New data show Shingrix can provide at least 10 years of protection against shingles in adults aged 50 years and over

2026-07-07 05:10:15 Health and Fitness

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Delhi, October 20: GSK announced positive interim results from the ZOSTER-049 extension study showing that overall Shingrix (Zoster Vaccine Recombinant, Adjuvanted) can provide at least a decade of protection against shingles (herpes zoster) after initial vaccination.[ii] The interim analysis data will be presented on 20 October 2022 at the IDWeek congress in Washington, DC, USA.

These results come from ZOSTER-049 (ZOE-LTFU), an extension from two phase III clinical trials[1] ZOE-50 and ZOE-70. From those trials, vaccine efficacy was 97%[iii] in adults 50 years and above and 91%[iv] in adults 70 years and above over a follow-up period of approximately four years.1 The ZOE-LTFU study, which follows participants from the ZOE-50 and ZOE-70 clinical trials for an additional six years, is ongoing and will continue to evaluate the longer-term efficacy, immunogenicity and safety of the vaccine.

Dr. Hemant Thacker, Consultant Internist and Cardio Metabolic Physician, Breach Candy, Jaslok, Bhatia and Reliance Hospital said: ?Shingles is a painful and distressing condition especially for the elderly. Despite treatment, elderly patients can suffer from severe complications and the persistent pain may cause difficulties in performing daily activities. A vaccine to reduce the incidence of this debilitating condition is the key. The results of the study released by GSK are promising. I am confident that a vaccine to prevent shingles, with long-lasting protection, will greatly benefit our growing elderly population and enhance their quality of life.?

Sabine Luik, Chief Medical Officer & SVP Global Medical Regulatory & Quality, GSK, said: ?We are delighted to see the continuing longevity of protection from our shingles vaccine. The findings from ZOE-LTFU demonstrate that it can provide a decade of protection against the pain, debilitating impact and potentially severe complications that shingles can cause in people aged 50 and over. These data significantly add to, and complement, the existing body of evidence demonstrating the long-term benefit of the vaccine, and we look forward to seeing additional results from this ongoing study.?

Sridhar Venkatesh, Vice President & Managing Director at GSK India said: ?Adult immunization is integral to maintain the wellbeing and quality of life of India?s growing elderly population, and to ensure healthy ageing accompanies the gains in longevity we have made as a nation. Diseases such as influenza, pneumococcal pneumonia and shingles, can be prevented by safe and effective vaccines. The encouraging results from the ZOE-LTFU trials demonstrate the long-lasting efficacy of Shingrix. Shingrix will be an important addition to our adult vaccination portfolio in India and help address an unmet preventive health need.?

Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chicken pox.Error! Bookmark not defined.,i[v],[vi] As people age, the immune system loses the ability to mount a strong and effective immune response, increasing the risk of developing shingles.Error! Bookmark not defined.,iv,v The disease can cause unbearable pain and, in some cases, intense pain continues after the shingles rash fades, that nerve pain (called post-herpetic neuralgia [PHN]) can last for months or even years.

The Recombinant Zoster Vaccine (RZV) is the first approved shingles vaccine to combine a non-live antigen with GSK?s adjuvant and may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting adults aged 50 years and above from this disease.[vii],[viii]

About ZOSTER-049i

ZOSTER-049 is an open-label, long-term follow-up (LTFU) study from two pivotal phase III randomised clinical trials (ZOE-50, ZOE-70). The study is evaluating the efficacy, safety and immunogenicity for six additional years after completion of the ZOE-50 and ZOE-70 studies. In the interim analysis conducted over the >4 years of long-term follow-up, representing up to 10 years since immunisation (mean: from 5.6 (?0.3) to 9.6 (?0.3) years post-vaccination), vaccine efficacy was 81.6%. From 1 month post-second dose in those initial studies up to year 10 post-vaccination (mean: 9.6 (?0.3) years post-vaccination), vaccine efficacy was 89.0%. The safety profile observed in this extension study is consistent with the established safety profile of the vaccine. No new safety concerns were identified. The incidence of serious adverse events was consistent with the age of the study population. No deaths or other Safety Adverse Events (SAE) considered related to vaccination were reported. Five cases of HZ-related complications (PHN - 3 cases and HZ disseminated disease - 2 cases) were reported.

About Shingles

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face.v The pain is often described as aching, burning, stabbing or shock-like.Error! Bookmark not defined. Following the rash, a person can also experience post-herpetic neuralgia (PHN) pain lasting from at least three months up to several years from the onset of rash. PHN is the most common complication of shingles, occurring in 5-25% of all shingles cases, depending on the patients? age.

About Shingrix

Shingrix [Herpes Zoster vaccine (recombinant, AS01B adjuvanted)] is a non-live, recombinant subunit vaccine which combines a recombinant antigen, glycoprotein E and the adjuvant system, AS01B.vivii,viii

About GSK

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.