President's Podcast: Preparing for the upcoming respiratory virus season

Carlos del Rio: [00:00:06] Hi, I'm Carlos Del Rio, president of IDSA. Welcome to the Let's Talk ID podcast. Joining me today is Dr. Meghan Pennini, the chief vaccines and therapeutic officer of H4. And H4 is the HHS coordination, operations and response element of the Administration for Strategic Preparedness and Response, ASPR At HHS. Today we are talking about the upcoming respiratory illness season, about specifically COVID-19 treatments and vaccines along with flu and RSV vaccination. Welcome, Meghan, and thanks for joining me today.

Meghan Pennini: [00:00:37] Thank you. I'm really happy to be here and very happy to share what I can about the upcoming respiratory virus season.

Carlos del Rio: [00:00:44] Fantastic. Let's go ahead and get started. One thing that we've all learned is that making predictions is difficult, particularly when it involves the future. But it's particularly difficult when it involves respiratory viruses. Nevertheless, what do you expect will happen this fall, this winter, with respiratory viral infections?

Meghan Pennini: [00:01:01] What we do expect with certainty is that we will see SARS-CoV-2 circulating, as well as RSV and influenza. So we do expect all three of those to be circulating. At the same time, we want to make sure that everybody understands what all three of those mean and what their risk factors are, individuals and what their risk factors are, and what providers have, physicians have, in their toolkit to help those that are at risk. In that vein, right, we do have treatments for both Covid-19 and for influenza. And for the first time this season, we have vaccines to protect against each of these viruses. So we do have now vaccines against Covid-19 and flu and also RSV. So that's really exciting for this upcoming season. And of course, we just want to stress that being up to date on vaccines is really important for health care providers to understand and of course for patients to understand that that is the best way for them to prepare for this upcoming season. One just last note, especially on treatments, specifically for the Covid-19 treatments, they are still available. And right now the oral antivirals for Covid-19 are still free, being distributed by my agency, ASPR within HHS.

Carlos del Rio: [00:02:16] It's incredible that we have now increasingly an armamentarium for viruses that not too long ago we all we had to do is basically say, you know, matzo ball soup and a Kleenex and stay home and that's about it. Now we actually have therapeutic options. And part of it I think it's because of the of the research that has been accelerated by Covid and by funding from HHS and other, you know, the government and other places to really develop, you know, better vaccines and bear therapeutics for these viral infections. You mentioned treatments. Let's talk a little bit about Covid treatments. What treatments are available?

Meghan Pennini: [00:02:51] Covid cases are on the rise. If you look at the latest data, you see week over week, hospital admissions for Covid-19 are up above 20%, increasing by 20% deaths by Covid-19. Also, unfortunately, on the increase. We've come such a long way in reducing those numbers over the course of the pandemic, but we still want to make sure that the tools that we have are being used to get those numbers even lower. We really do think we can get those numbers even lower for those people that are at higher risk. The treatments are important part of that for high-risk patients with mild to moderate illness, so these are prehospital space, there are two oral antivirals that are available. They are still being distributed by the US government. That's Paxlovid, which of course is Nirmatrelvir co-packaged with Ritonavir and Molnupiravir. Also available is remdesivir in the outpatient space, but that is available commercially. That's not something being distributed by HHS. And that of course, is not an oral medication. That is an infusion over the course of three days. But each of those oral antivirals that I talked about and of course, Veklury as well, really the data is very convincing that they've been shown to be safe. They've been shown to be effective. We especially want to stress that treatment of the oral antiviral with the oral antivirals needs to be done within five days of symptom onset. And I mentioned that because we continue to hear from patients and sometimes from providers as well. You know, I'll wait till the patient is sicker or as a patient themselves says, Well, I'll wait till I feel worse, which really is not the right way to think about antiviral medications in general.

