This illustration provided by AstraZeneca depicts packaging for their medication Beyfortus. U.S. officials have approved a new long-acting drug to protect babies and toddlers against a respiratory virus that causes thousands of hospitalizations each year. The Food and Drug Administration on Monday, July 17, 2023 approved the injection for infants and children up to 2 years old. (AstraZeneca via AP)
By Matthew Perrone
U.S. officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends tens of thousands of American children to the hospital each year.
RSV is a cold-like nuisance for most healthy people, but it can be life-threatening in the very young and the elderly.
The Food and Drug Administration approved the injection for infants and children up to 2 years old who face increased risk of severe RSV.
“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” said FDA's Dr. John Farley in a statement.
Last year, a surge in RSV cases flooded U.S. hospitals with wheezing children. There are no vaccines for babies yet, though Pfizer and other companies are working on them.
AstraZeneca’s drug, to be sold under the brand name Beyfortus, is a laboratory-made version of an antibody that helps the immune system fight off RSV. Under the FDA approval, babies — including preterm infants — can receive a single injection to protect against their first season of RSV, which typically lasts about five months. Children up to age 2 can receive another dose to protect them during their second season facing the virus.
Beyfortus, which will be marketed in the U.S. by Sanofi, is already approved in Canada, Europe and the U.K. Sanofi did not immediately announce the U.S. price of the treatment.
FDA officials approved the drug based on three studies showing Beyfortus reduced the risk of RSV infection between 70% and 75% among infants and children 2 and younger.
Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug.
A similar antibody drug won FDA approval more than 20 years ago, but it’s only recommended for high-risk babies and requires monthly injections. Pediatricians say the drug is underutilized and they expect the longer-lasting effect of AstraZeneca's shot to improve uptake.
In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die.
After decades of setbacks for RSV research, drugmakers have made big strides this year, launching the first vaccines against the virus. In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer. In August, the FDA is expected to make a decision on approving Pfizer’s vaccine for pregnant women, with the aim of passing along protection to their newborns.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
Carlo and Baker wrap up another week discussing the latest explosion in new Covid cases in the Northeast, President Biden's stalled agenda and more. Plus, Love, Hate, Ate featuring the question: why did movie dialogue get so hard to understand?
From extreme cold in Texas to devastating wildfires in California to the recent tornadoes in the Midwest, the U.S. experienced a string of severe weather events in 2021. Cheddar News speaks with climate expert Sweta Chakraborty on how these disasters are linked to climate change.
The sports world has been at the forefront of dealing with the pandemic ever since the NBA temporarily halted operations in March 2020 and opted to play in their Florida bubble. As the omicron variant and current COVID surge forces game postponements and player quarantines, how leagues manage to continue operations through the outbreaks could be a sign of what is to come for the general public. Dr. Robby Sikka, chair of the COVID Sports Society Workgroup and a former VP with the Minnesota Timberwolves, joined Cheddar's "Closing Bell" to talk about the ways in which the NBA, NHL, and NFL are innovating amid the disruptions.
According to the CDC, Black women are three to four times more likely to die from pregnancy-related causes than white women. The grim statistic is one of the main reasons why two organizations came together to do something. The Bump and the National Medical Association are partnering to launch The Black Maternal Health hub. The online resource will help expecting mothers feel supported, informed, and empowered throughout pregnancy and the early days of parenting. Jennifer Lee at The Bump and Dr. Rachel Villanueva, a clinical assistant professor of OB/GYN and member of the National Medical Association join Cheddar News to talk about the initiative.
Michelle Egger and Leila Strickland, Co-Founders of Biomilq, join Cheddar Innovates to discuss how their women-led team is recreating the process of milk production outside the body to combine both nutrition and practicality for new moms.
On this episode of Cheddar Innovates: Nucleus CEO breaks down what the future of the genomics industry looks like; Biomilq Co-Founders explains how they are is recreating the process of milk production outside the body to combine both nutrition and practicality for new moms; A look at Curiosity Stream's 'Top Science Stories 2021.'
Kian Sadeghi, Founder and CEO of Nucleus, joins Cheddar Innovates to discuss how he's making genetic analysis more accessible, what our genetic code can teach us about ourselves, and what the future of the genomics industry looks like.
On this episode of Cheddar Innovates: Omorpho Co-Founder explains the innovation driving gravity sportswear; Cool Beans CEO breaks down the science behind 'good mood food;' A look at Curiosity Stream's 'Building The James Webb Telescope.'
