The Centers for Disease Control and Prevention has approved a new Respiratory Syncytial Virus (RSV) shot for infants younger than 8 months, which may hit the market very soon.
“RSV is a serious illness that affects a lot of children, so this is important,” said Jill McCabe, medical director of the Pediatric Emergency Department at Inova Loudoun Hospital. “In the United States every year, there are 50-80,000 children admitted the hospital with RSV.”
McCabe was talking about Beyfortus, a new monoclonal antibody shot, which could be effective in curbing the numbers of young children impacted by RSV.
Generically called Nirsevimab, McCabe says Beyfortus is between 70-80% effective at preventing RSV, according to studies done prior to the CDC’s approval on Aug. 3.
Beyfortus was also recommended by the FDA in mid-July this year.
McCabe, who has worked in pediatrics for more than 30 years, says RSV can be a very serious health issue for infants. In recent years, RSV surges have brought childrens’ hospital systems across the country to — and beyond — capacity.
“An effective vaccine for RSV has been hard to come by,” McCabe explained. “It has eluded our technology and ability to prevent RSV.”
Beyfortus isn’t a vaccine. It’s a monoclonal antibody shot, which is different from a vaccine in that it delivers antibodies right to the system, rather than activating the immune system to create its own antibodies by injecting a person with a virus directly, as a traditional vaccine would.
“Beyfortus did a great job at preventing infection, particularly severe infection that require hospitalization,” Dr. McCabe said.
She says there are other RSV shots on the market already, namely the monoclonal antibody shot Synagis, which she says has been in use for around 20 years.
And while Beyfortus is similar, McCabe says there’s one key difference.
“It stays in your system longer,” she said. “Instead of having to get a monthly injection, you get one injection, and it prevents RSV for five months.”
“This antibody has a longer half-life than most monoclonal antibodies. That’s why it can last longer,” she went on.
“So far, from the studies, we don’t see any downside,” McCabe said. “The only real adverse effect has been a local reaction, like a small rash or redness, at the injection site, but that will go away quickly.”
She says the new drug has gone through the normal rigorous approval process from the CDC and is expected to arrive on the market after official recommendations by presiding U.S. health institutions.
“Once that recommendation occurs, any child under the age of eight months will be able to get that injection,” McCabe explained, adding that recommendations will likely come as soon as the weather changes and RSV season begins.
McCabe says she’s spoken with pharmaceutical representatives told her hospitals may even consider giving Beyfortus to babies right when they’re born — if they’re born during RSV season.
Children with certain conditions, such as lung disease, cystic fibrosis, to name a couple, will be eligible to get this shot in their second year of life as well, she said.
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