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“As a clinician who has received two Pfizer doses and a booster without any side effects, I wholeheartedly embrace vaccination to solve this pressing public health crisis. The key is for policymakers to identify the best tool for the job (i.e., Covaxin) and utilize it effectively to solve the widest-ranging public health crisis of the past century.”
Tayson DeLengocky is an ophthalmologist.
He shares his story and discusses his KevinMD article, “Why is the world’s first universal coronavirus vaccine not in the FDA’s toolbox?”
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Hosted by Kevin Pho, MD, The Podcast by KevinMD shares the stories of the many who intersect with our health care system but are rarely heard from.
Transcript
Kevin Pho: Hi, welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. My name is Kevin Pho, founder and editor of KevinMD. Today on the show we have Tayson DeLengocky. He is an ophthalmologist, and he wrote the KevinMD article “Why is the world’s first universal coronavirus vaccine not in the FDA’s toolbox?” So we’ll get into your article in a little bit, but first off, can you just share your story and journey to where you are today?
Tayson DeLengocky: I’m from Vietnam, and I lived in France and moved to the U.S. I took ESL, went to community college, and transferred to the University of Texas at Austin, the UT system. Then I resided and stayed in Texas for about 14 years before I moved out of Texas for medical training, which took me to Michigan, New York City, and working in Illinois, and now I’m working in Southern California.
Kevin Pho: So you’ve written several articles on KevinMD about Covaxin, which is the predominant COVID vaccine in India. Your KevinMD article is titled “Why is the world’s first universal coronavirus vaccine not in the FDA’s toolbox?” Now, for those who didn’t get to read your article, can you just walk my audience through it and share the story of why you decided to write it?
Tayson DeLengocky: I received the Pfizer vaccine the very first day it was available to us, so I have the two Pfizer doses plus the booster. And when we started talking about the fourth dose of the same thing again, I was thinking, why are we doing it? It doesn’t make any sense to me. I followed up with the vaccine in India, and it is a whole-virus, inactivated virus-based vaccine. It has very good data, and it’s one of the vaccine candidates before the FDA to be commercialized in the U.S.
And I see that the media doesn’t cover something that good, and the medical community doesn’t know. And to be honest with you, almost three years into the pandemic, into the third year of the pandemic, the public health policy officials have been changing the tone all the time. And even if you take Europe, the policy is different from the U.S., and Australia and New Zealand are very different. So we have the same data, the same facts, but the interpretation is very different. And we as doctors, I see that we don’t have a voice in advocating for our patients, in advising our patients.
I remember from the very first day of the pandemic, the officials were telling us that it was harmful to wear masks, because the public doesn’t know how to wear and adjust the mask correctly, so it would be harmful. And now you see the tone changed over time. And we are not doing any better in the third year of the pandemic than at the beginning, without any vaccination. The number of deaths, the number of cases, and the number of hospitalizations speak for themselves.
So we have the three best vaccines, as claimed by our American scientists, or as Dr. Fauci claimed, the best, the most desirable, the most desired vaccines in the world, and we don’t need anything else. And I think that’s a disservice to us, to the American public, in having the option of what vaccine to get.
Now, Covaxin has been applying to the FDA since June of 2021. So we need to allow all the good vaccines to come to U.S. shores, or at least to give them a chance. After six months of application to the FDA, it was not reviewed, and that was surprising to me. And Covaxin has been administered in India and in some other countries, 250 million doses already, so the data, because of the safety, speaks for itself. And it has been approved by the World Health Organization already. So why doesn’t the FDA approve it for a clinical trial in the U.S., so that we can see its efficacy in the U.S., so that we can have something for the American public? So that is the frustration that I have.
And I see that there is a complete blackout from the media and also from among so-called experts in public health, to the point that we see something is good and working, and there is no adverse effect like myocarditis. And recently the CDC finally released the study from June to November of last year, in the state of California and the state of New York, that natural immunity, meaning previous infection and recovery, provides more protection against the Delta variant than the mRNA vaccines combined. So you see that the natural immunity provides better protection than the vaccine itself. And when you combine the two together, you have better protection.
But this is a whole virus, inactivated, so it’s the closest form of natural immunity that we can give to the patient without causing the disease. And why don’t we have a chance at that? I don’t know the reason. And you know, Big Pharma, there are intertwined interests with each other, the media, and everything. So you don’t see it; even the medical community, physicians, don’t know anything about Covaxin to advocate for the patient. All I would like is this: We, the public, deserve the choice.
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Kevin Pho: If you go to the CDC website, I think there’s a lot of conversation regarding natural immunity. I think what the CDC says is that natural immunity is a little bit more variable and less predictable than the immunity you get from vaccines. But I wanted to ask about Covaxin versus the mRNA platform. Do we have any head-to-head studies comparing their efficacy?
