New medication means all infants should be inoculated against RSV: study

Not just infants with a history of underlying conditions or who’d been born prematurely but even healthy ones need to be inoculated against respiratory syncytial virus (RSV) as part of routine care, according to study in JAMA Network Open.

That point had been driven home last year by an RSV surge so intense that children’s hospitals ran short of supplies and the American Academy of Pediatrics pleaded for physicians in other specialties to come and help them the same way pediatricians helped during the worst of the COVID-19 pandemic.

All infants need to be protected from RSV, because most of those who needed intensive care last year were healthy babies, according to the analysis.

Last year’s run of RSV had been particularly intense because the mitigation efforts used to keep COVID-19 at bay during the 2020 to 2021 winter season also kept RSV in check but expanded the susceptible vulnerable population for the 2021 to 2022 winter season.

That all babies should be inoculated for RSV isn’t a new argument, Paul Offit, M.D., the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told Fierce Healthcare.

What is new is that the researchers note that palivizumab, a monoclonal antibody that targets the RSV F protein, had been the only such medication approved for use in the U.S. by the Food and Drug Administration, and only for high-risk infants. And the “significant cost” of palivizumab could prohibit its widespread use.

Paul Offit, M.D.
Paul Offit, M.D. (Children's Hospital of Philadelphia)

However, in July, the FDA approved the monoclonal antibody nirsevimab for vaccination against RSV, which should be cheaper for payers to cover partly because one dose lasts 150 days, whereas palivizumab must be given monthly. The Centers for Disease Control and Prevention (CDC) recommends which vaccinations should be given to infants and children.

“That’s one advantage with what the CDC did by putting it on the routine vaccination schedule for all infants,” Offit said. “They did this for the purpose of making sure that the private insurer would cover it because it’s a routine recommendation. That means in theory it will also be covered for the uninsured and the underinsured.”

In addition to nirsevimab, the FDA seems to be moving toward approval of Abrysvo, a vaccine for pregnant women that will allow their infants to ward off RSV.

In the JAMA Network Open study, researchers representing many universities and hospitals used data from 39 pediatric hospitals in the U.S. on 604 infants admitted for 24 hours or more to an intensive care unit because of laboratory-confirmed RSV infection. The data were collected between Oct. 17, 2022, and Dec. 16, 2022, during the height of last year’s RSV surge.

“Although having an underlying medical condition or history of prematurity is a factor associated with risk for severe RSV illness, most infants receiving ICU-level care were previously healthy and born at term,” the study said. “Younger and premature infants were at higher risk for intubation, but most intubated infants were born at term.”

The researchers looked at data for all infants up to one year old, but 70% of babies that had to be intubated were younger than three months and most of them had been healthy. Preventing acute RSV leading to hospitalization in infants might also alleviate long-term outcomes associated with such episodes including the risk of recurrent wheezing and/or asthma and even premature adult death.

“Let me put it this way,” said Offit. “Every year there are 1.5 million visits caused by this virus. There are roughly 500,000 emergency department visits. There are 60,000 to 80,000 hospitalizations. And between 100 and 300 deaths. RSV is the most common reason pediatric patients come to the hospital.”