Fight Back

COVID-19 Vaccine: Is It Safe?

December 14, 2020 Healthcare Consumer Rights Foundation
Fight Back
COVID-19 Vaccine: Is It Safe?
Chapters
Fight Back
COVID-19 Vaccine: Is It Safe?
Dec 14, 2020
Healthcare Consumer Rights Foundation

Latest reports indicate that COVID-19 cases are on the rise throughout the U.S., and many warn of more difficult days to come with the onset of winter. Throughout the pandemic, leaders have indicated that getting the pandemic under control hinges on creating and distributing a vaccine. 

But now that the first of the vaccines are rolling out to the public, consumers want answers to several pressing questions: how were these vaccines developed so fast? Will they be available for everybody? How will they distribute them? Most importantly, are they safe?

In this Fight Back! episode, we talk with vaccine expert Dr. Mike Ybarra, an Emergency Room Physician, and Vice President of Medical Affairs and Strategic Alliances at the Pharmaceutical Research and Manufacturers Association. Dr. Ybarra has over ten years of advocacy, health policy, and direct patient care experience. His background and knowledge will help us take a deep dive into the development of the COVID vaccine, its technology, and its implications for the public.

Show Notes Transcript

Latest reports indicate that COVID-19 cases are on the rise throughout the U.S., and many warn of more difficult days to come with the onset of winter. Throughout the pandemic, leaders have indicated that getting the pandemic under control hinges on creating and distributing a vaccine. 

But now that the first of the vaccines are rolling out to the public, consumers want answers to several pressing questions: how were these vaccines developed so fast? Will they be available for everybody? How will they distribute them? Most importantly, are they safe?

In this Fight Back! episode, we talk with vaccine expert Dr. Mike Ybarra, an Emergency Room Physician, and Vice President of Medical Affairs and Strategic Alliances at the Pharmaceutical Research and Manufacturers Association. Dr. Ybarra has over ten years of advocacy, health policy, and direct patient care experience. His background and knowledge will help us take a deep dive into the development of the COVID vaccine, its technology, and its implications for the public.

Speaker 1:

Hello, this is fight back a podcast by the health care consumer rights foundation. I'm Steve poisoner , founder and executive director or nonprofits mission is to help you navigate the complex healthcare system and understand your legal rights, options, and opportunities. When you encounter problems and obstacles, we want to empower you with the information you need to fight back and get the best possible care. Latest reports indicate that COVID-19 cases are on the rise throughout the U S in many warn of more difficult days to come with the onset of winter leaders have indicated that getting the pandemic under control, hinges on the creation and distribution of a vaccine, although options have been developed in record time, consumers are left with the daunting task of sifting through information in hopes of answering a whole host of pressing questions. Today, we will gather key information for our listeners with a discussion with vaccine expert, Dr. Mikey Bara and emergency room physician and vice president of medical affairs and strategic alliances at the pharmaceutical research and manufacturers association, his background and knowledge will help us take a deep dive into the development of the COVID vaccine, how it works and its implications for the public. How was this vaccine developed so fast? Will it be available to everyone and how will it be distributed? And most importantly, is it safe? We will cover these questions with Dr. Ebarra and much more let's get started. Welcome to the podcast, Mike,

Speaker 2:

Thank you. Thanks for having me,

Speaker 1:

Mike, as you know, polls show that there's a lot of concern in the public, you know , over the safety of the, of the upcoming COVID-19 vaccines. You know, I , the last vaccine that was developed, you know, two years and this one in the course has been finished in record time. What , uh, what should our listeners know , uh, from your perspective about the safety of these COVID-19 vaccines?

Speaker 2:

Certainly, I , I, I guess I want to start just by saying it's important for everyone that's listening to know that no steps were skipped in this process. That's really, really key. Although things are moving very fast. Um, no steps were skipped. Instead, what we were able to do as an industry was , uh, instead of kind of working purely in series, meaning step a to step B step C step D um, things were able to happen in parallel. So wherever possible, create efficiencies to move at as fast, a pace as a safety would allow. So some examples of that are using , um, digital clinical trials , uh, getting information from participants through an app. Uh, I'm actually a, in a COVID 19 vaccine clinical trial. Uh, so I went in to get two injections over the course of , of a month, but between that time I didn't need to go back. Uh , I was able to communicate through an app that I downloaded on my phone, and I did virtual visits with the clinical trial sponsors. Um, so that's one example. Another is companies now are manufacturing , uh , at risk. So they've decided to make the vaccines before they know if they're effective or if they've even been approved. And at the same time, we're really relying on decades of investment in technology. It's true that we were able to move very, very quickly. And there's an excellent timeline that shows this, the genetic code of the Corona virus. This novel coronavirus was released to the world on January 10th. And just a few days after that , uh , the first MRN vaccine was able to be created. Um, but it took many, many years to develop the platform that allowed that MRN a vaccine to be invented so quickly. And then of course, shortly thereafter, the vaccine was able to enter clinical trials. Um, so there's a lot of things that are working in our favor , um , to have a quick turnaround. Of course, it's funny to say things working in our favor because we're in the midst of a pandemic that's claimed so many lives and we really need to meet, we really need things to move this quickly , uh , if not faster. Um , but of course, again, not skipping steps and making sure that safety is the number one consideration,

Speaker 1:

Right? What are some of the side effects that you say you've taken the, the, the vaccine yourself? Uh, what, what are some of the reported side effects of this vaccine?

