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A highly anticipated new shot that can protect newborns from the ravages of respiratory syncytial virus may not be available to some families this season because of uncertainties about insurance coverage.

When the US Food and Drug Administration approved the antibody, nirsevimab, in July, pediatricians and parents were jubilant. RSV fills hospitals every winter with babies who are struggling to breathe. As many as 80,000 kids under the age of 5 are hospitalized annually in the United States with this infection, and up to 300 die, according to the US Centers for Disease Control and Prevention.

"Every pediatrician is jumping for joy that this preventative tool is available for newborns, because we see what happens when a healthy baby gets this terrible infection," said Dr. Sallie Permar, chair of the Department of Pediatrics at Weill Cornell Medicine and New York-Presbyterian Hospital.

The new shot, which goes by the brand name Beyfortus, slashed infants' risk of being hospitalized for RSV by 80% in clinical trials. It promised to be a game-changer for the youngest patients.

But on Wednesday, members of the American Academy of Pediatrics met with CDC Director Dr. Mandy Cohen for a more somber conversation. Many medical practices say they don't know how to pay for the shot and may not be able to get it this year. Hospitals too are struggling to figure out how to pay for it.

"We are so thrilled to have something available, but to then have it be so close but then still not getting it into arms, it's tragic," said Permar, who also works with the nonprofit Protect Their Future, which advocates for kids' access to vaccines.

RSV season is already underway, and doctors now acknowledge that Beyfortus may not be widely available this virus season.

"I think it's really challenging because for the first time in human history, we can prevent RSV in infants, but the ability to get those vaccines or those antibodies is going to be really tough this year," said Dr. Buddy Creech, a pediatrician at Vanderbilt University who is also president of the Pediatric Infectious Disease Society.

"We have this wonderful product that was approved in the 11th hour before RSV season, and now we're trying to roll it out for it to be maximally effective. It may take just a little bit more time."

Under the Affordable Care Act, most health insurance plans must cover the cost of immunizations like Beyfortus with no cost to patients. But because of a loophole in the law, insurers have a year to add new products to their plans, and it's not clear how fast they'll act or how much they'll cover.

In a rare move, the directors of the CDC and the Centers for Medicare and Medicaid Services sent a letter to insurance companies last week to spell out their legal requirements to cover three new immunizations for RSV — two designed to protect infants and one for adults over 60 — and stressed the importance of the shots.

Many insurers have expressed enthusiasm for the new RSV vaccines and say they understand their value: that they can keep people out of the hospital. Hospital care is much more expensive on an individual basis.

But the new immunizations are costly, and those costs can add up when they are intended for so many people.

Beyfortus isn't a traditional vaccine. It's a shot of long-acting antibodies that are designed to protect infants for about six months while they are most vulnerable to the virus. Like other antibody products, it is expensive: about $500 a dose.

Some doctors don't think they can afford to order it without knowing whether they'll recoup the costs.

"The issue is that this is much more expensive than any other product, and they don't know if they're going to get paid," said Dr. Sean O' Leary, chair of the American Academy of Pediatrics Committee on Infectious Diseases.

Pediatrics offices operate on slim financial margins. Vaccines are typically their second biggest expense behind the cost of staffing, said O'Leary, who is also a professor of pediatric infectious diseases at the University of Colorado Anschutz Medical Campus.

Beyfortus is recommended for every healthy newborn, and for some practices, that's a lot of babies to cover.

"You're easily getting into the hundreds of thousands of dollars for a medium-sized practice. That is just way too big of a financial risk if they don't know they're going to be paid back," O'Leary added.

O'Leary says the American Academy of Pediatrics and other advocates have been urging insurance companies to detail the specifics of coverage for Beyfortus, but so far, they haven't done so.

Although the Affordable Care Act protects people in most health plans from having to pay out of pocket for vaccines, it doesn't protect doctors from bearing some of the costs. Typically, pediatrics practices negotiate with insurance companies for reimbursement, and those rates may differ among providers.

