COVID-19 Vaccines – PediaCast 485

Show Notes


  • Dr David Stukus visits the studio as we explore COVID-19 vaccines. Learn about the various types, including how each one works and expected side effects. We discuss the clinical trials and FDA approval process… and we highlight the overall benefits and risks of vaccination. Also considered: vaccine hesitancy among healthcare workers and the general public. We hope you can join us!


  • COVID-19 Vaccines
  • Vaccine Hesitancy




Announcer 1: This is PediaCast.




Announcer 1: Welcome to PediaCast, a pediatric podcast for parents. And now, direct from the campus of Nationwide Children's, here is your host, Dr. Mike.


Dr. Mike Patrick: Hello everyone. And welcome once again to PediaCast. It is a pediatric podcast for moms and dads. This is Dr. Mike coming to you from Nationwide Children's Hospital. We're in Columbus Ohio.


It is Episode 485 for March 31st, 2021. We're calling this one "COVID-19 Vaccines". I want to welcome all of you to the program.


We have a very very very important topic for you this week. And I realized at this point, children who are under the age of 16 are not able to get COVID-19 vaccines. So why are we going to talk about them on a pediatric podcast?




Well, the reason is we also care about families as a whole unit. And parents have lots of questions about COVID-19 vaccines, as do lots of my family and friends, colleagues, other medical providers who've just had lots of requests to do a show on COVID-19 vaccines.


And so, we put one together. And the biggest place where I was getting request was actually from my colleagues like, "Can we talk about COVID-19 vaccines, the different types available, how they work, the clinical trials, the approval process, expected side effects, complications, short-term, long-term complications? What are the possibilities? What are the risks of the vaccine versus the benefits?"




And so, we put a show together for the pediatric provider crowd and put that last week on our CME podcast or Continuing Medical Education podcast, which folks who take care of kids can listen to those programs and get continuing medical education credits hours for. Shows and details are available at


So we put that together, but we realized right from the beginning that this would be a topic that parents would be interested in as well. So even though we sort of prepared it for a target audience of pediatric professionals, we also did our best to use plain language where we could, and explain complicated things as we went along. So that we could also use this interview on our parent podcast.




And so, the source of this interview is last week's CME podcast, but I really felt that it needed to be on the parent podcast as well because it is so important and so timely.


To help us with the conversation, Dr. David Stukus visited the studio. He's an allergist and immunologist at Nationwide Children's Hospital. He also hosts a podcast of his own, Conversations from the  World of Allergy. And that's a production of the American Academy of Allergy, Asthma and Immunology. He also sits on that group's COVID-19 taskforce on a national level. So he's really in tune with all things related to COVID and COVID vaccines, so we're really glad.


And he's one of our own here at Nationwide Children's. And we're able to get him on the podcast to talk and really pick his brain regarding COVID-19 vaccines. So, it's a really great conversation and I'm excited to bring it to you today.


Before we get to him, I did want to mention, you've probably notice that our last show was February 16th. And so, it's been six weeks since we've had a new episode of PediaCast for you, which is probably one of the longer periods of time without an episode since we started this back in 2006. So we've been doing this a long time.




And it's very unusual to go that long between episodes. But I did want to take a moment to explain. We had a family emergency. My wife and I, as you know, because we've talked about this back in January, we've been exercising more. And really, one of our New Year's resolutions was to be more active. And we actually started doing it like back in November.


And my wife began to have some throat tightness with exercise. No chest pain, no arm pain, nothing, no shortness of breath even really, just some tightness in the throat. So we went and saw her doctor and there was concern. Could it be like an exercise-induced asthma or vocal cord dysfunction? And so she tried a little albuterol and that didn't help.




And then before went down the road of vocal cord dysfunction, her doctor rightly so, got an exercise stress test because the symptoms of heart problems are not always classic. It's not always chest pain and pain radiating down your left arm. Really, any symptom with exertion, that comes on with exertion and then gets better when you stop exercising should really raise your antenna. And so she did an exercise stress test and it was abnormal.


My wife and I, we're in our early 50's. And her father, his first heart attack that he had, he was 53 years old. And so, there was that family history, so she had a heart cath two days after her exercise stress test. And during that heart cath, she had a very serious complication with a dissection of her right coronary artery.


And that lead to a heart attack in the cath lab, which lead a couple of hours later to cardiac arrest, including 13 minutes of CPR. And then that lead to her being on ECMO for a few days and then another week or so in the Intensive Care Unit. And thankfully, she's doing well at home now.




Thanks to many talented doctors, and nurses, and respiratory therapists, and patient care assistants at the Ohio State University Wexner Medical Center. And thanks to many many prayers and an outpouring of support from family, friends and colleagues.


Of course, there's much more to the story. And I journaled it as I went along on my personal Facebook page.  The posts are all public so you can find them easily. If you just search for Mike Patrick in Nationwide Children's, it's probably the quickest way to find me, and if you go back to February 19th, that post and sort of step forward from there, you'll be able to read through the story as it happened, if you are interested in hearing more about it.


Needless to say, it was an extremely anxious and scary time, but she's here and improving steadily. All her organ functions are intact. Her brain is working normally, which those are things you worry about after a prolonged cardiac arrest.




In many ways, she is a miracle. And our family is so incredibly appreciative of the outpouring of concern and prayers and support. Many of which came from you. And so, we are very very thankful for that.


All right, a couple of take-homes from this whole thing. Number one, if you have any symptoms with exercise, and it wasn't long after this, I talked to a 28-year-old who also had a heart attack. Family history was there and that's not always the case. So if you have any symptoms with exertion and those symptoms get better when you stop exercising, don't put that off. Make sure that you see your medical provider.


And then the other thing is just remember, there are no routine procedures really. We should not call them routine because there are risks and benefits with everything that we do. And we have to think through those when we do have medical procedures done. So, a couple of take-home points there.




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So let's take a quick break. We'll get my interview with Dr. Dave Stukus pulled up, and then we will be back with a discussion on COVID-19 vaccines. That's coming up, right after this.




Dr. Mike Patrick: Dr. David Stukus is an associate professor of pediatrics at the Ohio State University College of Medicine and a pediatric allergist at Nationwide Children's Hospital. Nationally, he serves on the COVID-19 Task Force for the American Academy  of Allergy, Asthma and Immunology.




