On the heels of the encouraging information from the past two weeks, and information about Pfizer’s and Moderna’s COVID-19 vaccines and their effectiveness, we wanted to check in with our good friend Ruth Werner to get her opinion. We discuss the current vaccines in production and the new technology used behind their speedy creation. We also dive into several things we still don’t know, including long-term effectiveness, virus mutation, and those populations who still haven’t been included in the Phase 3 testing, including children, those over 85 years of age, and pregnant women.
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01:00 Darren Buford: Welcome to The ABMP podcast. My name is Darren Buford, I'm the Editor-in-Chief of Massage & Bodywork Magazine and Senior Director of Communications for ABMP. I'm joined by my co-host, Kristin Coverly, licensed Massage Therapist and Director of Professional Education for ABMP. Our goal is to connect with luminaries and experts in around the massage body work and wellness profession in order to talk about the topics, trends and techniques that affect our listeners practices. Our guest today is Ruth Werner. Ruth Werner water is the former massage therapist, a writer, and an NCBTMB approved continuing education provider. She wrote a Massage Therapist's Guide to Pathology, is a columnist for Massage & Bodywork Magazine and Podcast host on the ABMP Podcast Network. Check out her show each and every Friday. Hello, Ruth and Kristen.
01:44 Ruth Werner: Hey, Darren, it's good to be here. Hi, Kristen.
01:46 Kristin Coverly: Hello, we're so happy to have you here. And yes, it's a little bit of a time warp. This is not Friday, but Ruth Werner is coming to you on the ABMP Podcast Network, we have pulled her over to the ABMP podcast, which is Tuesdays, because there are some hot topics that we need to address, so this has been a very big week for COVID-19 vaccines, let's talk about it. We wanna just give people a little bit of an update. We know there's still a lot of questions. We don't have all the information yet, but because people have so many questions and it is so important, we wanted at least pull on Ruth who is our pathology expert to just address some of those and let us know what we know as of today. So let's dive in.
02:27 KC: Ruth, what are your initial thoughts about the news of Pfizer's and Moderna's vaccines? Should we expect more on the horizon for other drug manufacturers or other people working on it? And then is there any way to know if there's an inherent benefit of one over the other? Will people be able to choose one over the other? So this is sort of like two horses in the race question, can you tell us a little bit more about those two players?
02:53 RW: So right now, as of this week, two vaccine manufacturers, Pfizer and Moderna, have announced as a result of their phase three trials that their vaccines are effective at something like 94.5%, and the other was at 95%. In any case, very, extremely effective way, way more effective than anyone ever thought would happen. They are not the only horses in the race, there are two other vaccines that are in phase three trials in the United States, and then there are dozens of other ones around the world. The other two phase two vaccines in the United States, one is manufactured by Johnson & Johnson, and one is manufactured by AstraZeneca, but what's interesting is that the Moderna and Pfizer vaccines, the ones that are ahead of the pack now, are using an entirely different kind of technology. And I wanna dive into that a little bit because it's fascinating, and I think anyone who's thinking about getting a vaccine should at least be informed about this. The Johnson & Johnson vaccine and the AstraZeneca vaccine, to my understanding, are not using this brand new technology.
04:07 RW: One of them, the Johnson & Johnson one, is going about this in a non-traditional way that we can talk about if you like, and the other one, I believe AstraZeneca is going about this in a much more typical way, where they're using sort of versions of disabled virus to stimulate antibody production. But what Pfizer and Moderna have done is they have taken some technology that was first pioneered in the early '90s, but basically the short version of what makes these vaccines unique is they are using a technology based on synthetic mRNA, and that stands for messenger RNA, and the... Here's the basic idea. Within typical, healthy functioning human cells, we have natural mRNA as part of our cell nucleus, and part of what that messenger RNA does is it instructs that cell and whatever it's supposed to be doing. Usually we talk about it in terms of instructing that cell in what sorts of proteins that should be producing.
