Breaking: FDA Approves First-Ever RSV Vaccine

After granting priority review status to its application, The FDA has approved the respiratory syncytial virus vaccine, adjuvanted (Arexvy), the first-ever RSV vaccine, to prevent lower respiratory tract disease caused by RSV in adults aged 60 and older, according to an agency news release.¹

RSV is highly contagious, and circulation is seasonal, with transmission typically beginning in the fall and peaking during the winter. For older adults, RSV is a common cause of lower respiratory tract disease, which can lead to life-threatening pneumonia and bronchiolitis. In adults aged 65 and older, RSV is the cause for between 177,000 hospitalizations and 14,000 deaths per year.²

Arexvy contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) in combination with manufacturer GSK’s proprietary AS01E adjuvant.²

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research.¹ “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening.”

FDA approval was based on the landmark phase 3 AReSVi-006 clinical trial (NCT04886596). There, the vaccine demonstrated statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-associated lower respiratory tract disease in adults aged 60 and older, as well as 94.1% efficacy against severe RSV-associated lower respiratory tract disease. Efficacy was 94.6% in older adults who had at least one underlying comorbid condition, such as certain cardiorespiratory and endocrine-metabolic conditions.²

The most common adverse events included injection site pain, fatigue, muscle pain, headache, and joint stiffness and pain. Atrial fibrillation within 30 days of vaccination was reported in 10 patients in the vaccine group and 4 patients in the placebo group.¹

Two other studies of Arexvy were also conducted, inclusive of approximately 2500 participants aged 60 and older. In one of these studies, where patients received Arexvy and an FDA-approved influenza vaccine concomitantly, 2 participants developed acute disseminated encephalomyelitis (ADEM), a rare inflammation that affects the brain and spinal cord; one of these patients died. In the other study, 1 participant developed Guillain-Barré syndrome.¹

The FDA is requiring manufacturer GSK to conduct a postmarketing study to evaluate the signals of serious risks for Guillain-Barré syndrome and ADEM. The company has also committed to assessing atrial fibrillation risks, although this is not a requirement of the FDA.¹

An additional clinical trial that aims to expand the lower age limit for vaccination to adults aged 50 to 59, is fully recruited, according to a GSK press release,² with results expected in 2023. Also expected are additional results from the AReSVi-006 phase 3 efficacy trial and the AReSVi-004 immunogenicity trial.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of Arexvy during their June 2023 meeting. The vaccine will be available for use ahead of the 2023-2024 RSV season.

“We are pleased that we can now add a [RSV] vaccine to providers’ options for patient care,” said John Kennedy, MD, president of the American Medical Group Association.² “With this vaccine, Americans over the age of 60, and particularly those with underlying health conditions like COPD, asthma, or congestive heart failure, will have a vaccine to help protect them against potentially serious outcomes from RSV.”

References

1. FDA approves first respiratory syncytial virus (RSV) vaccine. News release. FDA. May 3, 2023. Accessed May 3, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine

2. US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults. News release. GSK. May 3, 2023. Accessed May 3, 2023. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/