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Internal medicine physician Harry Oken discusses his article “mRNA post vaccination syndrome: Is it real?” In this episode, Harry explores the science, uncertainty, and human stories surrounding post-vaccination syndrome (PVS) linked to mRNA COVID-19 vaccines. Drawing on clinical data and personal experience, he explains how lingering immune reactions may affect patients and why research is urgently needed to clarify causes and treatments. Harry emphasizes compassion, scientific rigor, and the importance of investigating rare outcomes without undermining public trust in vaccines. Viewers will gain a deeper understanding of PVS, ongoing studies like Yale’s LISTEN project, and how medicine continues to balance innovation with safety.

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today, we welcome Harry Oken. He’s an internal medicine physician. Today’s KevinMD article is “mRNA post-vaccination syndrome: Is it real?” Harry, welcome to the show.

Harry Oken: Thanks for having me, Kevin. It’s a pleasure to be here and tell you a little bit about my story.

Kevin Pho: All right, let’s start from there. Let’s talk about your story and jump right into your KevinMD article.

Harry Oken: I’ve been in practice for about 40 years and seen a lot over those years. During the pandemic in Maryland, where I am, from about March 15 until about the second week in May, we were shut down. The type of practice I have, I send out an email newsletter almost regularly, but during COVID-19, I sent one out every day for about sixty days, trying to understand what was going on. Back then, if people can put their heads back to where we were, we were pretty scared. We had no idea what this virus was going to do, and I’m going to refer to that virus as the ancestral strain.

It was much more virulent than the virus we know today. Of course, during that time, we didn’t have a vaccine. We were looking for remedies. Any remedy that came up was oftentimes quickly said that it wasn’t efficacious. You remember the hydroxychloroquine story, etc. I was really right in the thick of it, writing every day and communicating with my patients.

As you may remember, people were going to the grocery store wearing gloves and goggles and were worried. We were wearing face masks. We were told by the public health experts what we had to do, what we couldn’t do, distancing, and isolation, and it was a mess.

I will say that during that time, we didn’t know what was going on, so precautions were needed.

I think as we got further and further into it, we recognized the value of distancing. Six feet? What was that about? Masking, double masking, KN95 masking. As time went on, I think we learned from what we were doing, what worked and what didn’t work. However, I think there was a lot of governmental pressure for us to follow what the experts were saying.

The experts at the time were Dr. Fauci, Dr. Birx, and Dr. Redfield. And so we did that. In 2020, the vaccine became available. The Pfizer and Moderna came available, and there was a very, very big push for everybody to be vaccinated. Very soon after we were vaccinated in 2021, we started to see a decline in mortality and hospitalizations.

It was quickly attributed to the vaccine, which, when you think about it, doesn’t really make sense. It takes six or eight weeks to get a vaccine response. The first vaccines, which were mRNA vaccines, were given, as you remember, at zero time and then three to four weeks later. They are going to take some time to have an effect on our immune system, but rather immediately, we were told these things work. They’re very effective and they’re safe.

As time went on, by 2021, the virus had already mutated from the ancestral version, which came from Wuhan, probably an accidental lab leak. It then morphed and mutated into a variety of different strains, which sequentially were probably less virulent.

Early on, we got the first two boosters followed by the… the first two primary series, and then boosters. We were pushed for boosters. Many people got boosters; many people got the illness. I think we can accept now that the natural immunity we get from the illness is every bit as good as any vaccine, probably better. But we were really pushed in many ways by our government officials to continue taking vaccines. We now know from some Cleveland Clinic data, probably the more vaccines you take, the more vulnerable you are to future COVID-19.

The COVID-19 virus now is very mild. It’s usually a two- to three-day phenomenon, and most people do well because they probably had COVID-19 before. Maybe the vaccine’s helpful, maybe not. My article talks about whether or not the mRNA vaccine is safe. I think when you look at the number of mRNA vaccines given in the world, we’re looking at over 12 billion vaccines given over this period of time. That’s an awfully big denominator. In order to see a signal of safety, that numerator is going to have to be pretty big to get people’s attention.

However, if you were one of those people who got a perceived vaccine injury, which might have been cardiovascular (particularly myocarditis in young men under 30), thrombotic (and we saw a lot of unusual thrombosis-related vaccine injuries), autoimmune, or rheumatologic (which happens to be my wife), if you were one of those people, or had menstrual abnormalities and neurologic abnormalities. The neurologic abnormality I’ve seen personally has been peripheral neuropathy.

If you were one of those people making up that numerator, because there were so many given, the denominator is so big, the numerator would have to be millions to see a big signal. But I can tell you there is a lot of unrecognized vaccine injury from the mRNA vaccine.

