Considering the Covid-19 Vaccine (with Dr. Chris Beyrer)

Chris Beyrer Faculty photo 10_15.jpg

As Covid-19 vaccines begin to roll out around the world, we talk to Johns Hopkins epidemiologist Dr. Chris Beyrer about how these vaccines were developed.

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Transcript:

[00:00:00] Dr. Chris Beyrer: [00:00:00] Now what Dr. Fauci is referring to is of course, the level of protection that we need such that our healthcare system is not overwhelmed by people sick with COVID. And if we got to that level at 75% or so of people were immunized, it would dramatically reduce the burden on the healthcare system, the hospitalizations, the serious disease, and we could resume social activity and seeing each other and seeing our grandkids, uh, kids going to school, uh, without the concern that the reductions in social distancing would lead again to the healthcare system being overwhelmed.

Sarah: [00:00:44] This is Sarah 

Beth: [00:00:45] and Beth. 

Sarah: [00:00:46] You're listening to Pantsuit Politics.

Beth: [00:00:48] The home of grace filled political  conversations.

[00:01:00] Sarah: [00:01:07] Hello, everyone. Welcome to another episode of Pantsuit Politics. This is a very special episode that we are thrilled to bring you with Dr. Christopher Beyrer. We're going to share that interview in just a moment about vaccines and epidemiology and all the new technologies with regards to vaccines coming our way in 2021. But before we get started, we got a little, little business to clear up.

Beth: [00:01:31] As we start to look at the end of the calendar, we wanted to lighten things up before we take two weeks off, which we always do at the end of the year. We just feel it's important to give ourselves and all of you a break. Especially after a year, like the one we've just had.

So there's gonna be a little levity for you here on Tuesday with our Ask Us Anything episode, we received so many questions of such a wide variety. And so that was so much fun to record and [00:02:00] we hope that you really enjoy it. And then on Friday, we're going to walk through the calendar of the year and really think about what we've learned in 2020, how the year has impacted us, how we look back with a little bit of hindsight on some of the things that happened in January alone, which was a really intense month before we got into the pandemic. 

So kind of some processing episodes next week, and then we will be off completely off, not on social media, much, uh, not hearing your podcast feed at all for the last two weeks of the year and we will get right back to it in January. 

Sarah: [00:02:38] Before we go, we want to share this conversation with you. We're hoping that this will arm you with good information as you go into the holiday season on zoom or wherever else, and start to engage with your friends and family and community about vaccines.

We are so thrilled to be here today with Dr. Chris Beyrer, the Desmond Tutu Professor of Public Health and [00:03:00] Human Rights at John Hopkins University. We are so excited because we know so many of you have questions about. Um, the vaccines coming to inoculate, all of us, hopefully against COVID-19, the new technology, how distribution work and how to build trust in your communities so that we can get the vaccine out into the population and hopefully start to return to some what of a normal life. And so thank you so much for coming on our show. 

Dr. Chris Beyrer: [00:03:30] Delighted to be here. 

Beth: [00:03:31] Dr. Beyrer, this year is the first time I've made an attempt in my life to understand vaccines. I have a nine-year-old and a five-year-old. And so we sat down together in one of the many days at home in April, we were trying to find something to do that was educational.

And we watched a little video and did an art project about vaccines. And what they learned from that project is that a vaccine is like, you know, a monster is coming at your body and [00:04:00] sometimes your body could confront a monster and think, well, let me try different ways of catching it, and it takes awhile and it's hard on your body, but a vaccine is like showing your body a picture of the monster so that it's ready if it ever encounters that monster in real life.

And I'm wondering if you could work with that extremely rudimentary understanding of vaccines to just help us all level-set on how you know, pre COVID, how did vaccine development work? And how should we understand what's going on when we take a vaccine? 

Dr. Chris Beyrer: [00:04:31] Well, it's a, it's a good example, I think, because what, what the current to current vaccines that are now being evaluated by the food and drug administration, the FDA for this emergency use authorizations, uh, they both do present the body with a kind of a picture, a kind of an image, um, uh, of, of the, the key part of the monster, which in this case is the spike protein of the [00:05:00] coronavirus. Um, that is a piece of genetic information and, and, uh, messenger RNA encapsulated in fat. And then your know, your body reads that picture makes that protein and then your immune response kicks in.

