FDA Approves GSK’s Arexvy as the World’s First RSV Vaccine for Older Adults

Today, the US Food and Drug Administration (FDA) approved GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy for older adults. Arexvy (RSVPreF3 +AS01E) was approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults 60 years and older.

With this authorization, announced on its Prescription Drug User Fee Act (PDUFA) date of May 3, Arexvy becomes the first-ever RSV vaccine approved for older adults.

Respiratory syncytial virus (RSV) is a common respiratory virus that typically causes mild, cold-like symptoms. While most people recover within 2 weeks, infants and older adults are susceptible to severe and even fatal infection. Older adults with comorbidities, including diabetes and chronic heart and lung disease, are at an increased risk of RSV hospitalization and death.

“In the United States today, there are about 177000 hospitalizations due to RSV, and about 14000 deaths due to RSV in older adults aged 65 years and above,” Dr. Temi Folaranmi, VP, US Medical and Clinical Affairs, Vaccines at GSK, told Contagion. “The opportunity to have a vaccine that would address this burden of disease is a significant public achievement.”

The FDA approval comes after reviewing positive phase 3 data from GSK’s AReSVi-006 (Adult Respiratory Syncytial Virus) trial. “Our primary endpoint in our study was to look at protection against lower respiratory tract disease caused by RSV, which gives us an excellent efficacy of about 82.6%,” said Folaranmi. “We also look at other endpoints such as acute respiratory illness, which gives us a very high efficacy as well.”

The secondary trial endpoint was to evaluate Arexvy in patients with comorbidities, in whom Folaranmi said there was a vaccine efficacy of 94.6%. Against severe disease, the efficacy was 94.1%.

“The RSV vaccine is made up of 2 components,” Folaranmi explained. “We have the preF fusion protein, which is combined together with a well-known adjuvant, the AS01 adjuvant. The combination of these 2 components provides very strong efficacy that is able to address the natural decline that you see in an immune system due to aging.”

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 1 in favor of the safety and efficacy of GSK’s investigational RSV vaccine. Today's approval confirms VRBPAC's recommendation.

“The opportunity to have a vaccine that can prevent this significant burden of disease is huge,” said Folaranmi. “Before now, there was no known intervention for addressing respiratory syncytial virus illness.”

The first-ever RSV vaccine is now approved, but there's still a long way to go to protect against the world's leading cause of lower respiratory tract infection. Catch up with Contagion's RSV coverage here.