Syncytial virus, FDA-approved vaccine for the elderly in the United States
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Green light in the US for the first vaccine against respiratory syncytial virus (RSV). There Food and Drug Administration (Fda) has approved it for people age 60 and older. The news was announced by the US regulatory body in a note.
A vaccine intended for adults over 60 years of age
Arexvy (this is the name of the drug) has therefore received the go-ahead for the prevention of lower respiratory tract diseases in adults caused by the RSV virus. “Elderly people, especially with underlying medical conditions, such as heart or lung disease or a weakened immune system, are at high risk of serious illnesses caused by RSV,” he said. Peter Markdirector of the Center for Biologics Evaluation and Research of the FDA. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease that can be life-threatening.”
What is respiratory syncytial virus
RSV is a highly contagious virus that causes lung and respiratory tract infections in people of all ages (it is also known for its impact on newborns). Circulation is seasonal, typically starting during the fall and peaking in the winter. According to the US Centers for Disease Control and Prevention, each year in the United States, RSV leads to an estimated 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults age 65 and older.
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Clinical trial data on safety and efficacy
The safety and efficacy of the vaccine were reviewed by the FDA based on data from an ongoing randomized placebo-controlled clinical trial in the United States and internationally in people over 60: approximately 12,500 received Arexvy and another 12,500 a placebo .
In the trial, the vaccine reduced the risk of developing virus-associated lower respiratory tract disease (LRTD) by 82.6% and the risk of developing severe disease by 94.1%. In two other studies, the vaccine was given to about 2,500 participants aged 60 and older. In one such study, in which participants received Arexvy concurrently with an approved flu vaccine, 2 developed acute disseminated encephalomyelitis (Adem), a rare type of inflammation affecting the brain and spinal cord, after receiving the two vaccines. spinal. One of them died. In the other study, one participant developed Guillain-Barré syndrome (a rare disorder causing muscle weakness and sometimes paralysis) after receiving Arexvy. The FDA requires the company (GlaxoSmithKline Biologicals) to conduct a post-marketing study to evaluate risk signals for Guillain-Barré syndrome and Adem. The manufacturer, again as part of the post-marketing study, has also undertaken to evaluate atrial fibrillation (reported in some participants in the trial on the basis of which the vaccine was authorized).
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