O'Leary says that because practices don't know where the numbers will land, some have been reticent to take on the risk of ordering the shots.

"For example, here in Colorado, we've gotten assurances from our top four payers that they're going to cover it, but we have not seen dollar amounts yet. And just because they say they're going to cover it doesn't mean they're going to cover the whole price," he said.

Beyfortus is meant to be given as close to birth as possible, so ideally, newborns could get it in the hospital or birthing center where they are delivered. But hospitals typically get a lump sum from insurers to cover the cost of birth, and right now, the cost of Beyfortus hasn't been factored into that.

Creech says he's heard of hospitals that may try to get around this by giving babies the shot after they are "discharged" to an outpatient clinic or another room in the same facility.

O'Leary says he has heard that pediatricians are taking a variety of approaches to test the health coverage waters for Beyfortus. Some are ordering just a small number of doses to see how their payors reimburse it. Then they plan to renegotiate if they don't get enough money back. Others plan to offer it just to their high-risk infants, similar to the way an older shot, Synagis, was given.

"I did hear about one practice where there was so much demand from the families within the practice that they said 'OK, but you have to pay $500 up front, and we'll give it back if we get paid.' And they're getting lots of requests," O'Leary said.

Sanofi, one of the companies marketing Beyfortus, is also offering extended payment terms for doctors who order directly from the company, so they can order the shots now and pay the company back almost at the end of RSV season, a spokesperson said.

The company said that as of October 1, coverage is in place for more than 90% of infant lives nationwide.

Some health systems are planning to just assume the financial risk of giving Beyfortus until insurance coverage kicks in.

Permar, the chair of pediatrics at New York Presbyterian, said she and "a chorus of others" convinced their health system, which has 11 hospitals that serve children, to assume the financial risk to offer the shot this year.

"We're going to assume that all of this reimbursement is going to catch up," she said, "but we're going to have to take on some risk initially. And that's a hard pill to swallow when we think about health care reimbursements being so challenged."

O'Leary said that he expected the rollout to be rough but that it's actually going better than in anticipated in some respects because people are working so diligently to try to make it happen.

Creech, at Vanderbilt, agreed.

"So I think hospitals are going to be creative; pediatricians are going to be creative, But if the federal payors, the insurance carriers and the CDC can be similarly creative and flexible, then we're going to see a win for patients," he said.

There were moves months ago to try to ensure broader access to the antibody shot.

In August, the CDC acted quickly to add Beyfortus to its schedule of routine childhood immunizations, which will eventually trigger full insurance coverage. It also added it to the Vaccines for Children program, which gives no-cost vaccines to children who might not otherwise get them. About half of babies born in the United States each year are eligible for immunizations through that program.

Many pediatricians participate in Vaccines for Children, but only about 12% of hospitals do, because it has rules that can be onerous in certain settings.

In order to join the program, for example, providers have to agree to carry all vaccines that the program covers. They must also agree to match the vaccines the government gives them with a stock of shots that they buy themselves, and they can't mix the inventory. This rule was meant to prevent vaccines paid for by the government from going to patients whose insurance would cover the cost.

On Tuesday, the CDC relaxed some of those rules so states can allow hospitals and birthing centers to carry a more limited selection of immunizations, including just the ones that are given to newborns: Beyfortus and hepatitis B vaccines.

The CDC also said doctors who serve only Medicaid-eligible patients don't have to buy a separate store of vaccines for privately insured kids. And it has dropped the minimum orders for Beyfortus so states can ship out small numbers of doses in areas where demand for the shots may be low.

And doctors can now borrow government doses of Beyfortus to give to paying patients, as long as they replenish the supply within a month or after five doses are borrowed.

These flexibilities will help, O'Leary said, but they won't eliminate all the barriers that are preventing doctors and hospitals from offering Beyfortus.

