According to the US Centers for Disease Control and Prevention, RSV causes between 60,000 and 120,000 hospitalizations in the United States each year and between 6,000 and 10,000 deaths among people over the age of 65. In Europe, according to the European Medicines Agency, RSV is responsible for 250,000 hospitalizations each year and 17,000 hospital deaths among people over 65 years of age.
“major public health interest”
“Older adults, particularly those with underlying health conditions, such as heart or lung disease or a weakened immune system, are at significantly increased risk of severe disease from RSV,” Professor Peter Marks, director of the FDA’s Center for Biological Evaluation and Research. He is pleased that “important public health progress has been made in order to prevent a potentially life-threatening disease.”
At the end of April, the European Medicines Agency issued a favorable marketing opinion for this vaccine, also considering it a “major public health interest”. It remains for the European Commission to make a final decision in the coming weeks.
94.1% lower risk for severe forms
Arexvy’s safety and effectiveness were tested in a study involving nearly 25,000 participants, over the age of 60, residing in 17 different countries. Half received a dose of the vaccine, and the other a placebo. “The vaccine significantly reduced the risk of RSV-associated lower respiratory tract infections by 82.6% and reduced the risk of RSV-associated lower respiratory tract infections by 94.1%,” the FDA notes. The study runs for three seasons to test safety and efficacy with repeated immunizations.
Among adverse effects, two participants in another study developed acute disseminated encephalomyelitis (ADEM), a rare type of inflammation that affects the brain and spinal cord, days after receiving the flu vaccine and Arixvi. In another study, a participant developed Guillain-Barré syndrome, in which a patient’s immune system attacks peripheral nerves. According to the FDA, GSK has committed to conducting an additional risk assessment related to ADEM and Guillain-Barré.
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