Speaker 2:

Certainly? Well, it's important for folks also to know, as , as I'm sure if you've ever taken a medicine, every medicine , um, you know, has some side effects and that's written on the label. Um, so when these medicines are reviewed and ultimately authorized by the FDA, there'll be a label for them as well. So everyone can kind of look at the label and kind of know what to expect. Um, I just want to make kind of, you know , one really important point and a question that I get asked often the vaccines that are being looked at can't make you sick with Corona virus . They can't make you infected. And that's something that I get a lot of, I get asked about quite frequently. So I just kind of wanted to put that out there. Um, the vaccines could cause side effects, but they can't make you sick with the virus that they're trying to protect you against. And based on what I've read , um , just from the various press releases and the, and the publications about these vaccines is that they have kind of common side effects , um , myalgias , um, perhaps some swelling , um, uh , in the lymph nodes around where it's injected , um, injection site pain. Uh, but really it's going to be up to the FDA to put in the label of the vaccine that it ultimately reviews and authorizes to know exactly what specific side effects you might expect. So it's a great question to have, because it's always better to prepare for those things to kind of know what could happen , um, so that you can be aware of them and not be surprised,

Speaker 1:

Right, at this point, are any groups of people who might want to be still concerned about the safety for them, you know, given their pre-existing conditions?

Speaker 2:

Well, I think vaccine sponsors, the companies that have sponsored these clinical trials have done a really remarkable job , uh, again, in a really short timeframe of enrolling diverse patient populations , um, particularly focusing , um , on minority communities and trying to increase the number of individuals from minority communities that are enrolled in the clinical trials. Uh , they've looked to, and to enroll a fairly broad age range as well. Um, you know, certainly 18, but also 18 to 65, but also enrolling elderly individuals. And then we're starting to see that the trials are including younger and younger folks as well, so that their specific data on ages. And then they also began doing trials on individuals that have comorbidities , um, comorbid conditions that might impact the immune system. So I know that some of the clinical trials have actually enrolled individuals with HIV hepatitis , um, in addition , uh, summer studying in pregnant women. So these are all really important patient populations to look at safety information. And again, when the FDA looks at all of this data, they come up with a label and a recommendation for who should get the vaccine. And so we're going to wait and see what the FDA ultimately says. And then certainly if you're in that, that patient population, or if you're in that target population , uh , we want to get those folks back summated quickly based on the guidance. Um, but then I think as more time goes on, I would anticipate that the , uh, indications or the , or the groups of people that are eligible for the vaccine will grow.

Speaker 1:

Right. So tell us a little bit about , um , who and when , um, we can expect to , uh, get the vaccine, which groups first in, what , in what order, what timeframe.

Speaker 2:

Yeah, yeah, certainly that , that's definitely something that , um, we're all really, really looking to and , and anxious to get the answer to. Um, you know, we're, we're kind of, we're kind of working through a complicated process now. It is important again for folks to know that the federal government through operation warps speed is actually pre procured , um , bought , purchased , um, the supply of vaccine basically for the whole us population. And then they're managing the distribution to States and they're based on, you know, based on what's been reported at this point in time, they're distributing it to States based on their population. And then the States , um, are putting together plans for how they're going to kind of get it out there to their population. There's some guidance. Um , so the CDC has an advisory committee on immunization practices. They met just last week in an emergency meeting and they put out a set of recommendations for how they think vaccine administration should be prioritized and not, not surprising. I think most folks , um, uh , recognized or expected that they would , um, recommend that in that first wave , uh , frontline healthcare workers along with nursing home residents should get the vaccine really early on. Um , and so they voted upon a set of recommendations and that included the frontline workers and nursing home residents, getting it quickly , um, followed thereafter by the elderly essential workers kind of so on and so on. Um , but those recommendations are recommendations, so they're not binding. Um, and in fact, the States are going to have to play an important role in coming up with specific plans for how they want to allocate and distribute , uh , within that, that possible States or within that state. So it's, it's possible that you could get your vaccine at a hospital at a pharmacy at your doctor's office. There could be vaccine clinics. Um, but I think each state is going to be a little bit different , uh , depending on how they kind of decide to allocate and what sorts of infrastructure they've set up,

Speaker 1:

Right. And who should get, which vaccine each vaccine has a little bit different characteristics, right. Will consumers get a choice?

