Dr. Aseem Malhotra: From Pro-Vax to Anti-Vax

I’ve been getting numerous notifications and requests regarding the newly published statements against the mRNA vaccines by Dr. Aseem Malhotra, a cardiologist from the UK who originally publicly promoted the mRNA vaccines against COVID-19 and is dual vaccinated himself.  So, what changed for him?  Why is he now speaking out against the mRNA vaccines?

Father’s tragic death from a heart attack:

Well, he became opposed to the mRNA vaccines after his father, Dr Kailash Chand, tragically died of a heart attack (in July 2021) following dual vaccination six months earlier. “Two of his three major arteries had severe blockages: 90% blockage in his left anterior descending artery and a 75% blockage in his right coronary.”  Despite his father being 73 years of age when he died, Dr. Malhotra thought that his father was too healthy to have had a “normal” heart attack, and suspected a link with the mRNA vaccine. This is despite the fact that he doesn’t believe in taking statin drugs for high cholesterol – even having gone so far as to suggest that stopping statins might save more lives and that statins probably don’t benefit anyone (Link, Link). Needless to say, this flies in the face of the weight of modern medical science. It also causes one to question if Dr. Chand had long-standing high cholesterol?  And, if so, what kind of treatment he may, or may not, have been taking? And, as it turns out, Dr. Chand did have long-standing high cholesterol and was “pre-diabetic” as well. 

Since the previous heart scans (a few years earlier, which had revealed no significant problems with perfect blood flow throughout his arteries and only mild furring), he had quit sugar, lost belly fat, reduced the dose of his blood pressure pills, started regular meditation, reversed his prediabetes and even massively dropped his blood triglycerides, significantly improving his cholesterol profile. (Link)

So why attribute Dr. Chand’s heart attack to the mRNA vaccines he took six months prior?
Then, in November 2021, I was made aware of a peer-reviewed abstract published in Circulation, with concerning findings. In over 500 middle-aged patients under regular follow up, using a predictive score model based on inflammatory markers that are strongly correlated with risk of heart attack, the mRNA vaccine was associated with significantly increasing the risk of a coronary event within five years from 11% pre-mRNA vaccine to 25% 2–10 weeks post mRNA vaccine. An early and relevant criticism of the validity of the findings was that there was no control group, but nevertheless, even if partially correct, that would mean that there would be a large acceleration in progression of coronary artery disease, and more importantly heart attack risk, within months of taking the jab. I wondered whether my father’s Pfizer vaccination, which he received six months earlier, could have contributed to his unexplained premature death and so I began to critically appraise the data. (Link)
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So, it was an abstract published by Dr. Steven Gundry that set Dr. Malhotra to suspect the mRNA vaccines as the true cause of his father’s coronary artery disease and lethal heart attack (discussed in further detail below: Link).
In short, though, as oncologist Dr. David Gorski put it:
I can see how such a death so close to home could shake Dr. Malhotra’s belief system of diet and lifestyle über alles as panaceas for good health. After all, if his father, who led the “right lifestyle” and walked 10,000-15,000 steps a day could succumb to coronary artery disease, then perhaps Dr. Malhotra’s faith in diet and exercise alone as panaceas against heart disease were misplaced or, at the very least, excessive.

As often is the case with those who believe in something very strongly, rather than question his existing belief systems, Dr. Malhotra appears to have started looking for “other” causes for his father’s sudden death. I can only speculate, but, given his apparent belief in diet as the be-all and end-all of cardiovascular (and general) health, my guess is that in his grief he was even more susceptible than he might have been to the blandishments of the antivaccine movement and that susceptibility ultimately led to his going down the rabbit hole of antivaccine misinformation and conspiracy theories bolstered by bad science. I will note that the reference to which he refers was an abstract of a particularly useless study by a physician associated with Goop, who used an unvalidated test for “inflammatory markers” after vaccination that showed nothing, as described by pediatric cardiologist Dr. Frank Han here and myself elsewhere. Citing very weak science is not a good look for a someone proclaiming himself as pushing back against “misinformation” promoted by the medical profession and claiming the mantle of evidence-based medicine. Also, as Dr. Han has pointed out, atherosclerosis takes years, not months, to develop. As someone who early in his career, before becoming interested in cancer, studied vascular smooth muscle cells and their role in atherosclerosis and restenosis after coronary angioplasty, I will reemphasize that point.

