Overall, the clinical benefit was sustained through the current follow-up period of up to 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
Mumbai, 20th October 2022: 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 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 ZOE-50 and ZOE-70. From those trials, vaccine efficacy was 97%[ii] in adults 50 years and above and 91%[iii] 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. 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.,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.[vi],[vii]