FDA Approves Antibody To Fight RSV

Infant receives a breathing treatment | Image by SUKJAI PHOTO/Shutterstock

A preventative injection to protect infants under 2 from contracting respiratory syncytial virus (RSV) was approved on Monday by the Food and Drug Administration (FDA).

RSV was a health crisis in 2022, putting many children’s hospitals in Texas at capacity, as The Dallas Express reported previously. It was considered a triple threat to children along with flu and COVID-19.

In a 24-hour period, the emergency room at Cook Children’s Hospital in Dallas saw 603 patients. Cook urgent care centers saw 760 patients during the same time frame.

“This is the very first small peak that we’ve seen, and we have not peaked out,” Natalie Carpenter, Cook’s director of emergency services, said then.

The injection from AstraZeneca was fast-tracked for approval by the FDA.

Beyfortus, the brand name of the drug, is expected to be available ahead of the upcoming 2023-2024 RSV season.

RSV season typically peaks in mid-December, the Fort Worth Star-Telegram reported.

“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, research director for the FDA’s Office of Infectious Diseases.

Beyfortus is a monoclonal antibody treatment, the company said in a statement. It is a laboratory-made protein that mimics the operation of the body’s natural immune system. It’s approved for use in all infants, even healthy infants born full-term.

“This virus can affect all babies, so not just babies with certain health conditions but even healthy babies,” Rachel Dawkins, medical director of the pediatric and adolescent medical clinics at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida, told CNN.

“So as a pediatrician, I’m very excited about the idea of having an immunization to prevent serious illness from RSV,” Dawkins added.

The FDA recommends that infants receive one dose of the antibodies before the RSV season to provide protection.

“Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families, and the healthcare system,” Farley said.

Clinical trials for Beyfortus began in 2016 and officially concluded last month, according to the FDA.

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