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Adult vaccination may not be a popular concept in India, but British biopharmaceutical, GSK, plans to bring its shingles vaccine Shingrix to India, next year.
Shingles (or herpes zoster) is caused by the reactivation of the virus that causes chicken pox, and is a painful condition in adults. The risk of developing shingles increases as the immune system becomes weaker and incapable of mounting a response, as seen in the elderly, for instance.
Study results
Interim data recently unveiled by GSK indicated that vaccination with Shingrixcould provide at least 10 years of protection, in people aged 50 years and above.
These results were from a long-term follow-up study ZOSTER-049 (ZOE-LTFU) that was an extension from two phase III clinical trials ZOE-50 and ZOE-70, GSK said. The earlier two trials revealed that vaccine efficacy was 97 per cent in adults 50 years and above and 91 per cent in adults 70 years and above, over a follow-up period of approximately four years, it said.
“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,” it added.
Clinical benefit
Dr. Javier Díez-Domingo, Principal Investigator, FISABIO (Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain), said that one in three adults would develop shingles in their lifetime. “We can now – for the first time – confirm that the clinical benefit of the Recombinant Zoster Vaccine overall, continues for at least 10 years after vaccination, giving patients and their healthcare providers peace of mind about the duration of protection against shingles,” he said, in a statement.
Sridhar Venkatesh, Vice President and Managing Director at GSK India said, adult immunization was integral to maintain the well-being and quality of life of India’s growing elderly population. “Diseases such as influenza, pneumococcal pneumonia and shingles, can be prevented by safe and effective vaccines,” he said. “Shingrix will be an important addition to our adult vaccination portfolio in India and help address an unmet preventive health need,” he added.
GSK’s 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, the company said.
Open-label study
ZOSTER-049 is an open-label study and the safety profile observed in this extension study was consistent with the established safety profile of the vaccine, it added. “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,” GSK said.
About 7,413 participants enrolled in the study, of which close to 61 per cent were female and the rest male. Further, the company said, 76 per cent were of white-Caucasian/European heritage, 18.7 per cent were Asian and 5.3 per cent were others. The long-term ZOSTER-049 is being conducted in 18 countries or regions.
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