Speaker 2:

That's a great question as well. I think that , uh, early on it, you probably won't have a choice early on, but we're just going to have to wait and see, because there are multiple vaccine , uh , candidates that are being investigated right now. I think a lot of consumers are aware of the top four kind of vaccine manufacturers right now. You've probably heard of Pfizer and Medina because they're right now under review by the food and drug administration, they have a review coming up next week or in the next couple of days, depending on when this is released, I guess, around the same time. And then Madonna has one in the middle of December. Um, but then there are also two other companies that are fairly far along and that's AstraZeneca who partnered with Oxford and then Johnson and Johnson , um, who are using a similar technology called an ad , no virus vector. Um, so those are the big four. I would say that folks probably recognize if you , um , have been kind of following the news on this front, but there are actually a number of other companies , uh, investigating various approaches for vaccines, for coronavirus, and they use , uh , several different technologies and, and, and , uh, kind of scientific approaches. And so over time, I think there will be more options. Um, but I think in the early days , uh , given at this point, there are two upper review right now in those early days, you know, you may not have a choice , uh, you know, that may be what is offered , uh , to you based on where you are in line. So frontline healthcare workers, for example, I'm an emergency physician. The vaccine has not yet been approved yet or authorized yet, but I already have been getting communications from the hospital that I work at about the allocation that they anticipate receiving, because they've heard from the district about the vaccine supply, they'll get , uh , based on the operation warps breed distribution. Um, and , and they said that they're gonna be having vaccine clinics shortly thereafter, the , the receipt and the, and the authorization . So we're thinking about it, but, you know, I don't, there's not multiple choices for me to choose from at that point. Uh , but at that got , got , it

Speaker 1:

Is a possible over time when there's plenty of supply that you might to get more than one or the cocktails might come together to make them even more effective,

Speaker 2:

Presumably you would only need to be vaccinated by one vaccine. Um, and then over time, we're going to look and see if individuals need booster shots. We just don't know yet enough about how long , uh, the , the, the response will be. So everyone probably knows tetanus is a good example. Um, again, as an emergency physician, I give a lot of tetanus boosters. Uh, that's one of the big things that we do whenever you have a cut or a traumatic injury, we give people their tetanus boosters, cause you need them , you know, about every five years, if you have a , an , if you have an injury, even if you're fully vaccinated. So as more kind of time goes on, we'll learn about whether or not we need to get boosters , um, for , for this vaccine. Um, but based on, you know, based on what I know now, you'll, you'll get your vaccine , uh, your, your kind of two shots, depending on which type of vaccine, both Pfizer and modernist required two shots. And then we'll wait and see if you need a booster. Um , I think one kind of big question that's out there is if you've already had COVID-19, do you need a vaccine? And again, we're going to kind of wait and see what the FDA says. I think there's a lot of folks that presume that you probably will still need to get the vaccine , um, in that , uh, you know, in that it will provide additional protection from you getting reinfected. So more to come on that. Uh, but , uh , those are the key questions that are being looked at right now, I think by the FDA. And we'll get more data when they, when they make their decision.

Speaker 1:

Right. You mentioned a AstraZeneca, the one in the UK, you know, with , uh, with Oxford university , uh, you know, there's been, you know, in the news, you know, some, you know , controversies over data quality. In fact, that there's been, I guess, a couple of people in their test groups that had some odd reactions to it now. Um, are you concerned about that particular vaccine?

Speaker 2:

Well, I , I think that folks should just be really okay. I guess, given all of the concern that folks have about the speed and the safety, I think folks should be reassured that the process is really working , um, that, you know, when, when signals , uh , come up in the data, then you take a pause. Um, a couple of the vaccine candidates have , have taken a pause. So that, that the , um , independent advisory boards , um , can look at the data and determine if they think that happened by chance, or if that happened as a result of the clinical trial. And then they let things kind of resume. And then in the case of , um, you know, a couple of the manufacturers they've let the clinical trials resume. So I actually think that, you know, of course you never want any bad , um, you , you don't want bad things to happen. Of course, the individuals that are volunteers for these trials , um, the good news is that the process is playing out exactly as it should. And that there are independent bodies that look at the data. Um, they make sure they investigate , uh, they look into it and then they make a decision if you should resume or not. So I think that , uh , again, with all of the concerns folks have had, and, and rightfully raised about the speed at which things are moving, there is a very , um, conflict . There is a very good kind of process for checks and balance, and it has played out in this process.

Speaker 1:

Is it your view that, you know, the UK and maybe some other , uh , European countries have a regulatory process that is the same rigor, you know , as here in the U S

Speaker 2:

You know, that's a great question. I'm not a specific expert , uh, in, in the, in the, the, you know , significant differences that might exist. But I will say that the USFDA is , is often considered the gold standard for review. Um, it's , I live in Bethesda just outside of Washington DC. Um, and , uh, the FDA is headquartered in silver spring, which is just a few miles from where I live actually. Um, and it's widely regarded as the gold standard. Um, so I think the FDA, I , I personally am really , um, you know, I , I take what the FDA, what their review process indicates , um , really, really seriously and I'm , and I'm pleased that they are taking every step , uh, as they would for any vaccine. So they have, you know, reviewed the data, they set guidelines for what they want to see in an , in a vaccine candidate. They sent that pretty early on. They wanted to see vaccine candidates that were at least 50% effective , uh , based on what's been reported , uh, the vaccine candidates that are under review now, or upwards of 95% effective, so much, much higher than the bar they set, which is great. And then they also wanted to see two months worth of safety data after the last injection. Um, so I mentioned I'm in a clinical trial for a vaccine I'm in the Madrona trial. And so I've received two shots. I got one shot in August. I got another shot in September, and then they needed two months of my data before they could kind of say, okay, we're ready, ready to review. And they needed to do that for all 30,000 people in the trial. So they going to look at just an absolute astounding amount of data , um, you know, 60,000 shots worth of data for the 30,000 people that, that enrolled. And we all, you know , logged in every day to provide feedback on how we're feeling, you know, provide our temperatures, answer a ton of questions, you know, get interviews with the clinical trial coordinators, you know, go in for blood draws. So there's an absolute, an enormous amount of data that they're looking at, and they're taking this really seriously. And then they're also holding an external advisory committee and that's happening right about now, depending on when this is published, where outside experts get to look at the data and provide their feedback as well.

