We discuss in this interview:

• The current situation with COVID vaccines
• Different vaccine classes
• How mRNA vaccines work
• Considerations for autoimmune patients
• Side effects
• Effectiveness of vaccines
• Interactions with biologic drugs
• The importance of gathering data
• The COVID Tracker (RAPS)
• Ask Dr. Munoz questions on our next LIVE Q&A

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Transcription

Clint: I’ve been getting a lot of questions recently about the covid vaccine, and questions coming in from people not just around the safety of the vaccine and the different types of vaccine, but especially around the implications if you have inflammatory arthritis. And whether there are any reasons to be cautious about getting the covid vaccine, especially if you are taking immunosuppressant drugs, and generally what the guidelines are? And whilst some of the guidelines aren’t yet clear, I’ve invited our very special friend of rheumatoid solutions onto the podcast.

Clint: So there’s a lot of questions coming in at the moment around the covid vaccine. And whether or not there are any contraindications when you have inflammatory arthritis or whether or not you should get the vaccine if you’re on the immunosuppressant drugs or whether or not, it’s OK. And so to answer the questions like those, I’ve invited a very special friend of our podcast back onto the episode today, Dr. George Munoz, who’s a rheumatologist from the Oasis Institute.com. Welcome back, Dr. George Munoz.

Dr. Munoz: Thank you, Clint. Happy new year to you and all of our listeners, and it’s great to be back.

Clint: And thank you for doing this on your weekend. It’s five o’clock in the afternoon on a Saturday, so you have very generously given us some of your time to answer some of these questions which keep coming in. Because there’s a lot of concern around whether or not we should or shouldn’t get this COVID vaccine. And, in fact, what is this vaccine? And so why don’t we start with what we know so far and you can help us understand potentially, what vaccines are sort of on the agenda at the moment? And at what stage are they being rolled out?

Dr. Munoz: So that’s about 50 questions that I’ll try to really make understandable. And I was told that if we can explain things during an elevator ride simply, then we actually understand them and it’s fascinating what’s happened here. And I want to recommend the COVID tracker as a source for people to look at from The New York Times and that’s tracking all the vaccines worldwide, so that’s a well-trusted source. But to answer your question, Clint, we have three vaccines right now that have been approved with several hundred in the pipeline. So these are a massive topic, I’m going to stick with the two mRNA vaccines first and so I’ll break this down.

Dr. Munoz: We’ve developed vaccines at an unheralded pace usually, they take four, or five, or seven, or ten years to develop. So the leveraging of resources and technology and doing phase trials simultaneously, instead of one at a time is part of the reason. And also the monetary support globally has been the reason we’ve been able to develop these vaccines at such a fast pace. OK, so I wanted to say that. We have several categories of vaccines for our listeners and patients on people to understand and physicians. And one of the new classes, which has never been really utilized in clinical medicine before, is the mRNA vaccine type of which there are several. We have also a vaccine that’s utilizing a vector, an adenovirus, which is really a virus for the common cold that has been broken down its assemblage and materials, removed, and replaced with DNA to form mRNA coating for the spike protein. So that’s another class of a vaccine and I’m going to stick with these two for now, but one is able to go to the COVID tracker. And look at some of these other viruses that are available antiviral agents, vaccines, and the two mRNA vaccines that currently have been released here in the United States, and are available under the Emergency Authorization Act. Basically, it allowed the release of a drug or the vaccine to be accelerated and use even though we don’t have all the information due to the severity of the pandemic.

