Japan approves GSK shingles vaccine Shingrix for at risk adults aged 18 and over

RZV, a non-live, recombinant sub-unit adjuvanted vaccine, was first approved in 2018 by the Japanese MHLW for shingles prevention in adults aged 50 years and over. This week’s approval represents a significant expansion of RZV's availability in Japan, now including all adults aged 18 and over considered to be at increased risk of shingles by their healthcare provider.

Nearly all older adults have VZV dormant in their nervous system, waiting to reactivate with advancing age. As people age, the strength of the immune system response to infection decreases, increasing the risk of developing shingles. People with a suppressed or compromised immune system, are also at high risk of shingles. It is estimated that about 600,000 people in Japan develop shingles every year.

The MHLW approval was granted based on data from six clinical trials involving adults aged 18 years and over who were among those at increased risk for shingles, including those who had undergone recent stem cell transplantation or kidney transplant, or who had blood cancer, solid tumours or HIV.

Shingles, also known as herpes zoster, is caused by a reactivation of the varicella-zoster virus (VZV) – the same virus that causes chickenpox.

Globally, most people over the age of 50 have dormant VZV in their nervous system and are at risk of developing shingles. Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also experience PHN, a long-lasting nerve pain that can continue for weeks or months and occasionally persists for several years. PHN is the most common complication of shingles, occurring in up to 10-18% of all shingles cases depending on the individual’s age.