Frustration grows amid struggle to roll out new RSV, COVID shots for children

Insurance barriers and distribution challenges are marring the rollout of highly anticipated new shots to protect babies from respiratory syncytial virus (RSV) and young kids from COVID-19, drawing anger and frustration from parents and pediatricians. 

Medical practices don’t know when, or how much, they will get paid for the pricey RSV shot, and they are struggling to find workarounds. 

For the updated COVID-19 vaccine, parents are finding availability is scattered, despite it being approved nearly a month ago. 

The vaccines come in different packaging and different dose sizes depending on the brand, and the Centers for Disease Control and Prevention (CDC) only recently said it’s OK to mix and match brands for young kids. 

Some pharmacies also have age cutoffs, meaning a visit to a pediatrician is the only way to get a young child vaccinated.

Alexis Young has been trying for weeks to schedule a COVID-19 vaccine for her three-year-old son, who started school for the first time ever this year. 

Young lives in a semirural area outside of Olympia, Wash. She said her pediatrician doesn’t have any doses, and the only two chain pharmacies she was able to find appointments at were out of network in her state Medicaid plan. 

“Every pediatrician in town that I’ve called says, ‘I don’t know, we have some ordered,’ or, ‘We haven’t ordered them at all.’ … It’s been this long chain of phone calls going from place to place to figure out where I’m gonna get my kiddo boosted. And I still have no idea,” Young said.

The struggles and headaches come as the U.S. enters a fall respiratory virus season with new COVID-19 variants already circulating, and the situation reflects the fact that the federal government is no longer buying and distributing most of the vaccines. That task has instead been left to the private sector and the U.S. health system.

This year “should be a respiratory virus season where we have more protection than we’ve ever had,” said Sallie Permar, chairwoman of the department of pediatrics at Weill Cornell Medicine and New York-Presbyterian Hospital. 

But instead, “it is like a puzzle that we all have to solve on how to get it not only for ourselves, but also for our children. And those processes don’t often overlap,” Permar said.

Pediatricians said Moderna’s single-dose vial reduces potential for waste. Pfizer still relies on three separate doses, and once a vial is punctured, it needs to be used within 12 hours. 

Pfizer recently announced a new return policy, under which physicians can return either unopened or partially used vials at any time, for the full invoice price. Still, Pfizer is easier to find. Pediatricians say even if they get Moderna doses, the amounts are limited, making it extremely hard for parents to find the appropriate shot. 

The new shot for RSV is causing even more headaches. 

For years, there have been no drugs that can prevent RSV, a lower respiratory tract disease that’s a leading cause of hospitalization in young children. RSV leads to about 58,000 to 80,000 hospitalizations and 100 to 300 deaths per year in children under 5 years old, most of them infants, according to the CDC.

Sanofi’s Beyfortus was approved in August. It’s a monoclonal antibody called nirsevimab, rather than a traditional vaccine, meaning babies will be able to directly receive antibodies to prevent severe RSV disease, rather than prompting the immune system to develop them. It cuts the risk of hospitalizations in infants by about 80 percent and was hailed as a game changer.

But the drug costs $495 per dose in the private sector, and according to pediatricians, it’s unclear if insurance companies will reimburse them for buying and administering it.

“Pediatricians generally are nice people who want to do the right thing. But if doing the right thing costs them a significant amount of money that they’re gonna lose and never get back, it may not be worth making the upfront investment,” said Suzanne Berman, a pediatrician in Tennessee.

A spokesman for the manufacturer Sanofi, which markets Beyfortus, said that as of October 1, coverage is in place for more than 90 percent of infant lives.

The company is also offering extended payment terms for doctors who purchase directly from Sanofi, meaning providers can order and receive Beyfortus to administer right away but they don’t have to pay back Sanofi until later this year, towards the end of RSV season.

Hospital systems are also struggling to figure out which insurance companies will reimburse for Beyfortus and when the coverage will start. The Affordable Care Act requires insurance companies to cover drugs like Beyfortus for free. But insurers have up to a year to add new products to their plans.

CDC officials told members of the American Academy of Pediatrics during a meeting last week they were working with insurers to impress the need for rapid coverage.   

The CDC approved Beyfortus for use in all infants up to 8 months old. Doctors said the best time to administer the drug is right after birth, if possible. 

“It would be wonderful if all birthing hospitals could administer nirsevimab before a newborn is discharged. But it doesn’t appear that that is financially feasible this year because of reimbursements,” said Kristina Bryant, a hospital epidemiologist at Norton Children’s Hospital in Louisville. 

Bryant said her hospital system hasn’t received doses yet, and the process for figuring out reimbursement is complicated.  

“You need to understand if it’s going to be reimbursed, are insurance companies requiring prior authorizations. You need to know how to counsel families. Does their insurance company cover that or not? What are their options if their insurance company doesn’t cover it? And so this takes time,” Bryant said.

But time is a luxury that children don’t necessarily have. 

RSV season is already underway in Florida and Georgia, and it will spread to the rest of the country later in the fall.

COVID-19 cases were rising even before most schools started in mid-to-late August. 

Buddy Creech, a pediatrician at Vanderbilt University Medical Center and president of the Pediatric Infectious Disease Society, said it’s common for providers to run into distribution challenges with new immunizations. 

“Right now we have two brand-new vaccines. We have an updated COVID booster. We have [a maternal] RSV vaccine and an RSV monoclonal that have never seen the light of day, and there’s an on-ramp there,” Creech said. 

“The challenge is that the season is upon us. COVID is here, RSV is showing up in many of our communities. So there’s a sense of urgency … We’re doing this for the very first time, and unfortunately, we happen to be doing it right as the respiratory season begins to start in earnest. In many ways, the timing could not be worse,” Creech said.

Updated Oct. 11 at 11:44 a.m.