FDA OKs First RSV Preventive Shot For All Infants
The FDA approved a monoclonal antibody shot — Beyfortus, produced by Astra Zeneca and Sanofi — to help protect the youngest Americans against respiratory syncytial virus. The treatment is expected to be available by the start of the fall RSV season.
The New York Times:
RSV Shot Is Approved For Infants
The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections for an illness that fills children’s hospitals year after year. The monoclonal antibody shot is expected to be available at the start of the fall R.S.V. season. The F.D.A. is also considering approval of an R.S.V. vaccine by Pfizer for pregnant women that is meant to protect infants from the virus. (Jewett, 7/17)
Axios:
FDA Approves 1st RSV Immunization For All Infants
SV is considered the second leading cause of death during the first year of a child's life, with infants six months and younger at greater risk of becoming severely ill. Around one to two out of every 100 children younger than six months with RSV may need to be hospitalized, per data from the Centers for Disease Control and Prevention. ... An uptick of cases last fall put a strain on children's hospitals ahead of the typical surge of respiratory viruses. (González, 7/17)
The Washington Post:
First RSV Antibody Treatment To Protect All Infants Approved In The U.S.
The preventive shot, called Beyfortus, isn’t a vaccine, but it works in a similar way, delivering a temporary shield of protection that lasts for a single winter respiratory virus season. It is made up of laboratory-brewed antibodies that block the virus from entering cells. The drug can be given at birth to infants born during the RSV season, or administered in a pediatrician’s office to babies before their first winter respiratory virus season. The shot is also approved for high-risk children up to age 2. (Johnson, 7/17)
CNN:
FDA Approves Antibody To Protect Infants From RSV
“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 Dr. 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,” Farley said in a news release.(Goodman, 7/17)