Later in the same article, Dr. Malhotra cites four cardiac arrests observed in the Pfizer trial. After admitting that these “figures were small in absolute terms and did not reach statistical significance in the trial, suggesting that it may just be coincidence”, he nonetheless claims that “without further studies it was not possible to rule out this being a genuinely causal relationship (especially without access to the raw data), in which case it could have the effect of causing a surge in cardiac arrests once the vaccine was rolled out to tens of millions of people across the globe”. While that is true enough, to conclude that some obvious adverse event due to the vaccines has been missed for nearly two years one has to ignore all the safety studies carried out since first millions, then tens of millions, then hundreds of millions, and then billions of doses of the Pfizer and Moderna vaccines were administered throughout the world.

As just a taste of these data, it’s noted that the UK has not noted an increase in mortality from ischemic heart disease since the vaccines rolled out.

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Self-published article(s):

On Twitter, Dr. Malhotra portrayed his most recent “Part 2” paper as “the most important announcement of my life and career thus far”. On September 26, 2022, Dr. Malhotra published “Part 2” of his findings in a “peer-reviewed” journal “Insulin Resistance” – a journal where the editor is Dr. Malhotra himself. “Part 1” was published back in June of 2022. So, these are really self-published articles. They were not been truly independently reviewed or published by a well-respected journal with no ties to or oversight from Dr. Malhotra. In fact, as epidemiologist Gideon Meyerowitz-Katz has pointed out, very little has been published in this “journal” since 2016, with nothing published at all since 2019 until the publication of Malhotra’s articles. “That is…unusual, to say the least.” (Link).
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Beyond this, these “papers” are not research papers.  Malhotra did no experiments or scientific research of any kind. The first review is billed as a “narrative review of the evidence from randomized trials and real-world data of the COVID mRNA products with special emphasis on BionTech/Pfizer vaccine”, while the second review is claimed to be a “narrative review of both current and historical driving factors that underpin the pandemic of medical misinformation”. In short, his “papers” aren’t based on any kind of scientific study. At best they are “narrative reviews” of existing data on COVID-19 – and he gets that data from many sources that have long been “anti-vax” and sensational or conspiratorial in nature, calling for a global pause of mRNA vaccines. Malhotra basically claimed to provide evidence that the likelihood of serious adverse events in the non-elderly population might be higher than the benefits of vaccination. The articles defined the risks of taking an mRNA vaccine against COVID-19 as “deeply concerning, especially in relation to cardiovascular safety”. 

Unreliable, sensational, and conspiratorial sources and associations:

Malhotra repeated these claims in a 27 September 2022 press conference hosted by the World Council for Health, an organization that falsely linked COVID-19 vaccines to thousands of deaths and multiple alleged safety issues. Other speakers were scientist Tess Lawrie, co-founder of the organization, and pathologist Ryan Cole, who also spread misinformation about the safety of COVID-19 vaccines in the past.
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Like Dr. Peter McCullough (a well-known anti-vaxx cardiologist; Link), Malhotra just isn’t very discerning or careful about his sources or the validity of the arguments he takes from these sources. Not only does he cite Peter McCullough directly as part of the basis for his concerns against the mRNA vaccines, he also cites an organization called the Health Advisory and Recovery Team, or “the HART Group.” – which is a collection of strongly anti-vaccine conspiracy theorists who make numerous false and outrageous claims against the mRNA vaccines. He also cites an abstract by Dr. Steven Gundry claiming that the mRNA vaccine will more than double the risk of heart attack within five years (Link). Of course, both Gundry and Malhotra misinterpret the nature of the normal human immune response to vaccination (entirely based on the PULS test).
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Dr. Malhotra even cites the infamous interview between Joe Rogan and well-known anti-vax conspiracy theorist Dr. Robert Malone who is often cited as “the inventor” of the mRNA vaccines. During this interview, Dr. Malone forwarded many false and misleading claims as well as a number of downright sensational and ludicrous conspiracy theories regarding COVID-19 and the mRNA vaccines (Link). Yet, Dr. Malhotra references Dr. Malone and this interview as being falsely framed by the BBC as a “known anti-vaxxer”.
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The BBC falsely framed a guest on popular podcast host Joe Rogan, Dr Robert Malone, as a ‘known anti-vaxxer, who is against vaccinating kids’, failing to mention that Dr Malone is a co-inventor of the very technology that led to the vaccine, has spent 20 years in vaccine development at US government level and was one the first to actually receive two shots of the Moderna jab.
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Aseem Malhotra, “Part 2
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Also, on October 7th, Dr. Malhotra even went on a podcast with the notorious anti-vaxxer and outlandish conspiracy theorist Robert F. Kennedy Jr. (RFK Jr.) to discuss his own anti-vax theories (Link).