So I I'm saying that just by way of, of answering your question to say, first of all, this is a new technology, messenger RNA vaccines have not led to licensed vaccines for any other infection, any other disease in the U S so, uh, so this is a new approach. Um, we have had, you know, many different approaches over the decades for vaccines, and they have evolved as, uh, our science has evolved as biotechnology advances have happened. And, uh, and of course they have generally speaking, gotten safer and safer.

Um, Uh, give you a great example. Uh, a relatively newer vaccine, uh, is the [00:06:00] vaccine against the human papilloma virus, HPV, uh, which of course leads to, uh, almost all of the cervical cancer in women. So, this is one of the first vaccines that really, uh, has an anti-cancer activity in addition to its, uh, antiviral activity.

And, uh, this is, this is a vaccine that is based again on a relatively new technology. Um, I was at the NIH, the national institutes of health, uh, the day the vaccine trial results were released for that vaccine. And I have to tell you, it was one of the most exciting days. I mean, there were essentially no cases of HPV acquisition in the women who'd been immunized.

And all the cases that did occur were in women who'd received placebo. Uh, the safety data was very compelling, uh, and it was clear that we had a new vaccine. So 

Sarah: [00:06:58] how does this new [00:07:00] technology differ from vaccines, you know, we've all been getting since we were a kid. 

Dr. Chris Beyrer: [00:07:06] Yeah. Yeah. Well, you know, the, the oldest and simplest vaccines were often just whole killed virus. Um, and, uh, they were immunogenic, um, for sure, some of them, but, but also they tended to, to lead to more reactions. Uh, some vaccines were what were called live attenuated vaccines. So vaccines we no longer use because we have eradicated the disease, smallpox, uh, was alive attenuated, uh, vaccine. And, and, uh, you may know some older relatives or friends will have these scars, uh, from them.

That vaccine, it, it now would not be licensed. We couldn't use a vaccine that caused that much of a reaction, that caused scarring. Uh, so that's an old technology. Fortunately it worked to eradicate smallpox and now we don't [00:08:00] need to use that vaccine. Um, but if we were to, if somehow smallpox came back into the world, um, And there are some reserves, uh, in a few countries, including the US, uh, we would have to develop a new, uh, a new vaccine using these newer biotech approaches.

Um, now, right now, with the coronavirus vaccines, the COVID-19 vaccines, uh, we are deliberately, uh, studying different, uh, vaccine approaches, different platforms as we call them, because we know that we're going to need multiple vaccines. Uh, and we also need to do the work to understand how these vaccines work in special populations.

Now you were just talking about your kids. Uh, so neither the Pfizer vaccine nor the Maderna vaccine had been studied in children under 12. The Pfizer vaccine did include older children, 12 to 18 years [00:09:00] old, and it looks safe and effective, uh, in those kids. Um, but we will have to do, uh, additional studies.

There's already one planned, uh, in children to assess the efficacy and safety in them. We also haven't, haven't studied these vaccines in pregnant women. Uh, and as you may know, 75% of the healthcare workforce is women in this country. So, uh, we, we are prioritizing healthcare workers as first line folks to get a vaccine, um, if they want it, uh, because of their occupational exposure. And that means a lot of women of childbearing age. 

Beth: [00:09:39] What about breastfeeding? Do we know if it's safe for women who are breastfeeding at this point? 

Dr. Chris Beyrer: [00:09:44] Uh, we don't know that. We have not, uh, enrolled either pregnant or lactating women, uh, deliberately in the trials. Uh, but you know, when, whenever you do a trial, 30,000 people. And the, the, uh, Pfizer [00:10:00] vaccine was even bigger. It was 44,000 people. You are going to enroll some women who are pregnant and don't know they're pregnant. Or some women who may subsequently become pregnant after being immunized. That's just going to happen because of the numbers.

 Uh, and so, uh, the, the plan is to follow everybody who's been in these trials for a full two years. The FDA is making their decision on the vaccines based on two full months of safety. That's why we had to wait until now to have enough safety data for the FDA to evaluate.

Sarah: [00:10:44] So if this new technology is showing such effectiveness, and I read an unbelievable article that they actually using the genetic code of the virus produce the vaccine in two weeks, it was just the trials that took so long. [00:11:00] That's correct, right? 

Dr. Chris Beyrer: [00:11:01] Yes.

