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By Kate Gawlik
Pictured above: Lucy Eager, a former Edward Hospital NICU preemie and now a healthy 7-year-old, did not qualify for a Synagis treatment to protect against RSV when she went home from the NICU. She acquired RSV soon after discharge and was hospitalized for 80 days with many complications.
Lucy Eager, born at 31 weeks, was small for her gestation, at 2 pounds 3 ounces. She spent 87 days in the Edward Hospital Newborn Intensive Care Unit (NICU), part of NorthShore – Edward-Elmhurst Health.
About 1month after discharge, Lucy had nasal congestion with a cough that progressed into respiratory distress. The diagnosis was respiratory syncytial virus (RSV) and the result was being hospitalized for another 80 days in a pediatric hospital because of many resulting complications.
Lucy did not qualify for Synagis (palivizumab), a monoclonal antibody therapy that protects against severe RSV infections. Neonatologists recommend Synagis for preemies who are discharged from the NICU during RSV season, which runs from roughly November through March. The qualifications for Synagis — which determine insurance coverage — are announced annually but typically include all infants born less than 29 weeks; additional criteria may include chronic lung disease, structural airway abnormalities and some neuromuscular disorders.
Despite efforts by pharmacists, neonatologists and pediatricians to get Lucy an initial Synagis therapy because of her low birth weight and long NICU stay, she was denied coverage. Lucy’s parents, Chris and Mandy, made the difficult decision not to pay the out-of-pocket cost of giving Synagis to Lucy, with a price tag around more than $1,000 per injection (depending on the month when treatment begins and qualifications, a monthly series of three to five shots is recommended).
Fast forward seven years, and stories like Lucy’s might become more rare with the July 2023 U.S. Food and Drug Administration approval of Beyfortus (nirsevimab-alip), a monoclonal antibody therapy that will give all infants less than 8 months of age protection against RSV at the beginning of RSV season.
In August 2023, the FDA added another level of protection against RSV with the approval of Abrysvo, a single-dose vaccine for women who are 32-36 weeks pregnant during RSV season.
“The release of these treatments is something that the medical community has been waiting for to expand on the Synagis program and protect more babies from severe RSV infection,” says Bob Covert, M.D., an independent neonatologist and assistant medical director of the Edward Hospital NICU.
“We as a team are creating new hospital guidelines for RSV therapies. The coordination is very complicated because it includes all babies less than 8 months of age at the beginning of the RSV season, where it previously only involved preemies. We have to consider what treatments will be given in the hospital and what will be given in pediatrician offices, we are looking at insurance coverage, and we are eagerly waiting to find out when each of these therapies will actually be available, which may not be immediate.”
What is RSV?
For many, RSV presents with cold-like symptoms (nasal congestion, sneezing, coughing, fever and decreased appetite) for about two weeks. Antiviral medications do not reduce the intensity of symptoms or the length of the infection, so they are not recommended. Like all colds, symptoms should be managed with acetaminophen or ibuprofen for a fever, along with fluids and rest.
The Center for Disease Control and Prevention (CDC) reports most children will have RSV by the time they are 2. It is spread through droplets when a person infected with RSV sneezes or coughs, as well as via close contact — like kissing a baby’s face — and touching surfaces contaminated with RSV and then touching your face.
In some cases, for infants and the elderly, RSV can be more serious than a cold, leading to bronchiolitis and pneumonia. Hospitalization is most common among infants less than 6 months of age, and the rate is around 1-3% of all infant RSV cases. The 2022-23 RSV season surged earlier than typical with additional hospitalizations beyond the norm, putting strain on pediatric departments, urgent care centers and medical personnel.
What can be done to prevent RSV?
Avoiding RSV starts with decreasing the spread by staying home when sick, covering coughs and sneezes, and frequent handwashing. If someone has RSV, it is recommended to increase the rate of disinfecting surfaces and decrease close contact with that person.
In addition to these common recommendations, the new treatments give added protection. Nirsevimab, a long-acting monoclonal antibody-based injection, has been approved by the FDA for infants less than 24 months. The treatment will be approved for infants at 8 months of age or less at the beginning of the RSV season. Nirsevimab does not treat RSV and is not given if someone tests positive for RSV. The monoclonal antibody is actually directed against the binding protein of the virus to prevent the infection; it is not effective in treating an already existing infection.
Another prevention option is for pregnant women to receive Abrysvo at 32-36 weeks’ gestation, passing RSV antibody immunization to the baby. This vaccine is recommended for pregnancies with expected deliveries during RSV season. It works as a polyclonal antibody response, which should be more resilient to mutations than a monoclonal antibody. When moms receive this vaccine at least 2-4 weeks before delivery, babies most likely do not need additional Nirsevimab therapy.
A second Nirsevimab dose, however, is recommended for high-risk infants who are 8-19 months during their second RSV season. Babies who might need this second round include preemies with chronic lung disease, as well as infants with diseases like cystic fibrosis or those who are immunocompromised. The CDC also recommends that American Indians and Alaska Native children receive a second dose.
Synagis will remain a treatment for preemies going home from the NICU during RSV season.
What should expectant parents do?
When navigating options, talk to both your obstetrician and pediatrician about the various treatments. The timing of the maternal vaccine or infant monoclonal antibody treatments during RSV season is vital to their effectiveness. Also review insurance coverage, costs and especially availability.
Edward Hospital staff has been reviewing research while planning and preparing for the release of Nirsevimab and Abrysvo. Until all the complexities are worked out, parents of term and near-term babies should discuss therapeutic options with their pediatricians.
The Eagers, including now 7-year-old, healthy Lucy, are encouraging the neonatologist team to keep fighting for the babies.
“This process is going to take time as we collect data, review our patients’ needs, and gather input from affiliated pediatricians and obstetricians,” Dr. Covert says. “The 2022-23 RSV season was unusual with high rates of infection and hospitalization. The FDA approvals give us more tools to keep infants healthy from severe RSV disease.”
The Division of Neonatology at Evanston Hospital provides family-centered neonatal care to over 500 premature and special needs infants who are admitted to the Infant Special Care Unit (ISCU) each year. Learn more.
Learn about pregnancy and baby services at NorthShore University HealthSystem.