A new immunization to protect babies against RSV was approved by the U.S. Food and Drug Administration this summer. It should be available in the Richmond area this fall, though a specific timeline of availability for providers across the state is still to be determined.
It’s called nirsevimab, and the brand name on the market is Beyfortus. It’s recommended for all babies up to 8 months of age as well as older babies with underlying health issues.
“This is the first year that we will have something [to help prevent RSV] for all babies, and not just those kids who are the most at risk,” said Dr. Tiffany Kimbrough, a pediatrician at the Children’s Hospital of Richmond at VCU.
Kimbrough said the hospital’s outpatient arm recently received the final layer of regulatory approval to offer the new drug and anticipates that it will be available for families by early October. Kimbrough said the hospital system is working on getting approval for inpatient administration of the immunization, and she hopes it will be available soon both in the hospital setting as well as physician offices.
“We're still very much in the logistics phase of getting this rolled out,” Kimbrough said. “I think availability is going to be the No. 1 logistical hurdle for this year, since we just got the approval as we're coming up on this season.”
She’s hopeful that with the new immunization this RSV season — which she said typically runs from October through March — won’t be like last season. Cases surged, resulting in more serious RSV cases among young babies and more pediatric hospitalizations. CHoR saw so many cases last fall that staff had to transfer babies to other facilities across the state.
“None of us want to turn away kiddos when the hospital is full. There were a lot of phone calls happening across the state [saying], ‘I have a bed, I have a bed,’ and kids getting transferred,” Kimbrough said.
RSV is a respiratory virus and Kimbrough said mild cases can just look like a cough and congestion with a low-grade fever. More serious cases — for which parents should seek medical attention — will come with symptoms like wheezing, an increased breathing rate and trouble breathing.
“For kids, that looks like their nostrils flaring, their ribs sucking in or their belly [being] really keeping hard when they're trying to breathe,” Kimbrough said. “All of those signs, especially in a young infant, are going to be reasons you're going to want to seek a higher level of care to make sure that your child's doing OK, and then get the support that they might need.”
In prior years, only immunocompromised children were recommended for a medication called palivizumab, sold under the brand name Synagis, to protect against RSV. Kimbrough said it wasn’t recommended for all young babies primarily because of cost, and it also had to be administered as five doses over five months, whereas this new drug only requires one shot each RSV season.
“There's no other single-dose product available right now,” Kimbrough said.
New vaccines have also been approved to protect pregnant people and those over age 60 from RSV as well. There’s been a lot of interest across the state in these new drugs, said Christy Gray, the director of the division of immunization at the Virginia Department of Health.
Gray said doses haven’t been ordered for localities and providers yet because some final logistics — like who will pay for the drugs — are still being worked out. She noted that the new immunization for babies will be part of the federal Vaccines for Children program that VDH administers. That means it will be available to families without insurance, as well as those on Medicaid.
“We are expecting we can have this product out into the field and into arms or legs this fall,” Gray said.
