Georgina Peacock vividly remembers a night when she admitted 20 babies, all struggling to breathe, into the hospital where she was doing her pediatric medical training. The illness that was robbing them of breath? Respiratory syncytial virus, or RSV.
Peacock and many others who are responsible for the care of the country’s youngest children have been moving heaven and earth for the past year and a bit, to make experiences like that a thing of the past.
They are trying to flatten the myriad hurdles that impede delivery of two new and expensive tools that, it’s believed, will change the way families of young children view RSV season and substantially lessen the load this virus places on hospitals when it is making its rounds.
One of the tools is a vaccine, made by Pfizer, that when given late in pregnancy generates antibodies that pass to the fetus. The other is an injection of antibodies — sold under the brand name Beyfortus, known by its scientific name nirsevimab — given to infants before their first RSV season, and a few high-risk babies going into their second RSV season as well. Those include babies born prematurely, or who have chronic lung disease, severe cystic fibrosis, or who are severely immunocompromised, and children who are American Indian or Alaska Native, who typically see higher rates of severe RSV.
“Anyone who works in the pediatric field understands that if we can immunize children against RSV, whether it’s through maternal vaccination or through nirsevimab, that’s really going to be life-changing as far as admissions to the hospital,” Peacock, director of the immunization services division in the Centers for Disease Control and Prevention’s National Center on Immunization and Respiratory Diseases, told STAT in a recent interview.
The good news is that many people who work in this field believe this year’s rollout of the new medical tools will run a lot smoother than last year’s rocky debut outing. They warned, though, that some hurdles will remain.
“I expect it will be better. I can’t say how much better,” said Sean O’Leary, professor of pediatrics at the University of Colorado School of Medicine, and a pediatric infectious diseases specialist at Children’s Hospital Colorado.
To their credit, the people who raced to put these products into use last fall managed to protect about half of the babies in the U.S. under the age of 8 months — the target cohort for this protection.
Still, there were plenty of frustrated parents whose babies were unprotected because the maternal vaccine was approved too late and because Beyfortus was in short supply. AstraZeneca and Sanofi, which make and market Beyfortus, did not anticipate the extent of the demand in the U.S. That has changed this year; Sanofi said recently there is enough product “for every eligible baby” here.
Even with more lead time and enough doses for all, getting these tools to those who need them — a process that includes birthing hospitals, pediatricians, obstetricians, and pharmacies — is challenging. Some work-arounds have been found. Some rules have been adapted. But the work is ongoing.
“Everybody wants this to happen,” said Nancy Foster, vice president of quality and safety policy at the American Hospitals Association, which has been coordinating efforts with its members to increase the number of birthing hospitals that can provide Beyfortus at birth. “I think for a number of reasons, it’s not going to be perfect” this year, she said. “Will there be more infants … inoculated? Yes, absolutely.”
The bug
RSV is a common virus that causes cold-like symptoms; it infects people at any age. But while most adults would probably write off an RSV infection as just a nasty cold, the illness triggered in older adults and babies is typically more severe. That is particularly true in young babies, whose lungs are still developing. RSV is the leading cause of hospitalization of infants in the United States. The CDC estimates that every year, between 58,000 and 80,000 children under the age of 5 are hospitalized due to RSV.
Spread of the virus is seasonal, with activity often picking up in the fall after kids go back to school. Activity usually peaks in December and January. (In 2021 and 2022, RSV circulation started earlier than normal; it, like other respiratory pathogens, seemed to have been knocked off schedule by the Covid-19 pandemic.)
Until last year, there was nothing that could be done to protect against RSV infection, despite decades of research. Then over the course of the spring and summer, two vaccines for older adults, one for pregnant people, and Beyfortus, which is effectively a shot of antibodies to protect babies against RSV at a time when their immune systems haven’t yet had a chance to develop its own, were all approved by the Food and Drug Administration and recommended for use by the CDC.
The tools: When and how they should be used
Everyone in the pediatric care sphere is excited about finally having some armor with which to shield infants against RSV. But that protection is relatively short-lived. It’s thought the maternal vaccine protects babies for about six months and the antibody shot for at least five months. That means the timing of delivery of these injections is critical.
The maternal vaccine can only be given between weeks 32 and 36 of gestation, to people who will reach that point of their pregnancy in September through the end of January. And at this point, it can only be given once. That may change, but for now a person who received the RSV vaccine during one pregnancy cannot get it for a later one. The next baby would need to be protected using the antibody injection.
Because of the duration of protection, babies whose parents opt to go the antibody injection route and who are born during or in the lead-up to RSV season should get Beyfortus at birth or at least before the baby goes home. This covers infants born between October and March.
Peacock said it would be “a missed opportunity” if an infant born in RSV season leaves the hospital without getting the shot. “They may go home and there’s another child at home that has RSV and so they come into contact with RSV before they go back to their pediatrician … where they can get the immunization,” she said. Foster agreed, saying the AHA agrees that whenever possible, birthing hospitals should be giving this shot to babies born during RSV season.
Babies born in the off-season — the spring and summer — should get a shot in the early autumn, as RSV season approaches. That means any time now. For those children, a pediatrician’s office will be the place they get this shot. That is also true for babies born in the RSV season who were either not born in a birthing hospital or who were born in one that does not deliver nirsevimab.
