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

  • Overall, the clinical benefit was sustained through the current follow-up period of upto 10 years after vaccination in adults aged 50 years and over
  • In the primary endpoint, the interim data demonstrated overall efficacy of greater than 80% over the follow-up period of approximately six to 10 years after initial vaccination
  • No new safety concerns were identified during the follow-up period
  • GSK plans to bring Shingrix to India in 2023

Chennai, India: GSK today 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.[i]The interim analysis data will be presented on 20 October 2022at 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%[ii] in adults 50 years and above and 91%[iii]in adults70 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 aging 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 chickenpox.Error! Bookmark not defined.,i[iv],[v]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,vThe 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.Error! Bookmark not defined.

The Recombinant Zoster Vaccine (RZV)is the first approved shingles vaccine to combine a non-live antigen with GSK’sadjuvant 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.[vi],[vii]

[1]ZOE-50 and ZOE-70 are placebo-controlled trials with two doses of recombinant zoster vaccine (RZV) two months apart. Vaccine efficacy (VE) was assessed in the modified Total Vaccinated Cohort (mTVC) of 7277 participants, i.e. excluding adults who did not receive second dose of vaccine or who had confirmed diagnosis of herpes zoster (HZ) ≤1 month after second dose. Data in subjects ≥70 years old were from pre-specified pooled analyses of ZOE-50/70, as these provide robust estimates for VE. HZ cases in RZV vs. placebo: ≥50 years (ZOE-50; median follow-up of 3.1 years): 6/7344 vs. 210/7415 and ≥70 years (pooled analysis ZOE-50 & ZOE-70; median follow-up of 4 years): 25/8250 vs. 284/8346 cases

[i]Strezova A et al. Long-term protection against herpes zoster (HZ) by the adjuvanted recombinant zoster vaccine (RZV): interim efficacy, immune and safety results at approximately 10 years after initial vaccination [abstract]. In: IDWeek 2022, 19-23 October 2022; Washington, DC, USA.

[ii]Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372:2087-96.

[iii]Cunningham et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-32.

[iv] Bricout H et al. Herpes zoster-associated mortality in Europe: a systematic review. BMC Public Health. 2015;15:466. Available at: Last accessed: October 2022.

[v] Mueller NH et al. Varicella Zoster Virus Infection: Clinical Features, Molecular Pathogenesis of Disease and Latency. Neurologic Clinics. 2008;26;675-697.

[vi]Cunningham et al. Vaccine profile of herpes zoster (HZ/su) subunit vaccine. Expert Review of Vaccines. 2017;16(7):661-670.

[vii]The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.

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