Sarah: [00:11:01] Which is unbelievable as well. So if we see this, this technology she rollout with Maderna and Pfizer and it's effective and it's safe, can we start to draw conclusions about the technology itself? I guess what I'm asking is, it feels like people are judging the, the speed at which this vaccine came forth and having distrust. Oh my gosh, it came so fast, but it seems like the answer is yes, because we're using a very different and new technology. 

And if we can see with this particular COVID-19 vaccine, that this technology is safe, effective, and we can get it so fast, maybe we can not just create more trust with vaccines overall, but start to educate the public on this new technology. And even, I mean, I don't know, like. Reassess the, the way we do trials, if we see this particular technology is [00:12:00] just a totally new ball game. 

Dr. Chris Beyrer: [00:12:03] Well, uh, you're absolutely right. Um, and there, I think there's, there's a, there's a couple of additional, uh, points to think about.

First of all, in terms of the technology, there's been a lot of interest in using both DNA based vaccines and. RNA based vaccines for more than a decade, this technology has been being worked on for a number of years. Um, there were a couple of challenges and one of the biggest ones was that in the, with the initial attempts.

And of course these were for other infections, not COVID, which hadn't emerged yet uh, that these products were being developed for. Um, they would inject the messenger RNA and the body would degrade it very, very quickly. You know, we needed to figure out a way to package it because you have to get it into the cell. It has to cross the cell membrane and get into cells [00:13:00] where the, basically the manufacturing, the protein manufacturer of the cell, uh, can make the spike protein. That's that's what the messenger RNA is a piece of genetic code for the spike route, or it has to get into the cell. 

And, uh, several years ago, uh, the breakthrough was discovering you could basically wrap these, uh, these messenger RNA, um, particles in, uh, in, in fat, essentially it's a, it's a lipid, um, uh, very, very small, uh, lipid envelope, um, which is a nanotechnology. Uh, and that is the real breakthrough because that allows. If you remember from your high school biology, the cell membrane of all mammals is a lipid bi-layer right.

And, uh, and so it's fat-soluble. And so that, that, um, lipid nanoparticle allows [00:14:00] the messenger RNA to get into the cell. The protein is then manufactured in those tiny little cellular organelle called a ribosome. Um, and then that cell expresses the spike protein on its surface and your immune system sees it and sees that it's foreign and starts to respond.

Sarah: [00:14:20] That's so interesting though, because that helps people, that, to me, that's so helpful because it says it's, it seems fast, but they've been working on this technology for years and it really came along at this moment where we've had these breakthroughs to make it possible. I think that should really help build public trust as well.

Dr. Chris Beyrer: [00:14:36] Yeah. Yeah, no. And, and it's been a, uh, an international effort. This, the, the, the, um, one of the key breakthroughs of course came from this small German biotech company, um, that partnered with Pfizer because Pfizer is a great big American company. Um, as to the question about the time and the speed, um, it's, it's the technology, but there's also a few [00:15:00] other things that are really important.

 So one is normally, uh, you know, you, you go through the, the effort to develop a new vaccine, you test it and do the clinical trials. And then there's typically a long lag between finding out that something is safe and effective and actually having it manufactured. And normally people would not invest in the scale up the factories, the manufacturer, all of that, um, unless you knew you had a winner. Unless you knew you had a, a safe efficacious product, but in the case of this global health emergency, Um, the decision was made by what's called operation warp speed. Um, maybe not a great name for people's anxieties, but nevertheless, uh, to invest in all of these technologies, right?

So taxpayer money is going into manufacturing. In the case of Pfizer, the [00:16:00] government pre-purchased a hundred million doses, uh, so that if we did have. Uh, a safe and effective vaccine, there wouldn't be a delay. We would have doses ready. Uh, so that is unprecedented, that has never happened before. And the funding for that came through the first recovery act, which you may remember, last spring sailed through the Congress, uh, had bipartisan support because basically our economy and our society was shutting down because of the pandemic. 

And basically we, we saved time by gambling on all the products. There was not a cutting of the time or cutting of the corners for the safety studies, for what's called the immunogenicity studies where you see if these vaccines are able to generate an immune response.

