CNN
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As a pulmonary critical care specialist, Dr. Cassondra Kramer-Barr is familiar with the effects that RSV (respiratory syncytial virus) has on the human lungs.
So when the U.S. Food and Drug Administration in July approved a new antibody that prevents severe disease in infants infected with RSV, she was excited and decided to get it to protect her then-6-month-old daughter Kate. I thought I wanted to.
She knows that respiratory syncytial virus season is approaching and that babies like Kate can quickly run into problems when the infection fills their tiny airways with fluid, making it difficult to breathe. I did.
But Duchess Kate’s pediatrician did not have the doses of Bayfortus, a new vaccination that the U.S. Centers for Disease Control and Prevention initially recommends for all infants under eight months of age entering the first respiratory syncytial virus season.
Manufacturer Sanofi announced in October that demand had exceeded planned supply and warned that it was running out of 100-milligram doses to give to infants of Kate’s age. CDC It was then recommended Doctors prefer the 100 mg dose for infants with underlying medical conditions and infants under 6 months of age.
Since Kate was mostly healthy, Cramer-Buhl didn’t search further to find the dosage. She now wishes she had done that.
“If the vaccine was more readily available, I definitely would have gotten it, knowing how sick she got,” she said.
Parents are eagerly awaiting the new vaccination, which clinical trials found to be 75% effective in preventing respiratory syncytial virus infections severe enough to require medical attention. Because RSV is the leading cause of hospitalization in infants in the first year of life, many were willing to pay the $500 co-pay.
But as we know, this treatment that was suggested to end RSV’s bad season has been discontinued this season due to concerns over cost, reimbursement, and shortages. Without it, the baby will still be seriously ill.
On Monday, October 30th, Kate came home from daycare with a cough. The coughing didn’t immediately alarm her parents, as it felt like a near-daily occurrence for their child to come home from daycare with a runny nose, cough, and watery eyes. But by that night, her coughs had increased in frequency, so Kramer-Barr and her husband, James, decided to play it safe and keep Kate at her home the next day.The plan was as follows James was assigned to look after Kate during the day while Cramer Barr, who worked the night shift, slept.
When Kate awoke to take over work late Tuesday afternoon, Kate was still coughing but was playing and drinking and didn’t have a fever, so Cramer-Buhl said at 5:30 p.m. Around that time, I went to work as usual.
Around age 10, her husband started sending her videos of Kate. She didn’t seem like herself and he was worried. Her breathing was a little fast, she was 40 to 60 breaths per minute.
Cramer Buhl showed the video to several co-workers, who agreed that her daughter looked sick.
Her husband took Kate to Children’s Hospital of Michigan. Arriving in Detroit for her diagnosis around 11 p.m., Kate was still happy and playing, but her chest was moving a lot with each breath, and the small muscles around her ribs were pulling in as she breathed. It was shown that he was working very hard. She also had a high heart rate.
“Initially, I think the emergency department thought, ‘Oh, maybe we can give her breathing treatment,’ and you know, she’s like, turn around and go home,” Kramer Buhl said. said. But that didn’t happen.
“Her condition was getting worse and worse,” she said.
On Wednesday, Kate was admitted to hospital and given a device called a high-flow nasal cannula to get more oxygen into her lungs.
Cramer Buhl said her daughter seemed stuck in a seesaw pattern. She improves and gets better for a little while, but then something happens and she gets worse again. By that evening, she was transferred to the pediatric intensive care unit for higher levels of respiratory support. They gave her oxygen by applying some pressure to help get the oxygen into her lungs. This relieved the small muscles around her ribs that were working to help her breathe.
“It helped stabilize her, but she hit a plateau and wasn’t getting any better,” Kramer Buhl said.
It was terrifying to watch my daughter struggle with breathing during long days and nights.
“All of my training has taught me that this person needs to be intubated and put on a ventilator, and of course that’s life-saving therapy,” she said, adding that she needed to be able to survive the crisis. He said it was a last-ditch effort to help the person breathe.
“I was so scared that that would happen to my baby,” she said.
When Bayfortus was approved in the summer, the two companies that make the drug, AstraZeneca and Sanofi, announced that it would be available for use in infants in time for this year’s RSV season.
Concerns about insurance reimbursement and cost prevented many pediatricians and hospitals from ordering it right away. But once the CDC and payers figured out how to solve some of these problems, giving doctors and hospitals new flexibility in ordering and paying for expensive vaccines, manufacturers were unable to fill orders. It was announced that it would disappear.
“This situation is extremely frustrating,” said Dr. Sean O’Leary, a pediatric infectious disease specialist at Children’s Hospital Colorado.