Dr. Munoz: So people need to understand this, mRNA stands for messenger RNA. It’s a message of the nucleic acid DNA material that was constructed to sequence the spike protein of the sars-CoVid-19 virion. This virus has on its outer shells, protein spikes that the virus uses to attach to human cells to gain entry into the cells. So it became a natural target to develop vaccines that would stimulate the person’s immune system and attack the target. In this case, the spike protein and create an immunological response of various types. The spike protein was visualized by special techniques, including sequencing and getting the genetic code for the virus or for the variant. And from there, the spike proteins were actually synthesized based on the sequence. And something very astounding was done to create mutations or changes in the code for the spike proteins. But yet so that these spike proteins are not active. But they have the three-dimensional configuration of the natural SARS-CoV-2 spike protein, for which the mRNA was then created by retro’s sequencing. And we now have the message of RNA Ribonucleotide proteins, amino acids, and sugars that code for that protein. And it was wrapped in little fat layers, which are called my cells. And that was done for stability because RNA is not stable, it won’t like hang out or it’ll degrade. And so they put them in little fat packets for a transfer into the cell and to create the basics for the vaccine. And the fatty envelope, which is in the vaccine, both the Pfizer vaccine as well as the Moderna vaccine, are then injected intramuscularly and they stimulate an immune response, creating in some cases symptoms similar to COVID or the flu or a viral infection, which could be some local mild pain at the site of the injection because it is an intramuscular shot. People may get some fatigue, fever, headache, and tiredness and these are some of the most common side effects. And also with the Pfizer vaccine, they had to put some other chemicals to stabilize the vaccine so that when it’s given, it stays fixated and able to work. And some people rarely, very rarely, some people can have a reaction to the vaccine but it’s very rare thank goodness. And it may be seen in people who have highly allergic backgrounds. But again, this becomes a discussion of risk-benefit because the vast majority of people do not have this and the vast majority of people are able to successfully be vaccinated without issue. So that’s how the mRNA viruses are constructed. And I’m not getting into unnecessary detail because there’s a lot more detail. There are handling issues in terms of temperature and differences between the Pfizer and the Moderna vaccine. But the third vaccine, which is the vector using the adenovirus, the common cold virus, with DNA and that is the Oxford AstraZeneca vaccine is a similar concept, but it’s not using mRNA directly, it’s using DNA, which is the original message. Again, for the spike protein to be injected into a person and allow their cells to then create the mRNA for the spike protein. And then create the spike protein for which the person’s immune system recognizes as foreign and then to begin an immune response for protection. In most cases, you don’t lead to significant death but, the problem is that we have a pandemic with millions of cases now. And it’s a numbers game of a small percentage that begins to overrun the capability of medical systems and this is why we’re doing this. So we are looking then at these three vaccines as the currently approved vaccines in the EU, Great Britain, the United States, the FDA and there are other vaccines. There is a Chinese vaccine and there is a Russian vaccine, which interestingly is named Sputnik V. And it is reminding us of your listeners who are of my generation and older, will remember the Sputnik spacecraft was part of the original race to the moon Russian spacecraft. And so we have a recrudescence of that concept that, this is a race to develop therapies for this global pandemic from multinational, international, many research camps, and private and national state-sponsored organizations. So I’ll stop there and see if you have any questions at that point.

Clint: Thank you. Well, the first thing that I’m sort of observing is just the level of complexity and the level of amazing development that has occurred in the last, less than 12 months since this has hit. And what I’m picking up from you is that this is something absolutely extraordinary that has been achieved to be able to come up with a vaccine in this amount of time. Word on the street is that it normally takes like 10 years to develop a vaccine like this and I see that you’re nodding your head. So this has been obviously fast-tracked, as you said, with all the money and all of the interest and all of the resources developed or allocated to this task. So thank you for all that background. And some people are now going to be wondering, well, what are the considerations then? It does seem like you have come a long way and It looks like vaccines are coming at us. And this is something that we should be considering because we don’t obviously get the virus if we haven’t had this already. And what considerations need to be looked at when people are thinking about getting the vaccine?

Dr. Munoz: So from a user perspective considerations, these are considerations that I hear from my patients, and then physicians are going to have considerations on the medical side. So let’s start with our inflammatory patients since this is our main audience today. And let’s start with the fact that we have been vaccinating our autoimmune patients for quite a while now for different conditions. For example, shingles, regular flu, and pneumococcal pneumonia. So the concept of vaccinating our autoimmune patients, especially if they’re going to begin biologic therapies in advanced immunosuppressive therapies, this is not new. I think one of the main considerations with the sars-COVID vaccine is number one, we’ve never had an mRNA vaccine ever, So this is first in class and if we have a first in class and anything, people will say, well, is it safe? Is it OK for me to take it if I’m on autoimmune medications or immunosuppressive therapy? Is it safe for me to take if I’m on steroids? How will it interact with my autoimmune condition? I think those are four major areas and we’ve had some guidance or commentary, I prefer to call it commentary, with preliminary guidance on some of these questions. And I will tell you that to date, we have no data on the safety or efficacy in specific autoimmune patients using the mRNA or the Oxford AstraZeneca vaccine in large numbers, we just don’t have it. What we have are phase one, phase two studies, and phase three studies, which means that immunogenicity was tested, meaning do the vaccines cause an immune response for protection? And the answer is, yes. Do they look generally safe in phase one? And the answer was yes, but these were populations that were not autoimmune patients, they were excluded. And they weren’t excluded due to concern of side effects of the autoimmune patients, they were excluded because this is a more complex population on the drugs that we’ve just talked about that might affect the interpretation of the data of their effectiveness for the general population. OK, so I want to be crystal clear there, they weren’t created or our autoimmune patients were not eliminated from the study out of fear that something bad was going to happen either in side effects or in effectiveness. But they didn’t want to take the chance and delay the rollout. OK, I’m just telling you, like how I see it, that’s how I see it. Now we have information on autoimmune patients with vaccines from the vaccination practices that I’ve mentioned to you that are common. The second and what I’d like to say with that is that generally speaking, there are no significant issues in this regard. What we do know from our population of patients and on immunosuppressive is that no live attenuated viruses should be used in our patient populations. And the SARS-covid vaccines are not live attenuated viruses. So, therefore from that perspective, they’re safe to use. I hope that is a major point that is clarified for our listeners and for physicians because this can be all be very confusing. The adenoviruses, which I spoke to you as the benign vector, vector simply means a tool for infection, that is part of the Oxford AstraZeneca vaccine. It is a common cold virus, not a SARS inactivated virus. And the machinery for duplication of the adenovirus has been eliminated. The only thing in it is the DNA for the spike protein to be translated and made into messenger RNA in the person and in the individual who gets vaccinated and then makes the spike protein to create the immune response. So this is not a live attenuated virus in the classic sense.