And there wasn't a shortcut on the efficacy trials, but the efficacy trials [00:17:00] went faster than we thought they would because there's so much COVID transmission and the rates of COVID are so high in this country. Uh, and it just turned out that while we were doing the trials, we had this extraordinary fall, second wave that we all know we're living through.

And, uh, and so that allowed the trials to get to their end points sooner than they would have had otherwise. And that's part of why we're, we're thinking that we're, we may have emergency use authorizations for both the Pfizer and Maderna products, you know, in the next week or two, um, may even be sooner than that.

Uh, and we will have because of pre-purchase and manufacturer and initial about 40 million doses by the new year. Uh, these are two dose vaccines. Uh, one of them is 21 days apart. The two doses, the other is 28 days apart. So [00:18:00] 40 million doses will mean we can immunize 20 million people. So we are going to start with a period of scarcity.

We are not going to have enough vaccine for all the people who would like it and want it. And that's going to be true probably through the best estimate is June or July. Uh, of 2021. Well, when we will have enough vaccine for all the adults in this country who want it, um, as I said, we have to do the additional studies and children under age 12, uh, to know about them that's would be about another or 120 million, uh, folks there's there's about 320 million and 220 million or so are adults.

Beth: [00:18:46] I just want to go back and make sure that I understood something you said about the trials. If I am hearing this, and I'm concerned about two months of safety data, it sounded to me like part of my [00:19:00] concern should be delayed because sometimes what causes a study to take so much time is that rate of transmission.

So it's not just time, it's, it's scale. And you got the scale. Am I understanding that? 

Dr. Chris Beyrer: [00:19:17] That's right.

Beth: [00:19:18] Okay, that's helpful. And when I here you say, we're going to be able to immunize 20 million people, how should I understand what that means? Because I have read a little bit about the vaccine as protecting me from disease if I get the virus, but not knowing yet what that means in terms of transmission. 

Dr. Chris Beyrer: [00:19:41] That's an extremely important for me. I'm so glad you raised that. Yes. These trials all have a harmonized design, essentially. They're all pretty much the same design and that design is that what we are looking at is the ability of the vaccine to protect you from [00:20:00] symptomatic COVID-19 disease and from severe COVID disease. Right?

 So one of the interesting and really challenging issues with this particular virus, and of course, it's a new virus that crossed over from animals, probably bats. Uh, sometime in late 2019, uh, and has this incredible infectiousness, which is why it has spread to virtually every country in the world so quickly.

Um, but it has a very wide range of clinical outcomes. So 40% of people who acquire COVID have no symptoms at all, don't know they've had it. And they don't know that they're infectious for others. Uh, of course a subset of people do get very serious disease and a subset of those people end up needing hospitalization, needing oxygen, often ending up on ventilators.

And then of course a subset of those people don't survive. [00:21:00] So, uh, it's a very wide range, but that told us right away, that at least some people's immune system can respond to COVID and protect them from getting seriously ill. That's extremely important because it means that a vaccine has a real chance of working.

You may know, for example, with the different virus that I've worked on for many years, the HIV virus, that when we say that somebody is HIV positive, it means that they have a positive antibody test. It doesn't mean they're not going to have HIV and quite the opposite once you're, once you have antibodies against that virus, it means without treatment, you're going to get gravely ill and it's a highly fatal virus.

So, so that's very important. Um, what happened with both Pfizer and Maderna is, uh, that essentially all the serious cases of COVID were in placebo recipients, it protected against severe disease. Uh, [00:22:00] one in one case, a hundred percent in the other, very close to it. So that's why we, uh, are, are, you know, so, so I'm encouraged by the efficacy data.

It's also true that, uh, it reduced symptomatic disease overall, very significantly, uh, in both of the, both of the trials. The other thing that's really encouraging is that, you know, the people who've been getting the sickest and, and doing the worst with COVID, as I'm sure you and your listeners know is older folks.

And particularly people over 65 and the death rates with this virus really go through the roof after 70, 80. Uh, it's, uh, it's very cruel in that way, but that it's really, really killed the, the oldest Americans. And that's why it's been so devastating in long-term care and nursing homes. So we wanted at least 25 to 40% of the people volunteering in these trials to be aged 65 and over.

So we could assess [00:23:00] the efficacy in older folks. And the great news there is that it looks just as effective in people over 65 as understood. It actually caused fewer reactions in the folks over 65 because older people have less vigorous immune responses so they have less of the, you know, the, the common side effects with both of these vaccines are basically pain, muscle pain at the injection site.

