Approved in the United States by the Food and Drug Administration (Fda) the first preventive treatment (based on monoclonal antibodies, but it is not a vaccine) for infants and children up to two years of age against respiratory syncytial virus (RSV). RSV is a common virus that circulates in autumn and winter. Most affected children have mild, cold-like symptoms, but some, especially those exposed to the virus for the first time, can develop life-threatening respiratory diseases such as pneumonia and bronchiolitis.
The treatment is given as a single dose by injection before or during the first winter season in which the child may be exposed to RSV. Children up to 2 years of age who remain vulnerable to RSV, such as those living with chronic lung or heart disease, may also receive the injection. On 31 October, the Commission already authorized the monoclonal antibody Beyfortus in the EU for the prevention of diseases of the lower respiratory tract, but only in newborns and infants during the first season, ie when there is a higher risk of infection. “RSV can cause serious illness in infants and some children and results in a large number of emergency room and doctor’s office visits each year,” said John Farley of the FDA’s Center for Drug Evaluation and Research. “The approval addresses a great need for products that help reduce the impact of RSV disease on children, families and healthcare systems.” Beyfortus, manufactured by AstraZeneca, is not a vaccine. Instead, it uses monoclonal antibodies against RSV, which are proteins designed to mimic antibodies made by the immune system against the virus. Unlike a vaccine, Beyfortus cannot train the body to identify RSV or produce its own antibodies in response to infection.
The FDA made its decision based on data from three clinical trials, which included nearly 4,000 children. In these studies, a single dose of Beyfortus reduced the risk of children needing medical attention for an RSV infection by 70 to 75 percent.
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