Dr. Munoz: So as far as side effects, I’ve already alluded to them, they are the usual mild side effects that can happen with any vaccine or with any viral infection, and I’ll just list them again. You can have an injection site reaction or tenderness, that can be mild to moderate lasting hours to a few days. Generally not a big deal, you can have fatigue, you can have a low-grade fever, you can feel tired, you can feel achy, just like a viral infection, you can have a headache and most of the time, these symptoms are mild and sometimes moderate. These vaccines require two shots, an initial and a booster. After three to four weeks, the immune response tends to be stronger with the second vaccine, the booster, because your body now has been primed. And we want this reaction so that if you come in contact with COVID-19, you have an immune response against the virus to attenuate.

Dr. Munoz: Now, what does it look like? How effective are they? And that’s a question that I would like to know. Here’s some good news, it looks like for the two mRNA viruses, the Pfizer and the Moderna, the effectiveness is in the ninety-four to ninety-five percent which is very high, so we’re really happy about that. What is the number that is considered necessary in order for a vaccine to be considered effective for COVID-19? The percentage is actually much lower, it’s 50 percent. And so the reason I tell you that is to then pivot to the Oxford AstraZeneca vaccine, whose currently stated effectiveness. Efficacy is lower than the Pfizer and the Moderna, it’s in the 60 to 70 percent range. And initial thoughts are that if the initial vaccine was lower when the full dose is given on the second, the effectiveness in the study came up to 90 percent. This has to be determined if this is true or simply a sampling error. But right now, we’re using the 60 to 70 percent effectiveness for the Oxford adenovirus AstraZeneca vaccine. So I’ll pause there and see if you have any questions or clarification there.

Clint: The first response is the information is sensational. And I know you just reporting on the commentary, but this is very, very reassuring information I’ve never heard before. So thank you very much, this is brilliant. And I’ve made some notes as we’ve gone here that so you can then give me a correction to my understanding. But because people with autoimmune conditions, including inflammatory arthritis, have been vaccinated before for other viruses successfully, we’ve got that history and can feel good about that. This isn’t the first time at the rodeo that that particular situation, none of the three options that are leading to the run at the moment are live vaccines. So that’s a crucial point that you’ve made and that’s very reassuring as well. And we’ve learned that in each of them, there are two shots, there’s one and then there is a booster some weeks later. And it’s typical when they’re intramuscularly injected to have some discomfort at that site and even to experience some of the symptoms of the virus itself. In response, your body basically responds and does what it needs to do to acclimatize to that intervention to make it resistant to that virus. So all of this sounds excellent, and are we on track if I understood correctly?

Dr. Munoz: You are on track and you have confirmed the full access of the information this far.

Clint: Thank you. Now, one nuance here is that you mentioned that often people before they go on biologic drugs, are given these vaccinations in preparation. What about if people are already on biological drugs? And I know there’s no data, so how could you comment on that scenario?

