The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for a renewed indication of GlaxoSmithKline’s (GSK) shingles (herpes zoster) vaccine, Shingrix (recombinant zoster vaccine, adjuvanted [RZV)]).
This vaccine is indicated for usage in adults aged 18 years and above who are at higher risk of the condition.
The latest approval, which expands the number of individuals who can receive protection from infection, was based on the findings from six clinical trials in adults.
The non-live, recombinant sub-unit adjuvanted vaccine, RZV, initially obtained approval from the regulatory agency in 2018 for preventing shingles in adults aged 50 years and above.
The vaccine comprises an antigen, glycoprotein E, and AS01B, an adjuvant system. It could aid in combating the age-associated reduction in immunisation response experienced by older people.
RZV is not intended for use in the prevention of primary varicella infection (chickenpox).
This vaccine is currently available in more than 30 countries to prevent shingles in adults aged 50 years and above, and in those 18 and over at higher risk.
The latest development comes after the US Food and Drug Administration (FDA) extended the review period of GSK’s new drug application for momelotinib to treat myelofibrosis by three months.
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