.

Robert Malone makes several misleading and unsubstantiated claims about COVID-19 vaccines in Judicial Watch interview

CLAIM
“Leaky vaccines” are causing SARS-CoV-2 to evolve rapidly; COVID-19 vaccines don’t prevent disease and death; childhood vaccine safety is doubtful
VERDICT more about the rating framework
DETAILS
Misleading: Like all other vaccines, COVID-19 vaccines don’t work 100% of the time, but are still highly effective at reducing the risk of severe disease and death. The claim that a “controversy” exists over the safety of childhood vaccines doesn’t reflect the scientific consensus. Several large-scale studies have established that childhood vaccination is safe.
Inadequate support: There’s no scientific evidence supporting the claim that it is COVID-19 vaccination that drives virus evolution and the emergence of variants. Several variants, such as Beta and Delta, had emerged several months before vaccines were available.
KEY TAKE AWAY
Many large, reliable studies have found that vaccinated children aren’t more likely to experience poorer health compared to unvaccinated children. No vaccine works 100% of the time, but even though the COVID-19 vaccine doesn’t prevent 100% of negative outcomes, they have been shown to be highly effective at protecting people from severe disease and death.

FULL CLAIM: “Leaky vaccines” are causing SARS-CoV-2 to evolve more rapidly than common cold coronaviruses; COVID-19 vaccines don’t prevent disease and death; “There are no laboratory correlates of protection”; childhood vaccines are “highly inflammatory” and there’s a “whole controversy about vaccines in a variety of childhood illnesses and long-term consequences”

REVIEW


On 9 September 2023, political activist group Judicial Watch posted a video of an interview with scientist Robert Malone, conducted by the group’s director of investigations Christopher Farrell. The video, which contains several claims about COVID-19 and vaccines, received more than 221,000 views on Facebook. A copy uploaded to YouTube received another 39,000 views.

Judicial Watch previously spread COVID-19 vaccine misinformation on the basis of vaccine adverse event reports. Malone himself has repeatedly propagated misinformation about COVID-19 and COVID-19 vaccines. He incorrectly claimed, among other things, that mask-wearing doesn’t reduce the spread of COVID-19 and that COVID-19 vaccines cause more severe disease and damage children’s organs.

The Judicial Watch video referred to Malone as “the inventor of mRNA vaccines”, a title that he often uses himself, implying he is the sole developer of this technology. But while Malone did make important discoveries that contributed to the development of mRNA vaccines in the 1980s, he wasn’t the only scientist to do so. Firstly, his work built on those of other scientists before him. Secondly, Malone’s work alone didn’t remove other obstacles to making the technology feasible. Contributions by other scientists were still needed to clear these hurdles.

In line with his record on claims about COVID-19 and vaccines, Malone made several misleading and unsubstantiated statements in the Judicial Watch interview. Many of the claims are also not new and were previously debunked by Health Feedback and other fact-checking groups. We explain below.

 

Claim 1 (Unsupported): “But apparently under the influence of these leaky vaccines—that’s the leading hypothesis—this SARS CoV-2 is evolving much more rapidly than the traditional beta-coronavirus, viruses that we call the common cold that are circulating”

The idea that COVID-19 vaccines cause the evolution of virus variants, by extension implying that vaccinating against COVID-19 is unhelpful, was initially promoted by another scientist named Geert Vanden Bossche, in early 2021.

It isn’t the first time Malone has advanced this hypothesis. Health Feedback reviewed this claim in August 2021 when it appeared in a Washington Times opinion piece co-authored by Malone. Despite calling it a “leading hypothesis” in the interview, Malone offered no evidence to substantiate it.

Experts told Health Feedback that such a claim is inaccurate and misleading. Firstly, any type of immunity in the population would exert a selective pressure on the virus—regardless of whether the immunity was acquired through infection or vaccination. Secondly, it’s natural for viruses to mutate over time, with or without vaccines. [See scientists’ comments here.]

Indeed, several variants, such as Alpha, Beta, and Delta, had emerged long before COVID-19 vaccines were available.

Emma Hodcroft, a molecular epidemiologist at the University of Bern, summed it up thus: “No matter what action we take, we have a future where we will have to deal with a virus responding to immune pressure”.

Malone’s baseless claim that vaccines are the “leading hypothesis” for the evolution of virus variants ignores actual hypotheses that scientists have put forward, among which are sustained transmission and infection in people[1-3] (see Figure 1).