In new guidelines about the Vaccines for Children program, the CDC said it recognizes that it may need to do more to help doctors get Beyfortus to their patients.

"CDC is continuing to explore operational policies that can help support these providers and will communicate any changes as soon as possible," the guidelines say.

For now, doctors are urging parents to be patient.

"It is such a big lift," Creech said. The goal is to immunize all babies younger than 8 months of age and children with certain risk factors who are younger than age 2, plus the millions of babies yet to be born this season. About 4 million babies are born in the US each year.

"That's a lot of manufacturing. That's a lot of distribution. A lot of figuring out who's going to pay for what and when," Creech said.

That answer doesn't sit well with Dr. Sharon Paige, a pediatric cardiologist who lives in the Bay Area. Paige is 37 weeks pregnant and has been hunting for any protection she can get for her baby, a boy who is due any day.

She just missed the window for the new vaccine for people who are pregnant, which is given between 32 and 36 weeks of gestation. The antibodies from that shot protect the baby through the first few months of life.

A few weeks ago, when she called her pediatrician and birthing hospital to ask about Beyfortus, she was told they didn't have it and didn't know whether they would get it.

"We know that last year, RSV just hit kids so hard, along with Covid and the flu. And so I just, again, it's another one of the head scratchers. Like, what is the holdup?" Paige said.

"It's scary because I know, unfortunately, from my experience on the pediatric wards that RSV can be really dangerous for little babies. It's really heartbreaking to watch a baby with RSV struggling to catch their breath with a breathing tube down their throat," she said.

Paige also has a 4-year-old in day care who wears a mask to school to protect her soon-to-arrive baby brother. Paige said she and her husband considered whether they might need to take her out of school for a while just to protect their newborn during the upcoming respiratory virus season but ultimately decided against it.

She says she's getting bombarded with ads on social media and elsewhere urging her to get the new RSV vaccines for her baby.

"When we hear from public health officials that we should be getting vaccinated … but then we can't actually go out and get that protection, even if we're willing to pay for it, It's just a confusing message, and it's frustrating," she said.

RSV Shot For Newborns Is Hard To Find Because Supply And Price Issues ...

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Emily Bendt cradles her two-week-old infant, Willow, at her home near Portland, OR in early October 2023. Bendt, a pediatric nurse, closely followed the recent approval of the RSV monoclonal antibody Nirsevimab but has been unable to find it for her daughter. Amelia Templeton/OPB hide caption

toggle caption Amelia Templeton/OPB

Amelia Templeton/OPB

Emily Bendt got excited when she first heard the Centers for Disease Control and Prevention had approved a new shot to protect infants from RSV.

That was back on August 3, when she was in the last trimester of pregnancy.

By October 5, she had given birth, and was cuddling with her new baby, Willow, on the couch at home in Vancouver, Washington.

This story was produced in partnership with KFF Health News.

But her excitement had turned into frustration. The new therapy, called Nirsevimab, had started shipping in September — but Bendt, a pediatric home health nurse, couldn't find it anywhere.

That very morning, at Willow's two-week check-up, Bendt had asked the pediatrician when Willow could get it. "She literally just shrugged and was like, well it's coming but we don't know when," Bendt says. "I don't know why I feel like I'm having to chase people down and still not get answers."

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Bendt searched online too, for clinics or pharmacies or government websites offering Nirsevimab — and found nothing.

By mid-October, demand for Nirsevimab had already outstripped supply, according to the pharmaceutical company Sanofi.

In response, the CDC issued interim guidance Monday to help pediatricians allocate the limited supply of doses, advising them to focus on the infants at highest risk of RSV complications: babies under 6 months old, and those with underlying medical conditions.

RSV is the leading reason babies under 12 months end up in the hospital, and an estimated 100-300 infants die from it in the U.S. Every year.

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Nirsevimab, a monoclonal antibody, is actually one of two new therapies available this fall that could dramatically reduce the risk of lung infections for infants.

