The winter respiratory season is in full swing, which means that homes, offices, and hospitals are full of children sick with respiratory syncitial virus, or RSV as it is commonly known. So far, this season is nowhere near as busy as it was a year ago, an ordeal I discussed in detail last November. I followed up that post with a primer on RSV, so please check it out if you want to catch up with the rest of the class.
In a nutshell, RSV is a respiratory virus that causes a yearly cold in most people but has the ability to invade the lungs and wreck havoc in infants, the elderly, and anyone between those extremes of age with a compromised immune system or risk factors for more severe disease. Last year, a record breaking wave of children requiring hospitalization crashed down upon us in the fall and lasted into the new year. Thankfully, at least so far, it isn’t as bad right now but it’s still bad. There is the definite possibility that a similarly severe peak is just around the corner, though that is unlikely even with recent CDC data showing a big spike in cases. My fingers are crossed…hard.
Just how bad an RSV season can be tends to vary from region to region. Though last year was pretty rough in most areas, there were some hospitals that didn’t have an atypically severe season, or whose peak numbers didn’t plateau for quite so long. Then there were places like Boston, where we spent several weeks far above capacity with kids lining the ER halls waiting on hospital beds and limited available space in pediatric intensive care units throughout New England. This forced small to medium sized community hospitals like mine to push past typical limits and to manage patients that would have been better off in a tertiary care center.
There were many days last season where my colleagues and I didn’t feel like we were able to provide safe and appropriate care for all of our patients, and we haven’t fully put it behind us. As this season approached, there was a sense of dread, as if we all shared one collective raw nerve. Thankfully the season so far has been manageable, for the most part. We didn’t see huge numbers of children in respiratory distress in October or November and instead there has been a more typical steady increase over the past few weeks.
It could have been much better, however. It could reasonably be argued that many children hospitalized right now, or who will require inpatient or PICU admission over the next few months, missed out on a safe and highly effective means of preventing significant RSV disease because of what increasingly appears to be incompetence. In fact, a lot of 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 3rd, the Advisory Committee on Immunization Practices and the CDC voted unanimously in favor of recommending the use of a recently approved injection proven to reduce the risk of severe RSV disease in young children. And just this week, the American Academy of Pediatrics has come out with their recommendations for which young children should be the focus of the drug’s roll out.
The injection contains a monoclonal antibody and works through passive immunity. These are protective antibodies usually only produced by the immune system when a child is infected with RSV, and one dose safely reduces the risk of medically attended (urgent care, clinic, physician office, ER visit, hospitalization) RSV by 75%. The plan was to get every child under 8 months and higher risk kids through 19 months immunized before the virus made its way up to the United States. We were hopeful that it would make a significant difference this season, but some roadblocks were expected:
There are several issues that will impede the roll out for this season:
- Pediatric practices will be busy dealing with the transition to a commercialized COVID-19 vaccine. Adding a new recommended medication that still lacks billing codes for its administration will result in these practices taking an intolerable financial hit, so they might wait until 2024-2025.
- Nirsevimab administration will likely require many pediatric practices to train staff or hire new staff in order to follow state guidelines. They might have to pay for and make room for additional storage capacity. They will have to pay, up front, for the doses. And all of this has to be done knowing that there might be significant hesitancy from caregivers and that it may take up to a year for insurance payments to reach their bank accounts. Many practices could opt out.
- Many children rely on the Vaccines for Children program to receive recommended immunizations. Nirsevimab, though not a vaccine, will be included in the program. This is a really good thing but VFC-funded products take longer to reach children than those that are payed for privately. RSV will get to many of these kids before they have access to the shot.
So here we are, nearly 4 months after that August post on nirsevimab. How is it going so far? Thanks for asking, but unfortunately not great. There were, not unexpectedly, significant problems with the roll out of the medication. Just not the problems that anyone predicted.
Things got off to a rocky start when, in early October and after significant strides had been made in reducing the risk of the potential financial concerns mentioned in the above quote, Sanofi announced that the demand for the drug was significantly higher than they expected. We were told to have very low expectations of receiving anywhere close to the number of doses being ordered. This didn’t sit well with the thousands of pediatricians and family doctors who knew that families would be clamoring for the chance to protect their little ones.
A supply problem wasn’t one of the potential issues predicted to possibly keep qualifying patients from getting their shot. There were supposed to be plenty of doses available for whoever needed one, so this October surprise from Sanofi was disheartening to say the least. Some shipments have gone out, however, and Massachusetts did better than many states, though we are talking about doses numbered in the thousands at best. We have only given somewhere between 100 and 150 doses at my hospital, which delivers around 300 babies every month.
Premature and very high risk infants have been prioritized, of course, but this still leaves the vast majority of qualifying children unprotected. That’s millions of infants. So many that it was almost comical, not that we would turn down even one dose, when there was an announcement in mid-November of a release of 77,000 additional doses for distribution across the country. This issue has even reached the hallowed (at some point in the past probably) halls of Congress, and a group of Senate Democrats is demanding answers.
There is a way for babies to achieve a similar degree of protection without receiving a dose of nirsevimab. An RSV vaccine, called Abrysvo, was also recently approved for use in pregnant women between the 32nd and 36th week of pregnancy as well as adults over age 60. In addition to reducing a mother’s risk of severe disease, protective antibodies have time to cross the placenta to the baby.
Adding insult to injury, however, many expectant mothers have been unable to get the vaccine. I have had many over the past month ask about nirsevimab availability as soon as I walk in the room. Demand is high, and pediatricians knew it would be. So why didn’t Sanofi? My assumption is incompetence. Somebody dropped the ball.
As of right now, it looks like there will be no additional shipments of nirsevimab going out until next RSV season. Available doses are understandably going to premature infants and older infants at very high risk of severe disease. And I’m am left forced to disappoint a lot of worried families. Nirsevimab has to potential to completely change the game when it comes to RSV in young pediatric patients. Next year really could be unlike any I’ve ever experienced. Again, my fingers are crossed.