Figure 1 – Hypotheses for the emergence of SARS-CoV-2 variants of concern, proposed by Markov et al.[1] In hypothesis 1, the virus circulates in a population for a sustained period of time but goes undetected. In hypothesis 2, the virus crosses over into wildlife (spillover), in which it circulates for a time, and then crosses over into humans again. In hypothesis 3, a person who is chronically infected by the virus and receives treatment provides the conditions for the virus to mutate and adapt to the treatments. Source: Markov et al.

Hodcroft pointed out that vaccination could well reduce the likelihood of dangerous variants occurring, particularly since it is infection that offers the virus opportunities to mutate:

“Even when vaccine-mediated immunity is imperfect, evidence suggests it makes it harder to be infected and harder to transmit—these are opportunities we take away from the virus. Further, it may be that those who may be vaccinated and infected may be able to eliminate the virus faster from the body, or have fewer viruses circulating while infected—all of which remove more opportunities for dangerous mutation.”

 

Claim 2 (Misleading): “And yet when Pfizer was confronted in the European Parliament about whether or not they had any data on whether they would actually protect against infection, replication or spread, they had to acknowledge that they didn’t […] the initial inoculations that have been proven to not prevent infection, replication spread, not prevent disease, and not prevent death. All of those statements are true.”

The claim that the vaccine doesn’t prevent infection, disease, and death lacks important context. No vaccine exists that works 100% of the time, and the COVID-19 vaccines are no exception. For this reason, a certain proportion of vaccinated people will still get sick with COVID-19 (breakthrough infection) and some will die. But something being less than 100% effective doesn’t make it useless (nirvana fallacy). COVID-19 vaccines have thus far been shown to be highly effective at reducing the risk of severe disease and death, even in the face of variants.

Malone also references an earlier claim by Rob Roos, a Dutch Member of the European Parliament, which went viral on social media in October 2022. Health Feedback covered the claim in an earlier review.

Roos had posted a video on Twitter of his exchange with Pfizer executive Janine Small. During the exchange, Small clarified that Pfizer didn’t test their vaccine’s ability to prevent transmission during the initial clinical trials. Roos claimed it proved getting vaccinated for others was “always a lie”, framing this as an admission by Pfizer.

Overall, the implication was that Small’s statement provided new and unexpected information.

But this is misleading. Firstly, the lack of data about the vaccine’s ability to prevent transmission was already indicated in the study containing the results of the clinical trials, published in December 2020[4]. The authors had stated in the study’s Research Summary that “Whether the vaccine protects against asymptomatic infection and transmission to vaccinated persons” was a remaining question.

Secondly, this information also wasn’t unexpected. Monica Gandhi, a professor of medicine at the University of California San Francisco, told PolitiFact that “the prevention of transmission (and asymptomatic COVID) were not primary endpoints of these trials and were never a claim of the pharmaceutical companies in developing these vaccines”.

Finally, vaccines that came before the COVID-19 pandemic have shown us that vaccines don’t need to prevent transmission completely in order to control the spread of disease. Sarah Caddy, a clinical research fellow at Cambridge University, dealt with this subject in an article for The Conversation. One example of such a vaccine is the rotavirus vaccine:

“[V]accines targeting rotavirus, a common cause of diarrhoea in infants, are only capable of preventing severe disease. But this has still proven invaluable in controlling the virus. In the US, there has been almost 90% fewer cases of rotavirus-associated hospital visits since the vaccine was introduced in 2006.”

The pertussis vaccine, which protects against whooping cough, is another example. Although it doesn’t completely clear the bacterium (Bordetella pertussis) responsible for the disease[5], the introduction of the vaccine in the 1940s still led to a decrease in cases from more than 100,000 cases per year to fewer than 10,000 by 1965.

 

Claim 3 (Factually inaccurate): “Neutralizing antibodies are not a proven correlative protection. There are no laboratory correlates of protection.”

In immunology, a correlate of protection is defined as “an immune marker statistically correlated with vaccine efficacy” or a predictor of protection[6].

Defining a correlate of protection comes with several challenges, which were discussed in a Perspective article by Gilbert et al., published in the New England Journal of Medicine[7].

