FDA approves world’s first RSV vaccine
The US Food and Drug Administration (FDA) has announced that it has approved the world’s first respiratory syncytial virus (RSV) vaccine for use in the US in individuals aged 60 or over.
RSV is a highly contagious virus which causes infections in the lungs and breathing tract. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which can cause pneumonia and bronchiolitis.
Arexvy, affiliated with GSK Biologicals, received approval based on results from the ongoing AReSVi-006 phase 3 randomised, placebo-controlled clinical trial. The vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD in patients aged 60 or over. Efficacy against severe RSV-LRTD ‒ known as an LRTD episode affecting every day, normal activity ‒ was 94.1%.
In April 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced a positive opinion recommending the vaccine for the prevention of LRTD in RSV-positive adults aged 60 or over. A final European decision is expected in the latter half of 2023.
Tony Wood, chief scientific officer at GSK, said: “Today marks a turning point in our effort to reduce the significant burden of RSV. 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.”
John Kennedy MD, president of American Medical Group Association (AMGA) commented: “For decades, AMGA and the healthcare community at large have been active in finding ways to increase adult immunisations. As a result, we are pleased that we can now add a respiratory syncytial virus 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.”
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