The RSV Immunization Is a Game Changer. Why Is It So Hard to Find?

Updated on 2024-02-19 14:29:15 0 0

By Rachel Murphy

Fact checked by Nick Blackmer

Illustration by Zoe Hansen for Verywell Health.

Key Takeaways

The new RSV immunization for infants is in high demand and short supply, which the manufacturer is working with the CDC to resolve.
The immunization, called Beyfortus, is expensive and not all insurers are covering it yet.
Pregnant people can get immunized during their third trimester to impart protection to their infants.

Bronchiolitis caused by respiratory syncytial virus (RSV) is the leading cause of infant hospitalizations, so when long-acting monoclonal antibody nirsevimab was approved in July 2023 for use with infants, pediatricians were thrilled.1 But as RSV season has begun, parents are struggling to find the immunization, despite the best efforts of the government and pediatricians.

The scramble led the Centers for Disease Control (CDC) to issue a late October Health Alert Network (HAN) Health Advisory to reserve 100 milligram (mg) doses of the immunizations for the highest risk children: those under 6 months of age and those with underlying health conditions that make them more susceptible to RSV.2

Here’s how it happened and what you can realistically do to get protected.

Supply Issues

Although excitement for nirsevimab, produced by Sanofi under the brand name Beyfortus, was high, the company failed to anticipate how intense the demand would be. According to Jesse Hackell, MD, chair of the Committee on Practice and Ambulatory Medicine for the American Academy of Pediatrics (AAP), parents have been eager to get the shot, leading to a shortage of 100 mg doses meant for infants over 11 pounds.2

“It’s no longer available for us to order because it’s been spoken for,” Hackell told Verywell. “I’ve heard rumors that I can’t confirm that [Sanofi] isn’t planning on making any more this year.”

Sanofi has issued a statement claiming they are working with the CDC and their manufacturer, AstraZeneca, to deliver additional doses, but as of October 26, they have not given a timeline of when more doses will be available.

Hackell said that most pediatricians have had much greater interest from parents in the RSV immunization than in shots such as the COVID vaccine.

A Matter of Cost

For physicians who still have doses of Beyfortus, there are additional roadblocks. Since Beyfortus is a monoclonal antibody and not technically a vaccine, some insurance companies are unsure how to classify it. Instead of covering it automatically and reimbursing physicians for the appropriate cost, some insurers are slowly deciding whether to cover the cost and how much to pay out.

This ambiguity is a sticking point for practitioners, as each dose of Beyfortus costs $495. Hackell said that many pediatricians are waiting to see if they will be reimbursed for the drug and, if so, how much.

“Some payers have indicated that they will be paying appropriately,” he said. “Others don’t have it loaded in the system, so you can’t find it. It’s not reasonable to expect pediatricians to commit to spending the money if they don’t know that if they administer it, they will get appropriately paid for it.”

Hackell said that while some insurance payers will say Beyfortus is covered, they may only commit to paying a portion of its cost, leaving pediatricians footing the bill for an expensive drug.

Despite the cost, some children receive the immunization without issue: those covered by the Vaccines for Children (VFC) program. Although Beyfortus isn’t technically a vaccine, the program has made a special exception to include it in the prescribed immunizations recommended for those under five.3

This federally-funded program provides vaccines at no cost to children who may not be able to pay for vaccines due to cost or lack of insurance. Physicians don’t have to pay for vaccines through VFC upfront. Hackell said that many pediatricians have supplies of Beyfortus for VFC children but don’t yet have it for privately insured patients.

“It becomes an equity issue,” Hackell said. “We can’t treat our patients the same way, and that doesn’t make us comfortable, but it’s the situation we’ve been placed in through no fault of our own because of the costs.”

A Secondary Solution

Until the supply of Beyfortus stabilizes, there is a secondary solution: vaccination while pregnant. Purvi Parikh, MD, medical director at Allergy and Asthma Associates of Murray Hill, says that pregnant people between 32 and 36 weeks gestation are the ideal candidates for the adult RSV vaccine called Abrysvo. If given at least two weeks before birth, the parent will share antibodies across the placenta, providing enough protection that Beyfortus isn’t necessary.

Hackell said there have been few issues with the adult RSV vaccine, so the next hurdle is convincing parents to take it and let their children’s pediatricians know that they are vaccinated, eliminating the need for infant immunization.

Sources

Suh M, Movva N, Jiang X, et al. Respiratory syncytial virus is the leading cause of United States infant hospitalizations, 2009-2019: a study of the National (Nationwide) Inpatient Sample. J Infect Dis. 2022;226(Suppl 2):S154-S163. doi:10.1093/infdis/jiac120

Centers for Disease Control and Prevention. Limited availability of nirsevimab in the United States—interim CDC recommendations to protect infants from respiratory syncytial virus (RSV) during the 2023–2024 respiratory virus season.

Centers for Disease Control and Prevention. CDC’s Vaccines for Children program addendum: special considerations for nirsevimab.