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.
Space travel is growing rapidly, and one billionaire businessman has purchased three SpaceX flights in order to push the industry forward. The Polaris Dawn, the first of three flights, will launch later this year, and its crew will conduct the first commercial spacewalk after they've reached the highest orbit in over 50 years. Jared Isaacman, Polaris Program Mission Commander and Founder & CEO of Shift4, joins Closing Bell to discuss the Polaris program's mission, when the first launch will happen and what it will entail, balancing his business with space exploration efforts, charitable efforts with St. Jude Children's Research Hospital, and more.
The most recent quarterly report from American Clean Power reveals the U.S. surpassed more than 200 gigawatts of total operating utility-scale clean power capacity in 2021. While it is a great milestone, significant policy issues have continued to slow growth for the industry and threaten our country's ability to meet emissions goals. John Hensley, VP for Research and Analytics at American Clean Power, joined Cheddar News to discuss more.
Cann, a cannabis-infused beverage company, announced today a $27 million Series A funding round from existing investors like Imaginary Ventures and a roster of new celebrity investors including Nina Dobrev, Adam Devine, Zoey Deutch, Jordan Cooper, Sara Foster, and Rosario Dawson. Cann is also announcing its first international expansion with the brand's launch in Canada. Jake Bullock, co-founder and CEO of Cann, joins Cheddar News' Closing Bell to discuss.
By 2050, nuclear power share of total energy consumption will dip to just 3.7% down from the already measly 4.5% it is today, according to the U. S. Energy Information Administration. However, a group of world powers including the U.S. and Japan is looking to reverse the trend. John Kotek, SVP of Policy Development and Public Affairs at the Nuclear Energy Institute, joined Cheddar News to discuss.
Scientists say the fossil of a 170-million-year-old pterosaur, billed as the world’s best-preserved skeleton of the prehistoric winged reptile, has been found on the Isle of Skye in Scotland.
Equip is a virtual treatment platform for eating disorders, and recently raised $58 million in a Series B round led by The Chernin Group. The company aims to revolutionize treatment for eating disorders by delivering virtual care teams and clinical expertise directly to families' homes. Equip says the need for its platform has only been exacerbated by the COVID-19 pandemic. The National Eating Disorder Association's helpline has had a 107% increase in contacts since the start of the pandemic. Kristina Saffran, CEO and co-founder of Equip, joins Cheddar News' Closing Bell to discuss.
Tonga's main internet connection to the rest of the world has finally been restored more than five weeks after a huge volcanic eruption and tsunami severed a crucial undersea cable.
Hank the Tank strikes again. The 500-pound black bear that has damaged more than 30 properties around Lake Tahoe last week broke into yet another home in its endless quest for a quick meal.