He's also that group's social media medical editor and hosts their podcast, Conversations from the World of Allergy. He's also a veteran of this podcast having appeared on many episodes of our program. But most important of all, Dr. Stukus is a trustworthy and reliable source as we consider COVID-19 vaccines.


So let's give a warm welcome to my friend and yours, Dr. Dave Stukus. It is great having you back on the show.


Dr. David Stukus: Well, thank you so much for having me. I am ridiculously excited for today's conversation. I'm an allergist and immunologist plus I'm a biochemistry nerd at heart. And I love psychology, which we're going to talk about how all of this intersects with today's topics. So I think this will be a lot of fun.


Dr. Mike Patrick: Yeah. I am really excited about today's conversation as well. I just want to mention for the audience that this is originally being recorded for our CME audience. So our target audience is pediatricians and other pediatric professionals, practitioners, folks who take care of kids.




But we're also going to put this one out on the regular PediaCast feed for parents, that program next week, because it is such an important topic.  And so you are going to hear us using medical jargon, but then also trying to translate into plain language a little bit as well. Which I think is something that all pediatric providers need to be able to do because as we go on to this phase of the pandemic when families have questions about COVID-19 vaccines, pediatricians and other pediatric providers are  going to be on the frontlines, in the position to answer parents' questions. And of course, we have to be able to talk to them in terms they understand, right?


Dr. David Stukus: Oh, absolutely, yes. So hopefully, we can model some of that today, but yeah, it's very complicated information. But I think we're going to hopefully do our best to translate that in terms that people understand.




Dr. Mike Patrick: Now, one of the terms that parents hear, and I think that there's a lot of questions about, is this idea of an mRNA vaccine, which we hear is different than other vaccines that have come before it and that parents are used to and have given permission for us to give their kids. So this is something different. What exactly is an mRNA vaccine?


Dr. David Stukus: mRNA is the abbreviation for messenger RNA. And if everybody goes back to your biology classes, keep in mind that this is inside our own bodies. And what these messenger RNA strips do is they are really blueprints. And they're just codes that our cells use to produce proteins. So it's like you build a house, you need a blueprint to know where to put everything structurally and things like that.


Our own DNA gets translated into these different signals. And there are other types of RNA as well that have different purposes in our body. But really, this is just sort of passing the torch from one part of the cell, on one specific blueprint to another. So instead of decoding our entire genome all at once, we can do short little snippets to produce the proteins that go on and do all that they need to do.




So we all have these in our bodies and this is a remarkable technology for vaccines as well.


Dr. Mike Patrick: Absolutely. So the DNA is on the nucleus and this little messenger RNA comes up and makes a copy of just a specific part of the DNA, takes it to a ribosome which uses that information to make a protein.


Dr. David Stukus: That's right. And then, the protein goes off and does whatever it needs to do.


Dr. Mike Patrick: Now, the messenger RNA, when it's done doing its job, does it hang around forever or is it short-lived?


Dr. David Stukus: It's short-lived. It has this little poly-A tail on it. So every time it gets copied and transcribed into proteins, that little tail gets shorter and shorter and shorter. Then once it's gone, the messenger RNA gets degraded. So it doesn't stick around forever.




Dr. Mike Patrick: So it has a limited lifespan. So we're not altering anyone's DNA permanently. There's none of that going on that we hear misinformation and myths about.


Dr. David Stukus: Oh, yeah, no. And it doesn't work backwards. So the mRNA doesn't go back into the nucleus. So it doesn't combine with our DNA in any way. So anybody who is talking about just lacks a fundamental understanding of how biology works.


Dr. Mike Patrick: And this is stuff that we do learn in… I mean, it might be AP high school biology, but it is general principles of biology that high school students even learn.


So walk us through then how do we get from the vaccine being injected into an arm into making a protein that our immune system can respond to, that gives us protection against COVID-19. So how do those mRNA vaccines work from a practical standpoint, from the syringe to the cell?


Dr. David Stukus: So this technology has been around for over 30 years. It's been studied in other viruses and for other vaccines, but it hasn't been licensed for use until now. It's been used in cancer therapeutics as well in some of those vaccines that they use.




So the technology has been advancing rapidly. And for the first time ever, when the genome for the SARS-CoV-2 virus was posted online, the folks making these mRNA vaccines could actually see what the blueprint was. And they could find a specific part that encoded for the spike protein.


And for everybody out there, the reason these coronaviruses which are RNA viruses have their name is because it looks like a crown when you look under a microscope of sorts. And the crown is because it has always little spikes on top of it. And those spike proteins are what the virus uses to bind to our body to gain entry, usually through our respiratory tract. And so it has different receptors it can bind to, to these spike proteins.


So the mRNA in vaccines, and right now it's the Pfizer and Moderna vaccines that use this technology, the mRNA is basically put inside a little tiny shuttle, like a space shuttle. That's this lipid nanoparticles which makes it kind of slippery. It gets injected into our body and then the lipid nanoparticle space shuttle allows the mRNA to get inside our own cells.




Once it's inside our own cells, the sort of outer shell, the vaccine goes away. Then we have this mRNA. And the mRNA has the blueprint to produce the spike protein. It doesn't actually produce the coronavirus. It does not cause infection.


And our own body's machinery actually reaps the mRNA, produces the spike protein which ends up on our own cells. Again, not causing us to get sick or causing infection. And then our amazing and robust and fantastic immune systems go to work. And they say, "Wait a minute. You're a spike protein. You don't look like the rest of me. I've never seen you before."


And that's how our B cells, and T cells, and antibodies really produce their response to it. And then we form this long-lasting memory. Therefore, if we ever encounter the coronavirus in real life and these spike proteins try to get inside our body, our immune system now can rapidly recognize it and mount a very robust response to prevent severe infection.




Dr. Mike Patrick: And one of the advantages of this whole process is that the mRNA, as it turns out, is relatively cheap and easy to produce versus actually trying to produce a protein. By letting your body be the factory, we actually can make the vaccines cheaper and more effectively, right?


Dr. David Stukus: Oh absolutely. And faster. So you can tweak it. So you can make these mRNAs to encode whatever you want it to encode. Of course, you want to make sure that it's the most effective part to build an immunoresponse. And it seems like they're actually mount more robust immunoresponse compared to some of the other vaccine technologies that we've used.


