Emily Bendt was in her third trimester when she first heard that the Centers for Disease Control and Prevention had approved a new vaccine for babies to protect them against respiratory syncytial virus (RSV).
On October 5, Bent held her newborn baby Willow on the couch of her home in Vancouver, Washington. She was excited to offer Willow a new treatment for babies called nirsevimab, which began shipping in September, but Bent, a pediatric home health nurse, couldn’t find it anywhere.
That morning, during Willow’s two-week checkup, Bent asked the pediatrician when Willow could be checked in. “She just shrugged and said, ‘Well, it’s coming, but we don’t know when,'” Bent said. “I don’t know why I feel like I have to chase people and still not get answers.”
Bent also searched online for clinics, pharmacies or government websites that offer nirsevimab, but found nothing.
Sanofi, the pharmaceutical company developing the drug with AstraZeneca, said demand for nirsevimab, sold under the brand name Beyfortus, had exceeded supply by mid-October.
In response, the CDC issued interim guidance on October 23 to help pediatricians allocate the limited supply of doses, recommending that they focus on infants at highest risk for complications from RSV: infants younger than 6 months of age and those with underlying medical conditions .
RSV is the leading cause of hospitalization in infants under 12 months of age, and it is estimated that 100-300 children under 5 years of age die from the disease each year in the United States.
Nirsevimab, a monoclonal antibody, is one of two new treatments launching this fall that could significantly reduce the risk of lung infections in babies.
Another option is the RSV vaccine made by Pfizer called Abrysvo. It is recommended first for adults 60 and older, then in September. 22 The CDC also approves its use in pregnant women to confer some immunity to the baby.
But this adult vaccine is only recommended during a relatively short period of pregnancy, between weeks 32 and 36, because of potential but unproven concerns that it may increase the rate of preterm birth. This may limit absorption during pregnancy.
By September when the vaccine is approved for use in pregnant women. On the 22nd, Emily Bendt gave birth. So for Willow and other babies like her, nirsevimab will be the only option to prevent RSV during this respiratory virus season.
Nirsevimab is approved for use in all infants younger than 8 months of age, as well as some older infants and young children considered to be at higher risk of severe disease from RSV. The American Academy of Pediatrics recommends that every infant whose mother was not vaccinated against RSV during pregnancy should receive nirsevimab during the first week of life.
The CDC is now requiring prenatal care providers to warn patients of potential nirelumab supply shortages, in the hope that increased maternal vaccination rates will help ease the need for nirelumab.
Pediatricians say the high cost of nirsevimab and bureaucratic hurdles in the Medicaid childhood vaccine distribution system are slowing the distribution of nirsevimab. They fear these issues could put babies at risk of unnecessary hospitalization this winter.
In clinical trials, nirsevimab reduced RSV hospitalizations and doctor visits in infants by nearly 80%.
“Honestly, this is groundbreaking,” said Katie Schaaf, director of infectious diseases at Kaiser Permanente Northwest.
Nirsevimab is a monoclonal antibody treatment rather than a traditional vaccine. The passive immunity it confers lasts for approximately five months. This is enough time to get babies through their first RSV season, when their risk for complications is highest.
After babies get through their first winter, “their respiratory tracts and lungs develop,” Schaff said. “Therefore, being infected with RSV in childhood rather than in infancy may be less likely to develop severe complications such as difficulty breathing and requiring the use of a ventilator.”
Schaaf’s own daughter contracted RSV as an infant and required emergency room care and later developed asthma, a condition more common in children with severe RSV infections.
Keeping babies out of hospitals this winter could be a game-changer for health systems stretched by a “triple epidemic” of respiratory viruses (covid-19, influenza and respiratory syncytial virus).
Last year was the worst season in history for RSV. Measures states took to slow the spread of the coronavirus early in the pandemic, such as masking, also suppressed RSV infections for a time. But as infection control measures were lifted, more infants and young children were exposed to RSV for the first time at the same time.
In Oregon, the surge prompted then-Gov. Democrat Kate Brown declared a public health emergency and forced hospitals to increase pediatric intensive care unit capacity. Some hospitals are even sending patients out of state.
“The promise of nirsevimab is that this will never happen again,” said Ben Hoffman, professor of pediatrics at Oregon Health & Science University’s Doernbecher Children’s Hospital in Portland and president-elect of the American Academy of Pediatrics.
But this depends on the treatment’s availability and whether providers can effectively deliver it to newborns.
