On October 13, Sanofi, a pharmaceutical company, made an unexpected announcement: supplies of Beyfortus, a new medicine called nirsevimab that is intended to shield babies from severe respiratory syncytial virus (RSV) infections, had not kept up with demand.
This is the first Respiratory Syncytial Virus season the medication has been accessible, and uptake has been strong, so in some ways that’s excellent news. It makes sense: Respiratory Syncytial Virus is the leading cause of hospitalisations for infants globally. The flood of new vaccines and other medicines that have been released this autumn to help avert the worst effects of the infection has been warmly greeted by paediatricians. Furthermore, parents still trust paediatricians and pay attention to their advice about vaccines, even in spite of the brief increase in vaccine hesitancy among children during the epidemic.
However, it also means that some kids haven’t been able to get the shot, and it highlights more serious, systemic issues with the way the US immunises kids.
The medicine should be given priority for the youngest and most vulnerable neonates due to the shortage, according to a recommendation made by the Centres for Disease Control and Prevention on Monday. Dr. Sean O’Leary of the University of Colorado Medical School, an expert in paediatric infectious diseases, contends that the scarcity was unavoidable.
O’Leary is in charge of representing the American Academy of Paediatrics before the Advisory Committee on Immunisation Practises of the CDC. He claimed that “we were consistently told that there would be plenty and that there would not be a supply problem.” “And so, I found that piece to be really frustrating.”
O’Leary was aware of a number of additional obstacles that would prevent the Beyfortus implementation. He stated, “The ridiculous way that we pay for vaccines in this country” is likely to cause obstacles for Beyfortus availability for some time. Insufficient supply should only be a temporary speed hump in the drug’s distribution.
How Beyfortus operates
Worldwide, Respiratory Syncytial Virus causes infant death. It results in 100–300 fatalities and 58,000 hospital admissions annually in the US alone. Therefore, it was hailed as a major advancement in children’s health when researchers a few years ago managed to develop a vaccine that would shield recipients from the virus’s most dangerous effects.
Babies who have other underlying medical issues or were born prematurely, even at the age of 19 months, are susceptible to severe Respiratory Syncytial Virus disease. But the first six months of life are when kids are most at risk, and over the past three decades, Respiratory Syncytial Virus has killed around 40% of otherwise healthy American infants.
Vaccinating infants who are only a few months old presents a challenge, too, as their immune systems are still developing and won’t be able to respond to the shots well. These infants must either receive antibodies as an injection after they are born or passively from their parents while they are still in the womb in order to be protected.
The latter kind of product is Beyfortus. It’s a monoclonal antibody that successfully shields a newborn from a serious Respiratory Syncytial Virus illness, much as a vaccine would in an older child with a stronger immune system.
Additionally, the CDC has advised using a different medication, the Abrysvo maternal vaccination, to immunise unborn children while they are pregnant. It functions by promoting the parent’s production of antibodies, which are then passed from the placenta to the developing child. Since the vaccination must be administered to the expectant mother between weeks 32 and 36 of pregnancy in order for it to be effective, kids born earlier this autumn will not be protected by it.
As a result, Beyfortus is their only line of defence against severe Respiratory Syncytial Virus.
For many paediatricians, it is financially risky to stock medications like Beyfortus.
There is currently a greater demand than supply for Beyfortus. However, we may anticipate that supply will better meet demand as the drug’s requirement becomes more predictable and as other monoclonal Respiratory Syncytial Virus antibodies in development are introduced to the market.
According to O’Leary, fixing the broken US health care system, which places significant obstacles in the way of some children’s access to Beyfortus, is more difficult. Because of the way the system is set up, many paediatricians must incur significant financial risks in order to maintain stock of Beyfortus. Access for patients who receive care at those practises is probably going to be hit or miss until demand also settles down and paediatricians are better able to predict how much inventory to keep on hand.
Why is it that some paediatricians find it so dangerous to carry specific vaccine goods on hand?
It has to do with how much and who is paying for the goods. In the US, there are two primary methods used to finance and deliver paediatric immunisations. Through a programme known as Vaccines for Children, or VFC, the federal government pays for the vaccinations of around half of all children in the United States. Enrollment in the programme is limited to children who meet certain requirements, such as being Medicaid-eligible, American Indian or Alaska Native, underinsured, or both, in order to ensure that cost is not a barrier to vaccination.
Private insurance companies cover the vaccination costs for the remaining half of American children, but only after the paediatrician administers them. The amount that insurance companies pay for each vaccine is frequently insufficient to cover the entire cost, and paediatricians frequently find out how much they will be reimbursed for a vaccine after the fact.
Respiratory Syncytial Virus (RSV) | What Is It & What Conditions Does it Cause (ex. Croup)
Because of this configuration, paediatric practises are at considerable financial risk when ordering any vaccine. However, the risk is minimal because the majority of vaccinations are quite inexpensive and the majority of parents are familiar with them, which makes demand pretty predictable.
However, the calculations for Beyfortus are entirely different: One dose costs a doctor’s office around $500, and since it was a completely new vaccine, it was difficult to predict how well-received it would be. According to O’Leary, “a medium-sized practise might have to spend $250,000 to cover their patient population.” “And they don’t have that much money lying around.”
“Family doctors and paediatricians want to do the right thing, too,” he continued, “but there’s a financial risk involved in simply keeping Beyfortus on the shelves.”
According to O’Leary, it would be fantastic to implement a universal vaccination programme that provided free vaccinations for everyone, as this is what other developed nations like the United Kingdom and Canada do. But he clarified, “That’s not where we are.”
Updated October 25, 2:00 PM ET: The amount of money a source thought a practise may spend on Beyfortus to cover its patient base has been modified in this story to more closely reflect the situation.
Updated October 25, 7:15 p.m. Eastern Time: A prior version of this article said that only federally financed clinics are authorised to provide immunisations under the immunisations for Children programme. Additionally, private practises administer these immunisations.