The tools: Their costs and what that means for how they’re deployed
It’s expected these products will be cost-saving, if they keep babies out of hospitals. But in a world used to a $12 vaccine to protect babies against hepatitis B or a $24 flu shot, the prices of these products are eye-watering.
The maternal vaccine costs $295 plus an administration fee. For pregnant people without health insurance, that’s a lot, said Brenna Hughes, who helps advise the American College of Obstetricians and Gynecologists on issues related to infectious diseases. “It’s really outside of the range of affordability for people who are uninsured for the most part,” said Hughes, a maternal fetal medicine physician at Duke Health in Durham, N.C.
Last year about 17.8% of eligible pregnant people got the Pfizer maternal vaccine. “Obviously, we would like much better coverage than that this year,” Hughes said.
Some are given by obstetrical practices that have made the commitment to stock the expensive vaccine. But more than half of the pregnant people who got the shot last year received it at a pharmacy, with a prescription from an obstetrician or gynecologist. And that may not change much over time.
“They’re not pediatricians. They don’t have that experience of storing and handling vaccines, of interpreting [CDC] recommendations,’’ said Claire Hannan, executive director of the Association of Immunization Managers. “It’s one thing for them to recommend vaccination, which we hope they are doing and being vigilant about. But it’s another to be a provider.”
(Delivery in pharmacies occasionally led to an unexpected problem last season. The maternal vaccine is the same product — and is sold under the same name — as Pfizer’s RSV vaccine for older people, Abrysvo. In a few cases, pharmacies gave pregnant people GSK’s RSV vaccine for older people, Arexvy, by mistake. That product is not licensed for use in pregnant people. Another problem that occurred on occasion was that babies born to pregnant people who had been immunized got Beyfortus anyway. Babies don’t need both and, given the costs, doubling up of these products shouldn’t occur, the CDC has said.)
Beyfortus is costlier still, priced at nearly $520 for babies going into their first RSV season. (For high-risk children going into their second RSV season, the cost is double that, nearly $1,040.) For pediatricians who buy vaccines in advance and get paid after they deliver doses, that cost can be almost crippling. Joseph Domachowske, a professor of pediatric infectious diseases at SUNY Upstate Medical University in Syracuse, N.Y., said last year he heard “a lot of pushback from our regional large pediatric offices, saying they just can’t afford what it will cost to bring in the doses that they’re going to need for all of their patients.”
O’Leary heard the same. “This product is so expensive for some practices it’s changing the way they do their finances because to cover their birth cohort, they have to pay so much up front they may have to take out loans to be able to do that,” he said.
It’s not less onerous for birthing hospitals, which typically get paid a set fee for a standard delivery set out in a contract. The AHA’s Foster said some hospitals have managed to cut side deals with some insurers to get extra compensation for the Beyfortus doses they deliver, but some insurers are refusing to discuss amending existing contracts.
Complicating things further is the fact that birthing hospitals aren’t the point of delivery of Beyfortus for babies born in the off-season. “Do you have a December [delivery] price and a June price?” Foster asked. “It requires everybody to get more imaginative about how to figure this out and what the right answer is.”
About half of the country’s babies are eligible for a CDC-run program called Vaccines for Children, which covers the cost of vaccines and vaccination for uninsured and under-insured children. The program is absorbing the cost of Beyfortus for VFC-eligible babies; Sanofi charges VFC $395 per dose.
Historically most birthing hospitals haven’t been enrolled in the VFC program, because they do not administer most childhood vaccines. (The exception has been the aforementioned hepatitis vaccine, which is given at birth. Its low price has meant most hospitals have just absorbed that cost themselves.) To give Beyfortus, they need to be in the program.
The CDC has seen a 24% increase in the number of birthing hospitals that are enrolled in VFC. Foster said the AHA continues to work with members and the CDC to make that process easier for birthing hospitals.
The prognosis
Sanofi has been taking orders for Beyfortus for months, offering birthing hospitals and pediatricians buying doses for the private market — in other words, not paid for by VFC — a 2% discount on doses ordered in July and August. Hannan, from the Association of Immunization Managers, said it looks like there should be steady supply throughout the season, though she worries it may not be equitably distributed.
CDC’s Peacock was trying to be realistic, noting that whenever a new vaccine comes on the market — and the CDC is treating Beyfortus as if it is a vaccine — it can take about five years for it to be fully integrated into the delivery systems.
“I’m hopeful that it won’t take five years to get there. Even with the challenges we had last year, we had [Beyfortus] coverage around 40%, which is really quite remarkable given the shortages and challenges with having a completely new type of product that we were delivering to children,” she said.
Despite the potential for lingering challenges, Domachowske, from SUNY Upstate Medical University, is hopeful the societal benefit of protecting babies from RSV will soon be apparent. “It’s working,” he said, pointing to a study the CDC published in early March that showed the effectiveness of Beyfortus in preventing RSV hospitalization in infants was 90% from October 2023 to February 2024. “We just need to improve our distribution and make sure we increase the number of babies that are eligible who are getting it.”
