Robert Malone’s statements on The Dana Show about vaccine safety and virus variants are inaccurate and unsupported

On 9 December 2021, The First TV network broadcasted this video interview between host Dana Loesch and Robert Malone. The interview went viral on Facebook, receiving more than 88,000 interactions only on Loesch’s Facebook page. In addition, a tweet from Malone sharing the video received more than 3,800 likes and 1,700 retweets.

Malone’s account was later permanently suspended by Twitter on 29 December 2021 for violating the platform’s policies about COVID-19 misinformation. Further user engagement also took place on other media platforms where Loesch shared the video, including YouTube.  Posts on other websites, like Gateway Pundit, also propagated similar claims from Malone.

Malone, a scientist who formerly worked at the Salk Institute, has previously spread misinformation about COVID-19 vaccine safety and effectiveness. Loesch introduced Malone as “the inventor of mRNA vaccines”. As Health Feedback explained here, this claim is inaccurate because the development of mRNA vaccines resulted from a collaborative effort involving hundreds of researchers and three decades of work.

During Loesch’s interview, Malone repeated some of his previous claims, including the claims that COVID-19 vaccines are experimental gene therapy and they violate the Nuremberg Code. Health Feedback covered these claims in earlier reviews and found them to be inaccurate.

Malone also suggested that COVID-19 vaccines are unsafe and ineffective, and claimed that vaccination is behind the emergence of SARS-CoV-2 variants, including Omicron. These claims are false, as we show in detail below.

Studies show that booster COVID-19 vaccine doses increase the immunity to viral variants, including Omicron

When questioned about COVID-19 vaccine boosters, Malone cited the concept of “high zone tolerance”. He claimed that repeated COVID-19 vaccine doses could “shut the immune response” through this mechanism, “just like what happens if you take too many flu vaccines”.

High zone tolerance is a phenomenon where the immune system stops responding to an antigen, which is any substance that induces an immune response, after repeated exposure to large amounts of that antigen. Researchers are exploring the use of mRNA vaccines in experimental animals to study how this phenomenon could be used as a potential treatment for autoimmune diseases. However, no evidence suggests that standard administration of COVID-19 vaccines, including boosters, can lead to tolerance. In fact, current data shows the opposite, as Shane Crotty, a virologist and professor in the Vaccine Discovery Division at La Jolla Institute for Immunology, explained to Health Feedback:

“The studies of immune responses to booster vaccines have all found strong immune responses—antibodies and T cells—to the booster vaccination. The best epidemiological data so far are also that the boosters improve immunity. The highest immunity against SARS-CoV-2 infection by Delta or Omicron has been seen so far in three-dose vaccinated individuals. Whereas it only took one or two doses to protect against Alpha.”

Estimates from the Imperial College London suggest that the Omicron variant is better at evading immunity. More specifically, while Omicron doesn’t seem to cause more severe disease compared to Delta, the level of protection from immunity provided by previous infection and/or vaccination against infection by Omicron is lower as compared to Delta. However, preliminary data from Israel, Australia, and the U.S. show that a booster dose could increase vaccine effectiveness against infection and provide up to 85% protection against severe illness.

Malone compared the alleged suppression of the immune response by COVID-19 vaccine boosters with the effect of repeated flu vaccination. This claim is misleading because studies evaluating the impact of repeated flu vaccination on vaccine effectiveness produced conflicting results^[1-5]. In 2020, researchers from the Canadian Immunization Research Network published one of the largest studies so far, which estimated the impact of repeated flu vaccination taking into account the previous ten flu seasons^[6].

The authors found that having received a flu vaccine in the previous year did reduce the effectiveness of vaccination in the following year. However, all vaccinated individuals showed greater protection against infection than unvaccinated individuals, regardless of the number of previous vaccinations received. In other words, repeated flu vaccination is still better than no vaccination at all. These results contradict Malone’s claim that repeated flu vaccination suppresses the immune response and support current recommendations for annual flu vaccination.

Despite the association between mRNA COVID-19 vaccines and heart inflammation in young people, such cases remain very rare and are generally mild

During the interview, Malone also referred to the reports of heart inflammation in young people following COVID-19 vaccination. In June 2021, public health authorities, including the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), reported a “likely association” of such cases with mRNA COVID-19 vaccines, particularly in young male individuals.

Malone claimed that these cases are “quite frequent”, as much as one case per 2,700 vaccinated people. In support of this claim, he cited a series of anecdotal reports—not published in a scientific journal nor publicly available—collected by the pediatric cardiologist Kirk Milhoan. Milhoan is under investigation by the Hawaii state medical board for promoting the use of unproven COVID-19 treatments like hydroxychloroquine and ivermectin. Local media also reported links between Milhoan and Pono Coalition for Informed Consent, an organization that spreads misinformation about the safety of COVID-19 vaccines.