Uh, and usually about a day or so of, uh, feeling fatigue, malaise, sometimes a low grade fever. Uh, those reactions were pretty common, but there are more common in younger people getting the vaccine than older. 

Sarah: [00:23:42] So Dr. Fauci has said that around 70 to 75% of Americans need to get the vaccine in order for the country to start getting back to normal. Can you help us understand that particular number? 

Dr. Chris Beyrer: [00:23:55] Well, I think the key thing to say is that we, we [00:24:00] have to, um, we have to, uh, understand, and this will take additional studies, the impact of these vaccines on, uh, whether or not somebody who's been immunized. Uh, we know you can still acquire COVID, but the question is, uh, will you be infectious for others?

Can you transmit it? The most likely scenario we think is that you probably still can get infected with COVID. You, you will have a shorter clinical course. We already see that from the trials and you probably will be less infectious and less infectious. Um, For others and hopefully, uh, we will see a big impact then on, um, reducing transmission.

We don't know that yet. What we do know is that for people who've been immunized with these two candidate vaccines, they are protected against severe disease or [00:25:00] serious clinical, uh, disease with COVID at the 94 to 95% level, which is just amazing. Um, now what Dr. Fauci is referring to is of course, the level of protection that we need such that our healthcare system is not overwhelmed by people sick with COVID.

And if we got to that level at 75% or so of people were immunized, uh, it would dramatically reduce the burden on the healthcare system, the hospitalizations, the serious disease, uh, and, uh, and we could resume social activity and seeing each other and seeing our grandkids, uh, kids going to school, uh, without the concern that, that the reductions in social distancing would, um, would lead again to the healthcare system, being overwhelmed.

 As you know, many, many States, many counties are already, uh, getting to the place where they're short on beds [00:26:00] and they're short on staff and people are moving medical personnel around to those most effected States, including the army reserve, uh, to deal with this problem.

Beth: [00:26:20] Knowing that we're not there yet and that our individual behaviors still make a dramatic difference, I wanted to ask you, this is a very particular question, but it just interests me. And it's my podcast. I read an interview where you were speaking about HIV transmission and talking about how in the context of HIV transmission, a challenge has been that women are so much more engaged than men with healthcare.

For a variety of reasons, but especially women between, I think you said 18 to 45, that, that population of women are so much more engaged than men of the same age. And I [00:27:00] wonder as we think about COVID and behavior, if you see any gender specific differences that we ought to be aware of and how we can work to overcome those.

Dr. Chris Beyrer: [00:27:10] Well, that's a really interesting question. Um, well, the first thing to say is there is a major gender difference in clinical outcomes and in death with COVID and that is it's been true all over the world. It's true in this country as well. Um, men are about twice as likely to die from COVID as women. Uh, and when we've tried to understand that and, and unpack it, it turns out that it really has to do with the genetics of the immune response, the human immune response.

So this may be a little bit in the weeds, but it's, it's important to understand. It turns out that some of the critical, uh, genes that allow you to respond to allow immune response to COVID are on the X chromosome. [00:28:00] So women have two X chromosomes. So women have twice the genetic repertoire. They have twice the genetic diversity through respond to Corona viruses, all Corona viruses, including COVID-19.

And that also tells you how old, the interaction of these Corona viruses with you know, with, with humans and with, uh, all the other mammals out there, um, has been going on because you know, this, this is very much in our, literally in our DNA. Um, so we've known that for a while. We also know that there are some big occupational differences, right?

So. A large proportion of the workforce in nursing homes is women. Uh, so they have had higher rates of exposure, uh, because of the spread in those indoor, crowded. Um, men, uh, of course are, are also overrepresented in some other uh, [00:29:00] occupations like law enforcement and EMT, uh, and, uh, and the meat packing industry, uh, where we've seen high occupational exposure.

So that's, that's a gender difference that can, that can play a role. Um, But I think, you know, behaviourally, uh, one of the things that you worry about, um, is whether or not there are, for example, uh, gender differences in mask wearing in some places, uh, that that could play a role.

 It certainly is also the case that the burden of COVID has been very high on women because of course, uh, it turns out that duties like helping to homeschool kids and educate kids at home in this, in this era when schools, schools have been closed falls, disproportionately on women. Men, men are not that evolved yet. Um, and that's true of so many of the other tasks too, [00:30:00] uh, of being at home. So, so the burden has also been disproportionately on women.

