RZV is a non-live, recombinant sub-unit vaccine that combines antigen, glycoprotein E, with an adjuvant system, AS01B to generate a varicella-zoster virus (VZV)-specific immune response
GSK obtains approval for Shingrix in Japan. (Credit: Mufid Majnun on Unsplash)
GSK announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved an updated indication for Shingrix (Recombinant Zoster Vaccine, Adjuvanted – RZV) to prevent shingles (herpes zoster) in adults aged 18 years or more and who are at increased risk of the condition.
RZV is a non-live, recombinant sub-unit vaccine that combines antigen, glycoprotein E, with an adjuvant system, AS01B to generate a varicella-zoster virus (VZV)-specific immune response.
It was already approved in 2018 by the Japanese MHLW for shingles prevention in adults aged 50 years and over.
With the latest approval, RZV is now available in Japan to all adults of age 18 and older who are at a greater risk of shingles, as identified by their healthcare professionals.
Shingles disease is caused by the reactivation of the VZV, the same virus that causes chickenpox. It is characterised by a painful, itchy rash on one side of the body.
The MHLW approval was based on clinical data from six trials.
It involved adults aged 18 years and over who were at increased risk for shingles. The participants also included patients who had undergone recent stem cell transplantation or kidney transplant, or who had blood cancer, solid tumours, or HIV.
The vaccine was launched in more than 30 nations to prevent shingles in adults aged 50 years and over, and adults aged 18 or over who are or will be at increased risk of shingles.
In 2021, GSK secured the US Food and Drug Administration (FDA) approval for Shingrix to prevent shingles in the US.
The approval was based on the clinical studies that evaluated the safety and efficacy of Shingrix in adults who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and those undergoing treatment for haematological malignancies.