May 3 (UPI) -- The FDA on Wednesday approved Arexvy, the first approved vaccine for Respiratory Syncytial Virus for people 60 or older.
RSV is a highly contagious respiratory tract disease and can be life-threatening.
GlaxoSmithKline Biologicals, maker of the vaccine, said in a statement Wednesday that the U.S. launch of Arexvy is planned for the 2023/2024 RSV season.
"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," said GSK Chief Scientific Officer Tony Wood in a statement. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries."
Related
The FDA said the approval is an important public health achievement.
"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 the FDA's Peter Marks in a statement. "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."
According to the U.S. Centers for Disease Control and Prevention, RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths each year among people 65 and older.
The Arexvy vaccine approval is based on the FDA's analysis of data from "an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older."
In the study, roughly 12,500 participants got Arexvy and another 12,500 got a placebo. The FDA said the vaccine significantly cut the risk of developing RSV-related lower respiratory tract disease by 82.6%. It reduced the risk of severe RSV-associated disease by 94.1%.
RSV is seasonal and affects all age groups, causing infections of the lungs and breathing passages.
The FDA is expected to make a decision on approval for an RSV vaccine for infants by summer. Pfizer's RSV vaccine for infants and seniors is safe and effective, according to clinical trials and is on track to be approved later this year.
Participants in the FDA's Arexvy study will remain in the clinical study through three RSV seasons to assess the vaccine's duration of effectiveness, safety, and effectiveness of repeat vaccination, according to the FDA.
In two other studies, the FDA said in a statement, "Two participants developed acute disseminated encephalomyelitis (ADEM), a rare type of inflammation that affects the brain and spinal cord, seven and 22 days, respectively, after receiving Arexvy and the influenza vaccine. One of the participants who developed ADEM died."
In one other study, one participant developed Guillain-Barré syndrome. It's a rare disorder that causes the body's immune system to damage nerve cells that can cause muscle weakness and sometimes paralysis. That happened nine days after receiving Arexvy.