Dr. Munoz: So we didn’t do our usual disclaimer that we usually start our sessions, which is again, this is my general commentary, some opinion, some guidance that I’m passing on from medical societies, including the American College of Rheumatology or www.rheumatology.org and common sense. Common sense is good and also some guidance that we’ve been utilizing protocols thus far in our patient population, which is obviously complex, immunocompromised, and to different degrees depending on their medication cocktail and also the presence or absence of prednisone, 10 milligrams and above. So let me start with this, that rheumatology.org or the American College of Rheumatology, published some general guidance in July of 2020. And basically, the information-based is that number one, we’re not stopping medications during the pandemic. If you’re on medications, don’t stop them and you only stop them if there are signs and symptoms of covid. You’ll speak with your physician, you’ll make a joint decision, you get tested, and based on these results, a decision can be made to temporarily halt therapy for a period of time until it is safe to resume. And this is a question of shared decision making between patients and their physicians. So migrating from that scenario to the vaccine, what do we do in terms of medications? And when to vaccinate, if and when to vaccinate? So based on what I’ve told you, OK, I hope that people are hearing me because I’ve really come full circle on this vaccination issue. I want people to know that I have gone ahead and received the vaccine, I got the Pfizer vaccine five days ago. And I thought it was important because I’m leading my patients and I want to show my patients that this is the best practice pretty much. And that everybody has individual decision making to do with their physician. And it always comes down to an assessment of the risk and the benefit of not doing it versus having COVID. And the risk and the benefit is affected by your medical regimen and your condition, your age, your comorbidities, and prednisone separately. So typically for the flu vaccine, for example, we have new data and relatively new data, that suggests that if you get the flu vaccine, you should hold methotrexate for two weeks after your flu vaccine so that it works. We don’t have the data for the SARS covid vaccines. My personal view on this for which we don’t have the data is that I will recommend my patients who are taking methotrexate to hold their methotrexate for two weeks if they are stable after they receive the covid vaccine. So this is a specific scenario where I am translating from data we have on the flu vaccine about efficacy, not side effects of the vaccine so that the vaccine works, OK?

Clint: Yes.

Dr. Munoz: Now, there doesn’t seem to be any reason why if you’re on a biologic at this time, the vaccine should be withheld and that’s just doesn’t seem to be. And again, this is recommending that everybody discuss this with their physician. I will say that people who are at higher risk are going to be people with multiple immunosuppressive and who have organ damage and who have, for example, kidney involvement or lung involvement, who are diabetic as the regular population is. But having prednisone, 10 milligrams or higher is going to significantly add risk to getting covid and having a bad outcome. Therefore, you should really strongly move towards the concept of getting the vaccine for the added protection because there is more risk there. And so this becomes an exercise for everyone of listing the comorbidities, the risk factors, and the very low risk of side effects from the vaccine itself.

Clint: Ok, well, thank you for sharing your personal choice there as well with regards to the vaccine, that is very interesting. And I’m sure you’re going to be one of the millions that roll this out and get vaccinated over the coming months or a year. And the landscape changes and we’re recording this early January 2021. If you’re listening and watching this some months from now, three years from now, then obviously we’re just going off the information. You’re going off the information that you have at the time. So thank you for all of that, I think you’ve covered just about everything that I wanted to know. Is there anything that you feel that we haven’t touched upon, anything that we’ve left out?

Dr. Munoz: So I would like to just add that here in the States, we have the CDC has a tracker that is voluntary to sign up for so that you are monitored post-vaccine for any side effects. I just feel it’s part of my civic duty to participate in these types of endeavors, just like I feel it’s my civic and professional duty to share this information with you and your listeners and my patients. And the more information we get, the better our recommendations can become. Autoimmune patient data will start to increase over the next three to six months on utilizing the international trackers, using the websites, including covid.com and the ACR’s site as well, tracking covid internationally. And so, I recommend that people avail themselves of these sources and these resources, trusted resources to see what’s new and how things are developing. And I think that’s it for now.

Clint: Yes, no, thank you very much. Again, just to reiterate how good this information is and how grateful I am, and I’m sure our audience for you to share this information. It’s very hard to find out this level of detail and specifically around inflammatory arthritis and the medications from any other source. So you really are a very, very valuable resource for us on this podcast. And Dr. Munoz, you’re joining us on January the 8th, which will just be in a couple of days from now as we release this podcast in our Rheumatoid Solutions and rheumatoid support group. So if you’re not part of those platforms, please come join us and you can ask questions of your unique circumstances to Dr. Munoz on those calls. We treat them like this, like general information based on Dr. Munoz’s opinions, but it’s very, very valuable and please come join us. Go to rheumatoid solutions.com to sign up and you can join Dr. Munoz and our other guests on a monthly basis. And to speak to Dr. Munoz yourself if you would like to have him as your rheumatologist, you can go to the Oasis Institute.com, where he does do telemedicine consultations and offers a tremendous professional service available for you all around the world at the moment. So definitely take the opportunity to contact the Oasis Institute.com. And let me add, Dr. Munoz has just started a podcast, and the first episode I believe is about to go live, this is so exciting. So if you like this format and you listen to the Rheumatoid Solutions podcast, whether you watch it on YouTube or you listen to it on your mobile device. Now, you can also add to your playlist, Dr.Munoz’s Podcast, too. So go to the Oasis Institute.com and find out the details and that is just going to be so valuable. And another great resource for everyone in our community who are living outstanding lives with inflammatory arthritis. So thank you so much, Dr. Munoz

Dr. Munoz: Thank you and thank you for the plug. And this Friday coming, I’ll announce to you the official name of the podcast for you and our listeners.