‘A huge win for families and kids’: Reducing babies’ RSV risk from two new angles

Parents will soon have new ways to protect babies from getting dangerously ill from respiratory syncytial virus, or RSV. “This is a huge win for families and kids,” said Stephen Thacker, M.D. He specializes in treating infectious diseases at MUSC Children’s Health.

He’s pleased that there are now two additional options for RSV protection for babies. One involves a vaccine just approved by the Food and Drug Administration for pregnant women called Abrysvo. The other is a medication for babies called Beyfortus. There was already another drug called Synagis, but it’s only for children 2 years and under at high risk of severe RSV.

The vaccine and drugs all take aim at an illness that spreads easily through coughing or sneezing.“It's one of the leading causes for hospitalization of young pediatric patients,” Thacker said.

Babies are especially susceptible to severe RSV because of their tiny airways, reliance on breathing through the nose and immature immune systems. Their symptoms can become very uncomfortable, and in some cases, life-threatening.

 

“They can get a fever. Young children also get a lot of secretions that are very hard to clear. It leads to coughing and respiratory distress in its worst form. They have to have something help them breathe, whether that be suctioning, extra oxygen, or in severe cases, intubation.” Intubation involves a tube that goes into the airway to support breathing.

“Additionally, as young children have trouble breathing, it makes it really hard to effectively feed them and help them stay hydrated. So we struggle with kids becoming dehydrated and needing to be hospitalized for that concern,” Thacker said.

Most kids will have had RSV by the time they’re 2. It usually causes mild illness. But a small number will get sick enough to end up in the hospital. When they do, it can be heart-wrenching, as the family of a 7-month-old Mount Pleasant baby discovered last year.

Abrysvo

So prevention is critical, Thacker said. One form of protection, the Pfizer vaccine for pregnant women, causes the body to produce antibodies that transfer to the baby. “It’s based on the successful vaccine for those of advanced age against RSV,” Thacker said, referring to shots for people 60 and up who are also considered at higher risk of getting seriously sick from the virus. “We use this same strategy of vaccinating mothers to protect infants from pertussis.”

The FDA approved Abrysvo this week for women who are 32 to 36 weeks pregnant. Research found Abrysvo reduced the risk of severe lower respiratory tract disease caused by RSV by 82% during the babies’ first 3 months and about 70% in 6-month-olds born to women who got the vaccine versus babies born to women who got a placebo.

The most common side effects in women who got the vaccine were pain where they got the shot, headache, muscle pain and nausea.

An advisory committee for the Centers for Disease Control and Prevention still needs to weigh in on the vaccine. Pfizer expects that to happen by October, and the vaccine to go on the market after that.

Beyfortus

Also becoming available soon: Beyfortus, an antibody that the American Academy of Pediatrics says protects against serious illness from RSV. Thacker described how it works.“It's a monoclonal antibody that protects children, reducing the chance that they might need to see a doctor by 75%. This is important because it is that first RSV season of a child’s life where, if they get infected, they can have their most severe disease.”

The antibody helps the immune system fight back against RSV. The FDA said clinical trials found Beyfortus, made by AstraZeneca, was safe and effective. Side effects may include a rash and a reaction where the medication is injected into the baby.

 

Beyfortus arrives after an overwhelming 2022 RSV season. “2022 was such a rough season because we had two years of kids being exposed to their first RSV season all at once. We’d just pulled back on some of the masking guidance. We brought kids back into schools - as we should - and we had an increased number of at-risk young children seeing RSV for the first time. This combination led to a much higher rate of RSV disease, earlier in the season, compared to what we've experienced,” Thacker said.

“I'm hopeful that we won't have that same experience moving forward. Certainly, this product being available will also help reduce the frequency and severity of RSV in our community.”

He said the medication should come out this fall. “The challenge, many of us expect, is that there may not be enough supply to meet the demand for the indication. Because the indication is really all infants younger than eight months in their first RSV season. That’s a lot of little bodies to get this medicine into, to protect them.”

That means doctors will have to prioritize. “During this first RSV season where this is available, health care systems, and many clinics are going to have to create strategies on really who can benefit most from this product if it's not widely available.”

He said the goal is to eventually make sure that Beyfortus is available to all babies. “The nice thing the CDC’s Advisory Committee on Immunization Practices did is that they recommended this be part of what's called our Vaccines for Children program. That's essentially our tax dollars at work, making an important statement that no matter who you are, no matter whether you have the funds to pay for it, childhood vaccinations are important, and you should be provided with them.”

RSV isn’t going away, Thacker said. But the new tools should reduce its impact. “We'll still have children that are challenged by other respiratory viruses, including flu and COVID-19, for which we have vaccines as well, but the volume will be less. I am hopeful we'll get to a point where we no longer have to worry about emergency departments and pediatric hospitals being  overwhelmed with the volume of patients that come in during our flu and RSV seasons.”