Meghan Pennini: [00:04:25] We know not just from Covid, but we know from decades of research with antivirals, that the sooner you start treatment, the more effective they will be. So really just want to stress that we shouldn't really be waiting until symptoms get worse. If somebody is high risk for severe outcomes, those treatments should be given to that patient as soon as possible. The treatments are a little bit different, right? As a reminder, the lagevrio molnupiravir is authorized only for use if other approved or authorized treatments are not appropriate or accessible. So that means paxlovid and outpatient remdesivir should really be used as the first option. And then the lagevrio molnupiravir can be used as an option if either of those products are not clinically appropriate or accessible. We know that paxlovid can sometimes be more difficult to prescribe because of the drug-drug interactions, but there are a lot of great online tools that can help physicians walk through that. The most notable one is the Liverpool Interaction tool. A lot of providers find that very useful and that can really again help providers understand how to deal with patients that are on other medications and how to prescribe paxlovid specifically with individuals, medical records. All of these medications right now are active against the currently circulating variants. So that's also another really important point. We are consistently updating our database to make sure that these medications, that these are still effective against the variants that keep popping up. And right now it's looking really good. All three of the medications that I mentioned, the two oral antivirals and remdesivir are all still anticipated to stay effective against the currently circulating variants.

Carlos del Rio: [00:06:10] Yeah, I think that's a lot of really useful information. I will also remind our listeners that the Infectious Society of America has a Covid-19 treatment guidelines and we update them regularly and you can get the information there and you also can get information on the drug-drug interactions. But I agree with you. I think there's three barriers that I see for antivirals. Number one is, is people don't know when to use them. Right. And I tell people, you need to use them in the right populations, like somebody an elderly individual. And we know that most people dying right now of Covid are over the age of 85. So if somebody's 82, 83 years old gets diagnosed with Covid, you don't wait until you get sick. You need to prescribe an antiviral to prevent them from getting sick. And this is what is very important to get into people's head is that we got to use these drugs early and we have to use them in such a way that the person does not end up in the hospital. You're worried about drug interactions. Most of them are very easy to manage. The most common one that I deal with is statins. And most patients you can stop the statin and then you can start the antiviral. And after you finish the antiviral, wait a couple of days and then restart the statin. There are few drugs that is a little more complicated to deal with. And in those situations you have remdesivir and you have also molnupiravir. I think I would have no difficulty in giving, you know, an 80-year-old individual molnupiravir because you're not worried about teratogenicity or other issues.

Carlos del Rio: [00:07:31] That's barrier number one. Barrier number two is, again, the drug-drug interactions that you mentioned. Barrier number three is the whole issue of a rebound. People have gotten into their head that paxlovid rebound and people say, well, if I take the medication and then I get the rebound, I'm going to have to stay isolated for longer than I wanted to. So why take the medication? And I remind people that you don't need to take antivirals to have a rebound. We see rebound in people that didn't get treatment. It may be a little more common in people that get treatment, but if you are of the right age, I'd rather have somebody have a rebound and most people rebounds don't end up in the hospital, don't end up sick. But what you don't want is to end up in the hospital if you're over the, especially elderly or immunosuppressed patients. So yes, we got antivirals. We need to use them better. We need to educate providers about the use of treatments. We need to get patients to really advocate for the treatments and access them effectively. And I think it's really important the information that you gave that there's still for now available for free, those antivirals are still available for free and for the foreseeable future, we still have supply that you can if you have prescription, you go to the drugstore and get paxlovid or molnupiravir as an outpatient or you get IV remdesivir as an outpatient infusion, but those antivirals are still available. So treatment is a game changer and we need to use it more effectively if we really are to decrease mortality.

Meghan Pennini: [00:08:48] Agree with everything you're saying. And just want to reiterate, too, there's other people at risk. Elderly, obviously, that is a big population, but also the immunocompromised, dialysis patients. You know, there is a list and you can certainly get more details. But as you said, it's really important that people understand the risk factors, their own risk factors, and that physicians understand those risk factors, too, and give the medications. We haven't heard about rebound as a hesitation in recent times, right? But we've heard that before. But I think you're right. I think that's still out there. And so I appreciate you mentioning that and exactly what you said. There's a lot of good studies showing that that happens regardless of whether you're taking a treatment or not. And the good news is those rebounds usually do not result in severe outcomes.

