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THE US Food and Drug Administration (FDA) on Monday approved a new preventive treatment to defend babies and toddlers against common and sometimes dangerous risks Respiratory syncytial virus (RSV). The injectable medication, called Beyfortus (nirsevimab-alip), is designed for all babies entering their first RSV season and for children up to 2 years of age who remain vulnerable to severe RSV infection through their second RSV season. RSV.
“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, MD, MPHdirector of the Office of Infectious Diseases at the FDA’s Center for Drug Evaluation and Research, in a statement.
THE Centers for Disease Control and Prevention (CDC) estimates that RSV hospitalizes 58,000 to 80,000 children under the age of 5 each year. RSV is the leading cause of hospitalization of infants under 1 year of age in the United States, with an average 16 times higher than the annual rate of flu.
Although RSV usually causes mild, cold-like symptoms in most infants and young children, some develop lower airway disease such as pneumonia and bronchiolitis (swelling of the small airways in the lungs). Premature babies and those with chronic lung disease or significant congenital heart disease are most at risk for RSV.
“Every year we have babies [with RSV] fill our hospital beds who are blue because they can’t breathe, are coughing and need oxygen – some need to be put on ventilators,” explains Yvonne Maldonado, MD, chief of the division of pediatric infectious diseases at Stanford University School of Medicine in Palo Alto, Calif. “This drug is a real opportunity to literally keep thousands of children out of hospital every year for decades, so families don’t have to suffer through all of this.”
How does the new RSV treatment work?
Developed by AstraZeneca and Sanofi, Beyfortus is a type of protein called a monoclonal antibody. It works by binding to a protein called F protein on the surface of the virus. When the drug is attached to this protein, the virus becomes unable to enter cells in the body, especially cells in the lungs, according to the European Medicines Agency.
Although Beyfortus prevents the disease, Dr. Maldonado stresses that it is not a vaccine. “A vaccine causes the body to develop its own long-term antibodies,” she says. A vaccine tricks your immune system into “learning” about the virus so it can build longer-lasting defenses that can fight off future infections.
A monoclonal antibody works differently. According Astra Zeneca, these lab-made antibodies mimic natural antibodies. Usually, a vaccine takes a few weeks to generate an immune response, but a monoclonal antibody kicks in almost immediately.
In general, vaccines provide durable long-term protection, while monoclonal antibody treatments are effective for a few months. In clinical trials, a single dose of Beyfortus, given as a single injection, protected against RSV for approximately five months, the length of a typical RSV season (usually fall to late spring).
Maldonado adds that the virus does not appear to mutate significantly, so it is unlikely that the formulation of the treatment formula will need to be changed over time.
The FDA has already approved another monoclonal antibody injection called Synagis (palivizumab), but that’s only for high-risk infants born severely preterm.
How well does the new RSV treatment work and when will it be available?
So far, Astra Zeneca said, clinical trials with infants have demonstrated that Beyfortus reduces the incidence of lower respiratory tract disease caused by RSV (such as bronchiolitis or pneumonia) by 70 to 75% compared to placebo.
A study also showed that the vaccine was safe and easy to administer, according to Maldonado.
The drug will only be made available to the public after a CDC advisory committee meets to determine guidelines for how the drug should be administered and who should receive it. Maldonado expects the meeting to take place before the end of August.
Is there a vaccine to protect babies against RSV?
A vaccine that can prevent RSV in babies is in the works. In May, an FDA advisory panel voted in favor of a vaccine for women in their second or third trimester of pregnancy to defend against lower respiratory tract infections and serious illnesses in young children up to age. six months old. FDA decision expected in August, drugmaker says Pfizer.
Maldonado anticipates that CDC advisers will consider questions about how these upcoming RSV vaccines and newly approved monoclonal antibodies might be offered. Should children receive both types of vaccines? Otherwise, how can parents decide what is best to protect their child?
“My feeling is that there’s going to be some sort of compromise where people are going to be encouraged to do what they think is best for their own situation,” Maldonado says. “I would encourage pregnant women to get vaccinated, just like we vaccinated pregnant women against whooping cough or whooping cough to prevent their babies from catching it. Then the question is, if the baby is already highly protected from the mother’s vaccine for the first six months of life, what additional benefit will the baby get from injecting Beyfortus in the first month of his life? All of this will have to be settled over time. »
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