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Clinical Trials Surrounding Effectiveness of RSV Vaccine

Key opinion leaders discuss ongoing clinical trials for respiratory syncytial virus vaccines.

Adam C. Welch, PharmD, MBA, FAPhA: We talked about the RSV vaccine as an annual vaccine during RSV season. There are some persistent data trials under way. We have 2 phase 3 trials that have been published looking at vaccine effectiveness for 1 RSV [respiratory syncytial virus] season, but the data have not been determined for persistence for more than 1 season.

Wanda Filer, MD, MBA, FAAFP: Maybe it will be for 2 seasons.

Laurene Mascola, MD, MPH: Yes, those data are going to be coming out, and it will throw a wrinkle in things if it’s going to be an every-2-year RSV vaccine. It will be interesting to see what’s going to happen because the strains don’t change. It’s either an A year or a B year, but it’s pretty similar from year to year. It will be interesting if the vaccine persistence isn’t for 1 year but lasts 2 years.

Wanda Filer, MD, MBA, FAAFP: If it’s 2 years, that ups the importance of reminder systems.

Laurene Mascola, MD, MPH: Oh, yes.

Wanda Filer, MD, MBA, FAAFP: I can’t remember what I’ve done every other year, and I’m sure I’m not alone in that regard. It goes to the issue of immunization registries, strengthening them, and making sure individuals not only report to them but also can access the information. That’s an issue we run into in a lot of states. But we need to have a robust state immunization registry so the patient can see it and know what’s up. I like to know what my car needs. I’d like to know what my body needs on a regular basis too.

Laurene Mascola, MD, MPH: I like the COVID-19 registries this year. You could get a COVID-19 vaccine card in your Apple Wallet, for example. I have about 7 yellow cards floating around my house telling me when I got my pneumonia vaccine or my yellow fever vaccine. I have no idea what I got. But having that in my Apple Wallet gives me the dates. We have to develop systems for vaccines other than COVID-19.

That’s helpful for me. I’m an older adult who can’t remember what she did yesterday, let alone which vaccine I got in what year. With many vaccines, we need to keep track of them for adults. For kids, there’s a gate. When children have to go to school, you look at your immunization card before you go to school. For adults, there’s no such gate. If you don’t get your vaccines, no one is going to tell you you’re missing vaccines unless your home medical care system reminds you.

Adam C. Welch, PharmD, MBA, FAPhA: With the RSV vaccine, we’re expecting an FDA indication and a CDC [Centers for Disease Control and Prevention] recommendation in early summer of 2023. RSV season tends to peak in the fall. Ms Singleton, will payers be activating early coverage for adult RSV vaccines?

Abby Lynne Singleton, PharmD, BCPS: Payers will work diligently to make sure patients have access to the vaccine as soon as they can. Typically, companies rely heavily on those ACIP [Advisory Committee on Immunization Practices] recommendations, which are published in MMWR [Morbidity and Mortality Weekly Report].

You mentioned the package insert and ACIP. There have been instances in the past when the indication from the package insert doesn’t align with what ACIP recommends. That’s where the situation gets sticky. You don’t want to have an instance where you don’t match that and you don’t match the recommendations for the entire United States. ACIP will sometimes take additional data and break them down by age categories and look further in depth than maybe what they did for the FDA, and then they’ll come up with additional recommendations. That’s where it gets tricky.

Adam C. Welch, PharmD, MBA, FAPhA: How do you see RSV vaccines altering the way we pay for and manage patients who have RSV infections?

Abby Lynne Singleton, PharmD, BCPS: Hopefully, we’ll see a decrease in RSV infections overall. That would be outstanding. For those who get RSV, hopefully hospital admissions and admissions to the ICUs [intensive care units] will decrease. Hopefully, morbidity and mortality will decrease in patients overall and vaccines will prevent those things.

Adam C. Welch, PharmD, MBA, FAPhA: We’ll reduce the overall cost of to health care system when these vaccines become available.

Abby Lynne Singleton, PharmD, BCPS: Yes.

Wanda Filer, MD, MBA, FAAFP: I’m going to raise an issue. At VaxCare, the company where I work, when a vaccine comes to market, even after it’s published in MMWR, the payers are typically required to pay. But sometimes there’s still a delay. If this vaccine is put on the ACIP schedule, as we expect, for the end of June and MMWR doesn’t get published until September, give or take, there’s a 12-week delay in payer coverage. That creates a crunch for the patient when the vaccine could be benefiting them as early as September and October.

It’s going to be very interesting. It’s going to be incumbent on payers to partner up with us, to say this is in the best interest of our clients, the individuals whose lives we insure, to protect them and get it paid for early. I’m going to put a plug in here because that’s money well spent. That’s spending on behalf of your patients—my patients. Waiting 12 weeks to get your systems in order is fair when you already know it’s coming. You should be ready to respond.

Marty J. Feltner, PharmD: That’s a great point. It’s also a financial burden on the pharmacies and the physician’s office that order the product. We may have 90 days if we’re lucky, and we’ve already paid for the vaccine. We got to wait another 30 to 60 days for reimbursement from the PBMs [pharmacy benefit managers].

Laurene Mascola, MD, MPH: The Advisory Committee on Immunization Practices isn’t a governmental organization. It’s made up of individuals from different organizations, and they set the recommendations on how and when to give the vaccine, the spacing between doses if necessary, etc. After the ACIP makes those recommendations, the Center for Disease Control in a month or 2 or 3 turns it into a written document. That’s referred to as the Morbidity and Mortality Weekly Report, which a lot of individuals look at as the bible. But once the Advisory Committee on Immunization Practices makes its go-ahead statement, it’s setting the standard for how the immunization should be given.

Transcript edited for clarity.

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