In October of last year, GSK laid out a plan to double its business in China by 2025, with much of that expansion dependent upon the success of Shingrix, the company’s recombinant zoster vaccine (RZV) to protect older people against shingles.
On Wednesday, GSK left little doubt about the benefit of Shingrix as it reported 100% efficacy from a post-licensing phase 4 trial of the shot. In the ZOSTER-076 study of nearly 6,000 participants age 50 and up, there were no Shingrix recipients who got shingles, compared to 31 cases in the placebo group.
It was the first efficacy trial of the vaccine in China. Shingrix was approved by the FDA in 2017 but didn’t arrive in China until 2020. GSK reported (PDF) a 60% increase in sales of Shingrix in 2022 to £2,958 ($3.7 billion), with China accounting for much of the growth, the company said.
The results of ZOSTER-076 generally lined up with data from the ZOE-50 and ZOE-70 trials, which evaluated the effectiveness of Shingrix in patients 50 and older and 70 and older in 18 countries and supported initial approvals of the vaccine in Europe and the United States. Those studies showed 97% efficacy for the shot and followed patients over a span of four years.
The varicella zoster virus (VZV), which causes shingles and chicken pox, is present in more than 90% of adults around the world. As people age and their immune systems deteriorate, they become more susceptible to VZV’s attempts to reactivate as shingles.
Postherpetic neuralgia (PHN) is the most common complication from shingles, occurring in 5 to 30% of shingles cases, depending on age. The disorder brings nerve pain that can persist for several years.
In China, there are roughly 6 million cases of shingles annually, with the numbers expected to rise as the population increases and ages, GSK said.