GaxoSmithKline (GSK) has secured approval from China’s National Medical Products Administration (NMPA) for Shingrix vaccine to prevent shingles (herpes zoster) in adults aged 50 years or older.
Shingrix is a non-live and recombinant subunit adjuvanted vaccine, which will be administered intramuscularly in two doses. Shingles is caused by the reactivation of the varicella zoster virus (VZV), which is the same virus responsible for chickenpox. According to the company, the approval is in response to last year’s inclusion of Shingrix on a list of 48 ‘clinically needed new medicines’ in China designated for expedited review.
The company is also planning to increase supply of Shingrix across the globe over the next several years and is investing in significant capacity expansion.
Shingrix’s approval is said to follow a comprehensive phase III clinical trial program assessing its efficacy, safety and immunogenicity in over 38,000 people.
The pooled analysis of ZOE-50 and ZOE-70 pivotal efficacy studies showed Shingrix efficacy against shingles greater than 90% across all age groups studied, in addition to sustained efficacy over a follow-up period of four years.
GSK said that the vaccine will be introduced in China in phases starting in 2020 for consistent and reliable supply to the customers.
At present, GSK has license for Shingrix in the EU, the US, Canada, Japan and Australia.