GSK announces positive results from the first efficacy trial of Shingrix, its recombinant herpes zoster (HZ) vaccine, in China. Specifically, the phase IV post-licensing trial evaluated the efficacy and safety of the vaccine in preventing shingles in adults older than 50 years. This included nearly 6,000 participants randomized to the Shingrix or placebo group and followed in an observer-blind design. No cases of shingles were recorded among the participants who received it. compared to 31 cases in the placebo group.
The results are in line with the conclusions of the pivotal Phase III trials ZOE-50 and ZOE-70, which investigated the efficacy and safety of Shingrix, which showed up to 97 percent effective in adults over 50 years of age during a follow-up period of approximately four years. The safety profile observed in this trial was consistent with the established safety profile of the vaccine. “The new data add to the growing body of evidence supporting the efficacy and safety profile of the vaccine in preventing shingles in adults over 50 years of age,” GSK said in a statement.
The use of the vaccine developed by GSK was authorized for the first time in the Asian country in 2019 for the prevention of herpes zoster in adults over 50 years of age. This post-licensing trial was conducted to meet a requirement from regulatory authorities to evaluate the vaccine efficacy and safety of two doses of Shingrix for the virus prevention in China. The trial further demonstrates its efficacy in preventing shingles in adults older than 50 years, regardless of gender, geographic region, and ancestry/ethnicity. The results of this Phase IV trial will be submitted for publication in a peer-reviewed scientific journal later this year.
The varicella zoster virus is present in more than 90 percent of adults worldwide. This remains latent in the nervous system, waiting to be reactivated in the form of herpes zoster with advancing age. The population of people over the age of 65 in China is increasing rapidly, with an expected percentage increase from 6.8 percent in 2000 to 23.6 percent in 2050. It is estimated that approximately six million cases of herpes occur each year zoster in the country and this figure is expected to increase in line with the aging of the local population.
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2023-08-24 08:51:50
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