Carlos del Rio: [00:09:32] I hear the rebound story from providers who say, well, I'm not going to prescribe it. So I think we need to educate people of what rebound is. And you know, it may be actually a good thing to have. I mean, I remind people the president had rebound, Dr. Fauci had rebound. So, you know, but they still receive their therapy because they were at the age that you need to get therapy.

Meghan Pennini: [00:09:49] Absolutely.

Carlos del Rio: [00:09:50] But let's talk about vaccines. You know, up to now, we have been used to HHS being sole distributor of Covid vaccines. But now that they're authorized by the FDA and now we're going to be seeing the companies have submitted applications to the FDA for the new monovalent boosters, we're going to talk about them, how is that changed now, the availability of vaccines? Today, I got an email from Pfizer saying you can pre-order your vaccines.

Meghan Pennini: [00:10:13] And that's good. We want there to be a smooth transition to these products going to commercial market. You're right, the vaccines are coming first. So we do expect that transition to commercial market in sync with the availability of the updated Covid-19 vaccine. All that to say that we do expect this and as soon as a couple of weeks. So really mid-September. We do expect and again there you know, have to have to caveat that. But as long as the FDA does take action and authorizes and approves those updated vaccines, that will be when we stop distributing the vaccines that we currently do. And everyone will go back to sort of their normal course of business on how to access those vaccines from commercial sources. We, of course, still, as HHS, are still interested in making sure there's broad access to those commercial vaccines. So I'm glad to hear that you're already getting emails about pre-ordering. I think that's fantastic. We want to make sure that these updated vaccines are available as much as they are now, and we want to make sure that there's still a no cost access scenario for every individual. So that means for the uninsured, that means for the underinsured that everyone is able to access these vaccines at no cost. For most Americans, that means that they will just get it through their normal insurance because preventive vaccines are usually covered at 100%. But for anyone who doesn't have insurance or for whom 100% coverage is not part of their insurance plan, there is the HHS Bridge program. And so they will be able to access those vaccines again at no cost through that program.

Carlos del Rio: [00:11:45] Yeah, I heard about Bridge recently and I think it's a wonderful program. And again, I want to emphasize that this is a way to promote health equity and vaccine coverage. And what we want to have is immunological equity, right? We want to be sure that everybody is protected regardless of their ability to pay. So we all are expecting this new monovalent booster targeting XBB 1.5. When do you think it will become available?

Meghan Pennini: [00:12:08] We're thinking everything is on track again for that mid-September timeframe. That's what we're all collectively gearing up to be sure we're ready for.

Carlos del Rio: [00:12:16] We're obviously speaking as friends here and as colleagues. The VRBPAC will meet, and then the CDC, ACIP will meet. And I've heard two different camps, right? It's a camp that says, I mean, we're the only country that recommended boosting for people six months of age and older. And when this new booster arrives and again, I hate to call it a booster because I'm not sure what exactly why we're calling it a booster. It's a new monovalent Covid vaccine of 2023. You think it's again going to be recommended for everybody six months or older? Are we going to be more targeted to specific populations?

Meghan Pennini: [00:12:53] I agree with you on the booster. We are trying to move away from that booster language and just talk about getting an updated vaccination as the virus evolves. So similar to how we get sort of updated flu vaccinations to be responsive to the current flu season, that's the nomenclature we have switched to for Covid-19 as well. Back to your question about who will it be recommended for, that is really under the ACIP and CDC purview. But I do think that there will be recommendations for everyone to stay up to date as that's currently recommended. And I do expect that that will be the same recommendation. The virus is evolving and we want to make sure that everybody is just staying up to date, getting the latest version of the vaccine so that they can have the most robust efficacy against the currently circulating variants, and the way the best way to do that is to get these updated vaccines as they come out.

