The U.S. Food and Drug Administration (FDA) has given the okay for an RSV antibody injection to be given to infants. Respiratory Syncytial Virus Infection (RSV) can be extremely dangerous for some infants and young children. It is estimated between 58,000 and 80,000 children under five years old are hospitalized every year due to the virus.
Children the FDA Hope to Protect
Those more susceptible to severe illness from RSV are:
- Infants. Especially, those six months old and younger.
- Premature infants. They are at high risk due to being born at an early stage of pregnancy. Generally, they are all underweight, some are born before their organs are fully developed.
- Those under two years old with congenital (present from birth) heart disease or chronic lung disease.
- Children with weakened immune systems.
- Young youth who have neuromuscular disorders. This includes children who have difficulty clearing mucus secretions or difficulty swallowing.
Basically, all children contract RSV by the time they reach the age of two. Normally, the virus causes mild, cold-like illnesses. However, for some, it can cause severe illnesses, such as:
- Pneumonia — which is an infection of the lungs.
- Bronchiolitis — which is an inflammation of the small airways in the lung.
New Antibody Shot
The new antibody injection approved by the FDA is called Nirsevimab. It can also be sold under the brand name Beyfortus. Unlike vaccines, this ready-made antibody can bind to RSV and block it from infecting healthy cells. This means the at-risk children’s immune systems don’t have to create antibodies from the illness or vaccine.
Additionally, the shot is given to the infant prior to RSV season and as a single injection. However, the FDA is also allowing an additional injection to be given to babies up to 24 months who are more vulnerable through their second RSV season.
Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, explained in a news release that “RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year.”
Additionally, the news release said that the FDA’s “approval addresses the great need for products to help reduce the impact of RSV disease on children, families, and the health care system.”
What’s Next?
The Centers for Disease Control and Prevention (CDC) will go over the data provided and see if it is okay to provide young children with the antibody. Additionally, the Advisory Committee on Immunization Practices (ACIP) has already drafted its approval for Nirservimab’s use. The draft also includes the organization’s clinical considerations for the antibody medication.
Once signed by the CDC, Nirservimab will become the second RSV antibody available. The first being Palivizumab or Synagis. However, unlike its predecessor, Nirsevimab will be available to all young children. Palivizumab has only been used to protect premature infants younger than six months.
By Sheena Robertson
Sources:
CNN: FDA approves antibody to protect infants from RSV
CDC: RSV in Infants & Young Children
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