“I knew that I would wake up in the morning and not have a clear conscience.”
Medical ethics professor Aaron Kheriaty filed a lawsuit back in August challenging his university’s vaccine mandates on behalf of himself and others who have natural immunity. Natural immunity results from contracting and recovering from COVID-19. Dr. Kheriaty was suspended, and the school put him on “investigatory leave.”
In this two-part interview, we discuss the rise of what Dr. Kheriaty describes as medical coercion, perverse incentives in the vaccine rollout, and why he thinks the overwhelming majority of vaccine mandates exclude natural immunity.
Dr. Kheriaty is a professor of psychiatry at the University of California Irvine’s School of Medicine and Director of the Medical Ethics Program at UCI Health.
This is part one of a two-part series. Watch part two HERE.
"We're treating perfectly healthy people as though they're a real & imminent threat."
Medical ethics professor @akheriaty on how the unvaccinated are being treated as if they were "unclean," even though many have natural immunity.
— Jan Jekielek (@JanJekielek) November 2, 2021
Jan Jekielek: Dr. Aaron Kheriaty, such a pleasure to have you on American Thought Leaders.
Dr. Aaron Kheriaty: Thank you, Jan. It’s great to be with you.
Mr. Jekielek: You have a very interesting role at UC Irvine. You play a few different roles. Tell me a little bit about what you do, because it’ll be very relevant to the rest of our interview.
Dr. Kheriaty: I’m an academic physician. I’m a professor of psychiatry at UCI. About half my time is spent teaching and administrative work, supervising residents and medical students in psychiatry. And, of course, seeing patients—treating patients in the outpatient setting, on inpatient units, and in our main hospital.
The other half of what I do is I’m the director of the medical ethics program at UCI Health at our hospital. That involves running our ethics consult service. So, 24/7—being available for doctors, nurses, other healthcare team members, or for patients and families to reach out to us if they’re facing a difficult decision. Maybe an end of life decision or a decision that has significant ethical or legal implications, and the doctors are not quite sure how to proceed, or the patient and family are not quite sure how to proceed.
That ethics program work also involves teaching. I teach the required ethics course for all the first and second year medical students. We do continuing education for our physicians, some public-facing work in bioethics as well, and distinguish lectures and other events for healthcare professionals and professional bioethicists.
Mr. Jekielek: Through your work in the hospitals, you actually contracted COVID. Subsequently, you got natural immunity through it. Tell me a little bit about that process.
Dr. Kheriaty: Sure. In July of 2020, I did get COVID, confirmed by two independent PCR tests from two independent labs, two days apart. All the classic symptoms, except for shortness of breath. I didn’t have to go to the hospital, but I had the loss of taste and smell and all the systemic and respiratory symptoms that everyone has now seen on that symptom checklist that we’re frequently asked about.
My symptoms lasted about 48 hours and I recovered. I became sick pretty quickly and I recovered pretty quickly. My wife and my five children also got COVID. Fortunately for the children, the illness was very mild, but it was confirmed by antibody testing. I believe I acquired the illness in the community.
One of the things that hasn’t been highlighted during the pandemic is that hospitals have not really been a site for the spread of COVID. When the personal protective equipment that we use in hospitals is used correctly, it’s very effective.
Even prior to the vaccines, we saw very little to no transmission of COVID in our hospital systems where doctors, nurses, respiratory therapists, and other staff were trained to don and doff the appropriate personal protective equipment, including N95 respirators.
Mr. Jekielek: The N95’s with this tight seal, you saw people that had worked for a while with these imprints on their faces.
Dr. Kheriaty: With the use of masks, they have to be used correctly. Otherwise, they can do more harm than good. The general public is generally not trained to use masks correctly. We don’t need to get into debates about the utility of masks or whatever. So yes, I acquired and recovered from COVID.
It was for me, actually, a very liberating experience afterward because I didn’t have to worry about the illness anymore. I knew the science on natural immunity. I knew that at that point, I was among the safest people to be around. I didn’t have to worry about transmitting the infection to my patients.
I still took all the precautions, of course, with personal protective equipment and other things that I was asked to do at the hospital, just as an additional safeguard. But I was confident at that point. I was in a situation in which I didn’t have to be subjected to the same kinds of worries that a lot of folks were still living with about, “ what if I get infected with this virus,” or” what if I get an asymptomatic infection and go and visit grandma, who’s frail and elderly, and inadvertently put her at risk?”
Mr. Jekielek: It sounds like you’re saying the science around natural immunity existed early on, even though there’s been numerous studies that have actually gone into looking at this in the COVID context.
Dr. Kheriaty: It’s basic immunology 101, that for the vast majority of viruses, after an infection with a virus, you don’t get reinfected with the same virus again.This is a basic principle that any parent of a child who’s had chicken pox understands. Even prior to the vaccine that was available for that particular virus.
We know from SARS-CoV-2, the virus that causes COVID. Its closest cousin is the original SARS coronavirus. Seventeen years after that original outbreak, we know that individuals have continued robust, very effective natural immunity. Memory B cells, memory T cells, and the B cells in the bone marrow and still circulating to some degree in the blood. Those are the cells that turn into the cells that make antibodies when you encounter the virus again.
