Shingrix Nearly 80% Effective Against Shingles in Older Adults up to 11 Years Post-Vaccination

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New long-term data show that Shingrix (Recombinant Zoster Vaccine [RZV], GSK) was nearly 80% effective against shingles in adults aged 50 years and older from year 6 to year 11 after vaccination, according to a GSK press release. The company also reported that vaccine efficacy remained high at 82% at year 11 following vaccination.

GSK announced the positive data from the ZOSTER-049 long-term follow-up phase 3 trial in an April 17, 2024, statement. The findings will be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2024 meeting, formerly known as ECCMID, being held April 27-30, in Barcelona, Spain.

The ZOSTER-049 study is an extension from 2 phase 3 randomized clinical trials, ZOE-50 and ZOE-70. ZOSTER-049 evaluated the efficacy, safety, and immunogenicity of RZV in adults aged 50 years and older at time of vaccination, for 6 additional years after the ZOE-50 and ZOE-70 studies were completed, and up to approximately 11 years of follow-up.

Over 7000 adults from 18 countries across 5 continents were included in the ZOSTER-049 trial, with vaccine recipients compared to historical controls, according to the GSK announcement.

The final study data showed 79.7% vaccine efficacy (VE) among participants aged 50 years and older cumulatively between 6 to 11 years after vaccination (95% CI 73.7–84.6). Also, RZV was 82% effective in participants at year 11 (95% CI 63.0–92.2), showing VE remains high in each year following vaccination.

Among participants aged 70 years and older, VE was 73.1% from 6 to 11 years after vaccination (95% CI 62.9-80.9), demonstrating high VE rates across all age groups, noted the manufacturer.

There was no new safety concerns identified during follow-up, and no serious adverse events were considered causally associated with RZV by the investigators. The most frequently reported adverse events in adults aged 50 years and older were pain at the injection site, myalgia, fatigue, and headache; however, most of those events were mild-to-moderate and generally lasted less than 3 days, according to GSK.

“These final data demonstrate continued protection over more than a decade with high efficacy maintained in both the 50+ and 70+ age groups,” said Javier Díez-Domingo, MD, PhD, principal investigator, Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain, in the GSK release. “Infectious diseases like shingles pose a significant risk to adults due to the natural decline in our immune system, and these data represent a remarkable advancement in our understanding of what can be achieved long-term for effective protection against shingles.”

GSK added that they are continuing to examine long-term data and conduct real-world studies related to VE, immunogenicity, and safety across indicated populations, including patients at the highest risk of shingles infection, in order to assess a need for future revaccination.

Source: New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade. News release. GSK. April 17, 2024. Accessed April 18, 2024. https://www.gsk.com/en-gb/media/press-releases/new-long-term-data-show-shingrix-continues-to-provide-high-protection-against-shingles-in-adults-aged-50-and-over-for-more-than-a-decade/