The countdown to winter is something Utahns look forward to. December, though, also ushers in RSV season, and for parents expecting new babies later this year, that can fill them with dread. Respiratory syncytial virus causes cold-like symptoms in a lot of people. But in babies, it can be serious.
There was also a big impact last year since the season was part of a tripledemic that included flu and COVID-19.
“Last year was the worst I've lived through,” said Dr. Andy Pavia, the director of epidemiology at Primary Children's Hospital, “but every two or three years we have an overwhelming RSV wave.”
Nationally, RSV puts up to 80,000 kids in the hospital every year, including the ICU. About 1,000 of those admissions are to Primary Children's Hospital in Salt Lake City.
But now there's a new drug called nirsevimab (marketed as Beyfortus) that can prevent RSV. It was approved by the Food and Drug Administration earlier this summer. And the Centers for Disease Control and Prevention have just recommended it for babies under 8 months old.
For the upcoming RSV season, Pavia said the new medication could have a “huge impact on parents and their children.”
In clinical trials, Beyforus was more than 75% effective at preventing hospitalizations. The drug is a shot of antibodies timed to boost the immunity of babies during their first RSV season.
For babies born in October and later, the shot can be given in the hospital or at the child's first doctor's visit — usually before the baby is two weeks old. Babies born earlier in the year could still get the shot in the fall.
“One shot will provide protection, if it's given in the fall, for the entire RSV season,” Pavia said. “And then by the time a child's entering their second year of life, they'll still be able to get RSV, but it will be much more like a cold at that point.”
Pavia called the drug “remarkably safe so far.” Because it isn't a vaccine, it doesn't ramp up the body's immune response to cause fevers and sore arms. The one risk could be an allergic reaction to the protein in the medication.
“But in the first year of life, children have a lot less allergies than they do later on and so we expect that to be very rare,” Pavia said.
Pavia thinks Beyfortus will be available to patients in Utah in September. And just this week, the Food and Drug Administration approved an RSV vaccine for pregnant people. But Pavia thinks it won't make as much of a difference this season – he said it will take a while for obstetrical providers to start stocking it, and it might take a while for people to choose the vaccine.
This interview has been edited for length and clarity.
Ciara Hulet: Beyfortus is a monoclonal antibody. It's not a vaccine, which means it may not be covered by insurance. Will families be able to find a way to get it paid for anyway?
AP: We expect as a preventive measure that, according to the Obamacare ACA [Affordable Care Act], it will have to be covered within a year of its being licensed. But that does give insurance companies a year to avoid paying for it. We hope that they'll do the right thing and pay for it right away, but they're insurance companies, so that remains to be seen. We expect that Medicaid will fairly soon announce that they're going to cover it, and it's covered under something called the Vaccine for Children Program, which is a program the federal government put in place that provides free vaccine to children who don't have private insurance and don't qualify for Medicaid. I do think that we'll hear fairly soon from Select Health, one of the larger insurers in Utah, that they will cover it. And if they don't cover it, they'll be hearing from me and many other physicians who think that that was a bad decision. But I think they're going to do the right thing fairly soon.
CH: What do you think Beyfortus will cost parents?
Andy Pavia: It's going to cost about $480 for the hospitals to buy a dose. I hope that that would be the maximum cost that a family would have to pay out of pocket. If you have insurance, but it doesn't cover this specifically, it will count against your deductible. In the year that you have a baby, you typically spend out your entire deductible. So maybe there won't be any extra cost out of pocket.
CH: If parents do have to pay out of pocket, how do they decide if the benefits outweigh the cost?
AP: If a typical hospitalization for RSV is two to three days, that's at least two to three days of lost work, plus maybe another day or two where you still have to stay home and help suction your child's nose so they can breathe. It might be a visit to the emergency room that's avoided. An emergency room visit usually starts at about $1,000 and goes up. So, yes, if your child gets RSV, you will save. You would have spent a lot more than the $480.
CH: Where do parents get this shot for their babies?
AP: Ideally, they'll get it before they leave the hospital, and if they don't, then they should get it at their first visit to the doctors, which would be at one or two weeks of life. And most offices will be trying to have it in stock and giving it.
Now, here's another wrinkle. Offices have to buy these products in advance, and then they get reimbursed by insurance when they give it to you, and they get paid to do that. But for some very small practices and for some rural practices, they may not have the means to purchase it in advance and keep it in stock. So one of the ways we're looking to fill that gap is by having health departments throughout Utah make it available in their vaccine clinics. It will be a decision made at the individual health departments. But I imagine that certainly all of the big health departments along the Wasatch Front will be able to provide it.
