{"id":1963,"date":"2023-11-09T10:43:23","date_gmt":"2023-11-09T10:43:23","guid":{"rendered":"https:\/\/healthynewsusa.com\/?p=1963"},"modified":"2023-11-09T10:43:26","modified_gmt":"2023-11-09T10:43:26","slug":"a-new-rsv-shot-could-help-protect-babies-this-winter-if-they-can-get-it-in-time","status":"publish","type":"post","link":"https:\/\/healthynewsusa.com\/?p=1963","title":{"rendered":"A New RSV Shot Could Help Protect Babies This Winter \u2014 If They Can Get It in Time"},"content":{"rendered":"
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Emily Bendt was in her third trimester of pregnancy when she first heard the Centers for Disease Control and Prevention had approved a new shot for infants to protect them from the respiratory syncytial virus, or RSV.<\/p>\n

By Oct. 5, Bendt was cuddling with her new baby, Willow, on the couch at home in Vancouver, Washington. She was excited to get Willow the new therapy for infants, called nirsevimab, which had started shipping in September \u2014 but Bendt, a pediatric home health nurse, couldn\u2019t find it anywhere.<\/p>\n

That very morning, at Willow\u2019s two-week checkup, Bendt had asked the pediatrician when Willow could get it. \u201cShe literally just shrugged and was like, \u2018Well, it\u2019s coming, but we don\u2019t know when,\u2019\u201d Bendt said. \u201cI don\u2019t know why I feel like I\u2019m having to chase people down and still not get answers.\u201d<\/p>\n

Bendt searched online, too, for clinics or pharmacies or government websites offering nirsevimab \u2014 and found nothing.<\/p>\n

By mid-October, demand for nirsevimab, sold under the brand name Beyfortus, had already outstripped supply<\/a>, according to the pharmaceutical company Sanofi, which developed the drug with AstraZeneca.<\/p>\n

In response, the CDC issued interim guidance<\/a> Oct. 23 to help pediatricians allocate the limited supply of doses, advising them to focus on the infants at highest risk of RSV complications: those under 6 months old, and those with underlying medical conditions.<\/p>\n

RSV is the leading reason babies under 12 months old end up in the hospital, and an estimated 100-300 kids under age 5 die<\/a> from it in the U.S. every year.<\/p>\n

Nirsevimab, a monoclonal antibody, is one of two new therapies<\/a> available this fall that could dramatically reduce the risk of lung infections in infants.<\/p>\n

The other option is an RSV vaccine from Pfizer called Abrysvo. It was first recommended for adults 60 and older, and then Sept. 22 the CDC approved its use<\/a> in pregnant people, too, to confer some immunity on their infants.<\/p>\n

But this adult vaccine is recommended only within a relatively short window in pregnancy, weeks 32 through 36, because of a potential but unproven concern it may increase<\/a> preterm births. That might limit uptake during pregnancy.<\/p>\n

By the time the vaccine was approved for pregnant people Sept. 22, Emily Bendt had given birth. So for Willow and other babies like her, nirsevimab will be the only option for protection from RSV this respiratory virus season.<\/p>\n

Nirsevimab is approved for all infants up to 8 months old, and for some older babies and toddlers considered at higher risk of severe illness from 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.<\/p>\n

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

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Nirsevimab\u2019s Powerful but Pricey Potential<\/strong><\/p>\n

Pediatricians say the high cost of nirsevimab and bureaucratic obstacles in Medicaid\u2019s vaccine allocation system for children are slowing down nirsevimab\u2019s distribution. They fear these problems leave infants at risk \u2014 unnecessarily \u2014 of hospitalization this winter.<\/p>\n

In clinical trials, nirsevimab reduced RSV hospitalizations and health care visits in infants by almost 80%.<\/p>\n

\u201cThis is groundbreaking, honestly,\u201d said Katie Sharff<\/a>, chief of infectious disease for Kaiser Permanente Northwest.<\/p>\n

Nirsevimab is a monoclonal antibody treatment, not a traditional vaccine. The passive immunity it confers lasts about five months. That\u2019s long enough to get babies through their first RSV season, when they\u2019re at highest risk for complications.<\/p>\n

After an infant\u2019s first winter, \u201ctheir airways develop and their lungs develop,\u201d Sharff said. \u201cSo 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.\u201d<\/p>\n

Sharff\u2019s own daughter had an RSV infection as an infant, needed care in the emergency department, and went on to develop asthma, a condition more common<\/a> in children who had severe RSV infections.<\/p>\n

For health systems worn down by the \u201ctripledemic\u201d of respiratory viruses \u2014 covid-19, flu, and RSV \u2014 keeping infants out of the hospital this winter could be a game-changer.<\/p>\n

Last year was a historically bad season for RSV. Earlier in the pandemic, measures that states took to slow the spread of covid, 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.<\/p>\n

In Oregon, the surge prompted<\/a> then-Gov. Kate Brown, a Democrat, to declare a public health emergency<\/a> and forced hospitals to add capacity to their pediatric intensive care units. Some hospitals even sent patients<\/a> out of state.<\/p>\n

\u201cThe promise of nirsevimab is that should never, never happen again,\u201d said Ben Hoffman<\/a>, a professor of pediatrics at Oregon Health & Science University\u2019s Doernbecher Children\u2019s Hospital in Portland and the president-elect of the American Academy of Pediatrics.<\/p>\n

But that depends on the therapy\u2019s availability, and whether providers can get it to newborns efficiently.<\/p>\n