T-cells, which are sort of involved in the other branch of our immune system, the cellular immunity CD4 and CD8 cells that are involved in attacking infected cells once we get infected with a virus, those things stick around for years. We know that vaccines have a role, obviously, in fighting infections. That’s clear.
But what vaccines try to do is they try to mimic and recreate as much of the response as they’re capable of recreating that we would have, if we were infected with the original virus. At least that’s how a traditional vaccine works.
So the gold standard of vaccine immunity is always natural immunity. Vaccines aim to recreate the response that our immune system has when it encounters the virus, but without having us get really sick. Of course, evidence began to emerge to confirm the notion that natural immunity for this coronavirus would work the same as natural immunity worked for previous coronaviruses.
Now, we have an enormous amount of very good research, at least as much if not more research on natural immunity as we have on vaccine immunity for COVID. We know that natural immunity is very effective, 99 percent effective against reinfection in most studies. The lowest estimate of any published study would put that at 95 percent effective.
We know that it’s durable, meaning that it doesn’t wane over time. We’re 20 months into the pandemic now, and we haven’t seen it decline. It seems to be on the same trajectory as the 17 year old natural immunity to the original SARS virus.
We have evidence in terms of what’s happening with our cells in the lymph nodes, and in the lungs, in the bone marrow. That the elements in our immune system that stick around and can respond to the virus very quickly even after circulating antibodies have declined. Antibodies always decline after an infection or after a vaccination.
There’s this notion out there that my level of immunity necessarily correlates with my level of circulating antibodies, and that’s just not true. Our body can’t maintain circulating antibodies to every pathogen that it’s ever encountered. If that happened, there would be so much protein in our blood, it would be like sludge, and the energy requirements of that are just too great. That’s not actually how our immune system maintains immunity over the long term.
We’ve got clinical evidence now, specifically for this virus, that with time and with new variants, natural immunity is not diminishing. And that’s good news. The vaccines remain effective against severe symptoms and against hospitalization.
But their efficacy now is clearly declining. It starts to decline at about four months. By six to eight months, the efficacy against so-called breakthrough infections is for some of the vaccines below 50 percent.
So natural immunity is certainly at least as good. What we know now is that for this particular virus, it’s superior to vaccine immunity. You could say that without denigrating the vaccines or denying their usefulness, especially for individuals that are vulnerable to severe illness, hospitalization, or death.
There’s the whole question about vaccinating individuals that already have natural immunity. What we know about that question based on the largest study that looked at this question from Israel is that the bump that you get in immunity from someone who’s are already had COVID—if you immunize them, and you compare that group to individuals that have already had COVID but don’t get vaccinated—how do these two groups fare in terms of reinfection?
Basically with the addition of the vaccine on top of natural immunity, you go from 99.7 percent efficacy against reinfection to 99.8 percent efficacy against reinfection. It’s not clinically meaningful or clinically significant in terms of the improvement. This is a study of tens of thousands of people from Israel that made that direct comparison.
Those numbers, that slight bump in efficacy was only against asymptomatic infection. If you look at symptomatic infection, at hospitalization or death—clinically meaningful outcomes—there was no difference between those two groups. No statistically significant difference in a very large population-based study.
The other issue though, with the idea of vaccinating individuals that already have natural immunity is, not only are you not going to benefit them, you’re not going to benefit anyone else. You’re not going to reduce their odds of transmitting the virus to anyone else.
But there are now about five independent studies that strongly suggest that individuals that already have natural immunity, when you vaccinate them, the risk of vaccine adverse events or vaccine side effects is higher for that group.
There’s also a hypothesis out there that, I think, is still not well established, it’s not proved. There’s some evidence suggesting that vaccinating that population might actually diminish their immunity, and the reasons for that are complex. I don’t know that we need to get down into the weeds on that debate.
So it’s not going to help these folks. They have higher risks of side effects from the vaccine. It’s not going to help the people around them because natural immunity already is sterilized. Natural immunity is as close to 100 percent effective as anything gets in medicine.
Not only does it prevent me from getting the virus and getting sick again, but it also prevents me from asymptomatically transmitting the virus to other people. Unfortunately for these vaccines, we don’t yet have any COVID vaccines that offer sterilizing immunity.
They don’t prevent you from getting a symptomatic or asymptomatic breakthrough infection, and subsequently transmitting the virus to other people. We saw a lot of this during the Delta variant surge that vaccinated individuals, while the vaccine offers them some personal protection against severe illness, they can still get infected and they can still transmit the virus to other people.
We have some vaccines that are sterilizing that prevent transmission. The measles vaccine would be a good example of that. That’s very fortunate for us because measles is extremely contagious, way more contagious than COVID is.
So if an individual gets the measles vaccine, they’re protected against severe symptoms of measles. They’re also protected against transmitting measles. So far for the current COVID vaccines that have been approved, or that are authorized for emergency use, we don’t have any vaccines that can do that.
