A year ago, hospitals across the country noticed a disconcerting trend. Despite winter still being a few weeks away, many were experiencing a shortage of pediatric hospital beds due to an early surge in respiratory syncytial virus (RSV). As a result, parents who needed to take their children to the emergency room faced longer-than-usual wait times. Some children were being sent to hospitals in other states. But the brutal season ended on a somewhat hopeful note: a variety of vaccines, including a monoclonal antibody treatment called Nirsevimab, were in development and would likely be available the following year.
That time has arrived. While RSV has yet to take off in an extraordinary way like it did in 2022, those who are looking to protect their children from the virus are running into a major problem: the much-hyped shot is in short supply. As many media outlets have reported, parents are struggling to find the shot for their kids, and some pediatricians are angry. What happened?
The FDA estimates that each year about 60,000 adults over the age of 65 are hospitalized with RSV while 6,000 to 10,000 die from the virus. Infants are known to face an increased risk. According to the Centers for Disease Control and Prevention (CDC), each year nearly 80,000 kids under 5 are hospitalized with RSV, and an estimated 300 die.
In July, the Food and Drug Administration on Monday approved the new RSV treatment for children up to 24 months old. The monoclonal antibody treatment, sold under the brand name Beyfortus, protects infants and toddlers by blocking the RSV virus from infecting cells. Technically, it's not a vaccine, but a single injection that would be given to infants and neonates born during or entering their first RSV season.
“Despite an aggressive supply plan built to outperform past pediatric immunization launches, demand for this product ... has been higher than anticipated.”
News of the approval gave many parents hope that this year’s season wouldn’t be as severe, as for the first time in history a treatment was available for their kids. But at the end of October, the Centers for Disease Control and Prevention (CDC) issued a health alert, warning about limited supply of Beyfortus. Due to this limited supply, the CDC recommends prioritizing available nirsevimab 100mg doses for infants at the highest risk for severe RSV disease — those under the age of six months, and infants with underlying conditions that place them at highest risk for a severe case of RSV, such as those who are immunocompromised or have lung disease.
Weeks before the CDC issued a health alert, the drug manufacturer, Sanofi, issued an update that demand had outpaced supply. “For the first time in history, health care providers are able to help protect an extraordinary number of infants against respiratory syncytial virus (RSV) disease,” the manufacturer said. “Despite an aggressive supply plan built to outperform past pediatric immunization launches, demand for this product, especially for the 100 mg doses used primarily for babies born before the RSV season, has been higher than anticipated.”
Dr. Kelly Moore, president of Immunize.org (a nonprofit organization that works to increase vaccination rates and is funded by the CDC) told Salon in a phone interview there’s more to the story that’s missing from the mainstream narrative. It’s not only that the manufacturer didn’t anticipate such a high demand, but it’s that a part of its anticipated supply went to the Vaccines For Children (VFC) program — a move that was never guaranteed.
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VFC is a federal entitlement program that ensures access to all recommended vaccines for children who are uninsured on Medicaid, or whose private insurance doesn't cover immunizations. It provides vaccines for nearly half of children under the age of 19 in the United States. Up until early August, Moore said, the manufacturer didn’t know if it would be accepted in the program because technically it wasn’t a vaccine.
“If we didn’t put it in the Vaccines for Children program, then half of families with babies who need this product wouldn’t have a way to pay for it, they won't have access,” Moore said. “They either would be uninsured and have to pay out of pocket, however much it cost, or it might take a long time before Medicaid got around to covering it as a drug instead of as a vaccine for the Vaccines for Children program, which makes that access almost immediate.”
While it’s good news that the shot will be available through the program, a consequence is that there is limited availability to those with private insurance.
“If we didn’t put it in the Vaccines for Children program, then half of families with babies who need this product wouldn’t have a way to pay for it."
“Once it became available through the VFC program, it became accessible to everybody who needs it and not just those who can afford to pay for it or who have private insurance that will cover it,” Moore said. “So that's how we got into this situation, and a lot of these changes in the demand dynamics only occurred at the last minute.”
Indeed, due to the timing of all the events Moore said the shortage would have been “almost impossible” to entirely avoid.
Dr. Ian Michelow, division head of Infectious Diseases and Immunology at Connecticut Children's Hospital, told Salon anticipation and expectations were definitely amped up, which could be contributing to a collective feeling of being let down.
“The anticipation and expectations built up because — as I remember very well because I was working in the hospital — of the huge surge of RSV that started in late September and October last year,” he said. “Even though it's difficult with a shortage, I sort of see the silver lining and hopefully I think the message is going to get through that this is a really new, and really fantastic product to protect babies.”
“We still do get 100 to 300 kids dying every year from RSV in the US. If that's your kid who ends up dying and this could have been prevented, that's a tragedy.”
Dean Blumberg, chief of pediatric infectious diseases and associate professor in the Department of Pediatrics at the University of California, Davis, told Salon he sees this as a “transitional year,” adding that the time-out of the roll-out as a whole was off. Not only from the approval and adding the shot to the VFC, but it takes time from approving a vaccine to educating physicians and getting hospitals to sign off on their own policies. Blumberg said he thinks if the approval happened even six months earlier, that perhaps we’d be entering this year’s RSV season from a different place.
“Hopefully all these issues can be ironed out by the next RSV season,” Blumberg said. “And we will have some use of the RSV vaccine, some children protected [this year], but not enough to really have a meaningful impact like hospitalization rates or even deaths.”
Unfortunately, Blumberg said, he thinks this RSV season will be close to a normal one.
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“We still do get 100 to 300 kids dying every year from RSV in the US,” he said. “In the smaller picture, if that's your kid who ends up dying and this could have been prevented, that's a tragedy.”
The good news is that there are other ways to protect children from RSV. Earlier this year, the FDA approved Pfizer's vaccine against RSV for adults over the age of 60, in addition to a vaccine for expecting mothers to pass immunity to their fetuses. There’s also palivizumab for very high-risk infants.
For frustrated parents and providers, Moore said it’s understandable.
“I understand and appreciate the frustration, it is so hard to have a new product you've been looking forward to for so long to protect the kids from disease that is scary for families of infants,” she said, “This situation is very temporary, it will pass and we have other options.”
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