There is another alternative. The alternative is the protein subunit vaccine, made by a company called Novavax, which works in a different way. Presenting your body with a known antigen. Your body has a known decay rate. The antigen, which is identical to the spike protein, is decayed over two to three weeks. It’s gone. But in the case of the mRNA vaccine, what’s happening is (and this is not probably happening in everybody) it’s given in the arm, it does get to the rest of the body. It’s a message, it gets into the cells, into the nucleus of the cells, and tells the ribosomes to make the spike protein.

For most people, that spike protein production is small, but there’s a group of people, and we don’t understand who those are, where the spike protein production continues, and it can continue for long periods of time. In the Listen study, which was published by researchers at Yale whom I’ve spoken with, they found that some people who were vaccinated had isolatable spike protein over 700 days after vaccination. That wasn’t supposed to happen.

We have this vaccine that for some people invokes an unusual response and promotes a whole variety of side effects, which I think are now being recognized. We have this thing about “safe and effective.” If, early on, you made any notion or rumblings that maybe it wasn’t so safe or maybe it wasn’t effective, or maybe we should only give it to the very vulnerable, then you were demonized. That’s why I wrote the article.

Kevin Pho: So, as you said, the denominator for those who got the mRNA vaccines was so large that you would have to have a significant numerator to have the signal pull through. What kind of symptoms are you seeing most commonly attributed that would make up some of that numerator?

Harry Oken: I think the most common things are thrombogenic issues: stroke, DVT, and pulmonary embolus. The patient I have has a rheumatic side effect, which is less common.

Early on, we were talking about, and we saw this with the mRNA vaccines, myocarditis in young men under 30. Now, a young man under 30 is very, very unlikely to get a problem from COVID-19. It’s probably better for them to have the natural illness than get the vaccine. That’s why in certain areas of the world, not the country, they’re no longer giving mRNA vaccines to men under 30 because their signal for getting myocarditis and pericarditis is there.

What’s interesting is if you look at the FDA threshold for doing something about side effects from a vaccine. If you look way back, let’s say to swine flu in the 1970s when Gerald Ford was the president and we were giving swine flu vaccinations, which were quickly brought to market. I was in college at the time and got an air injection. I still remember it. But there was a signal of Guillain-Barré associated with the swine flu. As soon as that signal was seen, it was about one out of 100,000. What did the FDA do? They pulled the vaccine. They said the risk is not worth the benefit.

In the late 1990s, the rotavirus vaccine came to market. The ACIP committee said, “This is important. Kids should get this.” When one or two kids out of 100,000 developed intussusception, they pulled the vaccine.

Some people think that vaccine adverse side effects with mRNA vaccines are as high as one out of 800. So what happened? We didn’t pull the vaccine. We’re still giving the vaccine. You can still see advertisements on television to get your vaccine.

I think it’s not as safe and effective as people think. In terms of being effective, even when you look at the Novavax vaccine, which is the protein subunit vaccine, does it keep you from getting COVID-19? No, it probably doesn’t. Like the flu vaccine, if you take a flu vaccine, your likelihood of decreasing your risk for flu is decreased by about 25 percent. But if you do get the flu vaccine, your risk of needing medical care falls by 60 percent. I think that’s the value of taking the flu vaccine, particularly for vulnerable people.

We can’t really say that for the COVID-19 vaccines, but not only that, the flu vaccine is on a safe, known platform that’s been available for years. The mRNA platform is new, and we don’t know as much as we should about it.

Kevin Pho: Now, is there any testing or biomarkers that we need to study mRNA post-vaccine syndrome effectively?

Harry Oken: I’m glad you asked that because we’re not in a great position to understand cause and effect. But I will tell you this. First of all, there is no commercial assay for the spike protein. You can’t get it. It’s only in research labs. That’s a problem. If you believe that you still have spike and it’s causing thrombogenic or cardiovascular or neurologic or autoimmune problems, you can’t commercially isolate the spike protein.

What you can do is check antibody titers to spike. It’s been said and published that an antibody titer of greater than 5,000 is consistent with circulating spike, and that circulating spike is possibly, probably, inflammatory, maybe even oncogenic. We don’t know. In the patient that I wrote about, her spike antibody was as high as 20,000. As she’s gotten better, it has fallen to about 10,000, but it’s still high.

The concept is that mRNA vaccines deregulate our immune system in some way that we don’t understand. If you think about the immune system in two ways, we think about the B cells, which make antibody, and the T cells, which defend us. It’s thought that the T cells are dysregulated and tired and the B cells are in perpetual churning out of antibody for some reason. If we look at those two isolated systems, B-cell, T-cell, TH1 response, TH2 response, we think that that dysregulation is being driven in some way by this vaccine.

