2023-05-04 11:35:01
The FDA (US Food and Drug Administration) has approved Arexvythe first respiratory syncytial virus vaccine (RSV) for the prevention of lower respiratory tract disease caused by this pathogen in people 60 years of age and older.
“Older adults, particularly those with underlying health conditions such as heart or lung disease or weakened immune systems, are at high risk of serious illness caused by RSV,” said Dr. Peter Marks, director of the Center for Assessment. and FDA Biological Research. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease that 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.”
RSV is a highly contagious virus that causes lung and respiratory tract infections in people of all ages. In fact, in children under two years of age it is the main cause of the dreaded bronchiolitis.
Its circulation is seasonal, generally beginning during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause pneumonia and bronchitis life threatening. According to the US Centers for Disease Control and Prevention, each year this virus causes approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 and older in the United States.
The safety and efficacy of Arexvy are based on the FDA’s analysis of data from an ongoing randomized, placebo-controlled clinical study conducted in the US and internationally in people 60 years of age and older.
The main clinical study of Arexvy, a drug produced by the GlaxoSmithKline (GSK) laboratory, was designed to evaluate the safety and efficacy of a single dose administered to persons 60 years of age or above. Participants will remain in the study for three RSV seasons to assess the duration of efficacy and the safety and effectiveness of repeat vaccination. FDA has been able to review available data from a single dose of Arexvy from the first RSV season of research.
In this study, approximately 12,500 participants received Arexvy and 12,500 participants received a placebo. Among those who received Arexvy and those who received a placebo, the vaccine significantly reduced the risk of developing lower respiratory tract disease by 82.6% and the risk of developing a more severe form by 94.1%.
Side effects
Among a subset of these clinical trial participants, side effects most commonly reported by people who received Arexvy were pain at the injection site, fatigue, muscle pain, headache, and joint stiffness/pain. Among all clinical trial participants, cases of atrial fibrillation were reported within 30 days of vaccination in 10 participants receiving Arexvy and 4 participants receiving placebo.
In two other studies, approximately 2,500 participants 60 years of age or older received Arexvy. In one of these studies, in which some people received Arexvy along with an FDA-approved flu vaccine, two participants developed acute disseminated encephalomyelitis, a rare type of inflammation that affects the brain and spinal cord, seven and 22 days later, respectively. One of these two participants died. In the other study, one person developed the Guillain-Barr syndromeIt is (a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) nine days after receiving Arexvy.
The FDA requires that the company perform a post-marketing study to assess for signs of serious risk of Guillain-Barré syndrome and acute disseminated encephalomyelitis. Also, although not required by the FDA, the company has committed to evaluating atrial fibrillation in the postmarketing study.
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