The Most Expensive Childhood Vaccine<\/strong><\/p>\n

For babies born without the protection of the maternal RSV vaccine, the American Academy of Pediatrics says the best time to get nirsevimab is at birth, before an infant is exposed to RSV at all.<\/p>\n

But babies like Willow who were born before nirsevimab became available will need to get it from an outpatient clinic.<\/p>\n

Except for the first dose of the hepatitis B vaccine, administration of childhood vaccines start one month after birth<\/a>, in a pediatrician\u2019s office, but the cost of nirsevimab might make that hard.<\/p>\n

About 70% of the patients at the Mid-Valley Children\u2019s Clinic in Albany, Oregon, are on Medicaid or are otherwise eligible for the federal Vaccines for Children program. Samaritan Health Services, which runs the clinic, has opted to purchase doses of the RSV shot nirsevimab without reimbursement so that the most vulnerable newborns can get the shot before they head home from the hospital.(Amelia Templeton\/OPB)<\/span><\/figcaption><\/figure>\n

At $495 per dose, it\u2019s the most expensive standard childhood shot, and insurers may not reimburse providers for it this year. That\u2019s a particular problem for small pediatric practices, which can\u2019t afford to lose that much money on a standard childhood vaccine.<\/p>\n

\u201cWhen all of a sudden you have a new product that you\u2019re supposed to give to your entire birth cohort, and you\u2019ve got to pay $500 that may or may not get paid back, that\u2019s just not financially viable,\u201d said Sean O\u2019Leary<\/a>, a pediatric infectious-disease specialist at the University of Colorado School of Medicine.<\/p>\n

Some insurers, but not all, have announced they will cover nirsevimab right away. Because of a quirk<\/a> in the Affordable Care Act, commercial insurance plans can wait up to a year after a new therapy is approved before they are required to cover it.<\/p>\n

Sanofi has announced an \u201corder now, pay later\u201d option for doctors, which would give them more time to work out reimbursement deals.<\/p>\n

Could Hospitals Help?<\/strong><\/p>\n

A government program that supplies free shots to about half the children in the United States is structured in a way that makes it hard to get nirsevimab to babies right after birth.<\/p>\n

Vaccines for Children<\/a> is a safety-net program that provides vaccines to kids on Medicaid, uninsured children, and Alaska Native and American Indian children.<\/p>\n

Health care providers can\u2019t bill Medicaid for shots like nirsevimab. Instead, they must 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 free to VFC-enrolled providers, which tend to be pediatric practices or safety-net clinics.<\/p>\n

But most hospitals aren\u2019t part of VFC, which presents a problem.<\/p>\n

\u201cMany of our newborns go home to caring, affectionate, loving siblings who are actively dripping snot at the time that the child is born,\u201d said Eddie Frothingham<\/a>, a pediatrician with Mid-Valley Children\u2019s Clinic in Albany, Oregon. \u201cThe sooner we can protect them, the better.\u201d<\/p>\n

Right now, only about 10% of birthing hospitals nationwide are enrolled in VFC and can get nirsevimab free.<\/p>\n

Until nirsevimab\u2019s debut a few months ago, most hospitals didn\u2019t have a strong incentive to participate in Vaccines for Children because childhood vaccines outside of hepatitis B are typically given to kids by pediatricians, in outpatient clinics.<\/p>\n

VFC can be burdensome and bureaucratic, according to interviews with several Oregon hospitals and immunization experts. The program\u2019s stringent anti-fraud measures discourage health care providers from enrolling, they say.<\/p>\n

Once enrolled, providers must track and store VFC-provided vaccines separately, apart from 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.<\/p>\n

Mimi Luther, immunization program manager for Oregon, said the rules are nearly impossible for most hospitals to follow.<\/p>\n

\u201cI 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,\u201d she said.<\/p>\n

The CDC has relaxed some program rules<\/a> in light of the shortage of nirsevimab, allowing providers to \u201cborrow\u201d up to five VFC doses for infants covered by private insurance \u2014 as long as those doses are paid back within a month.<\/p>\n

This has forced some health 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.<\/p>\n

Frothingham said that also creates an equity problem. Newborns whose parents don\u2019t have transportation, or financial resources, are more likely to miss those first pediatric appointments after birth.<\/p>\n

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 because of breathing problems or family poverty.<\/p>\n

\"A
Pediatrician Eddie Frothingham speaks with nurse Sydney Berschauer at the Mid-Valley Children\u2019s Clinic in Albany, Oregon, part of Samaritan Health Services. Frothingham says RSV has caused \u201cuntold misery\u201d in Samaritan\u2019s clinics and hospitals over his 28-year career.(Amelia Templeton\/OPB)<\/span><\/figcaption><\/figure>\n

\u201cIt\u2019s important to us that infants be able to access this regardless of their financial or social circumstances,\u201d Frothingham said.<\/p>\n

Nationwide, many birthing hospitals are trying to enroll in the VFC program for next year. But this fall, most won\u2019t have free nirsevimab on hand.<\/p>\n

Most babies who get RSV ultimately recover, including those who require hospitalization to help with their breathing. But it\u2019s challenging to treat, and each year some babies die.<\/p>\n

In his decades in medicine, OHSU\u2019s Hoffman has lost infant patients to RSV.<\/p>\n

\u201cKnowing 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,\u201d Hoffman said. \u201cNo pediatrician in the country is happy right now.\u201d<\/p>\n

This article is from a partnership that includes OPB<\/a>, <\/em>NPR<\/em><\/a>, and KFF Health News.<\/em><\/p>\n