Malone then cited a November 2021 study from Hong Kong published in Clinical Infectious Diseases^[7]. This study evaluated the risk of heart inflammation in adolescents aged 12 to 17 who received a Pfizer-BioNTech COVID-19 vaccine between June and September 2021.

The figure that Malone cited (one per 2,700) referred specifically to male adolescents who received the second vaccine dose (37.2 per 100,000, or one per 2,688 vaccinated individuals). The overall incidence of heart inflammation reported in the study was 18.52 per 100,000 (1 per 5,400) vaccinated individuals.

Malone cherry-picked this particular study that found one of the highest incidences of heart inflammation reported so far. However, this study has one important limitation: it used data from pharmacovigilance systems. As the Hong Kong Health Department explained in this official report on COVID-19 vaccine safety monitoring, these data might be partial and cannot establish a definite association between the event—heart inflammation—and vaccination. Malone also didn’t mention that all the cases reported in the study were mild and resolved after simple treatment.

Multiple studies in countries like the U.S., Israel, and Denmark, show that cases of heart inflammation following COVID-19 vaccination are overall very rare and mild, and most individuals recover fully within a few days^[8-10]. In contrast, COVID-19 poses a major and more common risk of heart inflammation and potentially serious cardiovascular complications. Some countries like the U.K., Sweden, Norway, Denmark, and Hong Kong now recommend a single dose of the vaccine in adolescents to mitigate the risk of heart inflammation in this group.

Safety data still indicates that the benefits of COVID-19 vaccination for individuals and the community outweigh the potential risks. Therefore, public health authorities, including the CDC, recommend “everyone ages five year and older get a COVID-19 vaccine”.

Both infection and vaccination can contribute towards the evolution of immune-evading virus variants; no evidence of COVID-19 vaccines being major drivers of such variants so far

When asked about SARS-CoV-2 variants, Malone claimed that “many of these mutations are being driven by the evolutionary selection caused by the vaccines”. This claim is unsupported and even contradicted by available data.

We should keep in mind that viral evolution will happen even in the absence of vaccination. Viruses evolve constantly through natural selection. As the number of infections grows, the virus has more chances to replicate and accumulate mutations. Pre-existing immunity in the population, whether it arises from vaccination or infection, provides an environment that can favor mutations that help the virus to evade immunity.

Malone incorrectly implied that SARS-CoV-2 variants evolved solely in response to the selective pressure exerted by vaccine-induced immunity. In doing so, he disregarded the effect of infection-induced immunity. However, all variants of concern identified prior to Omicron emerged in 2020, long before COVID-19 vaccine rollout, therefore none of them can be attributed to vaccination.

Although data about the Omicron variant are still too scarce for us to arrive at definite conclusions, no evidence so far suggests that it was driven by vaccination. Omicron was first identified in Botswana and South Africa in November 2021. Due to the high number of mutations it contained, especially in the gene coding for the spike protein, the WHO classified it as a variant of concern on 26 November 2021.

Malone claimed that Omicron “doesn’t fit the model of evolution off of the existing variance” because “it has no obvious immediate predecessors in other circulating viruses”. In an email to Health Feedback, Shane Crotty explained that this is incorrect and “Omicron’s closest ancestor actually predates the vaccines”.

Likewise, Emma Hodcroft, an epidemiologist at the University of Bern, explained in this ScienceInsider article that the origin of Omicron predecessors likely “goes back to mid-2020”. Hodcroft is a co-developer of Nextstrain, an open-source project that tracks in the real-time evolution of pathogens, including SARS-CoV-2, based on their genomic sequences. Using this tool, scientists can compare Omicron with previous variants and determine its probable ancestors, as shown in this Twitter thread by Trevor Bedford, a computational biologist in the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Research Center.

While the precise circumstances in which Omicron emerged remain unclear, scientists have developed three hypotheses to explain its evolution: 1) the virus had circulated widely in a population where virus samples weren’t highly collected and analyzed, 2) the virus accumulated mutations in a chronically-infected COVID-19 patient, and 3) the virus had evolved in an animal species and later infected humans.

A Gateway Pundit article also illustrated the self-contradictory nature of Malone’s claims. On the one hand, he claimed that vaccination is driving the evolution of virus variants “to a state where it may be more pathogenic” and that vaccination programs are “already starting to produce potentially catastrophic results”, so mass vaccination should be halted. But at the same time, he dismissed Omicron as a mild variant with “such [a] low risk for severe disease and death”—indeed on one occasion, he called Omicron a “Christmas present” and said that “this is about as good as we could possibly want right now in terms of outcomes”.

