The United States Food and Drug Administration (FDA) on Monday approved a new preventive treatment to defend infants and children from the common and sometimes dangerous respiratory syncytial virus (RSV). The injectable drug, called Beyfortus (nirsevimab-alip), is designed for all children entering their first RSV season and for children up to 2 years old who remain vulnerable to severe RSV disease during their second RSV season.
RSV can cause serious illness in infants and some children and results in a large number of visits to emergency rooms and doctors’ offices each year, said John Farley, MD, MPH, director 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 5 each year. RSV is the leading cause of hospitalization for infants under 1 year of age in the United States, averaging 16 times the annual rate for influenza.
Although RSV typically causes mild, cold-like symptoms in most infants and young children, some develop lower respiratory tract illnesses such as pneumonia and bronchiolitis (swelling of the small airways in the lungs). Premature infants and those with chronic lung disease or significant congenital heart disease are at the highest risk for RSV.
We have children every year [with RSV] they fill our hospital beds that are blue because they can’t breathe, cough and need oxygen, some need to be put on ventilators, says Yvonne Maldonado, MD, chief of the division of pediatric infectious diseases at Stanford University School of Medicine in Palo Alto, California. This drug is a real opportunity to keep literally thousands of children out of the hospital every single year for decades to come, so families won’t have to suffer through it all.
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 the 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, particularly cells in the lungs, according to the European Medicines Agency.
Although Beyfortus prevents the disease, Dr. Maldonado points out that it is not a vaccine. A vaccine causes the body to build up its own antibodies over the long term, he says. A vaccine prompts your immune system to learn about the virus so it can build longer-lasting defenses that can fight off future infections.
A monoclonal antibody works differently. According to AstraZeneca, these lab-made antibodies mimic natural antibodies. It usually takes a few weeks for a vaccine to generate an immune response, but a monoclonal antibody kicks in almost immediately.
In general, vaccines offer 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 (typically fall to late spring).
Maldonado adds that the virus doesn’t appear to mutate significantly, so the formula for treatment formula is unlikely to need to be changed over time.
The FDA has already approved another monoclonal antibody injection called Synagis (palivizumab), but only for high-risk babies born severely premature.
How well does the new RSV treatment work and when will it be available?
So far, AstraZeneca says, clinical trials with children have shown that Beyfortus reduces the incidence of lower respiratory tract illnesses caused by RSV (such as bronchiolitis or pneumonia) by 70 to 75 percent compared to placebo.
The study also showed that the injection is safe and easy to administer, according to Maldonado.
The drug won’t be available to the public until a CDC advisory committee meets to determine guidelines on how to give the drug and who should get it. Maldonado expects the meeting to be held by the end of August.
Is there a vaccine to protect children from RSV?
A vaccine that can prevent RSV in children is in the pipeline. In May, an FDA advisory panel voted to support a vaccine for women in the second or third trimester of pregnancy to guard against lower respiratory tract infections and serious illness in babies up to six months old. An FDA decision is expected in August, according to drugmaker Pfizer.
Maldonado anticipates that CDC advisors will consider questions about how these upcoming RSV vaccines and newly approved monoclonal antibodies might be offered. Should children get both types of injections? If not, how can parents decide what is best to protect their child?
My feeling is that there will be some sort of compromise where people will be encouraged to do what they think is best for their situation, Maldonado says. I would encourage pregnant women to get the vaccine just as we have vaccinated pregnant women against pertussis or whooping cough to prevent their babies from getting it. So the question is, if the baby is already highly protected by the mother’s vaccine for the first six months of age, how much more benefit will the baby get from giving the baby the Beyfortus injection in the first month or so of life? All of this will have to be sorted out over time.
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