Dr. Gundry, the PULS Test, and the risk of Heart Attack:

“Dr. Douglas Harrington, the [PULS] test co-developer, agreed. He said all vaccines induce that kind of response and that the results of the test in this situation are not something to be concerned about. It should not be surprising to anyone that a vaccine temporarily stimulates a transient inflammatory response, which the PULS test is sensitive enough to capture. But does that mean that those people are at risk, or you shouldn’t get vaccinated? Absolutely not,” he said. (Link)
In this light, it is also important to keep in mind that vaccines in general are known to be associated with increased heart inflammation. This is based on research of flu shots. However, multiple clinical trials have not supported an increased ACS risk with vaccination—on the contrary, studies have shown that the annual flu shot reduces risks of MI and ACS, Dr. Mohammad Madjid said.
“We know that there is some increased inflammation. That’s how the body works, that’s how the immune system works.”  (Link)
Note also that this very same inflammatory response would also be seen following a COVID-19 infection, except with more severity and with greater risks of long-term heart damage.
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In any case, Malhotra makes many more of the false and/or misleading claims that Dr. Peter McCullough also makes – including a misunderstanding of various statistical data regarding COVID-19 and the mRNA vaccines.  He just gets a lot of important concepts wrong (See interesting review of Dr. Malhotra’s paper by immunologist Viki Male here: Link).

Dr. Malhotra lying to gain credibility:

Back in June of 2022, Aseem Malhotra said he was “honoured to receive” an award “from the Chair of the BMA”. Except the award wasn’t from the BMA (British Medical Association) nor was it given to him by its Chair. Malhotra was simply lying, but why? The newly released BMA review of the debacle is quite a read (see below). See also a review of this incident here: Link

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Review by Immunologist Viki Male:

“He estimates that for every 230 elderly people vaccinated, we prevent one death, but that in younger (less at risk) age groups we need to vaccinate more people to prevent each death (true). He forgets to mention that there are other downsides to catching COVID that bother younger people, for example, inconvenience of time off work, it’s unpleasant being sick, risk of Long COVID. But actually, even just looking at his death rate data… I’d say this is quite in favour of vaccination…
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His final sentence is to suggest that his 73yo father’s CAD was a result of vaccination. I don’t want to dwell on this, because it’s clearly affected him, but it’s worth noting that the article itself says that this age group benefits from vaccination. ” (Link)
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Heart Attack Risk:

Specifically, regarding the most relevant claim of an increased risk of heart attack, there just is no credible scientific support for this claim. While there is good evidence for a real, but rare, risk of myocarditis (primarily in young men following the second mRNA dose that is usually mild and short-lived: Link), such evidence is lacking when it comes to any kind of increased risk of heart attack due to vascular disease and luminal occlusion within the arteries that supply the heart (Link).  On the contrary, COVID-19 mRNA vaccines were linked with a decreased risk of death in individuals with heart failure (HF), according to the results of a study presented at the European Society of Cardiology Congress in 2022 (Link). Why might this be?  Well, consider that a COVID-19 infection carries with it a much higher risk of heart inflammation.
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“It’s also important to keep in mind that, according to research (Link), the rate of heart inflammation (myocarditis) from the vaccine seems to occur at a much lower rate than heart inflammation caused by COVID-19 infection.” (Link)
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In fact, the mRNA vaccines have been associated with a decreased risk of mortality from all causes in the United States (Link, Link, Link, Link).

The Pfizer/Moderna Clinical Trial Data:

One of the main pieces of evidence in the article is a study published by Fraiman et al. in the journal Vaccine[1]. In it, the authors analyzed data from a previous study of adverse events reported in the clinical trials of the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines[2,3]. They concluded that “The excess risk of serious adverse events of special interest was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group” in both Pfizer and Moderna trials.

To arrive at this conclusion, the authors calculated how many more serious adverse events occurred in the vaccinated group compared to the control group. They then compared this figure with the number of people hospitalized with COVID-19 during the clinical trials.