“We all recognize that there are all the hurdles we have to overcome to achieve this this season, and many people have put in a lot of time and worked hard to make it happen, but , and then there was a staffing shortage,” O’Leary said. He is also a spokesperson for the American Academy of Pediatrics.
On November 10, AstraZeneca CEO Pascal Soriot told Reuters the company would prioritize the U.S. market for additional doses of Bayfortas this year.
On November 16, the CDC and FDA announced that they are expediting the acquisition of an additional 77,000 100 mg doses of Bayfortas, which will be provided to government and private programs.
About 3.8 million babies are born in the U.S. each year, and Bayfortus is recommended for all of them, O’Leary said. “So 77,000 doses is a lot, but in the grand scheme of things, it’s not that many compared to the doses that are needed. That doesn’t eliminate the shortage.”
Last week, White House officials met with AstraZeneca and Sanofi to discuss the manufacturing, distribution and availability of Bayfortas. In a memo about the meeting, the White House said senior administration officials emphasized the importance of manufacturers like Sanofi and AstraZeneca working with a sense of urgency to meet demand heading into the winter season. They also said they have begun planning to meet next year’s projected demand.
AstraZeneca declined to answer specific questions about the number of Bayfortas doses it has manufactured or shipped this year.
“Demand for Bay Fortas has far exceeded historical standards,” the company said in a statement to CNN on Monday. However, the company did not provide details about the standards it was referring to or its plans.
“Although we are on track to deliver all of the first doses ordered in the United States, we are committed to doing more and working with the CDC and government agencies to ensure delivery of all doses during the calendar year. We are pleased to confirm that we are accelerating the delivery of additional doses, and we remain committed to accelerating supply.”
Mr O’Leary said pediatricians had heard that it might not be possible to make changes this season. “Basically, what we were told is that if you haven’t ordered yet, you won’t receive anything, but if you do, you might receive some,” he said.
Antibody therapies like Beyfortus take a long time to create because they are grown in living cells in bioreactors. It is not easy for companies to produce more results quickly. O’Leary, who is also a vaccine advisor to the CDC, said it is his understanding that production of Bayfortus will take nine months.
And as the RSV epidemic nears its peak, hospitals say they are once again trying to cope with an influx of infants needing help breathing. it was not supposed to be like this.
“We’re busy, but being busy is frustrating because, for the first time in human history, we have a way to prevent RSV, but we’re still having trouble getting monoclonal antibodies to babies who need them. “Because we do,” said Dr. Buddy Creech, a pediatric infectious disease specialist at Vanderbilt University Medical Center. “There just isn’t any supply. I think that’s going to be the future, but this is going to be a tough transition year.”
Dr. James Barsarovich, director of diagnostic and laboratory medicine at Texas Children’s Hospital, said it didn’t help that, like last year, RSV outbreaks started early in some areas.
“The dramatic increase started in mid-September, and high activity continued through October and November,” he said.
Barsarovic said he is not yet considering Bayfortus or Pfizer’s new maternal vaccination, which is given to pregnant women to protect infants in the first few months of life, even though the number of infections is still declining.
“This is probably a case of too little, too late,” he said. “At the same time that the RSV surge was peaking, we just started receiving antibodies to give to patients. Nationally, we’re seeing some impact on the overall number of infections. I don’t think you can say that.”
After three days in intensive care, Kate Kramer-Barr is finally starting to recover.
“Her heart rate started to drop and her fever went away,” her mother said. “That’s when she really felt, ‘Okay, maybe the worst is over.’
After five grueling days, she said she was finally able to leave the hospital.
“I would have given anything to take that away,” Kramer Buhl said. “I think most parents feel that way.”
But they weren’t alone. Friends drove from 45 minutes away to deliver casseroles and scoop trash cans. The family needed all the help they could get.
“Hospitalization is a huge issue for families,” O’Leary said. “Even a short hospitalization of one or two days is a big problem. But many of these hospitalizations are much longer than that.”
If your child ends up on a ventilator, they may continue to have long-term health problems.
For now, the family is grateful to be home and grateful that Kate is back to her happy, healthy self, Kramer Buer said.
But they also face another dilemma. That is, if I could find one, I would get Bayforus for her this year.
Vanderbilt University’s Dr. Creech said vaccinations are still recommended for infants who have recently recovered from RSV, but because these infants are likely to have developed their own strong immunity from infection, many pediatricians say they are wondering whether they should instead vaccinate unvaccinated infants with the missing vaccine. I was not infected with a virus.
Cramer-Bour said she plans to follow her pediatrician’s recommendations. She also shared their experiences on social media to remind other mothers that vaccines for mothers and babies are coming this year that can prevent what happened to them from happening to other families. I’m trying to get you to know.
“That’s my big focus and talking to my friends who are pregnant,” she said of the Pfizer maternal vaccine. “That vaccine is now more freely available.”