SummaryTune into the second episode in our video series focused on Respiratory Syncytial Virus (RSV) prevention. In this segment, Avalere experts discuss RSV prevention products currently in development, specifically maternal immunizations and pediatric vaccines.
Elif: Hello again, and welcome to another episode of Avalere Health Essential Voice. Our podcast show covers a wide range of healthcare topics, and today we’re continuing our mini series on respiratory syncytial virus or RSV.
My name is Elif Alyanak and I sit in the policy practice here at Avalere, and I’m joined today by my colleagues, Mitchell Finkel and Luke Frazier. With today’s episode, we turn our focus to additional RSV prevention products currently in development, specifically maternal immunizations and pediatric vaccines.
Maternal immunizations as a method of RSV prevention in newborn infants is especially interesting. Historically, maternal immunizations or maternal vaccines, have been those that have wide uptake in use among the general population, and then are deemed safe for use in expecting individuals.
RSV maternal vaccines are novel, in that they will be among the first vaccines intended to be given to pregnant individuals for the production of the fetus for the first time, right after the baby is born.
And that’s new, right Mitchell?
Mitchell: Right. This research has been strategically aimed at developing a tool to vaccinate the mother, and provide effective virus prevention to the fetus, through to the baby.
So this will provide immediate protection to the newborn infant at birth.
Elif: And maternal immunizations are actually coming into the pipeline in addition to vaccines being developed to directly immunize children. Right? So how could that impact recommendations?
How would a provider determine which is better to give or to recommend?
Mitchell: Right. Again, we’re talking about three RSV preventive options for infants that are coming to market in relatively quick succession. In the last episode, we talked about RSV mAbs, which are used to prevent RSV in all infants.
Now we’re talking about maternal immunizations and traditional pediatric vaccines.
Luke: Right. As Mitchell mentioned, all three options, assuming regulatory review and approval, will be eligible for assessment and recommendation by the respective country NTAG, or the National Immunization Technical Advisory Group.
In the US, that’s the advisory committee on immunization practices, or the ACIP. These recommending bodies, ACIP included, will evaluate the available evidence post licensure, and make recommendations for use that include the actual schedule and timing of vaccination, and the guidelines for clinical use, such as the population that should be vaccinated, and also the ability for a provider to administer multiple vaccines during the same patient visit, for example.
So we talked previously about how the considerations relative to a pediatric RSV monoclonal antibody or mAb, and how a product like that’s reviewed by ACIP, and how that would be unique.
Right? So now we’re adding the additional considerations of a maternal immunization and a traditional pediatric vaccine for consideration by these advisory groups.
Mitchell: Yeah, and as Luke was saying, ACIP, like other advisory groups in each country, have a framework for reviewing evidence and making a recommendation. Along with assessing the disease burden and epidemiological data, these assessments consider other factors, such as safety and efficacy, cost effectiveness, implementation burden, and other factors before making recommendations for use.
Within the US, the ACIP uses a tool known as Evidence To Recommendation framework. The ETR framework helps ACIP members make recommendations and move from evidence to decisions.
It provides transparency around the impact of additional factors when considering a recommendation. This information is reviewed and considered by the ACIP work group in developing policy options for the ACIP’s consideration amongst six domain; one, public health problem, two, the benefits and harm in intervention, three, values, four, acceptability, five, feasibility, and six, resource use.
So if we assume that all three of these RSV preventive options; mAbs, maternal immunization and vaccines, all receive regulatory approval and demonstrate evidence supporting the recommendation for use, ACIP and similar groups in other countries must also consider how to use these recommendations when other preventive options are available.
Elif: Right, so we understand that NTAGs like the ACIP will review all of this evidence as they fall into these domains holistically, so ideally all equally. What are some unique considerations we should think of as providers try to navigate recommendations for use of both mAbs and vaccines?
Luke: Right, to that point Elif, while providers and recommending bodies like to have multiple options available to assure the supply in different options for different patient situations, there are a lot of different considerations we need to think through with those options available, and also certain situations patients will be in.
