FDA Approves First RSV Drug to Protect All Infants From Virus
While the infection often leads to mild, coldlike symptoms, it is the leading cause of hospitalization of infants in the U.S.
Parents have a new tool to protect their newborns from a common but potentially deadly respiratory virus that sends tens of thousands of babies to the hospital each year.
The Food and Drug Administration on Monday approved the first drug to protect all infants against respiratory syncytial virus. RSV is the leading cause of hospitalization of infants in the U.S., killing as many as 300 children under the age of 5 each year.
The FDA said it approved the drug Beyfortus from Sanofi and AstraZeneca based on studies that found it safely prevented the lower respiratory tract infections caused by the virus.
The “approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system,” said Dr. John Farley, director of the infectious-diseases office in the FDA’s drug division.
RSV season lasts from the fall to the winter. Until now, most children were forced to fight off infections on their own, unless they were babies deemed at high risk for severe disease and eligible for a different drug, Synagis, from the drugmaker Sobi.
“RSV season is a term that we use when we know that the hospital is going to get busy in the winter,” said Dr. Alexandra Yonts, pediatric infectious disease physician at Children’s National Hospital in Washington, D.C.
RSV is a relatively common virus that many people hadn’t heard about until cases spiraled last fall and winter.
As cases swamped emergency rooms late last year, roughly three-quarters of parents expressed worry to pollsters that RSV could seriously sicken their young children, according to KFF, formerly known as the Kaiser Family Foundation.
Infection affects the lungs and breathing passages in infants and older adults and often causes mild, coldlike symptoms. But it can lead to severe illness such as bronchiolitis or pneumonia, especially in the young and elderly.
Most children contract an RSV infection by the time they are 2 years old. Cases in babies and young children surged last fall and winter, overwhelming emergency rooms and pediatric hospitals.
An estimated 58,000 to 80,000 children younger than 5 years old are hospitalized because of RSV infection annually, according to the Centers for Disease Control and Prevention.
While Beyfortus isn’t a vaccine, it has a similar objective. The injection gives infants antibodies to neutralize the virus before their immune systems are mature enough to generate them on its own.
Beyfortus usually will require only a single dose. Under the FDA approval, infants can take it at the beginning of an RSV season or during if they are born after it has started.
Children who are at high risk for developing severe RSV can receive a second dose for a second RSV season if they are under two years, Sanofi said.
Sanofi plans to make Beyfortus available in time for this year’s RSV season. Before the drug can become widely available, CDC advisers will need to recommend the drug’s use.
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