Mr. Jekielek: At this point, we’re at 20, 21 months into the pandemic. What do we actually know about the prevalence of natural immunity in society?
Dr. Kheriaty: One of the current failures of our public health establishment in this regard is that we don’t have a really solid answer to that question, 21 months into the pandemic. We certainly have the means to do the necessary studies to figure out how many Americans have already been infected with COVID.
We have some estimates from the CDC that are many months old now. I think the last estimates they published were back in May. At that time, it was well over 30 percent of Americans. But that was before the Delta variant surge that we saw subsequent to that during the summer.
Most people estimate that probably more than half, somewhere between 50 and 60 percent of Americans have already had COVID and recovered, and have natural immunity, including many Americans that are already vaccinated.
There are several reasons the answer to that question is so important. One is that the two most basic numbers in epidemiology when we’re trying to get a handle on a disease, any disease, whether it’s an infectious disease or some other illness are incidence and prevalence.
Incidence is how many people over a given period of time will be newly diagnosed with the disease? How many new cases of COVID are there per month? Prevalence is how many total cases are there during a given period of time?
So, 21 months into the pandemic, we should know because it’s one of the two most basic statistics in all of epidemiology. It’s the first two stats every medical student learns about every illness that they study. We should know how many people have already had COVID.
Randomly sampled population-based testing, either serial testing of a cohort over time with PCR testing or antibody testing, would give us an answer to those questions. But also, there’s a T-cell test available now that can detect T-cells, some of those memory cells that I mentioned earlier, even after antibodies have declined.
Randomly sampled T-cell testing could tell us how many, and specifically which Americans have already had COVID, and therefore have natural immunity to this illness. That should obviously be taken into account when we’re doing a risk assessment, when we’re thinking about the whole issue of herd immunity and population-based risk.
I think it’s also important as we discuss the vaccine rollout policy. The notion that we vaccinated millions of people that already have immunity that’s superior to the vaccine, rather than allowing those vaccines to go to places in the world or to people that haven’t received their first dose yet. I think that’s a major failing and shortcoming of our public health response, and of our vaccine rollout policy.
What I’ve done in 2021 since January is work on vaccine allocation policies—again, first at the university. The university had a policy back when the demand for vaccines was outstripping the supply. In the early days of the vaccine rollout, we had more people wanting the vaccine than we had vaccine doses.
I was on the university’s committee that devised the policy for which people, and among the healthcare professionals, which of those ought to be first in line to be vaccinated—but also with the county. Within the constraints allowed by the state, how do we get the vaccines to the people who need it most?
I advocated publicly in the LA Times and other places that vaccine allocation should be based on people’s personal risk of bad outcomes from COVID. Age being the most important risk factor in that regard.
Making sure that the elderly were not deprioritized for the sake of some other interest group, including the idea of vaccinating healthcare professionals who could transmit the virus made sense back when we didn’t know that these vaccines didn’t offer sterilizing immunity. There were arguments about whether we vaccinate healthcare professionals first, or people who are likely to die of COVID first? I advocated that the people most at risk should get the vaccine first.
I advocated that the poor and underserved should have easy access to the vaccines. We didn’t set up a system here in the county that would somehow limit their access to vaccines. So I was deeply involved also in the whole question of vaccine allocation.
One of the things that never made sense to me during that whole process was why aren’t we paying attention to natural immunity? Are we wasting up to half of our vaccines on people that are not going to benefit from them when these things could be going out to people that need them more—that are at much higher risk of having a bad outcome if they get COVID, and much higher risk of getting infected with COVID because they don’t have natural immunity?
I see that as also one of our failures and the failures of the public health establishment. I wish I would have been more vocal at that time about raising this whole question of natural immunity in the vaccinated.
Mr. Jekielek: It seems like in terms of the public policy as it’s being implemented, this question of natural immunity which you’ve outlined is of critical importance for all sorts of reasons. It doesn’t seem to be factored in at all.
Dr. Kheriaty: I think there are at least three reasons why the CDC has dragged its feet on this question of natural immunity. It’s a question that in a recent interview, Anthony Fauci indicated he did not have a good response to why are we vaccinating people with natural immunity. Why aren’t we recognizing that natural immunity is equivalent to vaccines in terms of giving those folks the same kind of freedoms, and access to the workplace, and so forth that vaccinated individuals are now afforded?
I think the first reason, if you look at the public health messaging, is that there is worry that if we acknowledge natural immunity, there’s a fear that people are going to go out and deliberately try to get infected with COVID rather than getting vaccinated.
I don’t think that’s a worry that should stop us from being honest about the science. I think the real issue on natural immunity right now is not in relation to people that have not had COVID, and what kind of behavior they might engage in if you give them accurate information.
I think the question is what about all the people, probably more than half of all Americans who have already recovered from COVID? What kinds of risks and benefits are we subjecting those individuals toward?
What kind of discriminatory policies do we have in place that are excluding someone like me from the workplace when I’m 99.8 percent protected against reinfection, whereas someone who got the Johnson and Johnson vaccine, by the company’s own data that they submitted to the FDA, the J&J vaccine is 67 percent protective against COVID infection.
