GSK Gets US FDA Approval to Expand RSV Vaccine Use

The U.S. Food and Drug Administration (FDA) has increased the approved age by Arexvy, a respiratory syncytial virus (RSV) vaccine created by GSK, making it accessible to adults between the ages of 18 and 49 who are at a high risk of getting lower respiratory tract disease caused by the virus.

The vaccine is already approved in the United States to prevent RSV related disease in adults aged 60 or older and at-risk adults aged 50-59 years. The recent regulatory expansion is to cover younger adults with underlying health issues with a greater risk of severe respiratory complications.

Respiratory syncytial virus, which is also referred to as RSV, is an influenza-like infection which is caused by a common seasonal respiratory virus. It is one of the causes of pneumonia and severe respiratory disorder especially in infants and the elderly. The company says there are approximately 21 million adults under 50 years of age in the United States with at least one risk factor that may contribute to more significant illnesses with RSV infection, which shows the necessity to increase the scope of vaccination.

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With the new approval, Arexvy will enter a competitive vaccine landscape in the 18–49 age group. The vaccine is expected to compete with RSV vaccines such as mRESVIA developed by Moderna and Abrysvo from Pfizer, both of which are targeting broader adult immunisation strategies.

However, it will wait until the vaccine is broadly available to the new age group approved to be given a recommendation by the U.S. Centers for Disease Control and Prevention.

The expansion is also in line with a positive regulatory outlook in Europe. In December, Arexvy was supported by a panel of the European Medicines Agency in all adults aged 18 and above, which is the next step towards the broad implementation of RSV vaccine protection measures worldwide.