The other option is a new RSV vaccine from Pfizer. It was first recommended for adults 60 and older, and then on September 22, the CDC approved its use in pregnant people, too, as a way to confer immunity on their infants.

But this adult vaccine is only recommended during a relatively short window in pregnancy, weeks 32 through 36, due to a potential but unproven concern it may increase preterm births. That might limit uptake of the vaccine during pregnancy.

The CDC is now asking prenatal care providers to warn their patients about the potential Nirsevimab supply shortages, with the hope that driving up the maternal vaccination rate could help ease the demand for Nirsevimab.

The powerful potential promise of Nirsevimab

Supply is not the only challenge facing Nirsevimab. Pediatricians say its high cost, as well as bureaucratic obstacles in Medicaid's vaccine distribution system for children, are also slowing down Nirsevimab dissemination. They fear these problems leave infants at risk - unnecessarily - of hospitalization this winter.

In clinical trials, Nirsevimab reduced RSV hospitalizations and health care visits in infants by almost 80%.

"This is groundbreaking, honestly," says Dr. Katie Sharff, chief of infectious disease for Kaiser Permanente Northwest.

Nirsevimab is a monoclonal antibody treatment, not a traditional vaccine. The passive immunity it confers lasts about five months. But that's long enough to get babies through their first RSV season, when they're at highest risk for complications.

After an infant's first winter, "their airways develop and their lungs develop," Sharff says. "So getting RSV later, as a child instead of as an infant, [means the child is] probably less likely to have severe complications of difficulty breathing, needing to be on a ventilator."

Sharff's own daughter had an RSV infection as an infant, needed care in the emergency department, and went on to develop asthma, a condition that's more common in children that had severe RSV infections.

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For health systems that have been worn down by the so-called "tripledemic" of respiratory viruses – Covid, flu and RSV – keeping infants out of the hospital this winter could be a game-changer.

U.S. Health system was hit hard last winter by pediatric RSV

Last year was a historically bad season for RSV.

Earlier in the pandemic, measures that states took to slow the spread of COVID-19, such as masking, depressed RSV infections for a while, too.

But as infection-control measures were rolled back, more babies and toddlers were exposed to RSV for the first time, at the same time. The virus came roaring back. Serious RSV cases requiring pediatric hospitalization soared during the winter of 2022-2023.

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In Oregon, the surge prompted Gov. Kate Brown to declare a public health emergency and forced local hospitals to add capacity to their pediatric ICUs. Some hospitals even had to send patients out of state.

"The promise of Nirsevimab is that should never, never happen again," says Dr. Ben Hoffman, professor of pediatrics at Oregon Health & Science University's Doernbecher Children's Hospital, and president-elect of the American Academy of Pediatrics.

Nirsevimab is approved for all infants up to 8 months old, and for some older babies and toddlers considered at higher risk due to RSV. The American Academy of Pediatrics recommends that every baby whose mother did not get the RSV vaccine while pregnant receive Nirsevimab in the first week of life.

Sponsor Message Where should newborns get the shot?

Except for the first dose of the hepatitis B vaccine, the standard childhood vaccines start being given one month after birth, in the pediatrician's office.

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Nirsevimab could be given in hospitals, before newborns go home. Or pediatricians could give it at a baby's first office visit, but that can occur two weeks after birth, or even later.

It's unclear what clinical location will ultimately become the standard place where infants receive this shot in the U.S., or even if the shot will become standard for newborns. (That depends on whether the maternal RSV vaccine becomes a standard part of pregnancy care in the U.S.)

But what is clear is that neither pediatricians nor hospitals have become the go-to source for Nirsevimab this year, leaving many parents confused about where to find the shot.

