher risk. It is estimated that around 600,000 people in Japan experience shingles annually.
The approval from the MHLW was based on data from six clinical trials involving adults aged 18 years and older who were identified as being at an increased risk of shingles, including those who had recently undergone stem cell or kidney transplantation, individuals with blood cancer, solid tumors, or HIV.
Globally, the majority of people over 50 years of age carry dormant VZV and are at risk of developing shingles. Shingles typically manifests as a rash with painful blisters on the chest, abdomen, or face. The associated pain is often described as aching, burning, stabbing, or shock-like. Following the rash, individuals may experience postherpetic neuralgia (PHN), which is persistent nerve pain lasting weeks, months, or even several years. PHN is the most common complication of shingles and occurs in 10-18% of shingles cases, depending on the individual’s age.
RZV is a non-live, recombinant subunit vaccine that was originally approved by the Japanese MHLW on March 23, 2018, for preventing shingles in adults aged 50 years and older. It combines an antigen called glycoprotein E with an adjuvant system called AS01B, which helps address the natural decline in immune responses associated with aging and contributes to the challenge of protecting older adults from shingles. It’s important to note that RZV is not intended for preventing primary varicella infection (chickenpox).
RZV has been launched in over 30 countries for the prevention of shingles in adults aged 50 years and older, as well as in adults aged 18 years and older who are at an increased risk of shingles. It is the only shingles vaccine specifically indicated for individuals aged 18 years and older who are at an increased risk of shingles due to certain underlying diseases, conditions, or treatments.