Somebody who’s 67 percent protected can go back to work at the university. [While] I, who am 99 percent effective, have been banned from campus and put on investigatory leave. Soon, I will be placed on unpaid suspension because I haven’t been vaccinated. So this worry that people are going to go out and deliberately get COVID is one of the things, I think, getting in the way of an honest accounting and assessment of this in relation to policy making.
The second reason has to do with efficiency. The public health establishment during the vaccine rollout was very concerned that nothing got in the way of getting a needle in every arm. Any step in the process, like getting antibody testing, or let’s ask for a previous record of someone’s COVID infection before we decide whether or not to vaccinate them. Or give them the option to opt out if they already have natural immunity. That was seen as cumbersome.
That was seen as something that could slow down what should be a highly efficient turn-style medicine process of moving as many people through the vaccine administration as possible, as quickly as possible. So many people have voiced concerns that this might slow down efficiency.
I think the obvious answer to that is it doesn’t have to slow down your system at all. If people want to opt out on the basis of natural immunity, put the burden of proof on them. Just have them go get the testing on their own time. You don’t have to administer the T-cell test or the antibody test.
You don’t have to go dig up their old medical record establishing that they’ve already had COVID. Just ask them to bring that in, and their work can sign off on that as a kind of immunity passport. Rather than dividing people into the vaccinated and the unvaccinated, let’s divide them into the more immune versus the less immune in terms of assessing risks.
That’s another reason, but I think the answer to that is very simple and straightforward. We can address that concern about efficiency by just putting the burden of proof on the individual who’s going to opt out of a vaccination on the basis of natural immunity.
The third reason has to do with the public health establishment’s worries about their own credibility. Many worry, I think incorrectly, that if we acknowledge natural immunity, the obvious next question is how many people have it? So we have to do the population-based testing to see that 55 percent of Americans have natural immunity.
Many in the public health establishment will see that as an admission of policy failure, especially for the policies of 2020. Many Americans made huge sacrifices, including the loss of their businesses, a loss of income to stay locked down at home for months on end.
To practice social distancing, to wash their hands, scrub surfaces, put up plastic barriers, and do all kinds of things that most people willingly did as a sign of solidarity with others out of a well-meaning desire to protect other people from infection—to protect their loved ones especially. That was very noble.
But in my view, and you’ve talked to others on this program who’ve shared the same view, I think those policies were misguided. A more targeted approach would’ve been much more effective, done far less harm to people, including harm to people’s health.
There are always risks to medical interventions, however small the risks might be. We know that the risk of myocarditis, for example, is real. It’s higher, especially for younger people and younger men. We know that there are other risks from these vaccines. Again, some evidence that individuals with natural immunity may be at higher risk than the general population for side effects from the vaccine.
So we’re proposing using this intervention on individuals that don’t need it, that won’t benefit, or it won’t benefit other people—where those individuals will assume some degree of unnecessary risk. This does not make sense from a public health perspective. It certainly doesn’t make sense from the perspective of medical ethics.
It’s especially egregious when individuals are subjected to mandates, when their right of informed consent and their right of informed refusal to a medical intervention is taken away. And they’re facing a choice about getting vaccinated under threat of losing their job, losing their livelihood, being shut out from their ability to travel, or to access certain public or social goods or venues.
The ethics of vaccination in this case are very clear. Because the vaccines do not prevent infection and transmission, then we have to look at individual risk benefit analysis. We have to inform individuals of what the risks and benefits are.
This is a central principle of medical ethics. The right of informed consent, and the right of informed refusal for this intervention is being taken away from millions of Americans that are now subjected to vaccine mandates. Soon, the right of parents to consent or refuse on behalf of their children will also be taken away.
This to my mind is very concerning. This was, ultimately, the thing that as I saw it unfolding around me—first at the university and then spreading to other institutions in society—I decided that I had to stand up and try to do something about it.
That’s what led to my legal challenge of challenging the university, and the state of California Department of Health on their vaccine mandate on behalf of individuals that have natural immunity—individuals that are similarly situated to me to nudge the university and the state to recognize the science—to go through the careful fact finding process that you get when you take a case to court, and to require these institutions to answer for the reasons for their policy.
In my case, challenging the policy on constitutional grounds, on Equal Protection grounds. My legal argument is that this violates my Equal Protection rights under the 14th Amendment of the Constitution. I think it’s a strong argument on the merits of the empirical evidence that we have available.
Mr. Jekielek: As someone who is obviously intimately familiar with and dealing with all sorts of ethical questions around medical, end of life, and vaccine administration scenarios, you are faced with precisely one of these scenarios and have to feel compelled to act on it. I want to get a little more insight into your thought process here. I think there’s a lot of people out there who are asking these sorts of questions.
Dr. Kheriaty: Right. So several months ago, after our vaccine mandate at the university was promulgated and failing to get much traction in trying to engage the leadership in having an open and meaningful discussion, debate, conversation about the policy, I decided to publish my views on the university mandates in the Wall Street Journal. I co-authored a piece with Professor Gerry Bradley at Notre Dame, who’s a law professor.
