FDA approves injection for cold winter virus that kills hundreds of babies every year
The Food and Drug Administration (FDA) has approved a new drug to protect babies and toddlers against respiratory syncytial virus, also known as RSV, and is expected to be rolled out in the fall.
The drug, manufactured by Sanofi and AstraZeneca, will be one of the first defenses against the disease, which is emerging in the United States, filling hospitals and infecting millions of children each year.
“RSV can cause serious illness in infants and some children and results in a large number of visits to the emergency department and physician’s offices each year,” said John Farley, director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research at the U.S. FDA.
“Today’s approval addresses the great need for products to reduce the impact of RSV disease on children, families and the healthcare system.”
Beyfortus, made by Sanofi and AstraZeneca, is a vaccine approved for infants and toddlers with RSV
Approved Monday, the treatment, called Beyfortus, is a monoclonal antibody injection. Monoclonal antibodies are synthetic proteins that act like human antibodies in the immune system. They are often used in cancer treatment to destroy the outer layers of malignant cells.
The news comes months after the FDA approved two vaccines against the virus for adults over age 60.
RSV is a respiratory virus that causes cold symptoms in both children and adults. Symptoms, according to the American Lung Association, include congestion, runny nose, fever, cough and sore throat. Serious signs that warrant urgent care include difficulty breathing, not drinking enough fluids, decreased activity, and blue lips or fingernails.
Young children and older adults are the most vulnerable groups to the virus.
The Centers for Disease Control and Prevention (CDC) estimates that RSV is responsible for more than two million outpatient visits per year in children under the age of five. Up to 80,000 are hospitalized each year.
The virus has also been linked to 60,000 hospitalizations and 10,000 deaths in adults age 65 and older.
The shot has been tested on more than 3,200 babies. A study found that the six-month efficacy against severe RSV requiring medical intervention was 79 percent.
Other research has shown the drug to have an effectiveness of 70 to 75 percent.
Another vaccine from Pfizer, which would be used during pregnancy to prevent the disease in infants during their first six months, is currently awaiting FDA approval.