Carlos del Rio: [00:13:46] Time flies and the virus changes and doesn't wait for us. So the decision by the FDA, the recommendation was to target this vaccine to the XBB 1.5, which was the most common variant in circulation back in June. But since then we had EG.5 emerge and we know that the coverage there should be pretty good. But then we have this new curve ball BA 2.86 that has a lot of mutations and a lot of more immune escape. And you start wondering what's going to happen with XBB 1.5 monovalent vaccine. Is it going to be sufficient or are we seeing viral escape while we've been developing our vaccines and that, I think, is going to be a question that we're going to answer over time I think.

Meghan Pennini: [00:14:28] We've been with this virus now for a few years and we're learning a lot as we go. We're trying to figure out and stay ahead of it. Of course, we ran into some problems with the with the monoclonal antibodies on the treatment side. Right. Trying to sort of stay ahead of of the evolution of the spike protein. But back to your question on vaccines. The EG .5, like you said, is within the XBB family. Quite frankly, all of these variants, right, are within the XBB family, but some are more divergent than others. And as you pointed out, BA 2.86 is much more divergent than the EG.5, which is quite prevalent in the US right now. And also the FL.1.5.1, which is also very prevalent in the US right now. But again, both of those are very similar to the XBB .1.5 that the updated vaccine is meant to be reactive against. The BA 2.86, we really don't know if it's going to take off. Right now, we just have too few sequences to really determine what the replication profile of that is, if it's going to outcompete some of its other XBB sub-variant cousins, if you will. So it's too soon to determine. And of course, we still don't have really the definitive data with the updated vaccines to know will they be reduced, have reduced neutralization against that particular variant and to what degree I think is really the more of the question, right? I mean, I think we all expect there will be some reduction but may not be so dramatic that we think it would decrease the efficacy in a meaningful way. So we just have to wait for that data to come out.

Carlos del Rio: [00:15:54] And what we've also learned is that, you know, this vaccines are not very good at protecting you against infection and the protection against infection wanes fairly quickly. But there's still so far, even with this divergent variants, we are seeing significant protection against severe disease, hospitalization and death. Again, emphasizing why you want this vaccines, you want this vaccines to boost your immune system, to prevent you from getting severely ill, to prevent you from ending in the hospital and in the ICU and death. So there is a reason in that part has not really diminished that much. There is some waning of that immunity, but not as much as we see to the possibility of infection. So let's leave Covid alone. Let's talk about the other two viruses, influenza and RSV. So where are we now with influenza and RSV vaccination?

Meghan Pennini: [00:16:40] We're in a good place, right? Because, again, for the first time, we have vaccines that are available for both of these viral infections for this season. So the flu vaccine, the updated flu vaccines are available becoming more widely available as sort of they're getting into all their usual places of access and looking good for this flu season. The RSV vaccines, those were recently approved. Those are for age 60 and above. CDC really does recommend that that's also a conversation with your individual health care provider to determine your personal risk if you are in that age 60 or above category and whether the RSV vaccine is right for you. Those vaccines can all be administered at a single visit or they can be administered over time if they are all appropriate. There also recently was the option of pregnant women to get vaccinated for RSV to protect their newborns. So that is also good news. Just to round out the story for RSV and what we have in our tool kit for RSV, there are of two monoclonal antibody products that are also available for infants, and that is of course, to provide passive immunization. So not a vaccine, but the monoclonal antibodies to protect infants. One is for all infants really to get through that first tough season of RSV when they're first born and the other is available for high-risk infants to protect them when they need that for various RSV seasons.

Carlos del Rio: [00:18:06] The RSV vaccine, my understanding is that the decision from the CDC to say that it's a shared decision with you and your provider is because there was a neurological signal there. So you really need to have a conversation with your physician and try to decide whether you should receive it or should not receive it, what your risk is, etcetera. But they still the level of protection I think it's important. And I think as you're getting older, those diseases tend to cause significant morbidity and mortality.

Meghan Pennini: [00:18:33] Yes, I mean, I think just want to stress that there is that conversation component and I think it is because we want to just make sure that every individual is understanding their individual risk against their individual benefit for those particular products.

Carlos del Rio: [00:18:46] So a little bit of a rapid fire around, we're going to go back to Covid. If somebody says to me, you know, I've been infected, I don't need to get vaccinated, what do we tell them?