We made the case that the mandates which were being rolled out at many universities were unethical. In response to that, I had many people at my own university, at UC Irvine and other UC’s, UCLA reaching out to me. Students, faculty members saying, “Thank you for making this argument in the public square. I agree with you. And I’m very worried about this mandate.” They were worried for different reasons.
Some students reach out to me saying, “I have conscience based reasons that I don’t want to receive the vaccine, but I’m not a religious person. And I can’t in all honesty submit a religious exemption, which would probably be upheld, because I don’t want to pretend that I have religious beliefs or convictions where I don’t. But I have moral concerns. I have ethical concerns about these vaccines that struck me as very legitimate concerns.”
I worried about those folks, and the folks that were seeking legitimate medical exemptions, but could not get them. So I published a piece in “The Federalist” critiquing the narrowly-construed medical exemptions for these vaccines, and arguing that this was going to do harm.
It was not giving physicians sufficient discretionary latitude to make judgements about the risks and benefits of these particular vaccines for their patients, some of whom had rare conditions that might not be listed on the CDC’s list of contraindications, which was never meant to be comprehensive or all inclusive.
But if mandates were constructed such that if it wasn’t on the CDC list or in the FDA package insert, then your exemption didn’t count. That was problematic for medical reasons.
But then a month or two later, I received a letter that every physician in California received from the state medical board saying that if you, as a physician, write any inappropriate exemptions for masks or for other COVID interventions, and we read that to include vaccines, your medical license could be subjected to investigation and discipline.
In my 17 years of being a licensed physician, I have never received a letter like this from the medical board, and the colleagues I’ve talked to said the same thing. This was an extremely chilling kind of communication. I mean, to threaten a doctor, to threaten his medical license is not just to threaten him with the loss of his job at this hospital. It’s to threaten his entire livelihood. So that was scary.
As a response to that, physicians have decided in California not to write medical exemptions. It’s virtually impossible. I challenge your viewers to find a counterexample of this. It’s virtually impossible to get a medical exemption, even if you have an appropriate condition for a vaccine in California.
I have one patient who went to his rheumatologist, and the specialist told him, “Based on your autoimmune condition, I recommend that you don’t get the vaccine—taking account of your young age and low risks of a bad outcome from COVID, and risks from what I’ve seen—that this vaccine could actually harm you.”
The same patient, immediately after the doctor advised him of this, said, “Okay, can you write me a medical exemption for work?” The same doctor said, “No, I can’t, because I might be at risk of losing my medical license.”
So I saw this unfolding in California, and I began to realize that people were going to be harmed by not just the mandate policies, but by the pieces and the infrastructure that had been put in place to make sure that these mandates were enforced.
I started to imagine myself in January, in February when I teach the required ethics course for all of the medical students. II tried to imagine myself standing in front of the whole first and second year class in the lecture hall or on Zoom, if that’s the case—talking about integrity, moral courage, and doing the right thing under pressure.
I know that you’re at the bottom of the hierarchy in the hospital as a medical student. But if you see something unfolding around you that could harm patients, you have to step out and say something, even if you’re afraid.
I tried to imagine myself trying to say those things to students. If six months prior, I had seen something unfolding around me that I was convinced was wrong … Not just wrong, but in many respects egregiously wrong—violating core tenets of medical ethics that I’ve taught to medical students for years, principles of informed consent, for example—I knew that I would wake up in the morning and not have a clear conscience.
I said, “Okay, six months from now, I can wake up with a clear conscience because I stood up and tried to do something,” even though I knew that it was going to cost me when I did that. “Or I can put my head down and just try to take care of myself and get through.”
It was a hard decision, but my family’s been supportive. I’m convinced that I’ve done the right thing in trying to mount this legal challenge. It has cost me professionally, very dearly. I’ve been at the university my whole career. I did my residency training there, and joined the faculty immediately upon graduating. I have beloved colleagues there for whom I have nothing, but goodwill.
I have no resentment towards any individual at the institution. I miss them. I miss this month, not being able to work with the students and the residents, and my fellow attendees. It has cost me, but I wake up every morning with a clear conscience. It’s hard to put a price on that.
Mr. Jekielek: You describe some potentially egregious ethical violations. You mentioned one of them, this issue of informed consent. I have two questions. One is what are the egregious violations that you see? Can you outline them for me?
The other question intertwined into this is that these violations are obviously contingent on the scientific realities of the disease, how it affects people, the way the vaccines affect this. How would a different scenario affect the ethics of this?
Dr. Kheriaty: You’re right that the circumstances matter a lot when we’re talking about public health ethics, and when we’re talking about clinical ethics. So if we had vaccines that did a better job at preventing infection and transmission, if we had sterilizing vaccines for COVID, the argument, “Well, you might not benefit much from the vaccines, if at all, but do it for the sake of other people,” that public solidarity argument would be more persuasive.
It would carry more weight. It wouldn’t necessarily be decisive. I mean, you have to weigh that against the fact that you’re potentially taking away people’s rights of informed consent and informed refusal. I think it would complicate the ethics in certain respects and make the balancing between competing goods more challenging.