Dr. Mike Patrick: And then one of the disadvantages is that lipid nanoparticle space shuttle, as you called it, is fairly fragile. And so that's one of the reasons that it needs such cold storage temperatures so that it can remain intact and able to work correctly. But hopefully, there'll be more distribution of the kind of refrigeration units that are needed in order to store those and keep them working as they should.




Dr. David Stukus: Oh, absolutely. Yeah, that is one of the major limitations. And the two currently available mRNA vaccines also do require a booster dose either three or four weeks later to mount the most robust immune response.


Dr. Mike Patrick: And that's a good point. For the Pfizer, it is three weeks apart ideally. I mean that's what the studies used to show that it worked. And for the Moderna, it's four weeks apart. But that's really kind of arbitrary. The people who designed the vaccine picked a time period and then they proved that it worked. And so you just stick with it, right?


Dr. David Stukus: Yeah, exactly. A lot of this, if you think about everything that we do in medicine, at some point along the development process, you just have to pick a time period. And then, you have to study it and then see if it actually works or not.




Dr. Mike Patrick: And again, we'll talk about this more but the Pfizer is approved down the age 16, the Moderna is down to 18. That's just because when they wrote the application to the FDA, that's the age that the company's put on there. And so to some degree, it's not that the Pfizer is better for 17- and 18-year-olds than the Moderna, it's just that's what the application said.


Dr. David Stukus: That's exactly right.


Dr. Mike Patrick: Now, you mentioned that this technology has been used in cancer research. This is pretty interesting too because if you can get a cancer cell to make a protein that the immune system will attack, then you can selectively attack cancer cells. So that's pretty amazing.


It's also been used or studied in development of a CMV or cytomegalovirus vaccine, influenza vaccines, rabies vaccines, Zika virus. So we may be seeing more mRNA vaccines in the future. I mean, these studies are ongoing. But because of how important it was to get a COVID vaccine out there quickly, that's why it jumped quickly to the front of the line, right?




Dr. David Stukus: Oh, absolutely right. So, vaccine development is costly and it takes time. And for a lot of these diseases, as important as it is to try to eradicate them, we  didn't have the global pandemic call to arms and the rapidly rising mortality rates that we saw during the COVID-19 pandemic.


So really, for the first time in history, it was this amazing cumulative effect of, "We have the technology. We have the resources. We have the understanding. We have the ability to do it. We have the money. And now, we have the resources. And now, we have everybody's attention focused on one specific goal." We've never had that before.


And that's what allowed this to come to fruition less than a year after we first declared this a pandemic. I really can't emphasize enough that this is going to be seen as one of the greatest scientific achievements in the history of humanity. It is remarkable.




Dr. Mike Patrick: Yeah, I totally agree. Now just to play devil's advocate, some people would say it was rushed. That this was too fast. Is there any truth to that?


Dr. David Stukus: No. No corners were cut at all. This was also one of the most transparent processes I've ever seen. I read through all of the data that were published online before the Pfizer and Moderna and Johnson & Johnson vaccines went before the FDA for their emergency use authorization.

And these companies put them that's readily available. These are 75 to 90 pages long. So for a lot of folks out there, you may not want to read it unless you have trouble sleeping, of course. But all of the data are transparent.


Now, you can go through it. You can see exactly their inclusion, exclusion, criteria. You can look at all of their different endpoints that they used in regards to efficacy. You can look at all the safety data. It is all out there. And it's still out there readily available if you go to the FDA website. So there were no corners cut.




But again it was just all hands on deck that people enrolled on these trials. And by the way, these trails enrolled 30,000,  40,000 people each, which is amazing. So it's not like they looked at this and just a couple of dozen people and said, "Here we go." This was as robust as you can imagine.


Dr. Mike Patrick: And I think it's important for folks to understand that truly no corners were cut. And the reason that it normally takes longer, much longer for vaccines to come to the market is that, number one, you have to secure funding. And there's lots of different things competing for that funding.


The researchers have other responsibilities, other projects. This may not be first and foremost on their mind in terms of developing new vaccines that don't have the urgency that this one had.


And then in order to recruit 30,000 to 40,000 people, it can take a long time to convince folks to take an experimental vaccine that has not been approved yet. But all of those things were done in such a short period of time, again, because it was all hands on deck and because of the sense of urgency. But it still met all of the same criteria, went through all the same rigor as any other vaccine trial is expected to go through.




So I think that's really important for folks to understand that this was, even though it happened quickly, it was not rushed. Well, I mean it was rushed, but it was not rushed in a way that compromised the safety.


And of course you and I both had doses of our COVID-19 vaccines. So we're not only preaching at safety, we believe in its safety, and because we took the vaccines ourselves, right?


Dr. David Stukus: Oh, absolutely. As an immunologist, I took it upon myself to make sure that I read through all of the data. It's interesting because people were asking me back in October. And they say, "Are you going to get a COVID vaccine?" And my answer is always the same, "I don't know."

One, they're not available yet. And two, I haven't seen any evidence. So show me the evidence and then I can actually evaluate that with sort of my scientific background and understanding.


So I understand the data. I believe in the science behind it, which is remarkable. And then I recognize the importance of these vaccines as well. Not only for myself and for you, as healthcare providers, we're interacting with patients and we have been for the last year during this pandemic, but for society in general. So yeah, I trust it wholeheartedly.




Dr. Mike Patrick: And I remember asking you that. I remember asking you as my friendly neighborhood allergist, "Is this something that I should get for myself?" And you told me, "I don't know yet. Let's see what the data looks like before we make a decision." And so I appreciate that transparency. But having looked through it, you are a believer.


So we've been talking about the mRNA vaccine. Another one of the licensed vaccine with emergency authorization from the FDA here in the United States is the Johnson & Johnson Janssen vaccine. It's a little bit different. It's not an mRNA vaccine. How does this one work?


Dr. David Stukus: This is sort of the more traditional aspect of how do you sneak these things into our immune system without causing problems. So this actually takes advantage of an inactivated virus called adenovirus. And viruses are really good at getting inside our cells.




So you take out the infectious part of the adenovirus and then you hook it to a piece of protein that looks like the spike protein. And then we inject it into the body and then it gets inside our own cells. And our amazing robust fantastic immune system say, "That spike protein does not belong here." And then you form the B and T-cell response and antibodies and things like that.