Speaker 1:

So it is important for consumers to understand that tens of thousands of people have been tested here. Yes . That's the case. Yes.

Speaker 2:

Yeah, absolutely. I mean, really large clinical trials,

Speaker 1:

Right. And this 95% effectiveness, that sounds amazing. Right. I mean, w vaccines, a lot of vaccines don't have that level of effectiveness. Um , for example, the flu vaccine doesn't have anything close to 95%. So , uh, it sounds like people should be really optimistic about the impact this vaccine will have.

Speaker 2:

Yeah, I am. Um, and I remember the morning that I woke up and I saw some of this data published and it just was incredible to read. And so my excitement, I hope I can convey it to those listening. Um, and I I've paid really close attention to it. And in, I think, because I'm participating in the trial, obviously working in industry, but then also as an emergency physician, just knowing we really need this tool out there to help control the pandemic. Um , so the data is really great. It's, it's really positive. And so I think it gives us the sense that there's a light at the end of the tunnel. Um , but we're still in the tunnel and we need to do the things that work , uh , to get us to that, to that end of the tunnel. Um, just to , um , a point on the , on the efficacy. Um, and again, I've looked at this closely probably because I'm participating in the trial. Um, so I'll just kind of give the example based on what I've read of the, of the press releases. At least there are 30,000 people that are in the Madrona trial, me being one of them. And what they basically do is they give you the vaccine , um , you report how you feel, and then you're allowed to go live your life. I'm , I'm an emergency physician. I work and I see patients , um, I work at pharma and , um , work on medical affairs at pharma. Um, you know, I'm working from home in my pharma job, but I'm still going into the ER. So I do have exposure to individuals, but it's not a challenge trial. I , I wear PPE at work and basically they wait and see, and they , um, you know, see who gets COVID , um, in the 30,000 people and in the Madrona trial , um , based on what they reported a couple of weeks ago, I think it was around 196 people got COVID. Um, the vast majority of whom got placebo. Um, so, so 184 , I believe, or 185 got the placebo or Celine . Um, and then a small number of folks that actually got the vaccine got COVID. So then the second follow-up question is, you know, of the people that, that are in that group, you know, how many of them had really severe COVID versus kind of mild, and there were 30 severe COVID cases, you know, I don't specifically know what that means, but I can maybe assume that it's somebody that might need to provide immediate to be hospitalized, for example, or been in intensive care. Um, so they had 30 cases of severe COVID. They actually had one death in the trial and all of those folks were in the placebo arm. So it did not get the vaccine. So that's a pretty striking difference based on my read. Obviously I'm not at the FDA, I'm not looking at all of the data, but based on that, I, that was enough for me to get really, really excited and hopeful that , uh, again, we see a light at the end of the tunnel, and this is a vaccine that , that I want, I don't know what I got. I don't know if I'm in the control or in the , um, in the vaccine arm. Uh it's one-to-one 15,000 people got placebo, and then, you know , about 15,000 people got vaccine . So I don't know which one, and I'm kind of anxiously anxiously waiting,

Speaker 1:

Right? Uh , by the way, Mike, is it typical for these clinical trials to be done this way where , uh, you know, you're , you're the , the double-blind and there's the placebo group, and then the group getting the test vaccine, but then the , the, the folks that are getting the test vaccine aren't necessarily exposed to the disease that , that, you know, you're trying to vaccinate against. So is it possible, you know, to , to have done tests, you know, where you then expose the, to the vaccine? Or is that just too

Speaker 2:

Dangerous? Yeah, that's, that's one , um, that's, that's something that actually folks talked about and I've been asked that question before as well. Would I enter into a challenge trial? And, you know, my , um , personal take was that I , I, I didn't feel that comfortable. I felt like the risk that I'm taking in my current life for kind of enough , um, for , for, for me , uh , working in the emergency department, I, I like the, you know, I want to be able to wear PPE and all of that. So challenge trials are something that folks talked about, but not , um, you know, not something that we did because the risks are high it's, the disease does have a very high mortality rate still, and it's also unpredictable. We don't know who's going to get really sick , um, from COVID some people show very few symptoms and other people get really, really sick. Um , and some people die, and that is pretty unusual to have a disease that has such a wide spectrum of illness, where some people feel almost nothing and then other people die. Um , so it's just so unpredictable. That was not something that was done for these clinical trials.

