GSK Announces First-Ever RSV Vaccine Candidate Demonstrates Significant Efficacy in Older Adults, Reaches Primary Endpoint in Phase III Trial

On the 11th, GSK announced that its investigational Respiratory Syncytial Virus (RSV) candidate vaccine for adults aged 60 and above achieved positive topline results in the interim analysis of the Phase 3 clinical trial AReSVi 006. According to the review by the Independent Data Monitoring Committee (IDMC), the trial met its primary endpoint with no unexpected safety issues identified. The press release noted that this is the first time an RSV candidate vaccine has demonstrated statistically significant and clinically meaningful efficacy in people aged 60 and above. GSK will immediately begin discussions with regulatory authorities and anticipates submitting a regulatory application in the second half of this year.

RSV is a common contagious virus, divided into two major subtypes: Type A and Type B. It is one of the major infectious diseases that currently lacks an effective vaccine and targeted treatment. Elderly individuals are at higher risk of developing severe illness due to weakened immunity and underlying health conditions. RSV can exacerbate chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure, and other conditions, leading to pneumonia, hospitalization, and death. Globally, RSV causes over 360,000 hospitalizations and 24,000 adult deaths each year.

GSK's RSV candidate vaccine for the elderly carries the subunit of the prefusion RSV F glycoprotein antigen and the company’s proprietary AS01 adjuvant. AS01 is used in several of the company’s vaccines, and the combination of antigen and adjuvant may help overcome age-related immune decline in the elderly.

In addition to achieving the primary endpoint, the candidate vaccine showed consistent protective efficacy against both RSV A and B strains, with similar protection observed in individuals aged 70 years and older. Detailed results from this Phase III clinical trial will be published in a peer-reviewed scientific journal and presented at future scientific conferences. The clinical trial will continue to evaluate the long-term protective effects of an annual vaccination regimen in elderly patients.

GSK Chief Scientific Officer and R&D President Dr. Hal Barron said, "These data show that our RSV candidate vaccine provides outstanding protection in preventing severe outcomes in the elderly population due to RSV infection. These data have the potential to change the treatment of RSV. Based on their importance, we plan to engage with regulators immediately and expect to submit regulatory applications in the second half of this year."

References:

[1] GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate for older adults. Retrieved June 10, 2022, from https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-its-respiratory-syncytial-virus-rsv-vaccine-candidate-for-older-adults/

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