For example, whether a biomarker is a correlate of protection may depend on the clinical endpoint: a marker that correlates with protection against infection may not correlate with protection against invasive disease. Other considerations are different virus variants and the health differences between populations, such as between healthy people and immunocompromised people.

Nevertheless, Malone’s claim that “Neutralizing antibodies are not a proven correlative protection” conflicts with research showing that neutralizing antibodies against SARS-CoV-2 correlate with protection against infection and symptomatic disease[8-11].

In their article, Gilbert et al. acknowledged the need for continued research to better identify correlates of protection (CoPs), but also stated:

“Both binding and neutralizing antibodies have been accepted as CoPs by regulators and have provided very high value for vaccine research, development, and use for more than a dozen vaccines against diverse viral or bacterial diseases. Large studies have generated robust evidence that these antibody markers are CoPs for Covid-19 vaccines — indeed, more evidence than is available for many CoPs for other types of vaccines. The FDA has accepted the titer of neutralizing antibodies against likely circulating strains as a CoP for multiple Covid-19 vaccines.”

 

Claim 4 (Misleading): “The problems with the vaccine safety for all the childhood vaccination schedule and the vaccination schedule has gotten enormous. Kids are subject, you know, newborns are subjected to these highly inflammatory products and you know there is correlative data epidemiologically about a number of syndromes […] the audience is well aware of the whole controversy about vaccines in a variety of childhood illnesses and long-term consequences.”

Here Malone rehashes the old myth of “too many vaccines” and suggests there’s credible evidence that childhood vaccination is implicated in a greater risk of poorer health outcomes.

These claims aren’t substantiated by scientific evidence. Pediatrician and vaccine scientist Paul Offit pointed out that infants are exposed to much more immunogenic components (sugars and proteins that are present on microorganisms) from daily life than they would receive from vaccines:

“When babies are in the womb, they’re in a sterile environment. When they enter the birth canal and the world, they’re not. And very quickly they have living on the surface of their body, trillions of bacteria […] You actually have roughly a 100 trillion bacteria on the surface of your body—that’s more than you have cells in your body. Now each bacterium, each single bacterium, has between 2,000 and 6,000 immunological components […] Viruses also have proteins, and those are considered also immunological components. Now, if you add up all the immunological components that are currently contained in vaccines, it adds up to about 160. So think about that—160 immunological components, which consist of viral proteins, bacterial proteins, or bacterial polysaccharide—as compared to the trillions of bacteria, each bacterium of which contains 2,000 to 6,000 immunological components. So, I think literally what you are exposed to in vaccines is a drop in the ocean compared to what you’re exposed to in daily life.”

The Vaccine Education Center at the Children’s Hospital of Philadelphia also provides estimates of immunogenic components in vaccines. It shows that although children receive more vaccines now, the actual number of immunogenic components they receive from vaccines has fallen: in 1960, the number was about 3,200. In 2021, this number was about 160.

Malone’s language on a “whole controversy” around the safety of childhood vaccination fosters the impression that there isn’t a scientific consensus regarding the safety of childhood vaccines and that there are credible grounds for doubting their safety. This is incorrect. The U.S. Institute of Medicine concluded in a 2013 review that the childhood immunization schedule is safe[12]. And well-performed, large-scale studies have established that vaccinated children aren’t more likely to suffer from ill health compared to unvaccinated children[13-17].

The American Academy of Pediatricians “strongly recommends on-time routine immunization of all children and adolescents according to the Recommended Child and Adolescent Immunization Schedule”.

SCIENTISTS’ FEEDBACK


[The following comments come from the evaluation of a related claim by Malone.]
Emma Hodcroft, Postdoctoral Researcher, University of Basel:
Viruses are some of the fastest-evolving pathogens we know, which is part of what makes them so tricky. For instance, the human immunodeficiency virus (HIV) evolves so quickly that our immune systems can’t keep up with “recognizing” it. That’s part of why it’s a chronic—and if untreated, fatal—disease.

For most human viruses we encounter, however, the outcome is much less grim. Our bodies learn to recognise it, which protects us from infection and/or serious outcomes when we meet it again in the future. However, for many viruses this is a dance we participate in for the rest of our lives—though we learn to recognise what infects us, the virus will change, and we may not recognise it as well next time. In some cases, we may remain protected for the rest of our non-frail lives from serious outcomes, but not from infection itself, with or without mild symptoms.