To determine what kind of adverse events would be considered as serious for the purposes of the study, the authors looked to the Priority List of COVID-19 Adverse events of special interest by the Brighton Collaboration (BC), a program of the nonprofit organization The Task Force for Global Health. This list includes adverse events that have been seen with COVID-19, as well as those with a proven or theoretical association with vaccines in general or with specific vaccine platforms.

The now-published study was initially available as a preprint—a manuscript that hasn’t undergone peer review—in June 2022. Health Feedback previously reviewed it and found that the authors’ analysis didn’t support their conclusion. Scientists such as surgeon and cancer researcher David Gorskibiostatistician Jeffrey S. Morris, and nanomedicine expert Susan Oliver pointed out several issues in the study that indicated potential p-hacking.

P-hacking (also known as data dredging or data snooping) is the manipulation of data analysis to make the results look statistically significant when they aren’t. The study by Fraiman et al. showed several signs suggesting that the authors had analyzed data in a manner that favored their hypothesis.

First, the Brighton document lists “adverse events of special interest” (AESI) mainly as specific clinical diagnoses, such as enteritis/colitis, arthritis, and encephalitis. In order for the authors to count the number of serious AESIs associated with COVID-19 vaccines, they needed to determine which serious adverse events (SAEs) recorded in the vaccines’ clinical trials corresponded to the AESIs listed in the Brighton document.

The decision of whether an SAE corresponded to a Brighton AESI rested on the opinion of two independent clinicians, and a third one if the first two disagreed without arriving at a consensus.

However, the reasons for considering certain SAEs as corresponding to the AESI list are unclear and inconsistent. For example, one Brighton AESI is enteritis/colitis, for which the corresponding adverse events would be diarrhea and vomiting. However, the authors included diarrhea but not vomiting when counting relevant SAEs. Another example is the authors’ inclusion of arthritis as a serious adverse event, but not osteoarthritis (a form of arthritis).

The authors also excluded “events related to COVID-19”. While this exclusion could make sense when focusing on potential side effects of the COVID-19 vaccines, it introduces an important bias by eliminating adverse events that are expected to be much more common in the control group than in the vaccinated group. This means that the study was less able to detect harms from COVID-19. Overall, these observations suggest that the adverse events that the authors chose to analyze were the result of cherry-picking.

Second, the authors compared the people hospitalized with COVID-19 with the total number of adverse events in the control and the vaccinated groups rather than the number of individuals who reported the adverse events. Since one person can suffer multiple adverse events but only one hospitalization, this analysis leads to an overcounting of adverse events and over-represents the harmful effects of vaccination compared to the risks of COVID-19. For example, a person who reported colitis, diarrhea, and abdominal pain, would be counted as three adverse events, even though the three occurred in the same person and are likely related.

Finally, some of the included adverse events, such as diarrhea, abdominal pain, and rash, aren’t equivalent to a COVID-19 hospitalization in terms of disease severity. This analysis also doesn’t take into account the benefits of vaccination in preventing COVID-19 complications other than hospitalization, including cardiovascular problems.

Given the methodological flaws in the study, the analysis is unreliable and doesn’t support the claim that vaccines cause more serious adverse events than the benefits they provide.

Iria Carballo-Carbajal, HealthFeedback.org, Published on: 06 Oct 2022

The efficacy of COVID-19 vaccines:

Malhotra’s article referred to the absolute risk reduction (ARR) of 0.84% reported in Pfizer’s trial as “the true value of any treatment”, as compared to the reported relative risk reduction (RRR) of 95%. This comparison gives the impression that COVID-19 vaccines are ineffective or less effective than reported, which is incorrect and has been previously misused to downplay the benefit of COVID-19 vaccines.

The RRR and the ARR are two different and complementary ways of measuring the effect of vaccination. The RRR measures the risk of an event—for example, infection—in the treatment (vaccinated) group expressed as a proportion of the event rate in the control (unvaccinated) group. The ARR results from subtracting the event rate in the treatment group from that in the control group and represents the overall benefit of vaccination in the population.

While the ARR will always appear low compared to the RRR, this doesn’t mean that COVID-19 vaccines are ineffective, as Health Feedback explained earlier. In a Reuters fact-checkNatalie E. Dean, a biostatistician and assistant professor at Emory University, explained that the RRR is a “more meaningful” way than ARR to express how much a vaccine reduces the risk of COVID-19 because it is “irrespective of the transmission setting”.

