MLHW (Japan) approves updated indication for Shingrix for the prevention of Shingles – GSK

GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved an updated indication for Shingrix (Recombinant Zoster Vaccine, Adjuvanted – RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over who are at increased risk of the condition.

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