The American Academy of Pediatrics states that for infants who are not protected by maternal RSV vaccine at birth, the best time to receive nirsevimab is at birth, before the infant is fully exposed to RSV.
But babies like Willow who were born before nirsevimab became available need to get it from an outpatient clinic.
In addition to the first dose of hepatitis B vaccine, childhood vaccinations begin one month after birth and are administered in the pediatrician’s office, but the cost of nirumab may make this difficult.
At $499 per dose, it is the most expensive standard childhood shot, and insurance companies may not reimburse health care providers this year. This is a particular problem for small pediatric practices, which cannot afford to lose that much money on standard childhood vaccines.
“All of a sudden you have a new product that you’re supposed to offer to your entire birth cohort and you have to pay $500 that may or may not be repaid,” Sean said. It’s not feasible.” O’Leary is a pediatric infectious disease specialist at the University of Colorado School of Medicine.
Some insurance companies, but not all, have announced that they will cover nirsevimab immediately. Thanks to a quirk of the Affordable Care Act, commercial insurance plans can wait a year after a new treatment is approved before requiring coverage.
Sanofi announced it is offering doctors an “order now, pay later” option that will give them more time to work out reimbursement agreements.
A government program that provides free shots to about half of all children in the United States is structured in a way that makes it difficult to get nivolumab immediately after birth.
Vaccines for Children is a safety net program that provides vaccines to children on Medicaid, uninsured children, and Alaska Native and American Indian children.
Health care providers cannot bill Medicaid for vaccines like nirsevimab. Instead, they must register and join the VFC program. Through it, the federal government purchases vaccines from companies like Sanofi at a discount and then arranges for free shipment to VFC-registered providers, which are typically pediatric or safety-net clinics.
But most hospitals do not belong to VFC, which poses a problem.
Eddie Frothingham, a pediatrician at Mid-Valley Children’s Clinic in Albany, Ore., says: “Many of our newborns go home with loving, affectionate, loving siblings who are there when the child is born. Runny nose.” “The sooner we protect them, the better.”
Currently, only about 10% of delivery hospitals across the country have joined the VFC and can receive nirsevimab for free.
Until the debut of nirsevimab a few months ago, most hospitals had no strong incentive to participate in childhood vaccine programs because childhood vaccines other than hepatitis B are typically given to children in outpatient clinics by pediatricians.
VFCs can be onerous and bureaucratic, according to interviews with several Oregon hospitals and immunization experts. They say the program’s strict anti-fraud measures deter health care providers from participating.
Once registered, providers must track and store vaccines provided by the VFC separately from other vaccine supplies. People who administer vaccines to children must know what insurance the child has and record the dose of each injection in a state-run electronic records system.
Mimi Luther, Oregon’s immunization program manager, said it’s nearly impossible for most hospitals to comply with the rules.
“I look forward to the day when the federal government has the opportunity to modernize the system and make it easier for providers to register and stay registered,” she said.
In light of the shortage of nirsevimab, the CDC relaxed some program rules to allow providers to “borrow” up to five doses of VFC for infants covered by private insurance — as long as the doses are repaid within a month.
This is forcing some health systems to make difficult choices. Many people allow babies to leave the hospital without vaccinations, assuming they will receive them during their first pediatric clinic visit.
Frothingham said it also creates equity issues. Newborns whose parents do not have transportation or financial resources are more likely to miss their first pediatric appointment after birth.
Samaritan Health Services, part of Frothingham Health System, has decided to privately purchase a small amount of the vaccine to give at its hospitals to newborns labeled by doctors as high risk because of breathing problems or family poverty.
“It’s important to us that babies have access to this regardless of their economic or social status,” Frotingham said.
Across the country, many delivery hospitals are trying to participate in next year’s VFC program. But this fall, most people don’t have free nirsevimab on hand.
Most babies infected with RSV eventually recover, including those who require hospitalization to help with breathing. But it’s difficult to treat, and some babies die every year.
OHSU’s Hoffman lost infant patients to RSV during his decades-long medical career.
“It’s terrible to know that some children may be suffering because of delayed access or lack of access to products that could potentially save their lives,” said Hoffman. “There’s not a single pediatrician in this country who’s happy right now.”
This article comes from partners including OPB, NPR and KFF Health News. KFF Health News is a national newsroom specializing in in-depth journalism on health issues. To read the originally published article, Click here.