FDA Approves First Respiratory Syncytial Virus Vaccine for Adults Aged 60 Years and Older

The FDA has approved Arexvy (respiratory syncytial virus vaccine [RSV], adjuvanted; GSK) for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older. The action marks the first RSV vaccine to be approved for use in the United States.¹

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“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’s Center for Biologics Evaluation and Research, in a press release. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”¹

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.¹

“Today marks a turning point in our effort to reduce the significant burden of RSV,” said Tony Wood, chief scientific officer, GSK, in a press release. “Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”²

Arexvy contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01_E adjuvant. The safety and efficacy of the newly approved vaccine was based on data from an ongoing, randomized, placebo-controlled clinical study conducted in the United States and internationally in individuals 60 years of age and older. The primary clinical study assessed the safety and efficacy of a single dose of Arexvy administered to individuals 60 years of age and older.

Individuals enrolled in the study will remain through 3 RSV seasons to assess the duration of efficacy and the safety and efficacy of repeat vaccination. Today’s approval was based on the FDA’s analysis of data from a single dose of the vaccine in the first RSV season of the study.

Approximately 12,500 participants were administered Arexvy and 12,500 participants were given a placebo. Among those administered Arexvy, the vaccine significantly lowered the risk of developing RSV-associated LRTD by 82.6% and decreased the risk of developing severe RSV-associated LRTD by 94.1%.

Further, vaccine efficacy was 94.6% (95% CI, 65.9–99.9, 1 of 4937 vs 18 of 4861) in older adults with at least 1 underlying medical condition of interest, including certain cardiorespiratory and endocrine-metabolic conditions. Efficacy against severe RSV-LRTD, defined as an RSV-associated LRTD episode that inhibited normal, everyday activities, was 94.1% (95% CI, 62.4–99.9, 1 of 12,466 vs 17 of 12,494).²

The most commonly reported adverse effects in the Arexvy cohort were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Among all clinical trial participants, atrial fibrillation within 30 days of vaccination was reported in 10 participants administered Arexvy and 4 participants administered the placebo.

In 2 other studies, approximately 2500 participants aged 60 years and older were administered Arexvy. In the first study, in which some participants were administered Arexvy concomitantly with an FDA-approved influenza vaccine, 2 participants developed acute disseminated encephalomyelitis (ADEM) 7 and 22 days, respectively, after administration of the 2 vaccines. One of these patients who developed ADEM died. In the other study, a participant developed Guillain-Barré syndrome 9 days after receiving Arexvy.

The FDA is requiring GSK to conduct a postmarketing study to assess the signs of serious risks for Guillain-Barré syndrome and ADEM. Further, GSK has committed to assess atrial fibrillation in the postmarketing study, which was not required by the FDA.

“For decades, [the American Medical Group Association] and the health care community at large have been active in finding ways to increase adult immunizations,” said John Kennedy, MD, president, American Medical Group Association, in a press release. “As a result, we are pleased that we can now add a [RSV] vaccine to providers’ options for patient care. 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 against potentially serious outcomes from RSV.”²

References

1. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine. FDA. News release. May 3, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine?utm_medium=email&utm_source=govdelivery. Accessed May 3, 2023.

2. US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults. GSK. News release. 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. Accessed May 3, 2023.