Opinion
Video
Prophylactic Use of Monoclonal Antibodies for RSV in Infants
Preemptive treatment strategies for pediatric RSV are discussed by key opinion leaders.
Adam C. Welch, PharmD, MBA, FAPhA: So if these monoclonal antibodies are relatively short as far as the duration of protection that they provide and we’re not quite sure when the RSV [respiratory syncytial virus] season is, how can we best utilize these types of antibodies to protect infants when they’re born throughout the year?
Debra Boyer, MD, MHPE: There have to be policies that are fluid and can shift with the changing epidemiology that we see and with the changing illness that we see in these children. Having policies that are static, you can’t do that before October and you must stop them in March, is not going to be the best strategy. I don’t know whether Dr Chen has other thoughts, but that was my take from all this.
Kimberly C. Chen, DO, MSHLM: I agree with you. We all want to make sure [we use] patient-centric practices. And what makes sense and what affects the disease, that’s what we need to do to protect our patient. But one of the things we also [have] to keep in mind is patients [with] high-risk [disease], especially those [who] are immunocompromised, the ones that we talked about with lung disease, heart disease, congenital heart disease. If they’re in the process of being discharged from the hospital, it’s very important for the health plan. Always have a case manager. Just like the hospital’s case manager, they should work together on making sure the patient has good discharge planning. We talked about [the fact that prior authorization] takes at least 40 days, making sure we get that prior authorization start working on that. That way, patients, when they need the immunization, they are not waiting for that [preoperative care]. You handle things as such and make sure patients are supported. Those are critical for [a] health plan [and] a hospital case manager to work together to better support the patients.
Adam C. Welch, PharmD, MBA, FAPhA: We have this strategy to provide antibodies to infants to prevent RSV. And we talked about some of the challenges in that strategy. And this is fascinating because, and we’ve done this before with pertussis, there’s another strategy where you can vaccinate the mother while in the second half of pregnancy. And what will happen is [the] mother will build antibodies [and] pass them to the child. And when the child is born, they have a certain level of protection against pertussis that will provide that protection until they can get the vaccines for themselves over the 5 doses that they need in childhood. So there’s a maternal immunization strategy, and then there’s the fetal immunization strategy. We vaccinate all babies hours after delivery for hepatitis B, for example. Now we’re talking about RSV, and we have the option of the maternal strategy or the fetal strategy. So Dr Boyer, what do you see as the benefits and drawbacks of those 2 strategies?
Debra Boyer, MD, MHPE: Just as you said, they each have benefits and challenges to them. The concept of maternal vaccination was fascinating and great, a free transfer of antibodies, two for one: vaccinate mom and [the] baby get[s] some too. So [findings from] the studies show about an 82% efficacy to the instance of preventing severe RSV disease in the first 90 days. So that’s great because that’s a high-risk period for any symptoms. The challenge is that one of the highest-risk groups is [for] very premature infants. There’s no transplacental transfer of antibodies before 32 weeks of age or very little. If you’re born before 32 weeks of age, you’re not getting any benefit from it, and [it depends] on exactly when the moms are vaccinated. But these very premature infants are not going to get any significant amount of antibody, and they are the highest-risk group. So it can be effective for full term, and then some will provide some protection but only for about 90 days. And that’s where some sort of collaborative strategy or a multimodal strategy is going to need to be. Because after that time, the antibodies from the mom are no longer there and no longer protecting the baby. So there is a concern, as pregnant women [have], about getting vaccinated. So you have to balance the risks of preterm labor. But I don’t think they were found to be very substantial with maternal vaccinations.
Adam C. Welch, PharmD, MBA, FAPhA: You bring up an interesting scenario. If [the] mom was set to receive the vaccine at 32 weeks but the baby was born before 32 weeks, the baby is not protected. And furthermore, if that protection is only 90 days, then people who remain at high risk for severe RSV need a multimodal approach in order to optimize that care.
Adam C. Welch, PharmD, MBA, FAPhA: Dr Boyer, let’s talk now about some of the newer monoclonal antibodies that were just recently FDA [US Food and Drug Administration] approved. Can you speak a little more about the new RSV preventive antibodies story?
Debra Boyer, MD, MHPE: It’s interesting and hopefully will change how we look at this in this field. But this is a new monoclonal antibody. And what’s great about it is it has a prolonged half-life. So it means it’s 1 dose, and that can cover the infant over the entire RSV season. A lot of the issues that we’re talking about in terms of getting hydrocodone, getting them in every month to get their vaccines, would no longer be necessary. And this is looking like it will be effective in not only preterm, healthy, late preterm, full-term infants. There was a 76% efficacy noted in preventing lower airway disease. So that’s fascinating. And a decrease in doctor’s visits and hospitalizations are a little under 80%. As you alluded to, it’s good [that the] FDA approved for all infants, and it’s now awaiting the more formal CDC [Centers for Disease Control and Prevention] and ACIP [Advisory Committee on Immunization Practices] recommendations. So hopefully that will come out soon, and that could change the landscape.
Transcript edited for clarity.