05:20 RW: What these folks have done, Pfizer and Moderna, is they have created an artificial, a synthetic version of messenger RNA in a way that the body doesn't immediately reject it. And that's the first time that's happened. And in a way, that here's what it does, it gets into the target cells and it tells the cells to produce... Remember, messenger RNA tells cells to produce proteins, specifically it tells the cells to produce proteins that look like the spike on coronaviruses, and you might say, because this is what I said when I was first figuring this out, you might say, "Well, why on earth would we wanna do that because it's the spike on the coronaviruses that gains entry into its target cells and kills them off?" But this version, this sort of mimic of the COVID spike that we are now enlisting our own cells to produce, what it does is it alert the immune system and gets it ready and loaded with antibodies, in case we are ever exposed to the real spike proteins from Coronavirus, from this particular Coronavirus, the SARS-CoV-2.
06:45 RW: And it's so fascinating to see this happen. The woman, and I'm sorry, I don't remember her name, it was a woman who I think began fooling around with messenger RNA as a version of medication in the early '90s, and she ran into a lots of obstacles and she lost her professorship and she really was a pioneer that had to go through a lot to get to where we are, but here we are. And the two companies that are doing this are really building on the work that she began. There's a lot of things about this technology that are still unknown, this will be the first time that mRNA-based vaccines will be used on a large scale, and people listening especially people who are wary of vaccines may say, "Okay, that's my ticket out, I'm not playing in that until we have a long record of safety." I tell you a couple of things. One is so far, this has been tested in a total of, in the neighborhood of 74,000 people have been in the phase three trials, so far, we don't have reports of adverse events yet.
08:01 RW: When we compare that 74,000 people to the roughly 250,000 people in the United States who would be good candidates for the vaccine, that's a pretty small percentage. And so when these go into widespread use, the chances are excellent, we will see some adverse effects, but they are building into the distribution and the administration of the vaccine, some really innovative and I think forward thinking mechanisms to track this, for instance, everybody who gets one of these mRNA vaccines will be urged, not required, I don't think, but urged to download a thing called VSafe app that essentially text messages them to check in about how they're feeling, it provides mechanisms for them to report any kind of symptoms or long-term effects or if they get, whatever, all the things that we wanna track about people who are using these vaccines.
09:05 RW: I will also say that, and this verges on the political, but we have to. During our whole COVID crisis, I lost a lot of faith in the Centers for Disease Control and in the FDA, because there were attempts by the government to essentially take over control of these organizations and to take over control of their messaging and what kinds of work they would invest in. In the process of getting ready for our talk today, I revisited that, and people that I really, really respect are 100% behind the work of both the FDA and the Centers for Disease Control, and the way they are building out the structure and the messaging and the safety mechanisms around these vaccines. So I feel, this is just me, and anyone who has some concern or some skepticism should definitely look into it, but I will say given my own understanding and my faith in the people whose scientific expertise I am happy to rely on, I think we're on the brink of something really big, and it could be terrific.
10:21 DB: Let's take a short break to hear a word from our sponsors.
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10:56 DB: Now, let's get back to the podcast.
11:00 RW: Well, here are some things that we don't know. We don't know how the duration of this vaccine efficacy, so it may be that if this virulent strain of SARS-CoV-2 is still active in a year, people may need to have a booster and get a repeat, or if the virus mutates in the way that say flu virus has mutated, it may be necessary to get a repeat vaccine. So we don't know about duration. We have not tested this vaccine in young children or in people over 85 or in pregnant people, and so those are populations who at least on the front end of distribution will probably not be included until we know more about safety and efficacy for those populations. A big thing we don't know about these vaccines, and the term that I heard used today, I was listening to a discussion with one of the scientists I most revere. A big question we don't know is about what's called sterile... Let's see, sterile immunization. And what that means is that someone who's had one of these vaccines may be immune to them getting sick, but it is possible, we don't know yet, it is possible that they could still be carriers.
12:24 RW: In other words, they could still harbor the virus in their nose and their upper respiratory track, even though they aren't gonna get sick, they could conceivably make other people sick. And until we have that business pin down, we are not done with masks, and the general consensus among the scientists that I listen to and read today suggests that we're in masks for another six to eight months, one way or the other. Side effects, again, we don't know what the side effects will be, and other than those 74,000 people who have already been through the trials, so that's why we're gonna really encourage people to be participatory in reporting their experiences with these vaccines, they will probably be rolled out in December on a limited basis. And the main focus will be the people who are most at risk, so this is people who have underlying diseases that increase their risk of getting very ill, but also, as the mother of a paramedic, this means a lot to me. Frontline, first line health care providers, doctors, paramedics, ENTs, nurses, all the people who are working in those very high risk kinds of settings, those are the folks who will be invited and probably required to participate in the vaccines early on.