So as oppose the mRNA which is slipping in a blueprint and then our own bodies produce the spike protein, this is actually just giving us the spike protein to recognize as foreign and then mount an immune response. Again, it literally cannot cause infection. It's inactivated. It can't replicate. It's not making coronavirus run rampant inside our own bodies.


Dr. Mike Patrick: The advantage of this one is that it's easier to store. You don't need nearly the cold kind of temperatures because it's a more stable vaccine. And the Johnson & Johnson one looks like it's just one dose.




Dr. David Stukus: That's correct, yeah. Again, it just goes back to just how they wanted to study it. Looked pretty good. In actuality, could the Moderna and Pfizer have been one dose as well? Possibly. But we know absolutely that the second dose does give you that more robust response. That's just how they studied these certain vaccines.


Dr. Mike Patrick: And this is jumping a little bit ahead of ourselves, but there may be a yearly COVID vaccine like there's a yearly influenza vaccine. We still need studies to know how long the immunity last. But I guess that's one thing. If we are seeing that that one dose isn't enough, there could always be booster doses advised down the road.


Dr. David Stukus: Oh, absolutely. I mean it can be like the seasonal influenza vaccine. We have to see if the SARS-CoV-2 become part of our regular lives. And we have to learn to live with it and get booster vaccines. And a lot that we still don't know.


Dr. Mike Patrick: I just wanted to mention briefly these are not relevant for the American audience, but there's also a more really traditional antigen vaccine called the Novavax that's out there. And that is just the spike protein with some other materials inside the vaccine that helps the immune system work.




Adjuvants is what I guess we'd call them. But they help the immune system have a more robust response and you're just injecting the protein itself. And that's very much like other childhood vaccines that are out there. So that's other one that you may hear about, the Novavax.


And then another group of them is actually an inactive COVID-19 virus itself. In China, there's the Sinopharm and Sinovac vaccines that are just inactive or dead virus and that's much like the flu vaccine that's around, that we get, correct?


Dr. David Stukus: That’s exactly right. So there's a lot of different ways to approach this. And it's remarkable to see so many different companies trying to produce these different vaccines. When this all first started, I think many of us were hoping for one viable vaccine. There were eight at the get go of billions of dollars of research and investment and producing these and studying them. And we all said collectively, "If we can get one."




And I'd like to remind all of your listeners, before the studies were finished, the FDA said if we can get these to show 50% efficacy, that's going to be good enough. We blew way past that. Not we, they blew way past that.




Dr. Mike Patrick: Absolutely. It's really quite amazing, and so amazing that this really is the beginning of the end of the pandemic. And so if we can get the vast majority of people immunized over the summer, I mean we're looking pretty good going into the fall. Wouldn't you agree with that?


Dr. Patrick Stukus: I think the light is getting brighter every day. Hopefully, people understand that with viruses, viruses by themselves don't do anything in our world. They need hosts. And the SARS-CoV-2 virus needs humans to replicate and spread to one another.




So whether it's through people getting sick and developing some form of natural immunity which we still don't understand, or you get the vaccine. If enough people get it, then you run out of hosts. It doesn't spread as easily. It doesn't cause as severe illness. It doesn't fizzle out necessarily, but it becomes much more manageable.


Dr. Mike Patrick: Absolutely. So now folks, hear this and say, okay, this is great. We've got this vaccine. We can put an end to the pandemic, but what about this? What about that?


And one of those things is the immediate reactions that we have heard stories of, for instance, anaphylaxis. So a very severe life-threatening allergic type reaction within an hour or so of getting the vaccine. Why does that occur and how worried should we be about that happening to us or a loved one if they get the vaccine?




Dr. David Stukus: Yeah, this caused quite the uproar in early December when the first COVID vaccines were even being given to the general public in the United Kingdom. I think on day one, there were two reports of anaphylaxis. And the allergy community went, "Oh, my gosh!" because it didn't happen in the clinical trials with 20,000 people, 30,0000 people followed over eight weeks and getting two doses. It wasn't happening.


And then we start to seeing more and more reports in the United States. And as you sort of alluded to, at no point in history were we getting real time accounts of these reports. There was no vetting being done. There were media headlines left and right and it was just generating this uproar, especially in the allergy community.


And it turns out, if you take a deep breath and allow things to play out, not only were they studied very robustly, but the reporting system since they rolled out, with over a hundreds of millions of people getting these vaccines across the world and reporting the side effects, now we know that the rates of anaphylaxis are actually approaching what we see with other vaccines. 




So it's happening less than five in a million times, which is very rare. Which means 999,995 people out of a million don't have anaphylaxis when they get it. We're talking like you're more likely to be struck by lightning on your way to get your vaccine than have anaphylaxis.


And it's interesting, when you look at the ingredients of the Pfizer, Moderna, and Johnson & Johnson vaccine, there are no food derivatives, no food proteins. There's nothing that resembles an airborne allergen. There's no venom, there's no latex, at least for Moderna and Pfizer. So there's nothing  inherently allergenic.


People, when they start hearing reports of anaphylaxis, they're "Well, there's got to be something in here." So there's a couple of thoughts. One is many of these weren't actually anaphylaxis. And there are some common responses people have to a vaccine. There's something called a vagal response in which the vagus nerve which sort of run throughout our whole body is very powerful. And it can be activated from just being anxious or scared or being vaccinated. There's a lot of emotions that goes into this.




And when your vagal response gets activated, it can make you look very sick very fast. You can get cold, clammy. You can feel nauseated. You may vomit. You may start shaking, get jittery. You may feel tingly. You may feel like you're very very sick. And that just passes on its own. So it looks like anaphylaxis, but it's very different, because the risk is different.


Dr. Mike Patrick: And even seeing someone have that happen to you at the next station or happen to them at the next station over may induce a vagal response in yourself, right?


Dr. David Stukus: Oh, absolutely.


Dr. Mike Patrick: I mean, you can have a cluster of people in one institution. I know there was one hospital in Chicago that temporarily stopped giving COVID vaccines for a day because multiple people were having that reaction, and mostly likely from seeing others have that reaction or hearing about it.


Dr. David Stukus: I'm glad you brought that up because that was the other piece that didn't fit as you saw clusters in Alaska, Chicago and in California. And so, it doesn't make sense because if this was a true allergic reaction, there's no way that you're going to get six people with the same exact allergy that have the same exact allergic response all within the same afternoon.