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Mid Valley Children's Clinic in Albany, Oregon, where 70 percent of the patients are eligible to get free vaccines through the Vaccines For Children program. But Samaritan Health, which runs the clinic, has opted to purchase additional doses of the RSV shot Nirsevimab without reimbursement so that the most vulnerable newborns can get the shot before they even head home from the hospital. Amelia Templeton/OPB hide caption

toggle caption Amelia Templeton/OPB

Amelia Templeton/OPB

One major issue is the initial price: at $495 per dose, it's the most expensive standard childhood shot. Many pediatricians have been reluctant to order it, unsure about whether they'll be reimbursed by insurers.

Because of a quirk in the Affordable Care Act, commercial insurance plans can wait up to a year before they are required to cover it.

"When all of a sudden you have a new product that you're supposed to give to your in entire birth cohort, and you've got to pay $500 that may or may not get paid back, that's just not financially viable, says Dr. Sean O'Leary, a pediatric infectious disease specialist at the University of Colorado School of Medicine.

Some insurers have announced they will cover Nirsevimab right away, but not all.

Sanofi has announced an order-now, pay later option for doctors, which would give them more time to work out reimbursement deals.

Could hospitals step in and help administer Nirsevimab earlier?

Even when cost is not an issue, problems remain. A government program that supplies free shots to about half of the children in the United States is structured in a way that makes it hard to give Nirsevimab to newborns right after birth.

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The program, 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 can't bill Medicaid for shots like Nirsevimab. Instead, they have to register and enroll in the VFC program. Through it, the federal government purchases shots from companies like Sanofi at a discount, and then arranges for them to be shipped for free to VFC-enrolled providers, which tend to be pediatric practices or safety-net clinics.

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But most hospitals aren't part of VFC, which presents a problem. Pediatricians say the fastest, fairest way to get Nirsevimab to as many families as possible, is to offer it just after birth, before families leave the hospital.

"Many of our newborns go home to caring, affectionate, loving siblings who are actively dripping snot at the time that the child is born," says Dr. Eddie Frothingham, a pediatrician with Mid Valley Children's Clinic in Albany, Oregon. "The sooner we can protect them, the better."

Right now, only about 10 percent of birthing hospitals nationwide are enrolled in VFC and can get Nirsevimab for free.

In Oregon, out of more than 40 hospitals that deliver babies, just one is enrolled in VFC.

Nirsevimab highlights problems with Vaccines for Children

Until Nirsevimab's debut a few months ago, most hospitals didn't have a strong incentive to participate in Vaccines for Children. The rest of the childhood vaccine series is typically given to kids by pediatricians, in outpatient clinics.

The VFC program can be burdensome and bureaucratic, according to interviews with several Oregon hospitals and immunization experts. The program's stringent anti-fraud measures discourage health care providers from enrolling, they say.

Once enrolled, providers have to track and store VFC-provided vaccines separately, apart from their other vaccine supplies. The person giving a pediatric shot has to know what insurance the child has, and account for each dose in a state-run electronic record system.

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Mimi Luther, the immunization program manager for the state of Oregon, says the rules are nearly impossible for most hospitals to follow.

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A refrigerator at Mid-Valley Children's Clinic in Albany, Oregon with supplies of government-funded vaccines for children on Medicaid. The pink "VFC" stickers help clinics follow stringent federal rules and ensure only eligible children get the "Vaccines for Children" shots. Amelia Templeton/OPB hide caption

toggle caption Amelia Templeton/OPB

Amelia Templeton/OPB

"I look forward to the day when the feds have the opportunity to modernize that system to make it easier for providers to enroll and stay enrolled," she says.

The CDC has relaxed some program rules in light of the shortage of Nirsevimab, allowing providers to "borrow" up to 5 VFC doses for infants covered by private insurance - so long as those doses are paid back within a month.

For now, Nirsevimab is reaching patients in various ways, and many infants aren't getting it as soon as recommended.

This has forced some hospital systems to make difficult choices. Many are allowing infants to leave the hospital without the shot, assuming they will get it at the first pediatric outpatient visit.

