(Sharecast News) – GSK reported significant positive findings from its first efficacy trial of the ‘Shingrix’ shingles vaccine in China on Wednesday.
The FTSE 100 pharmaceuticals giant said the results highlighted the vaccine’s success in preventing shingles, or herpes zoster, in adults aged 50 and older.
It said the post-licence phase four trial, named ‘ZOSTER-076’, included nearly 6,000 participants, who were randomly assigned in equal numbers to either the RZV group or a placebo group.
During the course of the trial, there were zero reported cases of shingles among those who received the RZV, whereas the placebo group saw 31 instances.
The company said the promising outcome mirrored previous results from GSK’s pivotal phase three trials, ZOE-50 and ZOE-70.
Those trials, which studied the efficacy and safety of RZV, revealed a vaccine efficacy of up to 97% in adults aged 50 and above over a span of about four years.
The safety profile identified in the ZOSTER-076 trial also aligned with prior findings, bolstering the already-robust evidence in favour of the efficacy and safety of RZV for older adults.
GSK said the varicella zoster virus (VZV) is present in over 90% of adults and can remain latent in the nervous system, only to reactivate as shingles in one’s later years.
With China’s elderly population on the rise, the prevalence of shingles was a growing concern, with statistics projecting a growth in the population aged 65 and over in China from 6.8% in 2000 to an estimated 23.6% by 2050.
Current data suggested that China sees around six million shingles cases annually – a number that would likely increase as the population ages.
Regulators in China first approved the Shingrix vaccine in 2019 for preventing herpes zoster in adults aged 50 and above.
The latest trial was initiated to meet the requirements set by regulatory bodies to gauge the vaccine’s efficacy and safety in the local context.
GSK said the data further solidified the Shingrix vaccine’s efficacy in warding off herpes zoster across varied demographics including sex, geographic location, and ethnicity.
The company said it planned to submit the results from the phase four trial to a reputable, peer-reviewed scientific journal for publication later in the year.
“Shingrix, or RZV, is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over,” GSK explained in its statement,
“It combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunisation that contributes to the challenge of protecting adults aged 50 and over from shingles.
“In some countries, RZV is also approved for adults aged 18 years or over who are at increased risk for shingles.”
Reporting by Josh White for Sharecast.com.