The whole issue of risk stratification has been ignored during the pandemic. So the risks of COVID to a five year old are 1,000 fold different than the risks to an 85 year old, actually more than 1,000 fold different. Those kinds of distinctions seem to be lost with most of the public health messaging.
One of the big picture ethical problems that I’ve seen from the beginning of the pandemic, and certainly continuing on into the present day, is that the public health establishment has not seen its role in terms of how do we take complex science and emerging science, and make it comprehensible to the average American. Communicate it clearly to the public so that people can make good informed decisions based on their own reasoning and assessment, and consultation with their healthcare provider about how to proceed and what to do.
That requires a certain trust in the intelligence of the average American and their ability to make sensible decisions that not only benefit them individually, but also contribute to the common good. I think that should have been the approach, but unfortunately the approach is very often that the public health establishment begins with a particular behavioral outcome that they want to see—everyone staying at home during lockdowns, or a needle in every arm.
Everyone gets the vaccine, and any form of vaccine hesitancy—anyone raising their hand and asking questions that complicate the kind of simplistic, safe, and effective public messaging around vaccines—is seen as a problem to be overcome rather than a legitimate issue to explore, or a legitimate question that needs a good answer.
It’s one thing to simplify complex science so that people can readily understand it, who haven’t studied virology, immunology or biology. It’s another thing to give information in such a way that the purpose of the information is to make you behave in a certain way.
That very quickly slips into propaganda. That slips into well, even though it’s true that some people are harmed by these vaccines, we can’t mention that truth out loud because it’ll increase vaccine hesitancy, or it’ll scare people, or they will exaggerate the risks, or whatever.
Whether or not it’s intended, it comes across as an elite establishment that has contempt for the average American, that looks down on the ability of the average American to do their own research and to read these studies.
Many people out there are now very motivated to learn more about this virus, to learn more about immunity. They have access to research studies, and to people that are helping to accurately explain research to them. They’re often well informed, sometimes more well informed than even many of my colleagues in medicine. I think that’s a good thing.
The American public should be well informed. They should have access to accurate information. They may not be able to put their finger on exactly what it is that you’re not telling me or exactly what it is that you’re doing to try to sway me to behave in a particular way. But they know when they’re being manipulated, and they quite reasonably don’t like it.
One state in the Midwest published a public service announcement—a commercial explaining that there are fewer ingredients in the COVID vaccines than there are in a candy bar, and saying there’s lipids, fats, proteins and so forth in this vaccine. Comparing it to eating a candy bar, with a suggestion that somehow taking a vaccine is even simpler and safer than eating a candy bar, which is completely absurd.
I think your average American who sees a commercial like that and feels manipulated, maybe somebody who is inclined to get the vaccine and was perfectly happy to do it begins to wonder why all this pressure on me? Why all this kind of suppression of information about potential downsides, potential adverse effects, or differentiated risk based on age?
That erodes public trust. What we’re seeing right now with vaccine mandates is coercion. When you threaten people with the loss of their jobs, and threaten people with the inability to go visit a loved one who lives in Canada or lives in another state, that is coercive. No institutional review board would greenlight a human subject’s research study that involved that level of coercion. It would be totally contrary to federal law, The Nuremberg Code, and all kinds of other—the World Medical Association’s Helsinki Declaration.
These landmarks of 20th century medical ethics are being violated by many of the policies that are being put in place right now. There’s a lot of Americans who maybe can’t explain it in scientific, technical, or philosophical terms. They’re not a trained bioethicist, but they know something is unfolding around me that’s not okay.
Mr. Jekielek: There’s this perception among a significant number of people, this comes up regularly, that the risks of the vaccines are being downplayed a lot. Some of this wanders very much into what you would call conspiracy theory. But, there’s just a lot of people that are deeply concerned that the risks are not being conveyed to them, even by people who aren’t supportive of mandates or aren’t supportive of coercion. What are your thoughts?
Dr. Kheriaty: I’m likewise concerned about our level of monitoring of risks. These were very short clinical trials of these vaccines. Phase three, the last phase of the clinical trial’s process at the FDA, was only a couple of months long for these vaccines before they received emergency use authorization. Even the Pfizer that received full authorization had data that was minimal, especially in terms of the length of time, and the number of people enrolled.
But after a few months, the clinical trial was stopped so that the vaccine could be rolled out on a mass scale. When you have a small number of people enrolled in a clinical trial, and a short clinical trial, and that clinical trial is stopped earlier than it would be for most vaccines which take years, typically, to go through the FDA approval process—between when they’re developed and when they’re given approval and licensure—it’s a very long process.
This one was obviously shortened. We can understand the reasons why people wanted to shorten the process of getting these approved—to get them out there as quickly as possible. But as a result of that, whether that was the right decision or not, to shorten the length of the trial. Immediately after the trial was stopped, the placebo group, the control arm, the comparison arm in that clinical trial was eliminated because everyone was offered the vaccine.
