A new immunization hinted at an end to bad RSV seasons. But an ongoing shortage means babies are still getting sick

By Brenda Goodman, CNN

(CNN) — As a pulmonary critical care specialist, Dr. Cassondra Cramer-Bour knows intimately what RSV, or respiratory syncytial virus, can do to a person’s lungs.

So she was thrilled in July when the US Food and Drug Administration approved a new antibody designed to prevent severe disease in babies with RSV, and she wanted to get it to protect her then-6-month-old daughter, Kate.

She knew that RSV season was coming up and that babies like Kate can get into trouble quickly if the infection fills their tiny airways with fluid, making it difficult to breathe.

But Kate’s pediatrician didn’t have any doses of the new immunization, Beyfortus, which was initially recommended by the US Centers for Disease Control and Prevention for all babies younger than 8 months who were entering their first RSV season.

In October, manufacturer Sanofi said demand had outstripped the supply it had planned for and warned that the 100-milligram doses, the ones given to babies Kate’s age, were scarce. The CDC subsequently recommended that doctors prioritize 100mg doses for babies with underlying medical conditions and those under 6 months of age.

Kate was mostly healthy, so Cramer-Bour didn’t search further to find a dose. She now wishes she had.

“Knowing how sick she got, I definitely would have taken a vaccine if it was more easily available,” she said.

Rocky rollout leaves babies unprotected

Parents have been eagerly awaiting the new immunization, which clinical trials found to be 75% effective at preventing RSV infections severe enough to be seen by a doctor. Many were willing to shoulder the full $500 cost out-of-pocket to get it, as RSV is the No. 1 cause of hospitalizations in infants in their first year of life.

But this therapy that hinted at ending bad RSV seasons as we know them has been sidelined this season by concerns about cost, reimbursement and shortages. Without it, babies are still getting very sick.

On Monday, October 30, Kate came home from day care with a cough. A kid coming home from day care with a runny nose, cough or goopy eyes can feel like an almost-everyday event, so the cough didn’t cause immediate alarm for her parents. But by that night, the cough became more frequent, so Cramer-Bour and her husband, James, decided to play it safe and keep Kate home the next day. The plan was for James to watch Kate during the day while Cramer-Bour, who was working nights, slept.

When she woke to take over late Tuesday afternoon, Kate was still coughing, but she was playing and drinking and didn’t have a fever, so Cramer-Bour left for work as usual about 5:30 p.m.

About 10, her husband started sending her videos of Kate. She didn’t seem like herself, and he was worried. She was breathing a little fast: 40 to 60 times a minute.

Cramer-Bour showed the videos to some of her colleagues, who agreed that her daughter looked sick.

Her husband brought Kate to Children’s Hospital of Michigan in Detroit to have her evaluated around 11 p.m.  Kate was still happy and playing, but her chest was moving a lot with each breath, the small muscles around her ribs drawing in, indicating that she was working very hard to breathe. Her heart rate was high, too.

“I think initially the emergency department was thinking, ‘Oh, maybe we can give her a breathing treatment. You know, she’ll kind of turn around and go home,’ ” Cramer-Bour said. But that’s not what happened.

“She got worse and worse,” she said.

On Wednesday, Kate was admitted to the hospital and given a device called a high-flow nasal cannula to help get more oxygen into her lungs.

Cramer-Bour said her daughter seemed to be stuck in a seesaw pattern. She would improve and perk up for a bit, but then something would happen, and she would get worse again. By that night, she had been moved to the pediatric ICU for a higher level of breathing support. They gave her oxygen with some pressure to help get it into her lungs. That helped reduce the work of all the tiny muscles around her ribs that were laboring to help her breathe.

“That kind of helped to stabilize her, but she hit a plateau and just didn’t get better,” Cramer-Bour said.

Watching her daughter struggle to breathe through those long days and nights was terrifying.

“Everything in my training told me that this person needs to be intubated and put on a ventilator, and of course, that’s the rescue therapy,” she said, the last-ditch effort to support a person’s breathing through a crisis.

“I was just so scared that was what was going to happen to my baby,” she said.

Lingering questions about supply

When Beyfortus was approved over the summer, AstraZeneca and Sanofi, the two companies that manufacture the drug, said it would be available for babies in time for RSV season this year.

Concerns about insurance reimbursement and cost kept many pediatricians and hospitals from ordering right away. But just as the CDC and payors had worked out a way to resolve some of those issues – offering doctors and hospitals new flexibility to order and pay for the expensive shots – the manufacturers announced that they wouldn’t be able to fill orders.

“There’s a great deal of frustration with this situation,” said Dr. Sean O’Leary, a pediatric infectious disease specialist at Children’s Hospital of Colorado.

