Health
FDA Approves Bayfortus, a Drug to Prevent Severe RSV in Infants
of U.S. Food and Drug Administration (FDA) A new preventive treatment was approved Monday to protect babies and young children from common and sometimes dangerous diseases. respiratory syncytial virus (RSV). The injection, called Beyfortus (nirsevimab-alip), is designed for all infants entering their first RSV season and for children up to 2 years of age who are susceptible to severe RSV disease until their second RSV season.
“RSV can cause serious illness in infants and some children This results in a large number of emergency department and doctor visits each year.” John Farley, MD, MPHsaid the director of the FDA’s Office of Infectious Diseases, Center for Drug Evaluation and Research, in a statement.
of Centers for Disease Control and Prevention (CDC) An estimated 58,000 to 80,000 children under the age of five are hospitalized with RSV each year. Respiratory syncytial virus is the leading cause of hospitalization for infants under 1 year of age in the United States, at an average rate 16 times the annual hospitalization rate for infants under 1 year of age. influenza.
RSV usually causes mild cold-like symptoms in most infants and young children. Some people develop lower respiratory tract diseases such as pneumonia and bronchiolitis (swelling of the small airways in the lungs).. Premature infants and infants with chronic lung disease or severe congenital heart disease are most at risk of RSV.
“Every year we baby [with RSV] hospital beds full Some people have a blue face because they can’t breathe, they’re coughing, and they need oxygen. Some people need to wear a respirator. ” Yvonne Maldonado, Maryland, Director of the Pediatric Infectious Diseases Division, Stanford University School of Medicine, Palo Alto, California. “This drug is a real opportunity to literally get thousands of children out of hospitals every year for decades to come, so families don’t have to go through that kind of suffering.”
How do the new RSV treatments work?
Developed by AstraZeneca and Sanofi, Bayfortus 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 binds to this protein, it prevents the virus from entering body cells, especially those in the lungs. European Medicines Agency.
Beyfortas prevents disease, but Dr. Maldonado stresses that Beyfortas is not a vaccine. “Vaccines make the body produce its own long-lasting antibodies,” she says. Vaccines encourage the immune system to “learn” about the virus so that it can build long-term defenses to fight future infections.
Monoclonal antibodies work differently.according to AstraZeneca, these lab-made antibodies mimic natural antibodies. While vaccines usually take weeks to provoke an immune response, monoclonal antibodies work almost immediately.
In general, vaccines provide long-lasting protection, whereas monoclonal antibody therapy is only effective for months. In clinical trials, a single injection of Bayfortus provided protection against RSV for approximately five months, the duration of a typical RSV epidemic (usually from autumn to late spring).
Maldonado added that the virus does not mutate significantly, so it is unlikely that treatment will need to change over time.
The FDA has already approved another monoclonal antibody injection called Synagis (palivizumab), but only for high-risk infants born with severe prematurity.
How effective are the new RSV treatments and when will they be available?
recently, AstraZeneca In clinical trials in infants, Beyfortus has been shown to treat lower respiratory tract diseases caused by respiratory syncytial virus, such as bronchiolitis and pneumonia) by 70-75% compared to placebo.
Studies have also shown that the injection is safe and easy to administer, Maldonado said.
The drug will not be released to the public until the CDC’s advisory board meets to determine guidelines for how the drug should be administered and who should receive it. Maldonado expects the talks to take place by the end of August.
Is there a vaccine to protect babies from RSV?
A vaccine is under development that can prevent RSV in infants. In May, an FDA advisory group voted to endorse a vaccine for women in the second or third trimester of pregnancy to prevent lower respiratory tract infections and serious illness in infants up to six months of age.A decision by the FDA is expected in August, according to the drug company Pfizer.
Maldonado expects CDC advisers to consider questions about how future RSV vaccines and the just-approved monoclonal antibodies will be delivered. Should children have both types of immunizations? If not, how should parents decide what is best to protect their infants?
“My sense is that there will be a kind of compromise where people are encouraged to do what they think is best for their situation,” Maldonado said. “Just like we vaccinated pregnant women against whooping cough and whooping cough, we encourage pregnant women to get vaccinated. whooping cough This is to prevent the baby from getting infected. So the question is, if babies are already well protected from their mother’s vaccines until 6 months of age, how much more do they gain from giving their babies a Bayfortus vaccination at around 1 month of age? It will all need to be worked out over time. ”
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