ACIP Votes to Recommend Use of Arexvy for Respiratory Syncytial Virus in Older Adults

The CDC Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of respiratory syncytial virus (RSV) vaccine, adjuvanted (Arexvy) for adults 60 years of age and older using shared clinical decision making. This involves patients working on an individual level with their health care providers to determine whether RSV vaccination is appropriate.

Credit: jarun011 - stock.adobe.com

The ACIP recommendation was based on a comprehensive data package that included findings for older adults with underlying medical conditions.

“GSK’s successful development of an RSV vaccine to help protect older adults from RSV lower respiratory tract disease (LRTD) represents a major scientific advance, resulting from years of collaboration across academia, industry, and research centers,” Tony Wood, chief scientific officer, GSK, said in a press release. “We are grateful to the ACIP and CDC for recognizing the potential of Arexvy and look forward to partnering with public health officials, health care professionals and payers to make it available for eligible older adults in the US before this year’s RSV season begins.”

The data submitted to ACIP included findings from the first season of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, the results of which were published in the New England Journal of Medicine in February 2023.

The study showed that a single dose of Arexvy produced efficacy against LRTD caused by RSV in adults 60 years of age and older across multiple RSV seasons and following an annual revaccination. The findings indicate that a single dose of Arexvy is effective preventing RSV-LRTD and severe LRTD across 2 full RSV seasons, according to GSK. The FDA approved Arexvy on May 3, 2023, to prevent LRTD caused by RSV in individuals 60 years of age and older.

Arexvy contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. RSV develops in between 3% and 7% of healthy older adults in the United States and Europe each year, with an estimated 177,000 hospitalizations and 14,000 deaths each year in the United States. RSV can be especially severe in older adults, with approximately 18% admitted to an intensive care unit, 31% receiving home health services at discharge, and 26% dying within 1 year post admission.

In older adults, the virus is a common cause of LRTD, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis. The CDC has found that on an annual basis, RSV leads to approximately 60,000-120,000 hospitalizations and 6000-10,000 deaths among adults 65 years of age and older.

According to the study investigators, a similar pattern of vaccine efficacy was demonstrated across 2 seasons in adults with underlying comorbidities and in advancing age, which supports the impact Arexvy could have on individuals with the greatest risk of severe RSV outcomes.

A confirmatory secondary endpoint of the trial was efficacy after an annual revaccination schedule.

The results showed that cumulative efficacy across 2 seasons in those administered a second dose of the vaccine was 67.1% (97.5% CI, 48.1-80.0, 30 of 12,469 vs 139 of 12,498). This indicates that revaccination after 12 months does not confer an additional benefit for the overall population, according to the study. Investigators will continue analyzing longer term follow-up data and the optimal timing for potential revaccination, according to GSK.

ACIP also reviewed data from the ongoing Northern Hemisphere second season of the trial examining Arexvy’s effect across multiple seasons and the optimal timing for potential revaccination.

ACIP’s recommendation will next be reviewed by the director of the CDC and the US Department of Health and Human Services for review and approval. If approved, these recommendations will be published in an edition of the Morbidity and Mortality Weekly Report (MMWR) to advise health care providers on appropriate use.

Reference

US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices votes to recommend Arexvy for the prevention of RSV disease in adults aged 60 and older with shared clinical decision making. GSK. News release. June 22, 2023. https://www.gsk.com/en-gb/media/press-releases/cdc-and-prevention-acip-votes-to-recommend-arexvy/