In contrast, the ARR varies considerably depending on the transmission rate. An ARR of 0.84% in clinical trials simply indicates that the infection rate during the trial was low. This was due to the limited duration of the clinical trials and the strict COVID-19 control measures at that time, which translated into comparatively fewer infections.

However, the ARR increases when the number of infections rises, for example during the Delta and Omicron waves, because the vaccines’ benefits, specifically their ability to prevent COVID-19, becomes more apparent during infection waves[4].

Research shows that, contrary to what Malhotra suggested, COVID-19 vaccines do reduce the risk of infection and are highly effective against severe COVID-19 and death for everyone[5-7].

Iria Carballo-Carbajal, HealthFeedback.org, Published on: 06 Oct 2022

And, as Dr. David Gorski puts it:

Dr. Malhotra uses a number of common antivax techniques to make COVID-19 vaccines look as ineffective and risky as possible. For example, echoing the “number needed to treat” (NNT), a frequent measure of how many people need to be treated to prevent a single adverse event or death, Dr. Malhotra cites the “number needed to vaccinate” to prevent one death due to COVID-19 in various age groups, which he estimates to be 10,000 for people in their 40s. However, the source he cites is not even a scientific article but a blog post, as Meyerowitz-Katz notes:

One also notes that vaccines by their very nature necessitate vaccinating a relatively large number of people in order to avoid one death from the disease vaccinated against:

That is, of course, why the safety bar is so much higher for vaccines than other medications. They are administered to a presumably healthy population in order to prevent an infectious disease, not to a population ill with a disease in order to treat that disease.

Similarly, emphasizing absolute versus relative risk is another favorite tactic of those seeking to downplay the benefits of vaccinating. Come to think of it, emphasizing death as the only endpoint worth looking at, rather than considering severe non-death adverse outcomes, is another favorite tactic of antivaxxers. We do, after all, vaccinate to prevent not just death, but disease and serious complications. Another claim that he makes is that we should look at all-cause mortality after vaccination but are not doing that.

Of course, we actually are, and the UK (where Dr. Malhotra is based) has those data, as noted by Vicki Male:

Dr. Malhotra also cites Maryanne Demasi, claiming that she had shown that the original mRNA vaccine trials had failed to account for serious harms. (Unsurprisingly, Demasi now writes for the Brownstone Institute, which is how I remembered who she was, even though I don’t recall having written about her before.) He exaggerates the risk of myocarditis relative to the potential benefit of the vaccine in young adults and children, a topic that we’ve covered a number of times here, and cites reports to the Vaccine Adverse Events Reporting System (VAERS), exhibiting a lack of understanding of how VAERS works and acting as though all the reports were caused by the vaccines. Hilariously, he tries to make his spin seem more credible by noting that “knowingly filing a false VAERS report is a violation of Federal law punishable by fine and imprisonment”. (So what?) He then misrepresents a paper in Scientific Reports as having been published in NatureScientific Reports is Nature Publishing Group’s open access journal and nowhere near as prestigious as Nature itself—claiming an increase in cardiac deaths due to the rollout of the vaccines. If I give him the benefit of the doubt, this was poor scholarship. If I don’t, this is using an antivaccine technique in which any article published in a Nature Publishing Group journal, no matter how lowly, is misrepresented as having been published in Nature.

The misrepresentation of the journal aside, this was a flawed and highly problematic study, as described here. Based on a cherry picked citing of low-quality data, Dr. Malhotra concludes that “it remains a real possibility that my father’s sudden cardiac death was related to the vaccine” and a “pause and reappraisal of vaccination Policies for COVID-19 is long overdue”.

(Link)

Serious adverse events following COVID-19 vaccination:

Like any medical intervention, COVID-19 vaccines can cause side effects. The most common side effects of COVID-19 vaccines are mild and last only a few days. In contrast, severe reactions after COVID-19 vaccination are infrequent.

In the article, Malhotra suggested that COVID-19 vaccines are unsafe based on the “unprecedented” number of adverse event reports following COVID-19 vaccination compared to previous years and other vaccines. For that, he used data from the U.K. Yellow Card Scheme and the U.S. Vaccine Adverse Event Report System (VAERS).

However, this is a misuse of adverse event reports, as Health Feedback explained in earlier reviews. While these reports can be a starting point for investigating potential side effects of the vaccine, the reports alone don’t demonstrate that the vaccine caused or contributed to an adverse event. Therefore, the number of adverse events recorded after vaccination doesn’t indicate that the vaccine caused them or that the vaccine is unsafe.

