A failure to deliver for our children

What if there was an immunisation that could prevent the most common reason for hospitalisation in infants, but due to logistics, only a fraction of the population would receive it? This is our current reality. This winter, thousands of infants and toddlers will be admitted to hospitals with serious symptoms of respiratory syncytial virus (RSV) that could have been prevented. Nirsevimab is a game-changing product. It works similarly to a vaccine but delivers pre-made antibodies to prepare children’s immune systems to resist the worst effects of RSV. It will keep infants out of the hospital and prevent much suffering. That is — it would do so if we could actually provide it to our patients. Due to a combination of logistical hurdles, and now a shortage of the product itself, most infants won’t be able to access nirsevimab this year. As pediatricians, we find this incredibly frustrating, especially because this immunisation shows so much promise.

When the FDA approved nirsevimab in July, it was a moment to celebrate. The long-acting monoclonal antibody targets the most significant cause of lower respiratory tract infection in infants in the world. In randomised controlled trials, nirsevimab was shown to prevent RSV hospitalisations by 70%. Besides the human suffering this would prevent, both for infants and for their terrified parents, this translates into significant savings for an over-burdened health care system. Nationwide, RSV hospitalisations account for $709 million worth of annual health care costs — 90% of which is emergency department care. This is why last year, when RSV hit at the same time as a surge in influenza and COVID-19 among children, it resulted in a massive overload of an over-tapped pediatric health care system. This year was supposed to be different.

This month, however, the only maker of nirsevimab, Sanofi, announced it did not have enough supply to fill many new orders of its product, called Beyfortus, despite earlier promises that supply would not be a problem. The Centers for Disease Control and Prevention paused orders going to states who had ordered through the Vaccines for Children program, which provides immunisations to more than 40 million children, including those on Medicaid. The shortage is in the 100-milligram dose, which is needed for older infants.

This shortage came as a shock to pediatricians like us. We had advocated for insurance companies to cover this product and for the CDC to include it in the Vaccines for Children programme while fellow pediatricians were scrambling to overcome multiple logistical hurdles to offer it to their patients during the quickly approaching RSV season. The CDC recommended this immunisation for every child under 8 months of age during the RSV season, and all of our advocacy was premised on the need to ensure that all infants be able to access it.

The CDC has now responded to the shortage by recommending prioritising the most high-risk infants. Throughout the FDA and CDC approval processes, Sanofi made assurances that they would have enough supply. The company priced it at nearly $500 per dose, making it one of the most expensive products pediatricians are asked to stock routinely in their practices. Nonetheless, pediatricians had begun to place their orders.

Now if you call Sanofi to order the 100 mg doses of nirsevimab, you are told it’s not available. They simply didn’t make enough to go around. We have to think if something similar happened that impacted adults, there would be a bigger outcry, but children’s needs are often put last in our health care system; a system that is designed for adults. The initial response to the COVID-19 pandemic brought about rapid production and large-scale distribution of vaccines to adults across the country, but studies of the vaccine for children and infants were an afterthought of the drug manufacturers. The youngest children, under age 5, waited 18 months for a vaccine. Because of these delays, children died, were hospitalised, or ended up with long COVID during the omicron outbreak in the winter of 2021.

The scale of burden for RSV for our most vulnerable infants and toddlers is significantly higher than that of COVID-19. We have one older product, palivizumab, that is still available for the most high-risk infants and toddlers. But otherwise we are looking at a virtual desert of options for treatments of this virus, which is incredibly common. We’re afraid we have learned little from our prior failures to put children first, and once again, this winter numerous children will be hospitalized because we do not have a better system to deliver care to children.

To families this winter, we will be recommending the same things pediatricians always tell parents of newborns – wash your hands and keep your baby away from crowds. We will do the best we can. Next year, we hope, we may be in a better place to protect the next round of vulnerable infants.

Tribune News Service