Speaker 1:

The people who get really, really sick from COVID-19, is there a characteristic to them? Do they have, you know, pre-existing respiratory problems? Mainly

Speaker 2:

We do know that there are some comorbidities that put individuals at increased risk of severe COVID-19, but we also know that there are some factors at play that we just don't fully understand. Um, the virus has been, you know, impacting , uh, well, I've been taking care of COVID patients now for about 10 months, and there's still just a lot that we don't know. We've made a ton of progress in diagnosing and in treating . And thankfully from the pharma perspective, we have a ton of tools in our toolbox today. So many more than we did when the pandemic started. Uh , I remember early on , um, you know, we were just kind of ramping up and I would see people that I presumed had COVID do a test. It would take days if not weeks for the result to come back. Um, we had little to offer in terms of therapeutics , um, little to nothing to offer in terms of therapeutics. Um, and now, you know, I'm , I'm able to prescribe antivirals to people that need to be admitted to the hospital. If someone's really sick, we have anti-inflammatory medicines that help the later stages of the disease. Um, and then we have new antibodies , um , that just became authorized in the last few weeks. And when we have some at the hospital that I work at , um, some of my colleagues have been using them for , for patients that are, you know, the intended population that , that need it . So it is exciting that we have these tools. Uh, I still, again, though, we need to keep doing what we're doing in terms of masks and social distancing and hand-washing , um , because the vaccine is going to be, you know, a really effective tool that is hopefully right around the corner to bring the pandemic to an end.

Speaker 1:

Right . So , um , I have some family who's in these high risks groups because of preexisting conditions. Once they get a vaccine, Mike, then should they , uh , still take precautions or how should they begin to get their life back to normal if they're, especially if they're, if they're high risk. Yeah, absolutely. I

Speaker 2:

Think for the foreseeable future, even once you've been vaccinated , um, we're going to still need to take the public health precautions. Um, and that's in part because we, while the vaccine, we know where it's being looked at now , um, because it seems to show that it provides a lot of protection to people that got the vaccine. There's still things that we don't know. Um, like if you got the vaccine, are you able to transmit the virus? Um, like, could you give it to, I'll give you a good example. My , my own personal example, you know, it's likely that in the next few weeks being a , an emergency physician, I'm probably going to be offered the vaccine if I didn't already get it through the clinical trial. Um, but what we don't know is if , um , you know, if I get the , when I get the vaccine and I'm still taking care of patients with COVID, do I have the ability to still bring it home and, you know, give it a , you know, unwittingly of course, to my family. Um, so that's a key data point that we don't yet know. I think we will likely learn that soon. Um, but until we do, we need to keep doing all the things that we're doing in terms of masks, social distancing, and hand-washing

Speaker 1:

Right. Uh, so tell us a little bit about herd immunity. So how, how many people need to get the vaccine and, or sadly have gotten the disease. W w how does it work? W you know, in order to get enough people with some type of immunity in order to really kill off this , uh, this , uh, coronavirus,

Speaker 2:

Certainly there's been a lot of math done by folks far smarter than me to figure out kind of exactly where they think we need to be. Um, so what I guess I would say is, you know, the vaccine is, is showing really high efficacious, efficacy numbers. Um, and if it's authorized, I think the key thing is, you know, we want everyone to feel confident in taking it. If you're in that target population, if it's authorized for you, we hope, or I hope, I guess, that everyone will feel comfortable and want to go get it. Uh , the more people vaccinated, the more people protected, and the more likelihood that we kind of, you know, take away the oxygen that this virus needs to survive. Um, you know, if we don't get enough folks vaccinated, then the virus is still able to circulate. Um, but if you do a good job vaccinating populations, we've seen the viruses can, you know, go, you know, go, go down so low that you really don't see them anymore. Um, so that's my hope , um, is that we can, we can all work to increase vaccine confidence. And if you're in a population that , that is able to get the vaccine that you feel confident in doing so , um, because the more people that got vaccinated, the more people protected and the faster we can end the pandemic

Speaker 1:

Me . So you're really getting a vaccine, not only for yourself, but for your family and your friends and community.

Speaker 2:

Definitely that's right, right.

Speaker 1:

So let's talk about distribution challenges. You know, we've all read about how a dry ice company stock has gone through the roof because of this , you know, the special requirements to keep the , these vaccines, you know , at a super bowl temperature. So , so what , what's the latest on that?

Speaker 2:

Well, I'm really impressed. Uh, just again, doing my own kind of reading. Uh, I'm , I'm incredibly impressed by the work that Pfizer, for example, has done one of our member companies to invest in a cold chain distribution channel. Uh, that is incredible. Um, they're , they're , uh, just again, based on what I've read , uh, their virus needs to be kept at a really there , I'm sorry, vaccine needs to be kept at a very low temperature. And in order to do that, they made, you know, I believe billions of dollars in investments in cold chain , um, to keep the vaccine really, really cold and keep it , um, you know, keep it at the appropriate temperature. Um, so that's a factor and it's impressive that companies have stepped up to make the investments. Um, and then I know, you know, health systems and other folks in , in partnership with operation warp speed are working , um , on those points as well. So that once it arrives at the location, it can be stored , um , and then administered , um, you know, I , I did read the same thing about dry ice. Uh, you know , uh , my understanding is , is the dry ice is in high demand right now.

