In this video interview, Paul Offit, MD, of Children’s Hospital of Philadelphia, discusses three preventive measures to protect infants from respiratory syncytial virus (RSV) this season. Offit is also a member of the FDA’s Vaccines and Related Biological Products Advisory Committee.
The following is a transcript of his remarks:
Probably the most important reason for children to come to the hospital is a virus called respiratory syncytial virus, or RSV. People have been trying to make a vaccine against that virus since the 1960s without success, but suddenly this year, there are a couple of options for people trying to avoid RSV.
One is maternal immunization. Pfizer now has a vaccine which — if given between 32 and 36 weeks gestation before the RSV season, which is a winter season, to give that vaccine somewhere between September and January, if that 32 to 36 weeks falls in that timeframe — will induce an antibody response in the mother, which will be passively transferred through the placenta to the baby and will protect the baby in the first 6 months of life.
That’s when you see children getting hospitalized. There’s about 60,000 to 80,000 babies every year that are hospitalized, most are less than 6 months of age, and most of those are less than 3 months of age. So, it’s really too young for an active immune response to work; that’s why the passive immune response seems to be the best bet.
Now, one issue with that vaccine is that when it was submitted for licensure, it was submitted for licensure between 24 and 36 weeks gestation. But there was some concern about the possible risk of prematurity. There had been another vaccine made by GlaxoSmithKline, which was the same vaccine, given at the same period of time, and they ultimately stopped their program because they did have an issue with prematurity.
So when the FDA then licensed this, they didn’t license it for the 24-to-36 week; they licensed it for the 32-to-36 week gestation because they moved everything to the third trimester. So if there is a prematurity problem, it’s much less severe than if it occurs in the second trimester.
The second thing that is available is a monoclonal antibody, a long-acting monoclonal antibody. The trade name for which is Beyfortus and the generic name is nirsevimab, which is given as a single intramuscular injection, again, before the RSV season. It’s about 80% protective against severe RSV infection and 90% effective at preventing intensive care unit admission. So it, too, is a value.
The problem with that is it’s now in short supply. Therefore, even though the recommendation was to give this monoclonal antibody to everybody under 8 months of age before the RSV season, now the CDC has modified its recommendation to just those high-risk groups, meaning children who have chronic lung disease because of prematurity or those who are immune compromised, or children who have cystic fibrosis.
The sad part of that is that that’s not who typically gets hospitalized. I mean, most hospitalizations occur in otherwise healthy children: 80% of hospitalizations are in otherwise healthy children. But nonetheless, at least for this season, and I think it’s going to be the entire season, we are stuck with only giving this product to high-risk groups.
There is a third option which we never talk about, and I think I’m starting to understand why. It’s breastfeeding. Breastfeeding clearly decreases the baby’s chance of having to have an outpatient visit or go to the hospital or worse, go to the intensive care unit. There are 19 studies that have made that very clear.
I think what happens here, and I think one of the reasons we don’t talk about it as much is, first of all, not everybody can breastfeed. Some women are taking medications that are transferred in the breast milk that don’t allow them to breastfeed. Also, people work and it’s very hard, I think, to exclusively breastfeed when you’re working full-time.
So I think that one of the reasons we don’t talk about it as much is the sense that we’re shaming people or making women feel badly if they’re not breastfeeding, because it’s difficult for them. But I do want to say that it is clearly a value, and it is worth at least mentioning for people who make that choice.