WASHINGTON, DC – The U.S. Food and Drug Administration (FDA) on Monday approved the first-ever vaccine to prevent respiratory syncytial virus (RSV) in infants given to pregnant women.
The drug, marketed as Abrysvo and manufactured by Pfizer, received approval from the European Medicines Agency (EMA) in July.
With Monday’s approval, the FDA hopes to “provide health care workers and pregnant women with an option to protect infants from this potentially deadly disease,” the regulator said in a statement.
According to the agency, the vaccine’s safety and effectiveness have been demonstrated in a series of international clinical studies, which found a significant reduction in the risk of severe cases of RSV in infants under six months of age.
In May, the FDA approved the drug for people 60 and older.
According to The Hill, in order for women in the country to start getting vaccinated, the Centers for Disease Control and Prevention (CDC) must first issue recommendations.
According to the FDA, RSV is the leading cause of lower respiratory tract infections in infants worldwide. The virus usually starts circulating in the fall and peaks in the winter.
Although in many cases it causes only cold-like symptoms, sometimes it causes complications and can lead to bronchitis or pneumonia. It is especially dangerous during the first year of life.
The main symptoms of Abrysvo in pregnant women are pain at the injection site, muscle pain, nausea and headache, according to the FDA.