First RSV vaccine approved for older adults

For the first time, a respiratory syncytial virus (RSV) vaccine for older adults has been granted regulatory approval. While it is now approved in the US, it is the first RSV vaccine to be given a marketing authorisation anywhere in the world.

Adjuvanted vaccine Arexvy has been approved by the US Food and Drug Administration (FDA). It is authorised for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

The agency’s approval is important, because according to the US Centers for Disease Control and Prevention, RSV leads to around 60,000-120,000 hospitalisations and 6,000-10,000 deaths in adults 65 years of age and older every year in the US.

Approval of GSK’s RSV vaccine

The FDA granted approval of Arexvy to GlaxoSmithKline Biologicals.

The RSV vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.

In November 2022, GSK announced the European Medicines Agency (EMA) had validated a marketing authorisation application (MAA) under accelerated assessment for its RSV vaccine. Based on interim analysis data from a Phase III trial, it had potential to be the first approved vaccine for the respiratory disease caused by RSV. 

Now, the FDA has granted this milestone to GSK’s Arexvy.

Clinical evidence that led to the FDA’s landmark approval

The safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing, randomised, placebo-controlled clinical study in individuals 60 years of age and older.

The main clinical study of Arexvy was designed to assess the safety and effectiveness of a single dose administered to individuals 60 years of age and older. Participants will remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination.

In this study, approximately 12,500 participants have received Arexvy and 12,500 participants have received a placebo.

In participants who received Arexvy as well as those who received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6 percent and reduced the risk of developing severe RSV-associated LRTD by 94.1 percent.

One of GSK’s RSV vaccine studies, completed in 2020, assessed 1053 participants included adults over 60 years old.

Protecting against serious outcomes from RSV

“With this vaccine, Americans over the age of 60, and particularly those with underlying health conditions like chronic obstructive pulmonary disease (COPD), asthma, or congestive heart failure, will have a vaccine to help protect against potentially serious outcomes from RSV,” Dr John Kennedy, President of the American Medical Group Association (AMGA) added.

“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,” stated Tony Wood, Chief Scientific Officer for GSK.