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.
Bamboo-based toilet paper company Cloud Paper raised $5 million in a recent funding round. Its product is a bamboo-based alternative to traditional toilet paper made from trees, and its mission is to end the deforestation caused by traditional paper products. Cloud Paper says the raise will allow it to make significant investments in its supply chain, product development, and hiring. Ryan Fritsch, a co-founder of Cloud Paper, joined Cheddar News' Closing Bell to discuss.
Space tourism company World View plans to launch its first commercial flights in early 2024, with voyages to take off from iconic locations around the world like the Grand Canyon — but seemingly at a flexible price point. Dale Hipsh, president of tourism and exploration at World View, joined Cheddar to discuss what a trip to the stratosphere would look like with his company and its much less expensive take on space travel. "Our technology allows us to be more democratic, to offer more opportunities for people to experience near space, and that overview effect," he said. "So we're really thrilled to be bringing it to market."
A recent NOAA report found America's coastline could experience a century's worth of sea rise in just 30 years. By 2050, water on the U.S. coast will be 10-12 inches higher, causing major eastern cities to be hit regularly with floods, even on sunny days. Gary Mitchum, professor of physical oceanography at the University of South Florida, joins Cheddar News to discuss.
The Biden administration is launching a new task force to promote the use of 'cleaner' construction materials with lower life cycle emissions. This comes as the White House works to speed up government purchases of greener products. Sweta Chakraborty, climate change expert and U.S. president of "We Don't Have Time," joins Cheddar News to discuss.
Stephen Gardner, director at ETF Managers Group, explains why investors shouldn't be rushing to sell vaccine stocks like Moderna or BioNTech even as the spread of COVID-19 slows down.
On this episode of Cheddar Innovates: Evolution Devices CEO breaks down how the Evowalk wearable device can help those with walking impairments; Cresilon CEO explains how he's created a plant-based gel to easily treat wounds in both humans and animals; A look at Curiosity Stream's 'The Colorado Problem.'
Pier Mantovani, Founder and CEO of Evolution Devices, joins Cheddar Innovates to discuss how the Evowalk wearable device can help those with walking impairments, and how remote physical therapy is becoming a reality.
Joe Landolina, CEO and Co-Founder of Cresilon, joins Cheddar Innovates to discuss how he's created a plant-based gel to easily treat wounds in both humans and animals.
A new analysis reveals that for more than two decades, the West has been the driest it has ever been since 800 A.D. The drought which began in 2000 has brought more devastating wildfires and draining water reserves well below healthy levels. Climate Scientists and Adjunct Associate Research Scientist at Lamont Doherty Earth Observatory at Columbia University,Benjamin Cook, joined Cheddar to discuss more.
