Arexvy is specifically intended to prevent lower respiratory tract disease caused by RSV in people who are 60 years of age or older.
“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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”
Tony Wood, Chief Scientific Officer, 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."
Wood stated that the primary objective now is to ensure that the vaccine is accessible to eligible older adults in the US as soon as possible while pursuing regulatory review in other countries.
RSV is a common virus that can cause severe respiratory illnesses and leads to thousands of hospitalizations and deaths each year in adults aged 65 years and older, particularly those with underlying medical conditions such as chronic heart and lung disease and diabetes. (ILKHA)