Tayson DeLengocky: No, no. All this has been proven: Covaxin has been efficacious against all the variants so far, during the phase 3 clinical trial in India, during the surge of the Delta variant in India. And this is the only vaccine trial that provided efficacy against Delta with the two doses. And in the lab, with the three doses, the booster after six months, you have 100 percent immunity and 100 percent neutralizing antibodies specifically to the Delta variant. And with the booster, it provides 90 percent of the neutralizing antibody to Omicron. So that speaks for itself. And if we compare the rate of cases, the number of cases, the number of deaths, and the number of hospitalizations in the U.S. compared to India, we can see the fact. The reality speaks for itself.
Kevin Pho: I think one of the pushbacks that I read online is that they say we have enough vaccine supply in the United States, so why do we need yet another one? One thing that I think may be helpful is, because Covaxin is a more traditional vaccine platform, do you think that Covaxin would be better accepted by those who are resistant to mRNA because they think it’s a newer platform and are more hesitant to take it? Do you think that if Covaxin was approved here, we could use that and perhaps sway some of those who are hesitant to take an mRNA platform?
Tayson DeLengocky: Yes, definitely, definitely. That’s what I want to offer: People have a choice. The most common reason why people refuse to get vaccinated is the mistrust in the government, the mistrust in the public health policy, and the mistrust in the new technology. Those are the key issues. And yes, Covaxin, as a traditionally created platform, can help to persuade those people, those who are resistant.
And there are others. China also has the inactivated virus vaccine, but this vaccine is the only candidate that wants to be in the U.S. and in North America. So it’s trying to get through the FDA approval, but the thing is, it’s been six months already, and no clinical trial has been allowed. Do you think that 200 million people received Covaxin without severe side effects?
Yes, we have enough vaccine, but now they are starting to talk about creating a universal vaccine that would be able to adapt to the new mutations. The reason is that Covaxin is already universal, because it has been proven so far to be efficient against all the variants. And it received full licensure in India by the Indian FDA, full licensure meaning fully approved. And it has been recommended by the expert committee for approval for use from age two. And recently, for the past month, Covaxin has been used on kids from 15, and 40 million of those have been administered without any myocarditis.
In Europe, some countries say no Moderna for people under 30. And in the U.S., we are trying to push for pediatric use. So are we looking at the same data with a different interpretation? We’re talking about Europe. We’re not talking about the tower; we’re talking about Europe: Germany, Sweden, France, Spain. Why are they saying no Moderna under 30?
Kevin Pho: We’re talking to Tayson DeLengocky. He is an ophthalmologist, and he wrote the KevinMD article “Why is the world’s first universal coronavirus vaccine not in the FDA’s toolbox?” Tayson, what are some of your take-home messages that you want to leave with the KevinMD audience?
Tayson DeLengocky: We demand a good, traditional form of vaccine, which has been proven so far for the past year. And even the Indian prime minister got the shot himself rather than other Western-made vaccines. And I think it’s time for the FDA to allow a phase 3 clinical trial to see if Covaxin would be a better fit for our population in the U.S.
And we have been complacent over the past year because we have vaccines, OK, but unfortunately, as of today, our situation with the pandemic is worse than at the beginning, looking at the number of cases, looking at the number of hospitalizations and deaths. We have a higher number of cases, deaths, and hospitalizations than at the beginning, without any vaccine. And even, as you can see, the monoclonal antibody was withdrawn from treating COVID because it doesn’t work anymore.
Technology allows us to go down to the molecular level, or now the gene level, to target a specific protein. But we are treating a disease; we are not treating the whole person, or we’re not treating the whole virus. We’re treating a specific protein. So it’s just like our health care system now: We’re treating not the patient; we’re treating the disease, the symptoms, but not with the overall, holistic approach.
And yes, with the traditional platform of vaccination, creating the vaccine, even for Covaxin, it took them about 18 months to achieve that, from the beginning to the phase 3 clinical trial. And even for them, they had a very rigorous review by the World Health Organization. It was delay after delay after delay, so it was thoroughly reviewed by them. So the safety data is there, and the application is there in front of them, in front of the FDA.
I don’t want to get my fourth booster with the same technology. I want a more universal one, and that’s the whole reason why now people, even Dr. Fauci, start talking about a universal vaccine, because we have to catch up with the mutations. And if you have the whole virus stimulating the immune system, then you have more chance to have some efficacy against the mutations.
Kevin Pho: Thank you so much for sharing your time and insight, and thanks again for being on the show.
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