So there's something else. There's more to the story. So long story short, we have yet to identify what's actually causing the very rare yet true allergic reactions. Some attention's being given to something called polyethylene glycol which is present in Pfizer, Moderna, and then polysorbate which is present in Johnson & Johnson.


The only reason attention is being given to this is because of very rare case reports of true allergy to these ingredients prior to the vaccines. We're talking rarest of the rare. Well, it turns out, these extensive allergy evaluations and skin testing regiments had been utilized. And there are wonderful centers like Massachusetts General that had reported this, the PEG isn't the cause. We still haven't found the cause.


So we don't know what's going on. All I can say is in a very reassuring way, that anybody who has a history of food allergies, environmental allergies, [33:57 XX] allergies, medication allergies, you absolutely can safely receive any of the COVID-19 vaccines. All these vaccines should be given in the facility where you can be monitored for 30 minutes afterwards and epinephrine available just in case there's the very rare event of anaphylaxis.




By the way, all of these are easily treatable with epinephrine. There are no long-term consequences. Nobody has died from having allergic reaction to any of these vaccines after over a hundred million doses in the United States. So they are extremely safe.


Dr. Mike Patrick: I don't know anyone who has a PEG allergy, I'm not an allergist, or a polysorbate allergy. If you did have a history of anaphylaxis to those, what should you do?


Dr. David Stukus: So if you have a known confirmed history of anaphylaxis or allergy to polysorbate or to polyethylene glycol or any of the other minor ingredients in these vaccines, and again there's nothing allergenic, then you should avoid these vaccines. But how are you going to know if you have the allergy? Well, frankly, because you've had a severe allergic reaction.


And PEG is everywhere. It's in MiraLAX that we use all the time to help people go to the bathroom. It's present in cosmetics and foods that we eat and things like that. These are very rare. The only way you'll know is because you've had a prior reaction. And you've been evaluated extensively by a board-certified allergist who did extensive skin testing and they looked you in the eye and they said, "You have a PEG allergy."






Dr. David Stukus: It's the only way you're going to know about it. The only way you need to worry about it. So for most people, that's not the case.


Dr. Mike Patrick: And how long should you wait to be observed after having a vaccine to see if you're going to hear anaphylaxis?


Dr. David Stukus: Thirty minutes. Almost universally, it's going to happen within 30 minutes. And typically, it's within 15 minutes. So when you inject something that could cause an allergic reaction, it's going to happen pretty darn fast. It's not going to be hours later.


Dr. Mike Patrick: So five cases out of every million vaccines given. So again, I like the way you put that, your odds are going to be struck by lightning on your way to get your COVID vaccine is more likely to happen that to have anaphylaxis from the vaccine. They're very important perspective there.




And then, so as we move past the immediate issues with the vaccine, you don't hear a lot about side effects. So after the vaccine and particularly with the second vaccine, because you're going to have more robust of an immune response, we can see fever, chills, headache, body aches, fatigue, like we can with other vaccines. Talk a little bit about those reactions that night or the next day.


Dr. David Stukus: I actually don't like the term side effects when it comes to these symptoms because they are expected effects. This is what happens when our amazing robust fantastic immune systems recognize a foreign antigen. We mount an immune response, which can be like you said, systemic with fever and muscle aches and chills. It can be local with some pain and soreness at the injection site or rash at that site.


You can have some lymph nodes get a little swollen because our lymph nodes are part of our immune system. And you get that localized immune response, they may get a little swollen. But universally, these are short-lived, almost always self-resolved, and they don't increase risk for having any type of allergic reaction with the second dose.




Dr. Mike Patrick: I hear some people say, "Well, I didn't have any symptoms after either vaccine. Does that mean that I did not make good immunity?” Is there any correlation between the extent of your symptoms with the vaccine and how good your immunity is that you make?


Dr. David Stukus: No, not that I'm aware of. It's interesting because I was like that. I mean, my arm got sore afterwards. It's pretty sore for about 30 hours and it went away. But here we are, a board-certified allergist/immunologist and I'm like, "Huh, I didn't get the fever. I wonder if it didn't quite take." But that's not the case at all.


So there's so many variables in the equation as to who developed what symptoms and why that I wouldn't worry about it.


Dr. Mike Patrick: Yeah, I had one fever spike up to, I think, almost 101.8 and several hours after the second one. And the next day I felt fine and it was just that one fever spike.


So the next question is what about acetaminophen or ibuprofen, either before or after the vaccine? Would those decrease your immune response? A lot of people have had those questions.




Dr. David Stukus: There are very very limited evidence that would suggest that if you're taking ibuprofen or acetaminophen at that time you get your injection, that it may decrease the robust initial response. But it's very limited evidence and it doesn't actually pertain to these specific vaccines.


So the recommendation is if you're taking it every day on a regular basis, then don't worry about it, because there's a lot to go out there with rheumatoid arthritis or other reasons that they take these medicines. And then once symptoms develop, absolutely, do not hesitate. These are great medicines to help offer supportive care and it's not going to interfere with your immune response.


Dr. Mike Patrick: And there's no evidence whatsoever to say that if you took acetaminophen or ibuprofen or other nonsteroidal anti-inflammatory drugs, that you're more likely to get COVID-19 or severe disease or anything like that. Even if we say that there's a theoretical possibility, there's nothing to suggest that you don't have good immunity.




Dr. David Stukus: That's correct. Absolutely. And there's also no reason to take any type of vitamins or supplements prior to getting your vaccine because it's not going to boost your immune system or anything like that. So save your money, let the vaccine do what it's supposed to do. And I'll say it I think for the nineteenth time, we have amazing robust, fantastic immune systems that are really good with what they do.


Dr. Mike Patrick: And this is one of those things too, I think, that as providers, when we see families, we really ought to, like you said, this is expected. Not only with this vaccine, but with yearly flu vaccines, too. And so, a lot of people, when they get their flu vaccine, they feel achy for a day or two, and they say, "Oh, it gave me the flu." But whatever we can provide education, that that's not what's happening, that this is your immune system doing what we want it to do. And to explain that to people when see them at every opportunity just helps to increase healthy literacy and helps people understand the process of what's going on in their body.




