FDA approves shot for cold-like winter virus that kills hundreds of babies each year
The Food and Drug Administration (FDA) has approved a new drug to protect infants and toddlers against respiratory syncytial virus, also known as RSV, and is expected to be rolled out by fall.
The medication, manufactured by Sanofi and AstraZeneca, will be one of the first protections against the illness, which has surged throughout the United States, filling hospitals and infection millions of children every year.
‘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,’ said John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.
‘Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system.’
Beyfortus, made by Sanofi and AstraZeneca, is a vaccine approved for infants and toddlers with RSV
Approved Monday, the treatment, dubbed Beyfortus, is a monoclonal antibody shot. Monoclonal antibodies are synthetic proteins that act like human antibodies in the immune system. They’re often used in cancer treatment to destroy outer layers of malignant cells.
The news comes months after the FDA approved two vaccines against the virus for adults older than 60.
RSV is a respiratory virus that causes cold-like symptoms in both children and adults. Symptoms, according to the American Lung Association, include congestion, runny nose, fever, cough, and sore throat. Severe signs that warrant urgent care are difficulty breathing, not drinking enough, 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) estimate that RSV accounts for more than two million outpatient visits a year among children younger than five years old. Up to 80,000 are hospitalized annually.
The virus has also been linked to 60,000 hospitalizations and 10,000 deaths in adults 65 years and older.
The shot has been tested in more than 3,200 infants. One study found that the efficacy over six months against severe RSV that required medical intervention was 79 percent.
Other research has shown the drug has 70 to 75 percent effectiveness.
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.
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