Rather than continuing to follow that same cohort out as the vaccine was being rolled out—and simultaneously having a group that was getting the vaccine and a group that was not that could be compared, studied, and followed rigorously—we lost the comparison arm, or what’s called the control arm in the study. That’s a very significant problem because the level of safety monitoring during phase three trials is very rigorous.
You’re following the same people over a period of time to see what happens to them. You’re following them closely so that if they develop a medical problem, you can assess whether or not this may have been related to the vaccine. You can look at their medical records very carefully. If you start seeing a safety signal show up in the trial, you can make sure that you’re on top of it right away.
Once the trial is stopped, we’re left with these passive surveillance systems, which have been widely sighted and also widely critiqued. I think both sides in that argument are right in terms of these are important for safety monitoring, but they also have limitations. Their limitations are one of the current problems.
The VAERS system, which lots of folks are now familiar with, nobody had heard of it years ago—the Vaccine Adverse Event Reporting System. There are others both in the United States and abroad that do this. By passive surveillance, I mean that if something happens to someone, and they or a healthcare professional believes that this may be a vaccine side effect, they can voluntarily report to the VAERS system.
It’s an arduous process. It takes at least 30 minutes, and that’s when you know what you’re doing and there are no glitches in this system. It takes 30 minutes to report. The studies looking at how many cases are actually reported to VAERS uniformly show that cases are underreported.
One study from Harvard estimates that the actual number of vaccine adverse effects may be as much as 40 to 100 times higher than the numbers that we actually see in VAERS. So what happened in the early rollout of these vaccines is that we saw huge spikes in this VAERS system and in other systems abroad, suggesting that there may be safety problems with these vaccines, including potentially serious problems, including deaths.
Now, the response to that is always to say, “Well yes, these are unverified cases.” The CDC then has to subsequently investigate to see were these deaths actually related to the vaccine or were they not? That takes a lot of work, and a lot of human resources to dig through the medical records and to establish that this is not just a random correlation. There may be a causation role between the vaccine and the negative outcome.
That was done for myocarditis. The CDC did confirm there’s an elevated risk of myocarditis with the vaccines. But we still don’t know how serious that risk is. Because if you just look at the numbers in VAERS, it’s clearly statistically significant.
But if VAERS is potentially 10, 40, to 100 times underreported, we don’t know. Is the real number 10 times the confirmed cases? Is it 50 times? Is it 100 times? The answer to that question is we don’t know. And the fact that we don’t know is a problem. When we’re looking at vaccine risks and benefits, and we don’t know quantitatively how great are these risks …
We know that certain risks of thrombosis, myocarditis, and other adverse—Guillain-Barre syndrome, a kind of autoimmune neurological syndrome that can cause paralysis—we know that these are happening, but we don’t know with any precision, like we would if we were still doing the clinical trial. We don’t know with any precision how many people may be adversely impacted by a side effect like that. That’s a problem.
So we can criticize VAERS. But then we also have to say okay, well, if that’s not an adequate surveillance system for vaccine safety, what other safety systems are we putting in place? What are some more active surveillance systems where we’re continuing to follow a cohort with a control group at the same time to monitor medium-term risks, long-term risks to begin quantifying some of the known risks? That’s not happening.
So unfortunately, the answer to a lot of the pending and dangling questions that reasonable people have is we don’t know. What are the long-term risks of the vaccine? We don’t know. Are there fertility related risks? The answer to that is we don’t know. There’s certainly a lot of reported cases of menstrual irregularities.
The public health establishment is quick to reassure women that there are no known risks of fertility problems with these vaccines. But the absence of evidence isn’t evidence of absence. In other words, we don’t have evidence that it’s harmful, but we don’t have proof that it’s not harmful either.
So the NIH has set aside $1.5 million in grant funding to study this precise question. They wouldn’t have set aside that grant funding if there wasn’t still a question to be studied. People are being reassured that this is safe in this regard, when in fact the answer they should be given is we don’t know. There are unknowns regarding the risks.
When there are unknowns regarding the risks, then it’s all the more important to allow people to make their own personal risk assessment and decide whether or not this is the risk of COVID versus the risk of vaccine, which of those risks would I rather assume?
We need to be honest both about what we know, but also about what we don’t know. Informed consent involves telling people both what we know and what we don’t know. And this happens all the time in medicine.
Under the kind of precautionary principle, it’s standard practice in medicine when there is more than one option available to advise using a medication that’s been around longer, where we just have more clinical experience and more clinical data that’s accumulated over time, that this older medication appears to be safe in pregnancy because it’s been given to thousands of pregnant women.
But with a new medication, we have to inform a pregnant woman that the risks of this medication are still pretty much unknown. That kind of honesty and transparency is absolutely necessary, I think, for the trust of the public. Especially when you’re asking, nudging, or in this case, in many instances, forcing people to do something that they may have very legitimate questions about.
Mr. Jekielek: Based on what you’ve said, what studies that aren’t being done are of the most immediate importance to initiate, to answer some of these unanswered questions?