“We all saw all these hurdles that we were going need to overcome to get this done this season, and a lot of people spent a lot of time and worked really hard to make it happen, and then the shortage,” said O’Leary, who is also a spokesperson for the American Academy of Pediatrics.

On November 10, AstraZeneca CEO Pascal Soriot told Reuters that the company would prioritize the US market for additional doses of Beyfortus this year.

On November 16, the CDC and FDA announced that they had expedited the availability of 77,000 additional 100-mg doses of Beyfortus and that these would go to government and private programs.

About 3.8 million babies are born in the US each year, and Beyfortus is recommended for all of them, O’Leary said. “So 77,000 doses is a lot of doses, but in the grand scheme of things, it’s not that many relative to how many we need. It does not resolve the shortage.”

Last week, White House officials met with AstraZeneca and Sanofi to discuss the manufacturing, distribution, and accessibility of Beyfortus. In a memo about the meeting, the White House said senior administration officials underscored the importance of manufacturers such as Sanofi and AstraZeneca working to meet demand with a sense of urgency heading into the winter season. They also said they worked on starting to plan to meet next year’s projected demand.

AstraZeneca declined to answer specific questions about the number of doses of Beyfortus that have been produced or shipped this year.

“The demand for Beyfortus has far surpassed any previous standard,” the company said in a statement to CNN on Monday. But it declined to offer any specifics about the standards it was referencing or its planning.

“Although we are on track to deliver all doses initially ordered in the US, we are committed to doing more, and we are pleased to confirm that in collaboration with the CDC and government agencies we are accelerating delivery of additional doses this calendar year. We will also continue to work to accelerate supply,” the statement said.

O’Leary said pediatricians are hearing it might not be coming in time to make a difference this season. “Basically, what we have been told is that if you haven’t ordered already, you’re not getting anything, and if you have ordered, you might get some of it,” he said.

Antibody therapies like Beyfortus, which are grown in living cells in bioreactors, take an extended time to make. It’s not easy for companies to quickly generate more. O’Leary, who is also a vaccine adviser to the CDC, said it was his understanding that Beyfortus production takes nine months.

And as RSV season nears its peak, hospitals say they are once again trying to manage an influx of babies who need help to breathe. It wasn’t supposed to be this way.

“We’re busy, and it’s frustrating that we’re busy because for the first time in human history, we’ve got a way to prevent RSV, but we’re still struggling to get monoclonal antibodies into the babies that need it,” said Dr. Buddy Creech, a pediatric infectious disease specialist at Vanderbilt University Medical Center. “The supply is just not there. I think it will be in the future, but this is a tough transition year.”

It hasn’t helped that RSV season got off to an early start in some areas, just as it did the year before, said Dr. James Versalovic, who directs diagnostic and laboratory medicine at Texas Children’s Hospital.

“We saw a dramatic increase beginning in mid-September, with sustained high activity through the months of October and November,” he said.

Versalovic said he doesn’t see Beyfortus or a new maternal immunization from Pfizer, which is given to pregnant women to protect infants in the first few months of life, making a dent in case numbers yet.

“This is the case of probably too little, too late,” he said. “We just began receiving antibodies to deliver to patients right at the same time that RSV was cresting in this surge. I don’t think we can say that nationally it’s made any impact in terms of overall numbers of infections.”

Sharing her story to help other families

After three days in intensive care, Kate Cramer-Bour finally started to improve.

“Her heart rate started to come down, and she wasn’t having fevers anymore,” her mother said.  “So that was really when it felt like ‘OK, we’re probably through the worst of it.’ “

She was finally discharged from the hospital five grueling days later, she said.

“I would have just given anything to just take it away,” Cramer-Bour said. “I think that’s how most parents would feel.”

But they weren’t alone. Friends would drive from 45 minutes away to drop off a casserole or scoop out litter boxes. The family needed all the help they could get.

“Hospitalizations are a very big deal for a family,” O’Leary said. “Even a short hospitalization of a day or two is a big deal. But a lot of these hospitalizations are much longer than that.”

If a child ends up on a ventilator, they might go on to have longer-term health problems, too.

For now, Cramer-Bour says, they are grateful to be home and grateful Kate is back to her happy and healthy self.

But they also face a different dilemma: whether to get Beyforus for her this year, if they can find it.

Vanderbilt’s Creech says the immunization is still recommended for babies who have recently recovered from RSV, but because those infants are likely to have generated their own strong immunity from their infections, many pediatricians are wondering whether the scarce shots should go instead to babies who haven’t caught the virus.

Cramer-Bour says she’ll follow her pediatrician’s recommendation. She’s also trying to share her story on social media to help make other moms aware that there are vaccines this year for mothers and babies that can prevent what happened to them from happening to another family.

“That’s been my big focus, is talking with my friends who are pregnant,” she said of Pfizer’s maternal vaccine. “That vaccine is a lot more freely available.”

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