Sarah: [00:30:05] What I hope is, you know, with women, so engaged with the healthcare system and out there making vaccine decisions for their families, that as caregivers, as people intimately connected to their own families and extended families through caregiving roles, they will see the vaccine is really a community act. That getting the vaccine is not just about preventing your own illness, but it is about preventing a body through which the disease can spread, continue to be out in our communities.

And I think that that is that's so important and I so appreciate public health experts that just keep ringing that bell and telling us like, this is a, this is something that connects us all. And therefore the solution is going to take all of us. 

Dr. Chris Beyrer: [00:30:51] Yeah. I mean, I think, I think that's so true for example of mask wearing. And by the way, we're going to have to [00:31:00] continue the mask wearing in public spaces and in this era with the vaccines, until we know whether or not, they do reduce onward transmission. Uh, we just don't know that yet. We need to study it. 

Um, and, uh, and, and in fact, we've, we just did a recent blog post, uh, with, with Larry Corey. He was one of the, one of the leading people in the clinical trials at UW, um, university of Washington about this very issue. If I get the vaccine, will I still need to wear a mask? And at least for now the answer is yes, until we know about onward transmit. 

Beth: [00:31:38] I have a dear friend who says living the scientific method is hard. And I just keep trying to remember that. So as our listeners go into the holidays, and confront all kinds of anti-vax sentiment and conspiracy theory and misinformation about vaccines, what's the one thing that you would offer them to just kind of hold onto and remember in those conversations. 

[00:32:00] Dr. Chris Beyrer: [00:32:00] You know, when, when vaccines are working, we don't see their effects. Right. And you know, Americans are no longer afraid of smallpox. We are not concerned about yellow fever. We are not terribly concerned about polio.

You know, all of these were diseases, uh, that had enormous impacts and burdens on people's lives and all of them were resolved by vaccines. So, uh, I think the thing to remember is that, um, this is a preventive approach to health that has a long successful track record. And it's hard to see how it's working when you know, we're where we're not worried about polio.

 My parents' generation, my mother had polio. She has one leg shorter than the other. This was the great fear of their [00:33:00] childhood. And Americans were under all kinds of restrictions. Uh, you know, swimming pools. They didn't really understand how it was transmitted.

People, uh, really lived in terror. And of course we had an American president who ended up in a wheelchair from polio. Uh, Franklin Delano Roosevelt. Polio vaccines were, were one of the major scientific breakthroughs of the 20th century, and they transformed this country. And, uh, and I will just say to you that I think the COVID-19 vaccines are going to be, already are, perhaps the major scientific breakthrough of the 21st century.

Uh, and, uh, And I understand that people are anxious and afraid. What I would say to those who are really concerned and, and, and want to see more evidence of safety is, you're right. We all want to see more evidence of safety. And that is why everybody who's volunteered in these trials is going to be followed [00:34:00] for a full two years.

So the FDA emergency use is going to be based on the two months of safety data, but we are following everybody else going forward and we're going to accrue more safety data over time. Uh, that's going to be very important. We, we already have the efficacy data and with two products at over 90% effective in preventing serious disease, we have light at the end of this tunnel.

Imagine if both of these vaccine trials failed and we were in where the holidays are coming, the case load is rising, the hospitals are crowded and we have nothing to say to people except don't see your family over the holidays, stay at home, uh, celebrate with the people in your household, wear a mask outside.

Uh, you know, I think we're, we're in a much more hopeful place. 

Beth: [00:34:55] Thank you so much for your time today. This was really helpful. 

Dr. Chris Beyrer: [00:34:58] Oh, it's been great to talk to [00:35:00] you both. And, and, uh, as I said, I really appreciate what you're doing. I, I hope your listeners have a safe and, and, uh, joyous, uh, holiday season and, uh, and wear those masks. The vaccines are coming, but they're not here yet. 

Sarah: [00:35:15] We want to thank Dr. Chris Beyrer again for coming on our show. We're so happy to share that information with you. We look forward to ongoing conversations with all of you on social media in the new year about the coming vaccines. And until today's episode, when we share Ask Us Anythings, keep it nuanced, y'all.

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