First RSV antibody treatment to protect all infants approved in the U.S.
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Federal regulators on Monday approved a shot to protect healthy babies and some vulnerable toddlers against the respiratory ailment RSV, the leading cause of hospitalization among young children in the United States. Wp Get the full experience. Choose your plan ArrowRight 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.
Beyfortus, developed by Sanofi and AstraZeneca, is not the first preventive antibody treatment for RSV. But its approval marks the first time protection will be offered broadly to all healthy babies. The majority of children hospitalized for RSV were previously healthy, with no known risk factors, but the earlier generation of monthly shots were reserved for high-risk preemies or babies with heart or lung conditions.
In a large clinical trial, a single shot of Beyfortus was shown to be safe and effective in preventing babies from developing illness that required medical attention or hospitalization.
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“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,” John Farley, director of the office of infectious diseases in the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.
Beyfortus is part of a long-sought revolution in RSV prevention, which got a bump in public awareness after last year’s harrowing respiratory virus season. RSV surged earlier than usual, causing pediatric wards at hospitals to fill up at alarming rates.
But Sean O’Leary, a pediatric infectious-disease specialist at Children’s Hospital Colorado, said he expected logistical, educational and possible financial hurdles that could delay the drug’s rollout before this year’s winter respiratory virus season.
While the shot protects much like a vaccine, it is technically a drug, and there may be a learning curve for doctors, as well as parents, on integrating it into care. There are also questions about whether it will be immediately covered by insurers. Under the Affordable Care Act, preventive care has to be covered within a year of a product being recommended, so there could be a patchwork of coverage in the short term.
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“It’s hard to predict,” O’Leary said. “I’d love it if we could get high uptake in the first season, because it would prevent a lot of hospitalizations, but I’m not all that hopeful.”
No pricing information is available yet on Beyfortus, which will be offered before this year’s respiratory season. In a statement, Sanofi said it expected the product to be priced similarly to a new pediatric vaccine series and would share pricing information closer to the RSV season.
Most people experience RSV as a nuisance cold and are infected multiple times over their lives, but the virus can wreak havoc on young children’s tiny airways, leading to 58,000 hospitalizations of children younger than 5, and a few hundred deaths, each year. It is also estimated to kill as many as 10,000 adults 65 and older each year in the United States.
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Last year, at the RSV season’s early peak in November, children under 5 were hospitalized at twice the rate of previous season peaks, according to surveillance data from the Centers for Disease Control and Prevention.
A renaissance for RSV prevention
This year marks a turning point in progress against RSV for the most vulnerable age groups after decades of failures.
Two vaccines for adults 60 and older, made by Pfizer and GSK, were recently approved and will be on offer during the fall vaccination season, which will now include flu, coronavirus and RSV shots for older adults. A vaccine developed by Pfizer that is designed to be given during pregnancy to protect newborns is also under consideration by the FDA, with a decision expected by late August. That product offers protection similar to Beyfortus.
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David Hutton, a professor of global health at the University of Michigan School of Public Health, modeled the costs and benefits of Beyfortus and said it is clearly cost effective for high-risk babies. But when using $500 as a placeholder price per shot, based on assumptions about what the companies will decide, he said health economists will probably debate whether it delivers enough value to be used in all infants.
“It is kind of in a gray zone, where people will debate about whether it’s cost effective or not,” Hutton said.
Advisers to the CDC will make recommendations on how the shot should be integrated into health care. It provides protection similar to that of the RSV vaccine given during pregnancy, so if that product is also approved, as is expected, it may create some competition, Hutton said.
A monthly monoclonal antibody called Synagis was approved in 1998, but it requires five shots over a season, it carries a list price of more than $1,000 a shot, and its use is restricted to high-risk infants. O’Leary estimated that about 2 percent of babies born each year are eligible for those shots, and only about half get them.
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Source: The Washington Post