Experts have pointed before to low vaccination rate as a major contributor to the emergence of new variants. Now, some link the spread of Omicron to regions with low vaccine coverage from the South of Africa. COVID-19 vaccines not only prevent severe illness, but also reduce the likelihood of infection compared to unvaccinated individuals who haven’t been infected before. Thus, they reduce the opportunity for the virus to replicate and mutate, and in turn limit the emergence of new variants.

While SARS-CoV-2 might eventually improve at evading vaccine-induced immunity as more people get vaccinated, that isn’t a reason to stop vaccination. COVID-19 vaccines greatly reduced COVID-19 mortality^[11], even when the more contagious Delta variant was dominant. Current COVID-19 vaccines remain effective at preventing most cases of severe disease and reduce transmission to a certain degree, making them one of the best tools to fight the virus. By carefully surveilling new variants, scientists can reformulate current vaccines to maintain their effectiveness.

Conclusion

The most common side effects of COVID-19 vaccines, like fever and muscle aches, are mild and transient. Contrary to Malone’s claim, the frequency of serious effects like heart inflammation following vaccination is very low. The vaccines remain highly effective at preventing severe illness and death. While the evidence indicates that some variants like Omicron can reduce vaccine effectiveness against infection compared to other variants, booster doses reinforce pre-existing immunity and protect against hospitalization and death. Therefore, vaccination remains the best strategy to prevent getting sick and to reduce viral spread.

Malone’s claims that mutations “are being driven by the evolutionary selection caused by the vaccines” and “Omicron doesn’t fit the model of evolution off of the existing variance” because “it has no obvious immediate predecessors” is incorrect. Omicron’s closest ancestor actually predates the vaccines. Omicron appears to have emerged in South Africa, which has a low vaccination rate.

The claim that booster COVID-19 doses “shut down the immune response” is also incorrect. The studies of immune responses to booster vaccines have all found strong immune responses—antibodies and T cells—to the booster vaccination. The best epidemiological data so far also show that the boosters improve immunity. The highest immunity against SARS-CoV-2 infection by Delta or Omicron has been seen so far in three-dose vaccinated individuals, whereas it only took one or two doses to protect against Alpha.

UPDATE (29 January 2022):

Following the publication of the review, we included a mention of an article published in Gateway Pundit on 24 January 2022 that contained related claims.

REFERENCES

• 1 – Valenciano et al. (2018) Exploring the effect of previous inactivated influenza vaccination on seasonal influenza vaccine effectiveness against medically attended influenza: Results of the European I-MOVE multicentre test-negative case-control study, 2011/2012-2016/2017. Influenza and Other Respiratory Viruses.
• 2 – Domínguez et al. (2017) The effectiveness of influenza vaccination in preventing hospitalisations of elderly individuals in two influenza seasons: a multicentre case–control study, Spain, 2013/14 and 2014/15. Eurosurveillance.
• 3 – Ohmit et al. (2013) Influenza Vaccine Effectiveness in the 2011–2012 Season: Protection Against Each Circulating Virus and the Effect of Prior Vaccination on Estimates. Clinical Infectious Diseases.
• 4 – Skowronski et al. (2017) Serial Vaccination and the Antigenic Distance Hypothesis: Effects on Influenza Vaccine Effectiveness During A(H3N2) Epidemics in Canada, 2010–2011 to 2014–2015. The Journal of Infectious Diseases.
• 5 – McLean et al. (2018) Association of Prior Vaccination With Influenza Vaccine Effectiveness in Children Receiving Live Attenuated or Inactivated Vaccine. JAMA Network Open.
• 6 – Kwong et al. (2020) The impact of repeated vaccination using 10-year vaccination history on protection against influenza in older adults: a test-negative design study across the 2010/11 to 2015/16 influenza seasons in Ontario, Canada. Eurosurveillance.
• 7 – Chua et al. (2021) Epidemiology of Acute Myocarditis/Pericarditis in Hong Kong Adolescents Following Comirnaty Vaccination. Clinical Infectious Diseases.
• 8 – Simone et al. (2021) Acute Myocarditis Following COVID-19 mRNA Vaccination in Adults Aged 18 Years or Older. JAMA Internal Medicine.
• 9 – Husby et al. (2021) SARS-CoV-2 vaccination and myocarditis or myopericarditis: population based cohort study. British Medical Journal.
• 10 – Witberg et al. (2021) Myocarditis after Covid-19 Vaccination in a Large Health Care Organization. New England Journal of Medicine.
• 11 – Gupta et al. 2021. Vaccinations Against COVID-19 May Have Averted Up To 140,000 Deaths In The United States. Health Affairs.