Dr. David Stukus: I couldn't agree more. There's some cool research in psychology and behavioral economics realm that does suggest that. If you tell people, "You know what, if your body does this, that's great news. That means your immune's responding really well. It's going to be short-lived," and those people are less likely to have hesitancy with the next one or they'll just expect it as normal.


Dr. Mike Patrick: Now, what about little further. So now we are maybe a week, a month, after our vaccines. Are there any problems that have been identified? Now, a couple that come to mind that I've heard of is little platelet counts, thrombocytopenia. We heard about blood clots in Europe. Is there anything to worry about in the intermediate or longer timeframe after the vaccine?


Dr. David Stukus: Honestly, no. And here's why, because if you take a wide group of the general population, there's going to be a background rate of any type of event happening. There are 110 people every day in America that develops Bell's palsy.




Dr. David Stukus: And when you look at all these vaccines, you can't just say, "Oh, I got the vaccine, and then I had these symptoms." You have to compare it to people who don't actually get the vaccines, and what's the background rate, and prevalence in a sense and things like that.




So through robust and ongoing monitoring, nothing has panned out that shows the vaccine as causing or increasing risks of any of these conditions. These are all happening whether you get the vaccine or not. You just don't hear about them because it goes back to what we talked about before. We're not having intense scrutiny and real-time reporting and media headlines of every single person that experiences any symptoms after they get their COVID vaccine. So correlation does not equal causation.


Dr. Mike Patrick: Yeah, that's really important. I think with the blood clots, the most recent one, if you look at the background level of the incidents of blood clots per million people, it was actually less in the COVID-19 vaccinated folks. Not to say that COVID-19 protects you from blood clots but just that it's not a causative factor in this. It sometimes happens and sometimes it happens after you have the vaccine, but that doesn't mean the vaccine caused it. It would have happened anyway.




Dr. David Stukus: Right. And if you look at the trials, with all their transparent data, people died during the trials but they died because of motor vehicle accidents. I think there was a murder in one of them or something like that. So it's not like the vaccine caused you to have a car crash and die in that motor vehicle accident. It's correlated with it.


Dr. Mike Patrick: So again, the bottom line is here. It is safe to get these vaccines and we would highly recommend them, unless you have a specific anaphylaxis to PEG or polysorbate and that's really about it at this point.


So what is the role of the allergist in advising folks on vaccines? Just in general. In fact, I had folks ask me, "Hey, I have this allergy. What shall I do?" And my answer is talk to your allergist. If you have an allergist who diagnosed you with a particular issue and you have a question about it, go back and talk to your allergist. Would you advise the same?




Dr. David Stukus: Absolutely. I think we have two important roles. One, from a public health standpoint. I think that we're a specialty that's very well equipped to understand a lot of these pandemic in regards to viral transmission, how it impacts our immune system, how vaccines work and how we deal with immunity and things like that.


So I think that we need to be promoting good public health messaging and explaining things in ways that people understand. And then, with our own patience, we need to talk to them about risk and say, "Listen, your risk is not elevated based upon your history of dog allergy or peanut allergy or anything like that."


Another way we can help is something that we've done in our institution is when our own employees report having prior severe reactions to vaccines or injected medications, we actually batch them and they all get their vaccines in the special clinic that we set up that's actually staffed by allergists, including myself and our allergy nurses.




And I'll tell you something, Mike. It's interesting. People walk in already having reactions. And what I mean by that is they're so nervous. They are, they're legitimately scared of what's going to happen to them because of what they've read online or just confusion or anything like that. And what we do is we spend time with them. We talk them through it.


A lot of folks still have subjective symptoms. They say, "Oh, my gosh, I feel tingling." Or they may even have some flushing, but they have a history of that, and they flush when they get emotional or when they take some medications. And then, we sort of just talk them down. And we spend time with them and reassure them and calm them. It's been one of the more rewarding parts of this whole pandemic for me, the staff is.


Dr. Mike Patrick: Yeah, what about Guillain-Barre syndrome? Folk who have maybe had that happen after they had a vaccine, is that, it just came to mind, another one of the reasons not to, maybe?


Dr. David Stukus: No, it's not listed as a contraindication this time. We don't fully understand why some people get that after vaccines. It's likely that people are predisposed to develop this and whether they get acute infection or they actually get the vaccine as the cause or not. But actually you made me think of another important point.


When people out there listening are trying to do decide, "Should I get the vaccine or not?" that's not the question. The question is, "What's my risk and benefit from the vaccine compared with my risk or benefit from getting COVID in real life?" That's the question.




So that's what we were trying to compare here. Because if you think about actually getting sick with COVID, that's injecting a whole bunch of messenger RNA into our bodies.




Dr. David Stukus: And it's causing all kinds of havoc as well. So if you're really worried about that, that's the real question I want people to ask themselves, what's the risk from the vaccine? What's the risk from actually getting sick?


Dr. Mike Patrick: Yeah, really good point because you're right. Once you get the natural disease, you got a whole lot of that stuff in your body.


Dr. David Stukus: Oh, yeah. And it's out of control.


Dr. Mike Patrick: Speaking of, this is a great transition. I wanted to talk a little bit about the SARS-CoV-2 variants. So we hear about some subtle differences from one type of SARS-CoV-2, one strain so to speak versus another, some differences in the spike protein. What exactly are those variants and is there something that we need to be concerned about?




Dr. David Stukus: Yeah, so viruses naturally mutate as they evolve. And the reason this happens is, so coronavirus, it's RNA, it's a single-strand RNA that once it enters our body after binding, it actually has its own instructions to produce some of these proteins to help it replicate. Well, during the replication process, mutations naturally occur.


Sometimes, it's because these different codons get replaced or you skip a codon or something gets deleted and so on and so forth. Well, a lot of these mutations do not confer benefit to the virus. And so, when those mutations happen, it just goes away and it doesn't spread from one person to the next.


But some of the mutations actually make the virus better with what it does. Maybe it makes the spike protein better at grabbing on to our receptors. Maybe it actually makes it more virulent so it can actually replicate faster when it's inside our bodies. Maybe it actually makes them more severe and things like that.




So when you something as prevalent as the COVID-19 pandemic and we have a lot of hosts that haven't been sick with it and spreading from one to the other, these natural mutations, the ones that select for an advantage will spread faster and more easier. And what's happening is so this is an expected outcome. This is why the seasonal influenza vaccine needs to be changed every year because the influenza virus mutates really rapidly and really well. So we want to produce a vaccine that's good at preventing that year's infection.