13:48 RW: And then for people who are fundamentally healthy and not on the front line, we'll need to get in line, which again, because it's new technology and because we... I'm content to let other people try. I'm not really a doctor, so I'm fine with hanging back a little bit, but I also... I don't live in a place where we really have been ravaged by the virus. My county, my entire county reports usually under 10 cases per week, so because I live way out in the country and it's just not very crowded here, so I don't feel particularly targeted or at risk, if I did, I probably would be a lot more enthusiastic about getting in line. I said early on when people were beginning to make noise about a vaccine beginning to be available, I said, "You know, I will line up for a vaccine the day after Dr. Fauci injects his daughters." But I have seen what Dr. Fauci has to say about this, and he's very excited and very much in favor. Between him and several other people whose work I admire, I'm pretty happy about this new technology.
15:01 RW: Now, a downside of both of these, but particularly the Pfizer vaccine, it has to be kept at negative 70 degrees Celsius, which is negative 94 degrees Fahrenheit, and it has a pretty short shelf life, it's only like two weeks or something. Pfizer has, along with developing the vaccine, they have actually developed special shipping containers that you stock up with dry ice, in order to keep the doses at the correct temperature. And that was good thinking, 'cause a vaccine that's effective, but that you don't have any method for shipping out, it's the same thing is not having an effective vaccine. So Pfizer has invested in creating a shipping package that works with this mechanism. The Moderna vaccine also has to be kept cold, but that can be kept at negative four Fahrenheit, that's still colder than a lot of people's freezers but it's not that much colder. And so that's probably more practical in terms of widespread distribution.
16:09 RW: Both of these vaccines will require at least two doses, and they're talking about those two doses I saw anywhere from two to four weeks apart, and then people still have to sequester for a minimum of two weeks after that and just in case, but that looks like the protocol. The Johnson & Johnson vaccine, which is not out of phase three trials yet, they're still in phase three trials, that is based on only one dose, and I believe does not have to go through a deep freeze, I think that can just be refrigerated. The Johnson & Johnson vaccine took some more typical coronaviruses like cold viruses and manipulated them to look like COVID, like disabled COVID, in order to enact our own immune responses to that, or an acquired immune response to that. So that also is new technology, but it looks more like the old fashion take a virus, bang it on the head, so it can't really do anything bad to you and then inject it. That's a typical polio vaccine, for instance. And that's the AstraZeneca version, I think.
17:21 DB: Ruthie, do you know... Let me ask you a question. I think I read this online, but maybe you can back this up or not. Is the normal flu vaccine, just comparing the amazing stats here with how successful this COVID vaccine is. Isn't the normal flu vaccine only like 40% to 60% effective?
17:38 RW: That's exactly right. Yeah, a typical flu vaccine is about 40% to 60% effective with the added benefit that if you get the flu vaccine and you get the flu, you are much more likely to have a less severe experience with that year's flu. So while it may not provide complete coverage, it provides good coverage in terms of severity, and it remains to be seen, if COVID ends up being like a seasonal outbreak that we have to update every year.
18:15 DB: And do you know if... Maybe you already addressed this, but if you've already had COVID, is there that likely that you're probably gonna get or should seek out the vaccine? Or we just don't know?
18:27 RW: Yeah. Thanks for bringing that up. I did not talk about that and I wanted to, it's in my notes. And the answer is, we don't know. Lots of people have had COVID and they don't know, and that should not be a bar to their getting the vaccine. What is more of a question is if people who have had it, who know for sure that they've had it, should they get vaccinated? And what I can tell you is, at least the CDC says there is not enough information on which to make a recommendation about this question. What we know so far, and I really am gonna work on a blog post on this, is that the antibodies to a naturally acquired COVID infection, looks like they don't last terribly long for most people, it's like four to six months or something. But here's the thing, our antibody tests, they kind of... They're awful. They really aren't very good, they don't give very precise information, and so we have this idea about how long the antibodies last, but it's sort of a shot in the dark.
