FDA approves vaccine against 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 young children against respiratory syncytial virus, also known as RSV, and it is expected to be available in the fall.
The drug, made by Sanofi and AstraZeneca, will be one of the first safeguards against the disease, which has skyrocketed across 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 emergency department and doctor’s office visits each year,” said John Farley, director of the Center for Evaluation and Research’s Office of Infectious Diseases. FDA Drug Administration.
“Today’s approval addresses a great need for products that help reduce the impact of RSV disease on children, families, and the health care system.”
Beyfortus, made by Sanofi and AstraZeneca, is an approved vaccine for infants and young children with RSV
Approved Monday, the treatment, dubbed Beyfortus, is an injection of monoclonal antibodies. 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 60 and older.
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. Serious signs that warrant urgent care are shortness of breath, 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 per year among children under five years of age. Up to 80,000 are hospitalized annually.
The virus has also been linked to 60,000 hospitalizations and 10,000 deaths in adults 65 and older.
The injection has been tested in more than 3,200 babies. One study found that the six-month efficacy against severe RSV requiring medical intervention was 79 percent.
Other research has shown the drug to be 70 to 75 percent effective.
Another Pfizer vaccine, which would be used during pregnancy to prevent disease in babies for the first six months, is currently awaiting FDA approval.
