RSV Seasons is here, so where is our Beyfortus?

The winter respiratory season is in full swing, which means homes, offices and hospitals are filled with children suffering from respiratory syncytial virus (RSV). So far, the season has been nowhere near as busy as it was a year ago, a test I discussed at length last November. I also cover getting started with RSV following this article, so check it out if you want to keep up with other students.

Simply put, RSV is a respiratory virus that causes most people to get a cold every year, but it has the ability to invade the lungs and can be fatal to infants, the elderly, and anyone older with a compromised immune system or risk factors for the flu. People wreak havoc. More serious illness. A record-breaking wave of children requiring hospitalization hit us last fall and continues into the New Year. Thankfully, at least so far, it’s not that bad, but it’s still pretty bad. It’s likely that a similar severe peak is coming, although that’s unlikely even if recent CDC data shows a significant increase in cases. I crossed my fingers… hard.

The severity of RSV season tends to vary by region. While most areas had pretty bad conditions last year, some hospitals didn’t have an unusually bad season, or the peak numbers didn’t last very long. And then there are places like Boston, where we spent weeks well beyond capacity, with kids lining up in emergency rooms waiting for hospital beds and limited available space in pediatric intensive care units throughout New England. This forces small and medium-sized community hospitals like mine to move beyond typical constraints and manage patients who would be better off in a tertiary care center.

There were many days last season when my colleagues and I felt like we were unable to provide safe and appropriate care to all of our patients, and we are not completely out of it yet. As the season approaches, there’s a sense of dread, as if we all share some primitive nerve. Thankfully, the season has been manageable for the most part so far. We did not see large numbers of children experiencing respiratory distress in October or November, but rather the more typical steady growth over the past few weeks.

However, things could have been much better. It is reasonable to believe that many children who are currently hospitalized, or who will require hospitalization or PICU admission in the coming months, are missing out on safe and highly effective ways to prevent severe RSV disease due to increasing inability. In fact, many pediatricians, family doctors, and parents are not very happy right now.

In August, I wrote about nirsevimab (brand name Beyfortus), which had just been approved for use in children at risk for severe RSV disease:

On August 3, the Advisory Committee on Immunization Practices and the CDC voted unanimously to recommend the use of a recently approved shot that has been shown to reduce the risk of severe RSV illness in young children. Just this week, the American Academy of Pediatrics put forward their recommendation that young children should be the focus of drug promotion.

This injection contains monoclonal antibodies and works through passive immunity. These protective antibodies are typically produced by the immune system only when children are infected with RSV, and one dose safely reduces the risk of RSV by 75% from an RSV visit (urgent care, clinic, doctor’s office, emergency room visit, hospitalization). The plan is to vaccinate every child under 8 months old and those at higher risk up to 19 months before the virus spreads to the United States. We hope this will have a significant impact this season, but expect some obstacles:

There are several issues that will hinder the launch of this season:

  1. Pediatric clinics will be busy transitioning to commercial COVID-19 vaccines. Adding new recommended drugs that still lack administrative billing codes will cause these practices to take an intolerable financial hit, so they may have to wait until 2024-2025.
  2. Administration of Nirsevimab may require many pediatric practices to train staff or hire new staff to follow state guidelines. They may need to pay for additional storage capacity and make space. They must pay for doses upfront. All of this must be understood that caregivers may be hesitant and that insurance payments may take up to a year to reach their bank accounts. Many practices have opt-out options.
  3. Many children rely on the Childhood Vaccines Program to receive recommended immunizations. Nirsevimab, although not a vaccine, will be included in the plan. This is indeed a good thing, but VFC-funded products take longer to reach children than privately paid products. RSV reaches many children before they are exposed to vaccines.

It has been nearly 4 months since the August post about nirsevimab. How’s it going so far? Thanks for asking, but unfortunately not very good. Unsurprisingly, the rollout of the drug has had major problems. It’s just not a problem anyone predicted.

Things got off to a rocky start in early October when Sanofi announced that demand for the drug was significantly higher than they expected, after making significant progress in mitigating the risk of potential financial issues mentioned in the quote above. We are told that expectations for receiving doses close to those ordered are very low. This makes thousands of pediatricians and family doctors uncomfortable, knowing that families will clamor for a chance to protect their children.

Supply issues are not one of the potential issues expected to prevent eligible patients from receiving the vaccine. There were supposed to be enough doses for people who needed them, so Sanofi’s October surprise was frustrating, to say the least. However, some shipments have been sent out, and Massachusetts is doing better than many states, even though we’re talking about thousands of doses at best. Our hospital delivers about 300 babies a month, but we only administer 100 to 150 doses of vaccine.

Of course, premature and high-risk infants have been prioritized, but this still leaves the vast majority of eligible children unprotected. That’s millions of babies. The numbers are so high it’s almost comical, but that’s not to say we’ll turn down even a single dose of the vaccine, as it was announced in mid-November that an additional 77,000 doses would be released and distributed across the country. The question has even reached the hallowed (probably at some point in the past) halls of Congress, where a group of Senate Democrats are demanding answers.

There is a way for babies to get a similar level of protection without receiving a single dose of nirsevimab. An RSV vaccine called Abrysvo was also recently approved for use in pregnant women between 32 and 36 weeks of pregnancy and in adults over 60 years of age. In addition to reducing the mother’s risk of serious illness, protective antibodies have time to cross the body’s placenta and reach the baby.

However, to add insult to injury, many expectant mothers are unable to get vaccinated. Over the past month, I’ve had a lot of people ask about nirsevimab as soon as I walk into the room. The demand is high, and pediatricians know it. So why doesn’t Sanofi do this? My assumption is incompetence. Someone dropped the ball.

As of now, it appears there will be no additional shipments of nirsevimab before the next RSV season. Understandably, available doses are used in premature and older infants who are at high risk for severe disease. I had to let down a lot of worried families. Nirsevimab has the potential to be a game-changer for RSV in young pediatric patients. Next year really could be different than any year I’ve ever experienced. I prayed again.

#RSV #Seasons #Beyfortus
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