Any type of immunity present in the population will provide a selection pressure for the virus to get around this immunity, if it can. In many cases however, and particularly for viruses like coronaviruses, evidence suggests that this escape is usually not complete, particularly over shorter time periods. This means that even if you get infected, you benefit from “imperfect immunity” by being protected against severe outcomes.

We see this reflected in what we have learned from SARS-CoV-2 vaccination data. This means that even when viruses have selection pressure on them from population immunity, it is not correct to assume, as the article does (“ever more powerful vaccines will have to be developed”), that just because we may see some level of immune escape, this means that booster vaccines will be needed forever, or beyond the most vulnerable, or very frequently.

But most importantly, it’s not only vaccine immunity which provides this selection pressure: immunity from infection does as well, despite the impression given by the article (“The more people you vaccinate, the greater the number of vaccine-resistant mutations you are likely to get”). In fact, it is hypothesized that some of the variants we have already seen, with some apparent immune escape like Gamma, arose in places where previous infection levels (and thus infection-mediated immunity) were high, and thus this may have put pressure for immune escape.

Thus no matter what action we take, we have a future where we will have to deal with a virus responding to immune pressure, whether through most of the population being infected eventually—and with more transmissible variants like Delta as well as reopening, we can see this future clearly in the huge waves in areas with low vaccination rates—through vaccine-mediated immunity, or through a combination of both.

What’s key is that there’s a huge difference in how you reach these two goals. The risks of vaccination are incredibly low, particularly for the mRNA vaccines, and means we can keep the transmission rates of the virus low *while* getting high population immunity. On the other hand, we know that SARS-CoV-2 has very real risks for many people in our population. Even for age groups where the risk is relatively low, if you infect millions of people, you will see bad outcomes. Allowing the entire population to be infected—even excluding the most vulnerable—will cause a lot of hospitalizations, deaths, and suffering along the way, which is entirely preventable through vaccination.

Finally, population-level immunity achieved through infection requires, by definition, high levels of virus transmission. This provides the most opportunity for the virus to find itself in people with the imperfect immunity where immune-avoiding mutations could be selected. On the other hand, vaccine-mediated immunity could be achieved with zero virus circulating. While that extreme may not be realistic, we can achieve it while keeping virus levels very low, minimizing the chance that the virus has to have these mutations selected for.

While it’s true that except for eliminating SARS-CoV-2 entirely, we cannot entirely stop the virus from developing escape mutations, we can make this much harder. Even when vaccine-mediated immunity is imperfect, evidence suggests it makes it harder to be infected and harder to transmit—these are opportunities we take away from the virus. Further, it may be that those who may be vaccinated & infected may be able to eliminate the virus faster from the body, or have fewer viruses circulating while infected—all of which remove more opportunities for dangerous mutation.

In short, there is no future in which we won’t have to potentially face mutations that escape immunity to some degree. However, the future that is much less risky is reached by minimizing the chance of these mutations and minimizing the risk by which we achieve population-level immunity, and that’s through vaccination.

Dale Fisher, Professor (Department of Medicine), National University of Singapore:
It is theoretically possible that variants could escape vaccine-related immunity, but all the variants of concern to date have shown increased transmissibility, and in some cases, immune escape in the absence of vaccines.

Angéline Rouers, Senior Research Fellow, A*STAR Infectious Diseases Labs:
There is a confusion about the relationship between vaccination and mutations. The massive vaccination of the population doesn’t promote mutations and lead to “exposure to more and more risk”. On the contrary, the rapid vaccination of as many people as possible is crucial to stop the variants. The virus mutates not because of vaccination but because it is a virus, and every virus in the world can mutate.

Some of the mutations make the virus stronger and sometimes more transmissible. Some vaccines may become useless against certain variants but for now—even if it is demonstrated that there is a reduction in neutralizing activity against the variants—vaccines are still effective. But if not enough people are vaccinated, the variants will continue to emerge.

REFERENCES

   

Published on: 14 Sep 2023 | Editor:

Health Feedback is a non-partisan, non-profit organization dedicated to science education. Our reviews are crowdsourced directly from a community of scientists with relevant expertise. We strive to explain whether and why information is or is not consistent with the science and to help readers know which news to trust.
Please get in touch if you have any comment or think there is an important claim or article that would need to be reviewed.

ifcn-fact-checkers-code-of-principles-signatory