Right? So for instance, recommendations will need to consider such situations as maybe an infant that’s protected following maternal immunization, but might not have been born early enough that the protection doesn’t last throughout the entire RSV season.
So should that baby then receive the mAb and, or vaccine option in that instance? Or if we think about what if a baby’s been born prematurely, before a maternal immunization option is available, then what’s the available option for that infant?
Is the mAb and, or vaccine in that case? I think similarly, on a separate point, the current mAb option has been used in high risk infants. Could that influence how new mAb options are used and considered among recommending bodies and providers?
And more over, I think another consideration here is how can the mAb and vaccine options be co- administered with other vaccines by providers among these populations?
So we know that ACIP will always follow the science and evidence provided for a product. Right? And their evidence, and their recommendations, excuse me, will be grounded in data, safety and efficacy.
But they must also consider how these options will be used for RSV prevention and they’ll want to focus on clear and concise guidelines that limit any provider confusion when administering these products.
So I think when thinking about a traditional pediatric vaccine in this space for example, considering the epidemiology and burden of RSV in infants, it’s highly likely that ACIP could readily consider an annual or seasonal recommendation for the use of mAbs and vaccines, like we see with the current influenza recommendation.
Mitchell: And as Luke was saying, we know ACIP is always going to follow the evidence, so we expect additional evidence to be available related to the timing of vaccination in this population.
Mostly because as it stands, the childhood vaccination schedule is quite busy. Children receive a majority of their routine immunizations in the first two years of their life. Evidence generation and review would need to account for the children and parents’ susceptibility and feasibility of a new vaccine in this population, given the complexity of the childhood immunization schedule.
Luke: Yeah, those are all good points Mitchell, and I think that last one in particular, the point on the childhood vaccine schedule, is really important. It is quite busy, and this schedule’s been made even busier by the presence of COVID vaccines, and now possibly broader RSV prevention across all infants.
Right? So I think it’s very important to consider the role that providers play in vaccinating kids and infants. With such a highly prevalent disease, in an ideal scenario, physicians would want to have multiple tools at their disposal to prevent RSV in these populations.
Of course, safety and efficacy will be critically important, but another factor, I think duration of protection, will play into decision making as well. So if maternal immunizations or mAbs provide protection for a period that may not cover the entire RSV season, how is that protection then supplemented to ensure protection throughout the entirety of this season?
And for how many seasons should babies be protected for then subsequently? Is it just the season during the first year of life, or should some babies be protected for a second season as well?
Or should that just be reserved for those at highest risk for RSV? I think there are a lot of considerations that still need to be worked through in this space.
Elif: I think the two of you have really highlighted how the scientific evidence will be of utmost importance here. With these potential considerations for use and recommendation in place, there will also be important implications in terms of access to these products.
Right? What do we think will happen in terms of coverage pathways, Mitchell?
Mitchell: Yeah, that’s a good question. We expect that both maternal immunization and the pediatric vaccines will follow traditional vaccine like pathway, meaning they would be FDA approved and then receive an ACIP recommendation.
That ACIP recommendation, we expect to trigger private sector coverage for both the maternal immunization and the pediatric mAb. When we think about maternal immunizations, we also expect it to be covered by Medicaid, especially in light of the Inflation Reduction Act’s required coverage for adult vaccines.
For pediatric vaccines, we also expect vaccines for children inclusion. So all children should have access the vaccine, no matter their insurance status.
Elif: It certainly is really important to consider the innovation coming for RSV prevention in infants. And while there are unique consideration for both recommending bodies and providers, I think ultimately we’ve seen that the evidence generated, and the current programs and statutes providing access and coverage, will really play into how these products will be used in preventing RSV across infants.
I think this was a really great conversation and I want to thank you Mitchell and Luke, for joining me today. And thank you all for tuning in to the Avalere Health Essential Voice podcast. Please stay tuned for the additional episodes we have in this RSV mini series, as we look towards RSV prevention in older adults, which has been a long time goal when we talk about vaccination across the life course.
If you’d like to learn more, please visit us at our website, www. avalere.com.
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