Speaker 1:

Yeah, I think it's minus 94 degrees Fahrenheit is what the Pfizer vaccine needs to be stored at , uh , is , is , uh, Moderna the same. My minus

Speaker 2:

Standing is there's also needs to be kept cold, not quite as cold. Um, and , and again, there's probably, you know, there's obviously a reason for that. Um, they, they have the data to know exactly why , um, both vaccines use a technology called M RNA and , uh, M RNA is , uh , is , uh , is an exciting technology. Obviously it's doing , uh, showing great results with those high efficacy numbers. Um, and MRA though it does what we know about it, or what I know about it is it degrades quickly. Um, so if it's kept at room temperature, it'll degrade very quickly. Um , once it's injected , uh , in the vaccine, it actually degrades in your body very quickly as well. Um , so the way that they keep it and , and get it to the right place and get it injected is they have to keep it very, very cold. And an analogy that I read that I really stuck out for me is you can kind of think of it like an M and M where the chocolate on the inside is the MRN . And if you keep it in a kind of room temperature or hot temperature, it's probably going to get soft and melt. Um, so they put the kind of outer coating on it. Um, in the case of the vaccine, they put kind of a lipid wrapping around it, and then they keep it really cold. Um , so that it , it gets to the intended point in time where you can inject it or for in the case of an M and M so that you eat it. And it's not melted.

Speaker 1:

Ah , interesting. I read in fortune magazine yesterday that the there's, there's a couple of leading candidates for vaccines in China , uh, and the, the two Chinese vaccines do not require, you know, this super cold , uh, distribution. So is it the case, Mike, that, you know, there may be a role for all kinds of vaccines in order to get this around the world? Some might have certain strengths versus others.

Speaker 2:

Absolutely. That's a really good point. Well, we talk about is , um, at pharma, we talk about having multiple shots on goal as the analogy you need to have multiple companies researching multiple modalities , um, to have kind of, you know , multiple chances of success. The , the kind of first reason that you need that is because making medicine is very complicated and oftentimes medicines do not make it all the way through clinical trials. So you can't just put all of your bets on one vaccine , um, because that's a , that's a risky bet. Um, so there've been a number of companies investing in this space and looking at various approaches. Um, and so that's a good thing because more shots on goal means more likelihood of, of success. And then it also, each vaccine has slightly different characteristics. You just talked about too . One needs to be kept at negative 90 another . I believe it's negative 20. Um, even another one actually can be stored. It kind of typical refrigeration temperatures. Um, some of them are to dose. Some of them are one dose. So all those things help us in a very big, big world that we live in with very diverse health systems, even in this country, different parts of the country have different health systems and different needs. So I think all of that is really important

Speaker 1:

Right now. You said earlier that these vaccines , uh , there's zero chance you can actually get COVID-19 from the vaccines. Is that, were you referring to just Pfizer and Moderna or is that, does that apply to all the major leading candidates today?

Speaker 2:

Yeah, well, I think that's a, it's a common thought. I think that, that vaccination , um, I think, well, I guess since I get the question a lot, I just thought to lead lead with that , um, that I think a lot of people when they hear vaccine , um, they ma they must think , um , you know, perhaps I'm getting kind of an attenuated form , um, and that's kind of classic vaccine approach. There are some vaccines out there that kind of have the , um, kind of an attenuated virus. My understanding of, of a lot of the research right now is , um, is that it's actually looking at approaches that are more, you know, taking just a tiny piece in this case of MRN , which is making , um, just, just the outer spike protein, you know, there's , there's no way that you can get Corona virus from that. Um, and so most of the, the leading candidates are not looking , um, you know, they're not going to get you sick from COVID-19, there's a possibility that you could experience side effects. Um, but you know, I, I want folks to feel comfortable that you , you know, it's not like you're going to get the vaccine and then get COVID from the vaccine. Um, so that , that's a question I've gotten a lot, but I'm also interested in hearing, you know, I , I encourage my, my work colleagues, my family, you know, come to me with your questions because I want to , um, to kind of know what they are and hopefully try to address them.