19:34 RW: So there may be benefit in people, especially people who had a mild case of COVID in getting vaccinated, because it looks like this process is designed to create an antibody response that's a lot more... That is very aggressive, but right now, I have not seen a strong statement one way or the other, saying people who know that they've been infected should definitely get the vaccine or should definitely avoid it. There's just not enough information yet.
20:06 KC: I think that's like the collective societies inside. We have a lot of hope pinned on this, we have a lot of fingers crossed, and yet there's a lot of concern and uncertainty and still missing information, so definitely a conversation in progress, I think, this is the beginning of a longer conversation.
20:28 RW: What was the Winston Churchill quote? "This is perhaps the end of the beginning." As you say, Kristin, there are still a lot of unanswered questions, but the safety question is the biggest one, and that will always be the case any time there's ever a new medicine. We don't really know. The last time I remember this being a big issue was when the COX-2 inhibitors came out and it was like a miracle drug for people with autoimmune disease, this is a kind of anti-inflammatory, and then it turned out that it was really damaging to a lot of people's hearts and they pulled that stuff off the market so fast, but you didn't know that until it got out of clinical trials and into broader use in the general population.
21:12 RW: We have to face the possibility that this may happen, but right now, the experts and the scientists and the statisticians and all of the other people who are involved in this are basically what they're doing is what I tell everybody to do when they're making decisions about massage, which is weigh the risks and benefits, and if you can demonstrate that the benefits of developing and distributing and using this vaccine is heavier than the risks of not, 252,000 deaths as of this morning, then you make the vaccine available and people will use it or they won't use it. That's a whole different question. And again, the nice thing about having a vaccine that is, if it is truly as effective as it has shown to be in trials, we can get away with a smaller portion of the population being vaccinated and still establishing good herd immunity.
22:10 DB: I was gonna ask you earlier, we talked about the 70,000 people who've been involved in the trials, is that a lot, or is that a very low number?
22:21 RW: Oh gosh, you would ask me that, wouldn't you? I think it's a lot, but I'm not an expert on vaccine trials or on drug trials in general. Several of the scientists that I was reading today said the same thing is, not only did the vaccine appear to be very effective and they did it in populations, some people got the vaccine, some people got placebo and then they went out and live their lives in the way that they would normally live their lives, and then we looked at who got sick, and not only did only a tiny, tiny number of the people who got vaccinated, gets sick. None of them got really sick, all of the really extreme versions of COVID, the ones that put people in the hospital were among people who were not vaccinated. So what that suggests is it's not just protective, it's protective against the really virulent cases, which is... That's very, very promising.
23:22 RW: And I was happy to see in these trials that that's... In research we call an effectiveness trial is looking at whether an intervention works in a real life setting, and efficacy trial is in a lab setting where you control all the variables in order to get the clearest possible answer, but an effectiveness study and it's... Unfortunately, those words are so similar, but they mean different things, an effectiveness study or an effectiveness trial looks at an application in a real world setting, like people get the vaccine and they go out and they live their life, and then we check on them to see if they get sick. It's a lot more... It gives us some more usable data in terms of, is what this trial suggesting, is that really true? Because these people are out and still are out in the world, I don't know anyone personally who's involved in the trial, but I have lots of friends who have family who are trial subjects right now, and that's kind of great. Right? It's really... What an opportunity to be a hero.
24:31 DB: That's exactly the way I thought about it too, especially when it was... I mean, I'm talking about early in the beginning, when we first mentioned this, I think, either I had written on something like this on social media or I'd seen somebody else do it, but just like what a brave act for people to do, especially early on, when we knew so little. Just amazing that people would step up and do something like that. I wanna thank our guest today, Ruth Werner for joining us to find out more about Ruth, visit RuthWerner.com and her podcast, I Have A Client Who, is available every Friday on the ABMP Podcast Network. Thank you, Ruth.
25:08 KC: Thanks for that great information, Ruth.
25:10 RW: Thanks, everybody.
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