So with the SARS-CoV-2, this was a very expected phenomenon, because this is what happens in nature. There's been a few significant variants that had been noted. And when you look at what the CDC talks about, they talk about variants of interest, variants of concern and then the ultimate of variants that should make us change everything we're doing.


So there's really three variants of concern right now. The first one was identified in the United Kingdom in the autumn. It's the B117 lineage. It's just different nomenclature that we use to represent what changes. And this was a change in the spike protein. In fact, all of them were.




There's another one that was first identified in South Africa, the B1351 lineage. And then one that was identified in Brazil actually in travelers who landed in Japan, this is the P1 lineage.


And what these different mutations do is they cause variations in the spike protein, which could make it spread faster or potentially make people more sick. Now, to put this in perspective for everybody, there's been less than 8,000 of these variants identified total in the United States. Thirty million people had been infected with COVID-19 that we're aware of in the United States. We're talking less than .03% of these variants.


Now, you can easily argue and say, "Well, Dave, if we're not doing all the sequencing and recognizing this thing, we're probably underestimating that." I couldn't agree more. We're also underestimating how many have actually had COVID-19 as well.




So at this time, there's no evidence to suggest that this is rampant in the United States or across the world. There's very limited evidence to suggest that these variants may actually transmit easier. And if you look at the actual studies done, these are all sort of statistical models that are done. It's not actually proof that that was happening. So through modeling and looking at prevalence and some of the data that we have, there's a suggestion that especially the United Kingdom variant may actually spread faster compared to the other variants.


So there's a lot we don't know but I want to put that in perspective for everybody.


Dr. Mike Patrick: Yeah, as we test antibodies against the variants, I would suspect that that's done in laboratory conditions and which doesn't necessarily equate to what's happening inside the body. So is there evidence that vaccinated people with these variants are still getting severe disease.


Dr. David Stukus: No, there's evidence actually that shows the contrary. So it's interesting, we didn't know about these variants. If it probably weren't that prevalent when the Pfizer, Moderna trials are happening last summer and early fall. So it didn't get a chance to test those vaccines against some. They're now going back and actually looking more in the laboratory setting to see if you can get neutralizing antibodies, things like that.




But the Johnson & Johnsons and AstraZeneca vaccines were being studied while these were increasing in the United Kingdom and South Africa. And they actually found that the efficacy looks pretty darn good against these variants as well. Same thing with neutralizing antibodies.


So it's an evolving situation. I know that there's a lot of media headlines that are putting everybody on red alert. I am by no means saying we should let our guards down when the pandemic is over and we should stop wearing masks and stop washing hands. I encourage everybody who's interested and willing to get vaccinated to get vaccinated as fast as you can because that's our way to sort of prevent spread of these variants. The less host available, the less it can spread.


Dr. Mike Patrick: But as of right now, the vaccine as it is, even if a variant were to come along, you're going to be way more protected with the vaccine on board than if you don't have the vaccine.




Dr. David Stukus: Absolutely. And the way, I think about these vaccines, they are almost perfect at preventing death and severe illness hospitalization. They're really that good.


Will people still potentially get sick? Yeah, absolutely. But what's that going to cause? It may just cause more of the runny nose  cold-like symptoms that we're familiar with the other viruses.


Dr. Mike Patrick: And if there does come a time when we say, no, we really need another vaccine against a particular variant, that's something that could actually be made pretty quickly just with change in that messenger RNA a little bit. Just tweaking that spike protein that the immunization is going to help people's cells make.


Dr. David Stukus: That's right. They're doing it as we speak, actually.


Dr. Mike Patrick: And by the way, you mentioned the Oxford  AstraZeneca vaccine when we were going through the different kinds of vaccines, we didn't mention that one. But that is another one of the adenovirus vector vaccines, correct?




Dr. David Stukus: That is correct, yeah.


Dr. Mike Patrick: Okay, so I think we've made the case that the COVID-19 vaccines are safe. They've been studied well, they work well. We would advise the vast majority of people to get them unless you have anaphylaxis to specific products and then talk to your allergist.


And yet, we put this message out there and there are still a lot of vaccine hesitancy out there among the general public. Not even just the general public, even among some healthcare workers. Where do you think that vaccine hesitancy comes from?


Dr. David Stukus: That's complicated. We know without a shadow of a doubt that there's a very strong and formative anti-vaccine  movement across the world. There are people out there that are doing everything they possibly can to infiltrate the messaging on social media and the media headlines to make people afraid of these vaccines.


Conspiracy theory reigns supreme. I promise you none of these vaccines contain microchips that are injected into us. It's ridiculous. None of them will actually cause us to develop 5G sensitivity or anything like that.




There are other concerns about these vaccines will cause women who are pregnant to have natural abortions or things like that because some of the proteins and the spike proteins resemble that in the uterus. Well, that's ridiculous as well because we'd be seeing that all over the place when people actually naturally got infected with COVID-19, which we weren't seeing.


So it's a whole host of conspiracy theories and active attempts at misinformation and disinformation. So we can't discount that.


Traditionally, there's been hesitancy among different groups as well. We know that a lot of minority and different ethnic populations have had terrible tragedies with how the medical systems has interacted with them and experimented on them and forced hysterectomies in the Hispanic population, for instance. So there's a level of distrust that's already there.




We already know that there's some background vaccine hesitancy always, especially with seasonal influenza vaccine. And then, really, I think people just don't have a hard time understanding what these vaccines do and don't do. And hopefully, that's why conversations like this can help you understand what's actually involved in being vaccinated and what that does inside our body and things like that.


So it's robust, there's a lot of misinformation we need to combat among healthcare workers. It's interesting, I don't understand why. We should understand this but another phenomenon that's happened and we have to address it because it's true is people's political ideologies are lining up very closely with their willingness to get a vaccine.


So we've had a really hard year in the United States. We had an election everybody's aware of. We had the pandemic. We have a lot of racial unrest as well. So people really are distrusting a lot of what's going on in the world right now. But we do know that one's political ideologies may make them more or less reluctant to get a vaccine as well.




So there's a lot to kind of take in there. But hopefully through ongoing conversations and discussion with it, we can change people's mind or at least get them information to help make an informed decision.


