On October 19, GSK announced that the ZOSTER-049 extension study yielded positive interim results: Shingrix provides at least 10 years of shingles protection in adults 50 years and older.
Shingrix is the second FDA-approved shingles vaccine after Zostavax. In May 2019, Shingrix was conditionally approved by the NMPA for the prevention of herpes zoster in adults 50 years of age and older. This vaccine is more than 90% effective in preventing shingles and subsequent neuralgia at all ages, while Merck’s Zostavax is only 60%-70% effective.
ZOSTER-049 (ZOE-LTFU) is an open-label long-term follow-up study and an extension of two Phase III ZOE-50 and ZOE-70 studies. The study followed subjects from the ZOE-50 and ZOE-70 studies for an additional 6 years to continuously assess the long-term efficacy, immunogenicity and safety of Shingrix.
An interim analysis showed that Shingrix was 81.6% effective from 6 to 10 years after initial vaccination. The protective efficacy of the vaccine was 89.0% from 1 month after the second dose to the 10th year.
At the fourth year of follow-up, Shingrix was 97 percent effective in the 50-year-old group and 91 percent in the 70-year-old group.
During follow-up, no new safety risks were identified. The incidence of serious adverse events was consistent with the age of the study population, and there were no vaccination-related deaths or other safety adverse events.
Shingles is caused by reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. As we age, the immune system gradually loses its ability to initiate a strong, effective immune response, increasing the risk of disease. A common complication is postherpetic neuralgia, which can last from months to years.
Shingrix is also the core product in the field of GSK vaccines. In the first half of this year, sales doubled to 1.429 billion pounds, and the annual revenue is expected to exceed 3 billion US dollars. With the extraordinary market performance of this product, GSK also ranks among the top 10 global vaccine giants.
Sabine Luik, Chief Medical Officer at GSK, said: “We are delighted to see the continued extension of Shingrix’s protection. The ZOE-LTFU study results show that it can provide over a decade of clinical benefit in preventing shingles in people over 50 years of age. neuropathic pain and potentially serious complications. These data complement existing evidence of the long-term benefit of the vaccine.”