The Japanese Ministry of Health, Labor and Welfare (MHLW) has indicated a new indication for GlaxoSmithKline’s (GSK) herpes vaccine Shingrix (recombinant herpes vaccine, adjuvanted [RZV]).
This vaccine is for adults 18 years of age and older who are most at risk of getting sick.
The recent approval, based on the results of six clinical trials in adults, expands the number of individuals who can be protected from infection.
The RZV non-live recombinant subunit adjuvanted vaccine was originally approved by regulators in 2018 for the prevention of herpes zoster in adults 50 years of age and older.
The vaccine contains antigen, glycoprotein E and AS01B adjuvant system. This may help counter age-related declines in immune responses in older adults.
RZV is not indicated to prevent primary varicella (chickenpox) infection.
The vaccine is currently available in more than 30 countries to prevent shingles infection in adults aged 50 years and older and in high-risk groups aged 18 years and older.
The latest development comes after the US Food and Drug Administration (FDA) extended the review period for GlaxoSmithKline’s application for its new drug, mumotinib, to treat myelofibrosis by three months.