Speaker 1:

Right. So when you , when you do experience some side effects, like from the flu shot, a sore arm, that kind of thing , um, is that actually a good sign that, Hey, the , the body is reacting here and, and , uh , that's what you want to happen. Certainly. Yeah ,

Speaker 2:

It could be, you know, that's, that's a great question. Um, you know, a lot of the side effects that I'm aware of are likely because the immune system is kind of ramping up. Um, and it's kind of, you know, it's interesting, cause I think in medicine, oftentimes folks , um, you know, think the fever a fever might be , uh , a problem in and of itself, but for us in medicine, it's actually a fever as a sign of something. Um, you know, we, we often treat the fever to make people comfortable. Um, but that's more just telling us that there's an infection , um, when somebody comes in with a fever. Um, and so, so oftentimes the side effects are kind of telling us something , um, as opposed to necessarily a problem. Of course, if they make you sick, you always have to talk to your doctor. But I think you're getting at an important point, which is that, you know, these are all signs that the immune system is, is, is active. Um, and so in this , in a certain sense, it's kind of a , it could be considered a good sign. Um, it just really depends on your specific situation. Um, and again, I want folks to, you know, I'm going to take a look at that FDA label and , and obviously, you know, trying to learn a lot from it when ultimately a vaccine as authorized,

Speaker 1:

Right. Uh , you mentioned , uh , that's some of the vaccines that are going to be single dose. I believe that Johnson and Johnson one is a single dose. Right. How, how, how do you happen to know how far away are we from a single dose option?

Speaker 2:

Yeah. So those four are the ones that we've been talking about. I think most folks probably recognize the names of the companies because they're all in phase three or have completed phase three clinical trials. So Pfizer and Madonna , um , completed their phase three clinical trials. They're still studying the vaccine and it's still undergoing kind of long-term , um, you know , long-term study, they're gonna keep monitoring people like myself that are in the trial for a very long time. Um, and they're continuing to study it in different patient populations like kids. Um , but they've submitted to that da. So we're waiting on the FDA now to see what , what, what comes next. Um, the two other companies that are in phase three are Johnson and Johnson. Um, AstraZeneca, there are other companies out there though that are pretty , pretty far along, you know, also in early phase three or in phase two. Um, so I think the , the next two that you mentioned that are kind of, you know, deep in the phase three are the ones that we've been talking about. That's J and J and AC, I believe AstraZeneca, I believe, but there are many other companies researching that are pretty far along. And so I , uh , you know, I just, I look at the news kind of constantly and I kind of follow it and I'm very, very interested as a , as I think a lot of folks are. Um, but those are the, the ones that are furthest along at this point.

Speaker 1:

Right. Um, so how concerned are you about the , the double dose compliance issue? You know, people getting the first one, then they forget to do the second one or the first one to hurt. And I don't want to get the second one. W w what , what are your thoughts on that?

Speaker 2:

Yeah, I think that's a good reason why we just need to keep talking about these things. Um, we need to kind of meet people where they are answer any questions, concerns they might have, and then really clearly communicate the , the follow-up . I think you're absolutely right. Follow-up can, can sometimes be a problem , uh , if you've ever had to interact with the healthcare system, you know, all of us, including myself , um, have , have had issues , um, you know, getting that , uh , you know, being a hundred percent compliant with everything that your doctor recommends, but this is really, really important. I've heard some really innovative things being talked about , um, you know, using technology to remind people. Um, I believe I heard operation warp speed is , is including cards when they distribute as well. So folks, you know, have the good old fashioned reminder card. Um, so I think it's going to be an all of the above type of approach , um , in compliance with the second dose is really important.

Speaker 1:

Right. Uh , do we know for fact that, that if you don't get the second dose, you're not going to get any value?

Speaker 2:

You know, we, we don't know , um , enough, I don't know enough to say , um, I think that we could get a little more information on that when some of the data is published or the FDA , um, kind of comes out with their decision. We might get some information, but what, you know, the trial that I was in, it was a two shot trial. And then the data that was reported out was , um , starting. They started looking for infection kind of efficacy seven days after the second shot. So we really can't say based on what we know now, that's publicly available. We could learn more in the coming weeks. Um, but, but that's what we know now is the efficacy rates for seven days after that injection, I stayed right in injections all sorry .

Speaker 1:

Right. I think , uh , the federal government is creating a database for the , for, to help , uh, with , uh , with the double dose compliance. Right? So if you go into a Walgreens in Miami and get your first dose and , uh, and then the second injection, you go into a CVS in Houston , uh , uh, I believe they're gonna have , or at least the idea is to create this database so that they , so they know which one you got, you know, when

Speaker 2:

Yeah, no, I'm not, I honestly, I'm actually not familiar. If that database is up and running, what I've been kind of telling my friends and family is just get prepared to know what day you need to go back and ask what vaccine you got. I actually practiced that myself. When I got my flu shot, I'd never asked what, who made my flu shot. Not that it mattered, but just to kind of see how just to kind of test drive it. And I just asked as they were injecting it and they told me the manufacturer and I wrote it down. Um, so that's what I encourage my family to do is , uh , when, when your time is , uh , to get the vaccine , uh , when is your, when it is your time to get the vaccine, just to ask, ask which one you got and when you need to go back.

Speaker 1:

Right. Right. And , and all of this will be free to the entire country for this first round of yeah .

Speaker 2:

Yeah. The good news is, I mean, first of all, companies made commitments and tremendous, tremendous investment , um, around vaccine affordability. Uh, but then also the government made an investment. They, they, through the operation, warp speed had procured a supply of the vaccine , um, for the, the U S population. Um, and so it's , it's a great , uh, you know , great investment , um, that the value of the vaccine is going to be really, really incredible in terms of getting us back to normal.