Dr. Mike Patrick: Absolutely. What are some strategies in your mind as medical providers, folks who take care of kids and families, we're going to get lots of questions about the vaccine? A lot of families trust their pediatric provider and they say, "What shall I do? What do you think of this?"


So we're in a position really to talk to families. And what should we be saying? How can we increase acceptance of COVID-19 vaccines as we engage with families in the exam room?


Dr. David Stukus: I think we should discuss it with every single patient and family at every single encounter. It can be very simple along the lines of "Do you have any questions regarding the COVID-18 vaccines and do you plan to get one? If so, why or why not?|




And then just listen. Just sit back and listen. Don't interrupt and let them talk about it. Make it as just standard part of normal care that this is what we're talking about today. Or ask some personal questions. How has the pandemic impacted your family? And you may find that they've lost loved ones or the emotional toll that it's taken on them.


And then we can segue that into the vaccines and talk about how these vaccines are a way for all of us to get back to some semblance of normalcy, where we can safely visit with others and hug our loved ones we haven't seen for a year and get back to doing a lot of things we want to do.


So there's no single approach that you can take. But unless you actually address it, you're never going to reach anybody. Make it a part of your standard visit every single time.


Dr. Mike Patrick: Yeah, I totally agree with that. The more that we can do to normalize it, like this is a normal thing that we're going to talk about and answer folks questions about the science and the things that we talk about today. I think when you demystify how things work and explain it in ways that parents can understand, and it may take doing that over the course of many visits, but you just let them know what the science is and why you believe what you do.




But then also having some empathy for their position because anyone who's vaccine-hesitant at the core for most people, I mean there are folks who are out there just trying to cause problems. But at the core of it for most people is they care about their family and they don't want to do something to their children or to themselves that they think could be harmful.


And so, having that empathy that were all coming from  the same place of wanting to care for kids, wanting to care for families, wanting to do what's best for your health. I think that at least puts us on the same level to be able to talk about these things. Whereas, if we come in with the judgmental attitude, "How can you not believe this?" you're not going to get very far if you take that approach, right?


Dr. David Stukus: Oh, I agree. Right. So nonjudgmental, absolutely. Should never up to us to say, "This is exactly what you need to do." That's not our role.




It never should be our role. There are always options. And if we really talk about shared decision-making, it's our job to really discuss risks and benefits and frame things in a way that people can understand. So they can then take their own preferences and values and then come up with a shared decision about how to proceed. So that's our job, frame thing according to risks and talk about any questions they have and make it as personal as possible.


Dr. Mike Patrick: Yeah, absolutely. Well, this has been definitely an enlightening conversation and hopefully helpful to providers out there, but also to families and patients and folks who are making that decision and looking at the risks and benefits and making a decision about COVID-19 vaccines.


Because at least here in Ohio, beginning March 29th, anyone that's 16 and older can get a vaccine. No, does 16-year-olds count or 17, 18 for the Pfizer?


Dr. David Stukus: I think it's 16 for Pfizer, right.






Dr. Mike Patrick: Okay, 16 and 17-year-olds, Pfizer, 18 and older, everybody. And beginning March 29th, at least here in Ohio, it's basically a free-for-all, that anyone, if you can find the vaccine, get it. And of course, we would highly encourage everyone to get it. But if you have specific questions, definitely ask your doctor about those.


One last thing, I wanted to just remind folks about the Allergy and Immunology Program here at Nationwide Children's Hospital. I know you guys are opening up a new food allergy clinic. Tell folks about that.


Dr. David Stukus: Yeah, it's exciting time here at Nationwide Children's. So I am honored and privileged to be the director of our brand-new Food Allergy Treatment Center. And we have a brand-new clinic space up at the  Louise Center facility. So it's little north off our main campus. And that's going to allow us to expand all of our current services.


We love helping families navigate their child's food allergy diagnosis. Unfortunately, there are a lot of people that are misdiagnosed. So we try to clarify that. We address psychosocial concerns. We do tons of oral food challenges. And really, we treat individual families where they are. It's not one size fits all.




And as we sort of offer some of the business up there, that allows us at the main campus to expand all of our other services. So we have a very active asthma programs and we have a Jeffrey Modell Primary Immunodeficiencies Center where we have some of the greatest minds in our country really working with families to get the best diagnosis and treatment for these truly severe primary immunodeficiencies. We have a very active drug allergy program as well, because we know that for the vast majority of people labelled as having a medication allergy, they're actually not allergic in the first place.


So we handle all that. And of course, if you just have sneezing when you're around your dog, come see us. We can help you with that, too.


So thanks for bringing that up. And we love what we do. We have one of the largest pediatric allergy immunology divisions in the country. We all love treating patients and families and we have a fun time at work as well.




Dr. Mike Patrick: Yeah, the drug allergy one, we did a podcast together. It's Episode  37 of this program, PediaCast CME, Drug Allergies and the Importance of Getting Them Right. And I love the data that you always quote, that 10% of all people think they're allergic to penicillin, but of those people, only 10% really are. And so, if you've been told in the past that you have an allergy to penicillin, talk to an allergist and see if that really is true or not.


Dr. David Stukus: We're generally friendly people.




Dr. Mike Patrick: Most of the time.


Dr. David Stukus: Most of the time.


Dr. Mike Patrick: And we will put links in the show notes for this episode over at and to the Allergy and Immunology Program at Nationwide Children's Hospital. Also, a link to that CME program I talked about, Drug Allergies and the Importance of Getting Them Right.


I also have COVID-19 vaccine information from the CDC, from UpToDate. Those will both be at the website in the show notes as well. And then, you actually did an episode of Conversations from The World of Allergy, your podcast on COVID-19 vaccines. And I'll put a link to that episode for folks who would like to hear you talking about COVID-19 vaccines even more.


So once again, Dr. Dave Stukus with Allergy and Immunology at Nationwide Children’s Hospital, thanks again for stopping by today.




Dr. David Stukus: Thank you so much for having me. I hope this is helpful for your listeners.




Dr. Mike Patrick: We are back with just enough time to say thanks once again to all of you for taking time out of your day and making PediaCast a part of it. I really do appreciate that.




Also, thanks to our guest this week, Dr. David Stukus with Allergy and Immunology at Nationwide Children's Hospital.


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Thanks again for stopping by. And until next time, this is Dr. Mike saying stay safe, stay healthy and stay involved with your kids. So, long, everybody.




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