Kevin Pho: What does it say about the mRNA platform? I know that there was hope in using this platform beyond COVID-19, right? Now with the current administration, I know that they’re pulling a lot of funding for the mRNA platform. What does it say for the future of this platform going forward?

Harry Oken: Well, they did pull funding, but only for vaccine technology. I think there’s something there which might be terrific for oncology and other areas to create targeted methods of dealing with certain disease entities. The reason why this was developed, it came out of biodefense because if there was a pandemic, the thought was, since this is a totally synthetic vaccine (different than the Novavax vaccine, which is a protein subunit vaccine), we could figure out the genome of the microbe that is threatening us. We could create an antigen quickly. There are no biologic products used, and we could, voila, have our vaccine.

That’s why all the eggs were put in that basket. Dr. Redfield, who was head of the CDC during the Trump administration, was one of the first people to come out and say, “I think this was a lab leak.” Of course, he was demonized for that. That was about three months after Trump was out of office. He came out and said, “This was an accidental lab leak. That’s what’s going on.” He was demonized until later. It’s generally accepted that this was a lab leak.

Dr. Redfield was very important in making sure that all the eggs weren’t put in one basket and we just had an mRNA vaccine. He pushed for having an alternative, which is the protein subunit vaccine, which I think is a safer vaccine. Whether it’s efficacious or not, I’m not so sure, but it’s a safer vaccine.

At this point, what I tell my patients is, and I follow recent recommendations from the Cleveland Clinic, which is most people who had the original vaccine (which was two, followed by one booster) or the illness likely do not need to be vaccinated again for COVID-19. Because it’s a mild illness. I think one of the things that I really scratch my head on is why the American Academy of Pediatrics is still recommending or endorsing COVID-19 vaccinations for children six months to five years of age when we know there are all these problems with the vaccine. When you look at the mortality rate of COVID-19 for children, it’s infinitesimally small. It’s much smaller than flu. Certainly, vulnerable kids should get flu shots. The flu vaccine is a safe vaccine. Give it. But COVID-19 vaccination? When we know there are so many problems?

Kevin Pho: In terms of a distinction between the mRNA platform and say something like the Novavax, right? Would that change your thinking if they only recommended platforms other than the mRNA?

Harry Oken: I think it would be better. I think the safety record for Novavax is much better. I think there are so many uncertainties about the mRNA vaccine because in certain people, there are no brakes to tell your body to stop making this spike protein, which you don’t need.

Now, this spike protein has been found all over the body. Recently, there was an article that showed that a woman in Japan had a breast cancer, and they isolated the spike protein within the cancer. We don’t need to continue making a protein that we don’t normally make. Who that’s going to happen to is anybody’s guess because it doesn’t happen to everybody. I think it’s a relatively uncommon event, but again, we don’t know the downstream effects of these vaccines. There are people who have gotten five, six, or seven mRNA vaccines at the advice of their physician or the CDC. I think we need to take a good look at this. A really good look.

Kevin Pho: So in the patient that you talked about in your article, how is she doing in terms of her post-vaccine syndromes? Have those symptoms dissipated over the years?

Harry Oken: What happens to her (who, for your audience, is my wife), and when she has gotten COVID… Her symptoms started about three to four weeks after she got her third vaccine, which was the first booster. It was not clear at all what was going on at first.

As time went on, there was no other explanation for her reactive arthritis. What we see for her is a waxing and waning of her antibody titer. When she really flares, she gets swollen joints. Her knee can be the size of a small melon and needs to be drained. She is fortunately responsive to corticosteroids, but that has its own problems. Right now she’s doing well. It looks like she flares if she gets COVID-19. Last October she had COVID-19; she flared. Then in March or April this year, she probably had COVID-19 and has flared. She’s now under control, thankfully.

Kevin Pho: We’re talking to Harry Oken. He’s an internal medicine physician. Today’s KevinMD article is “mRNA post-vaccination syndrome: Is it real?” Harry, let’s have some take-home messages that you want to leave with the KevinMD audience.

Harry Oken: The take-home message, I think, is that now, based on what we know, we should question who gets the COVID-19 vaccine, particularly an mRNA vaccine. I reserve it for the most vulnerable people. These are people probably 70 or 75 and over who have comorbidities that you’re really worried about them getting COVID-19, because we can’t say at this point, based on newer data, that continued vaccination decreases our risk for the illness. Now the illness is much milder.

Kevin Pho: Harry, thank you so much for sharing your perspective and insight. Thanks again for coming on the show.

Harry Oken: Thank you.