Dr. Kheriaty: There are many. The population-based randomly sampled testing of Americans in different regions of the country and stratified into different age groups, to know how many people in various categories of age, and so forth, have already had COVID. We need to answer that question about natural immunity.
That’s very important for the overall big picture understanding of where we’re at in this pandemic, and in terms of getting on top of a virus that is eventually going to become endemic. That means that everyone, eventually, will be exposed to COVID—which doesn’t have to be a big, scary thing.
Because if you’re exposed at a young age, you have very good outcomes, and you develop very good natural immunity to the virus. We need to make sure that, obviously, the elderly and other people who are at risk of bad outcomes are protected in any way that we can, including deploying vaccines as appropriate for that purpose, and developing new and hopefully better vaccines for that purpose.
We need to answer the question about natural immunity, especially now that it looks like the FDA is soon to approve the vaccine for five to 11 year olds based on what I consider to be very inadequate and thin data. We need rigorous, prospective, forward-looking research on vaccine safety in different populations.
The vaccine safety questions that could have been answered in a longer, rigorous clinical trial, we very likely can’t get as good as a clinical trial would’ve been. It’s unlikely at this point that we would be able to randomize people to a vaccine arm versus a placebo arm, which is helpful for the gold standard research that you want on drug or vaccine safety and efficacy.
So we can’t randomize people, but we could have what’s called a naturalistic study of the people that choose to get vaccinated, and the people that choose not to get vaccinated. We match them according to age, gender, and co-occurring medical conditions. Then we compare the outcomes across time.
We follow the same cohort across time to carefully monitor with regular testing and checkups, and not just wait for them to choose or not choose to report if something bad happens that might be related to the vaccines.
We can’t get up to the gold standard that we should have had during phase three testing, but we can try to get as close to that as possible and continue to study medium and long-term potential adverse effects of these vaccines so that they can be quantified. The efficacy of the vaccines could also be very profitably studied in that way.
We know now that vaccine efficacy, particularly against infection—not so much fortunately against severe symptoms and hospitalization, but efficacy against infection and transmission—is declining with time and with new variants.
As additional variants emerge, some of which, unfortunately, might be able to better escape vaccine immunity, it would be really good to have a rigorous cohort that’s being studied across time in terms of what’s happening in those who are vaccinated, those who are not vaccinated. Those, of course, with natural immunity as well, to have that as the benchmark of comparison for the other two groups.
Mr. Jekielek: So you contend that coercion in this scenario is unethical. Is there any scenario that you might imagine where coercion, and I don’t mean forcing a needle into someone’s arm, but the type of coercion we’ve discussed would be appropriate from an ethical perspective?
Dr. Kheriaty: I don’t think you could ever forcibly inject someone with a drug or a vaccine against their will if they are a competent adult. It’s one thing if you have a cognitively disabled person, you have another individual consenting on their behalf. We do that routinely in medicine for children, or for adults who don’t have the ability to understand the risks, benefits, and alternatives to the proposed treatment. But for a competent adult, it’s a form of assault. It’s never okay.
Now, if someone chose not to get something and that’s putting themselves and especially putting others at undue risk, could there be an emergency situation in which those folks might be restricted from certain activities? Yes. I think that may be warranted. But those circumstances certainly don’t obtain right now during the pandemic.
There is no emergency for children in COVID right now, even though the committee that advises the FDA, just yesterday, made a recommendation to authorize the vaccine for five to 11 year olds under the Emergency Use Authorization.
The condition for what counts as an emergency has never been defined by the public health establishment. That’s another problem that has occurred during this pandemic. That’s a very important question that’s never been answered. That question is also necessary to know—when is the pandemic as a defined public health emergency over, right?
The threshold for that always seems to be receding over the horizon. Lots of Americans can sense this. We were promised two weeks to flatten the curve. Then it was basically lock down till we get a vaccine. Then we rolled out the vaccine, and it’s this threshold for herd immunity. That threshold keeps moving up, and people start worrying for perfectly legitimate reasons that what counts as an emergency is always left fuzzy. These emergency powers are not being relinquished.
The Italian philosopher, Giorgio Agamben, talks about this. He cites Schmitt’s definition of the sovereign. The sovereign is the one who really … The locus of real political authority in any society is the person who is authorized to declare what he calls the state of exception or the state of emergency.
If you think about that, well yeah, that makes sense. If this guy who’s appointed by whoever has the authority to declare a state of emergency, that’s an enormous amount of power. That’s a real locus of power. What are the checks and balances on that power? I think these are real concerns of the relationship between public health authority during a state of exception or state of emergency, and our governing powers in a representative democracy.
[Narration]: Next week on American Thought Leaders.
Dr. Kheriaty: Pharmaceutical companies convinced the federal government that they shouldn’t be liable for any harms or vaccine-related injuries that their products cause.
Mr. Jekielek: The ethics of testing COVID-19 vaccines on children.
Dr. Kheriaty: No sane society should ever subject children to risks to try to shield adults.
Mr. Jekielek: And the rise of a two-tiered society.
Dr. Kheriaty: There are mechanisms being put in place for biosecurity surveillance.
This interview has been edited for clarity and brevity.
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