Speaker 1:

You know, Mike are , I remember getting my polio vaccine back in elementary school is a long time ago, 1962, that all kids were lined up, you know? And they , they, they distributed the polio vaccine in a sugar cube . What happened to that technique? How can you always definitely get needles now?

Speaker 2:

Yeah. I saw something on Twitter that that's where the spoonful of sugar came from. I don't know if that's true, but I, I , I saw the , uh, I saw it on Twitter, so, you know, take it for what it's worth.

Speaker 1:

Right. Yeah . Interesting. Well, I got to tell you the, the , uh, the impact that the pharmaceutical industry is going to have here on the country, in the world by , uh , working at record speed here with so many different choices. It's just, it's just mind boggling, very exciting that the, our , our scientific academic, you know, the medical communities , pharmaceutical companies, you know, even the government, I mean, everyone seemed to be working together, at least with this particular part of the pandemic crisis. Uh, the vaccine part of it is, is , uh, is amazing.

Speaker 2:

Yeah, I , I agree. And I , um , you know, it's, it's been really rewarding , uh, if that's an appropriate word to use in this, in this, in this very challenging time, but it's been rewarding to work for an industry that really left kind of nothing on the line. Um, you know, the folks at the companies that we represent at pharma have , um, invested, you know, innumerable hours, decades of research , uh , billions of dollars , um , to meet the moment. Um, and so I'm really excited for the fact that we're on the cusp of, of, of this , um, this vaccine review. Um, and , and as I started , uh , I'm , I'm excited, I'm ready. Uh , and I'm hopeful , uh , to , to get a vaccine here shortly,

Speaker 1:

Right. Two final questions. And then we'll, we'll wrap up here. First is when do you think, you know, the United States can get back to something close to, you know , pre pandemic, normal life?

Speaker 2:

Yeah, well that depends a lot on the vaccine uptake. Um, the P the, the vaccine has the ability to bring a rapid end , um, but, you know, we need folks to be willing to take it. And so that's why vaccine confidence is so important. Um, you know, again, we can see the light at the end of the tunnel. We shouldn't ignore everything that we know works right now until we actually get to that point. Um, but then distributing it and making, you know, making sure the millions of people that are eligible for it are willing to get it. That's, that's a whole another challenge , um , that I know you're, you're thinking about. We're clearly talking about it now. And, and a lot of other really , um, you know, really smart folks were thinking and talking about it. So , um, it's , I, I certainly hope that 2021 is, is the year. Um, but I encourage everyone when it's, you know, if you're , when you're eligible, if you're eligible to consider vaccination. Cause I think it's , uh , it's going to be the thing that really gets us back to normal.

Speaker 1:

Right? Yeah. Let's hope for a great 20, 21. My last, my last question here has to do with, you know , what have we learned about pandemics and vaccinations and so forth? How , how are we better equipped to , to deal to deal with the next pandemic now? Yeah, certainly think that , um,

Speaker 2:

You know, again, the, the investment that has been made over the last, you know, decades scientific advances, everything we know about viruses in particular really did , um, uh, put us in a good place to be able to respond quickly. You know, I personally am, am excited by the , the, the multiple platforms that companies kind of had ready to go. Um, and that's why I think you saw the ability to, to kind of sequence or create the vaccine so quickly after the genetic code was released. Um, so I think we've got to keep investing in those platforms , um, and we need to have a robust ecosystem that allows companies to do that. You know, I think a lot of folks want to want to , you know, kind of just go after the pharmaceutical industry. Um, and I don't think that will help us continue to be prepared to respond to future pandemics , um , because you know, the investments that we're making today in technology , um, will, will help us for whatever comes next. Um, so, so the investment in MRN , for example, over the last decade , um , because those companies had investment, they had capital, they could do that, that set us up to be able to respond today. We don't know what the next challenge is going to be. Um , so we need to make the investments in new technology now , uh , to prepare us for whatever comes next.

Speaker 1:

Mike, thank you so much. Great information really appreciate you being on the podcast today. Thank you.

Speaker 2:

Thank you for including us in our perspective, thanks for including me and letting me talk about , um, you know, as being a participant of a clinical trial , uh, working as emergency physician, but then, you know , most importantly, the, the job that pharma and getting to represent the companies that are doing this work. So thank you.

Speaker 1:

And thanks for being an ER, doctor, what a tough and important job, especially right now. So thanks for your service there.

Speaker 2:

Thank you. I really appreciate it. It's it's definitely been a year.

Speaker 1:

I want to thank you for listening to today's fight back podcast. Our mission is to provide you with the healthcare resources and information in a refreshing and interesting format. I also want to thank Dr. Ebarra for joining us on our podcast and providing you our listeners with the information you need to keep yourselves family, friends, and the community safe. For more information, please visit our [email protected] , consumer rights.org. While on our website, you can check out additional podcasts or access more information and resources to help you navigate this healthcare system and get the care you deserve. We also welcome your input and stories that we can use on future podcasts. This is Steve poisoner, and this is fight back a podcast by the healthcare consumer rights foundation. Thanks for listening. I look forward to our next podcast. Talk with you soon.

Speaker 3:

[inaudible] .