Frothingham says that also creates an equity problem. Newborns whose parents don't have transportation, or financial resources, are more likely to miss those first pediatric appointments after birth.

Samaritan Health Services, the health system Frothingham works for, has decided to privately purchase a small number of doses to offer in its hospitals, for newborns whom doctors flag as high risk, due to breathing problems or family poverty.

"It's important to us that infants be able to access this regardless of their financial or social circumstances," Frothingham says.

Nationwide, many birthing hospitals are trying to enroll in the VFC program for next year. But this fall, most hospitals won't have free Nirsevimab on hand.

Most babies who get RSV ultimately recover, including those who require hospitalization to help with their breathing. But it's challenging to treat, and it does kill an estimated 100-300 children every year.

In his decades in medicine, OHSU's Hoffman has lost infant patients to RSV.

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"Knowing that some kids may potentially suffer because of delayed access or absence of access to a product that could potentially save their lives is awful," Hoffman says. "No pediatrician in the country is happy right now."

This story comes from NPR's health reporting partnership with Oregon Public Broadcasting and KFF Health News.

Woman Tells Mom She Must Get This Vaccine To See Newborn Baby

A woman on Reddit has shared why she wants her hypochondriac mom to get the Tdap vaccine in order to see her granddaughter.

"I have a newborn and my parents live 2 states away and want to come visit to see her. They are very dysfunctional and my mom has a long history of having debilitating anxiety as well as being a hypochondriac and living her life based on fear. She thinks she's going to die if she takes any new or unknown medication or vaccine into her body," the woman began.

The woman shared that her baby's pediatrician advised that anyone who wants to be around the baby be vaccinated.

"My baby's pediatrician said anyone who is around my newborn should have the flu shot and whooping cough vaccines (whooping cough over 65, which is just the Tdap/tetanus vaccine). My mom got the flu shot already, which is shocking in itself that she actually went through with it since she's never had it before. Of course she is complaining to my sister about it and saying she feels horrible. She is having a meltdown about getting the tdap vaccine," the woman shared.

"My entire life all I've heard from her is 'the tetanus vaccine is the worst one, I couldn't lift my arm for 3 days after and was horrible when I got it years ago." She is now saying she "can't tolerate the tdap so she can't get it.' Mind you, she is saying all of this to my sister and won't say it to my face because she is non confrontational and has communication issues. I just heard about all this last night and have not had a chance to talk to her yet.I'm trying to decide how much to push the issue," she continued.

The woman then revealed that the chance of her mom getting whooping cough is slim.

"My dad just retired so he's also not around anymore. The risk of her giving my child whooping cough is very slim based on this. They have a long history of being flaky/unreliable so the fact that they even are planning on coming here at all and actually went and got their flu shots is out of character for them and I'm shocked they actually did it. I'm a nurse and I am strongly pro vaccinating," she concludes before asking if she is wrong in this scenario.

READ MORE: Grandma Kicked Out of Wedding for Wearing Skimpy Outfit, Arrested

Users in the comments section agreed that the woman was not wrong.

"Your baby, your decision. Just calmly tell mumsy either she gets the vaccines or she doesn't see the baby. Then stand back and ignore the noise," said one person.

"Ur baby's health is the priority. It's reasonable to ask ur parents to be vaccinated, especially since ur pediatrician recommends it. Your mom's fears are understandable, but they shouldn't put your newborn at risk," someone else added.

"No It's always better to be safe than sorry, especially when it comes to the health of your newborn," chimed in another.

"Not at all! Your baby, your rules," wrote another Reddit user.

Whatever the reason, celebrities often have a lot to say about vaccines and vaccination, whether they're lobbying against legislation, questioning scientific data or spreading misinformation by way of opinion disguised as fact. Below, find out which star was so upset that his wife vaccinated their children that he ended up getting lawyers involved, as well as which star has been under fire for spreading misinformation about the link between autism and vaccines.

Gallery Credit: Jacklyn Krol

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