GSK plc has made a step forward with its adjuvanted recombinant RSV vaccine, Arexvy, by submitting a regulatory application to the European Medicines Agency (EMA) for expanding its use to adults aged 50 to 59 years. If the application is approved, Arexvy would be the first RSV vaccine available for this particular age group, aiming to offer protection against RSV-associated lower respiratory tract disease in Europe.

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
Source:
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
Check out our mRNA service to expedite your vaccine research
About PackGene

PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.

Related News

How to make mRNA therapeutics safe from the start

The success of mRNA vaccines against COVID-19 has unleashed a flood of interest in using the technology to create more vaccines and treatments for everything from rare diseases and infections to cancer. But before new mRNA therapeutics are put to use, they need to be...

read more

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way.
READ MORE

AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies.
READ MORE
aav icon

Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.
READ MORE