Meghan Pennini: [00:18:55] I think we have to remind them, right, that people are still being hospitalized. I mean, Covid-19 is still a serious infection. It is still one of the top leading causes of death in this country, unfortunately. Yes, we’re all very grateful that it's not the extent that we were experiencing, you know, a year ago, two years ago. And that is in large part right to the medical countermeasures that have been developed to the vaccines and the treatments that are preventing some of these most severe outcomes, as well as to some extent to the natural evolution of the virus. But these tools are incredibly important to keep people safe and to keep people from experiencing severe outcomes. They're safe, and we know that they're effective and we know they're doing their jobs. There are starting to be studies to show that even aside from preventing severe outcomes in the acute setting, right, with that initial infection, there may be some benefit even for long Covid and other sort of post-infectious sequelae with Covid-19. So again, some studies starting to show those, but we're continuing to develop more robust studies for that, both on the vaccine side and the treatment side.

Carlos del Rio: [00:19:58] And reminding people who've been infected that hybrid immunity is very good.

Meghan Pennini: [00:20:01] Absolutely.

Carlos del Rio: [00:20:02] So, you know, your infection or vaccination is actually better than just infection alone and the level of protection you get. So somebody who's gotten two doses, but they haven't been boosted, they're very concerned about what's happening right now. And they call me and said, should I go to the pharmacy and get the current booster or do I wait a couple of weeks to get the new booster.

Meghan Pennini: [00:20:19] You know, individual decision. But we expect those updated vaccines to be available pretty soon, maybe even by the time this is, you know, released to the public. You know, for most individuals, it does make sense, right, to think about how will you get the most robust protection in this coming season? And we do think that's the updated vaccines. That being said, you know, if you just got a recent shot of the current bivalence or if you plan on getting one soon, that does not preclude you from getting an additional shot sometime in the future. You know, usually there's about a two-month window that's recommended. We don't know specifically what that window will be when the FDA takes action, but probably around that. So getting a shot now doesn't mean you can't still get one updated going forward.

Carlos del Rio: [00:21:00] That, I think is a discussion that we all need to have with our patients, because I am hearing, you know, a lot of people all of a sudden seeing the increase in cases are saying, well, I need to get my booster. I haven't gotten it. And it's an interesting discussion. And yes, some people you say, you know, go ahead and get it and then you'll get the other one later on. And other people, you can say wait until a couple of weeks and then you'll get the booster. But don't miss the opportunity to vaccinate. When people say, I'm interested, I want to get vaccinated, the best we can do is just tell them, you know how best to get the vaccine, because otherwise you may miss an opportunity to vaccinate. Anything else you want to add before we end?

Meghan Pennini: [00:21:34] Just really appreciate you inviting me. I mean, this has been a great conversation and a great opportunity to just really stress we're better prepared for this winter season than we have been in a while and just really want everyone want to make sure we're all getting the word out for all these various tools that we have in our tool kit now to really help anyone who's vulnerable get through this season and get through it and staying healthy, staying out of the hospital and certainly preventing those severe outcomes. Just another word from my agency perspective and getting back to the variants and how do we stay ahead of the game for all of these pathogens? Remind everyone that we continue to invest in developing vaccines and treatments and diagnostics that will stay ahead of the curve for Covid-19 and for these other pathogens. That is a continued commitment from our side at HHS.

Carlos del Rio: [00:22:21] Well, I want to thank you and all your colleagues at HHS. I mean, you guys are continuously working to keep America safe. And throughout the pandemic, you have been incredibly helpful and really advancing vaccines and therapeutics. I've worked with you in multiple fronts, and I've always been impressed about, you know, the way that you're thinking ahead and you're thinking about equity and you're thinking about how do we better protect people, what can we do and how can we make sure that that our treatments and our vaccines get to the people that need them and get in time to them? So thank you for all you've done and thank you for being with me today.

Meghan Pennini: [00:22:53] Absolutely. And thank you. And thank you to all your listeners who I know work so hard every day to make sure these products get to the patients that need them. So thank you.