Why We Were Not Properly Winterized for RSV Season

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Earlier this fall the Centers for Disease Control and Prevention (CDC) gave an alert to likely shortages of drugs to treat infants with lower respiratory tract disease associated with respiratory syncytial virus (RSV). RSV itself is becoming more of a scary household name, sometimes being linked to COVID-19 and seasonal influenza in what has sometimes been dubbed a “tripledemic”.

“A big part of the flu increase in November,” said Scott Roberts MD, a Yale medicine infectious diseases specialist, in a news release on the tripledemic, “was our lack of immunity from having not been exposed to the virus for several seasons due to masking and other precautions, many of which have fallen to the wayside” (1).

COVID-19 primarily spreads through air transmission, whereas RSV spreads via contaminated surfaces. “Flu, on other hand, is somewhere in the middle, and can spread from respiratory droplets, aerosols, and through contaminated surfaces,” added Roberts in the news release (1).

It’s important, therefore, to practice what the CDC calls “respiratory etiquette,” specified Thomas Murray, MD, PhD, a Yale Medicine pediatric infectious diseases physician, in the news release (1). “That means coughing into a tissue and disposing of it immediately in the garbage.”

However, on July 17, 2023 FDA approved a new drug, Beyfortus (nirsevimab), to prevent RSV in babies and toddlers. John Farley, MD, MPH, director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research, said in an FDA press release about the approval, “[This] approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system” (2).

Beyfortus has been approved for use in all infants up to the age of eight months old, which is different to the previous treatment, palivizumab, that was only approved for those infants considered to be at the highest risk of contracting RSV. Furthermore, Beyfortus is only required to be administered once, whereas palivizumab needs to be given once a month during RSV season (3).

This new therapy, along with other approvals and breakthrough therapy designations for alternate drugs, such as Arexvy from GSK (4),or RSVpreF from Pfizer (5), have given the public health system the feeling it was superlatively winterized. Unfortunately, supply has significantly lagged demand for Beyfortus, to the point that senate democrats are demanding answers about this shortage—lawmakers, led by Sen. Tammy Duckworth, have requested more detailed information from AstraZeneca and Sanofi about the supply issues and why there was unpreparedness for demand (3).

It’s easy to blame pharmaceutical companies, but the situation is much more nuanced than simply stating manufactured supply was too low. While that’s true, and while that’s partly because COVID-19 created an expectation for more vaccine hesitancy among parents than actually occurred, costs and payments played into readily available supplies, meaning payment and incentive systems also needs extra scrutiny in this case.

About half of pediatric vaccines in the US are paid for by the federal government through the vaccines for children program. Its main goal is to remove cost as a barrier so that eligibility is narrowed down to “Medicaid-eligible, under or uninsured, or American Indian or Alaska Native” children (6).

The remainder of vaccines are paid by private insurance; however, payment by insurance companies is made after the pediatrician has administered the dose. As a result of this method of payment, there is uncertainty as to whether the insurance company will cover the full cost of the vaccine, which is risky for the pediatrician (6).

Because most pediatric vaccines are inexpensive, the payment approach by insurers isn’t typically a dominant factor in terms of overall supply and access. However, Beyfortus is much more expensive, costing nearly $500 a dose, which is not likely to be manageable for a medium-sized practice to be able to vaccinate their patient population (6).

While it is debatable if RSV is part of a tripledemic, it is part of a perfect storm when it comes to supply and access of treatment. With demand for treatment difficult to estimate and a novel vaccine with a price tag misaligned with the vast majority of pediatric vaccine precedents; under-ordering from pediatric practices was inevitable andfurther fed into the lower demand models being used by manufacturers for production. Lastly, a lack of natural immunity from being “closeted” due to the pandemic has had a knock-on effect, inflating more cases than would otherwise have naturally occurred. The supply issues with RSV drugs have demonstrated a good case example for industry to learn from going forward.

References

1. MacMillan, C. ‘Tripledemic:’ What Happens When Flu, RSV, and COVID-19 Cases Collide? Yale Medicine Nov. 22, 2022 (Updated: Jan. 12, 2023).
2. FDA. FDA Approves New Drug to Prevent RSV in Babies and Toddlers. FDA.gov, Press Release, July 17, 2023.
3. Weixel, N. Senate Democrats demand answers from manufacturers over RSV drug shortage. The Hill, Nov 17, 2023.
4. Playter, G. FDA Approves First RSV Vaccine. PharmTech.com,May 10, 2023.
5. Pharmaceutical Technology Editors. Pfizer Receives FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate. PharmTech.com, March 2, 2022.
6. Landman, K. The RSV Shot Shortage isn’t Just a Supply Problem. VOX, Oct 25, 2023.