Currently approved for use in individuals aged 60 and older in countries like the US, Europe, Japan, the UK, and Canada, Arexvy’s potential age indication expansion is supported by positive outcomes from a Phase III trial. This trial illustrated comparable immune responses in adults aged 50 to 59 to those observed in individuals aged 60 and above.
The trial, which was observer-blind, placebo-controlled, and randomized, analyzed the immune responses in participants aged 50 to 59 without pre-defined chronic diseases in comparison with adults aged 60 and older. The study successfully met its primary endpoints, demonstrating that RSV-A and RSV-B neutralization titers one month post-vaccination in the 50-59 age group were on par with those in the older cohort.
Tony Wood, GSK’s Chief Scientific Officer, commented on the trial’s findings, highlighting the potential of the RSV vaccine to extend protection to adults aged 50 to 59, particularly those at increased risk for RSV-LRTD due to certain health conditions. The trial reported that the safety and reactogenicity profile of the vaccine was in line with the initial phase III program findings, with the most common adverse events being mild, including pain, fatigue, and headache.
RSV is known for causing severe respiratory illness, especially among the elderly, immunocompromised individuals, or those with conditions like COPD, asthma, and chronic heart failure. By potentially extending the vaccine’s use to include the 50-59 age group, GSK aims to reduce the incidence of RSV-associated illness among these adults.
A decision by the European regulatory authority on this application is expected in the latter half of 2024. This initiative follows GSK’s strategic move to enhance its respiratory and inflammatory asset pipeline through the acquisition of Aiolos Bio for $1.4 billion.
The encouraging results from the Phase III trial [NCT05590403] were shared at the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting, with plans to present final results at an upcoming medical conference and in a peer-reviewed publication. Additionally, these findings will be submitted to the FDA and other regulatory bodies to support the possible expansion of the vaccine’s label.
Arexvy combines recombinant glycoprotein F stabilized in the prefusion conformation with GSK’s proprietary AS01E adjuvant, marking a noteworthy development in the prevention of RSV. The vaccine’s current approval for older adults and the proposed extension to a younger age group underscore GSK’s ongoing efforts to address RSV prevention across a broader population.
![rsv vaccine rsv vaccine](https://static.packgene.com/wp-content/uploads/2024/02/rsv-vaccine.jpg)
1. https://www.gsk.com/en-gb/media/press-releases/new-data-for-arexvy-show-potential-to-help-protect-adults-aged-50-to-59/
2. https://www.cnbc.com/2024/01/31/gsk-posts-blowout-rsv-vaccine-sales-raises-outlook.html
![GMP mRNA](https://static.packgene.com/wp-content/uploads/2023/05/GMP-mRNA.jpg)
Check out our mRNA service to expedite your vaccine research
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
Related News
Skyline Therapeutics Receives FDA Orphan Drug Designation for Gene Therapy for Retinitis Pigmentosa
BOSTON & SHANGHAI, September 2, 2024 – Skyline Therapeutics, a gene therapy company focused on innovative treatments for rare and severe diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SKG1108....
Novavax Receives Emergency Use Authorization for Updated Covid-19 Vaccine
Novavax has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its updated Covid-19 vaccine, NVX-CoV2705, joining other vaccine manufacturers in addressing evolving virus variants. The EUA permits the use of Novavax's...
Turn Biotechnologies Reports Historic Skin Cell Rejuvenation Breakthroughs at ESDR this Week
Company will present data from its successful rejuvenation of fibroblasts and keratinocytes to influential gathering of international dermatologists MOUNTAIN VIEW, Calif., Sept. 4, 2024 /PRNewswire/ -- Turn Biotechnologies, a developer of novel mRNA medicines and...
H5 influenza vaccines: What needs to be done to reduce the risk of a pandemic
As the global threat of H5N1 influenza looms with outbreaks across species and continents including the U.S., three international vaccine and public health experts say it is time to fully resource and support a robust strategy to address this and future potential...
Related Services
![](https://static.packgene.com/wp-content/uploads/2023/01/9-1.png)
Plasmids GMP Services
![](https://static.packgene.com/wp-content/uploads/2023/01/10-2.png)
AAV GMP Services
![aav icon](https://static.packgene.com/wp-content/uploads/2023/01/9-1.png)