GSK has announced that National Medical Products Administration (NMPA) has approved Shingrix. The product is recombinant subunit adjuvanted vaccine intended for the prevention of shingles in adults of age more than 50 years.
Earlier the product was included in the list of 48 ‘clinically urgently needed new medicines’ in China.
Varicella-zoster virus reactivation causes shingles, which remains dormant in the nervous system and gets activated with the advancement of age. As per the company, there are around three million people affected with shingles in China.
The approval is based on Phase 3 clinical trial involving 38,000 people. ZOE-50 and ZOE-70 were the two trials in which the product has showed efficacy in more than 90% of patients; efficacy sustained for four years. Adverse events include redness and pain at the site of injection.