Furthermore, COVID-19 vaccines have been the subject of “the most intense safety monitoring in US history”, according to the U.S. Centers for Disease Control and Prevention (CDC). This fact alone could explain a higher rate of adverse event reporting for COVID-19 vaccines compared to other vaccines.

Malhotra suggested that COVID-19 vaccines were associated with an increased risk of cardiovascular problems by citing a conference abstract published in Circulation. This abstract purportedly showed a 25% increase in the risk of a coronary event within two to ten weeks after receiving an mRNA COVID-19 vaccine.

The American Heart Association, which publishes the journal, was later notified about “potential errors” in the abstract and issued an expression of concern stating that the results “may not be reliable.” Jeffrey Morris, director of the division of biostatistics at the University of Pennsylvania, told FactCheck.org that “the lack of details on the patient selection, analysis approach, and other details,” make it “impossible to evaluate.”

Malhotra also cited “the disturbing findings” of another study claiming to show an association of COVID-19 vaccines with a 25% increase in emergency calls for acute coronary syndrome and cardiac arrest among people aged 16 to 39 in Israel. This study wasn’t published in Nature, as Malhotra claimed, but in Scientific Reports, another peer-reviewed journal that is part of Nature Portfolio. The study was heavily criticized for having serious methodological flaws, as FactCheck.org explained, and is currently under investigation by the journal’s editors.

Iria Carballo-Carbajal, HealthFeedback.org, Published on: 06 Oct 2022

Heart inflammation risk lower for vaccine vs. COVID-19 infection:

Malhotra claimed that “one of the most common mRNA COVID-19 vaccine-induced harms is myocarditis”, an inflammation of the heart muscle. He added that cases of myocarditis “rocketed from spring 2021 when vaccines were rolled out to the younger cohorts” and although these cases are “not often fatal”, they might cause “likely permanent” heart muscle injury with potential negative effects in the long term. There is currently no scientific evidence supporting these claims.

It is true that mRNA COVID-19 vaccines have been associated with an increased risk of myocarditis, particularly among young males. But some have exaggerated this risk to promote the narrative that COVID-19 vaccines are unsafe, as Health Feedback documented in earlier reviews.

One of the most recent studies evaluating the risk of post-vaccine myocarditis was published in The Lancet in June 2022[8]. Using data from large U.S. healthcare databases, the study found an increased risk of myocarditis and pericarditis after receiving an mRNA vaccine, particularly in men aged 18–25 years and after a second dose. The rate of heart inflammation in this population after the second dose was 2.17 per 100,000 people who received the Pfizer-BioNTech vaccine, and 1.71 per 100,000 people who received the Moderna vaccine. The authors concluded that the benefits of vaccination continued to outweigh the risk of such rare cases of heart inflammation.

In fact, current evidence indicates that post-vaccine myocarditis is typically mild and self-resolves quickly[9]. This risk is also much lower than the risk of heart complications after getting COVID-19 itself, which can increase the risk of cardiovascular disease for up to one year[10].

A few studies did find that people who had post-vaccine myocarditis showed heart abnormalities for up to eight months after recovering[11-13]. But what Malhotra didn’t mention is that these abnormalities were generally less severe and caused fewer complications than typical myocarditis due to other causes. This, together with the good clinical outcomes of the patients, don’t suggest that post-vaccine myocarditis has long-term health implications, as Malhotra suggested. However, additional studies with longer follow-ups would provide us with much more information about the consequences of post-vaccine myocarditis.

Malhotra also claimed that no clinical trial data had demonstrated that vaccination reduces the risk of myocarditis in subsequent infection. He added that “in fact the risks may be additive”, without providing evidence for this claim. It’s important to keep in mind that clinical trials usually don’t have the capacity to detect very rare adverse events such as the cases of myocarditis associated with COVID-19 vaccination, which occur at a very low rate and might only become apparent in populations larger than those typically involved in trials.

But there is one study published in Circulation in August 2022 that does address Malhotra’s question about whether the vaccines reduce myocarditis risk following infection[14]. This study analyzed the risk of myocarditis after COVID-19 infection and after vaccination in records from England’s National Immunization database for more than 40 million people aged 13 and older.

The analysis showed that people infected with SARS-CoV-2 before receiving a vaccine were 11 times more at risk for developing myocarditis within 28 days of testing positive for the virus than people who didn’t test positive. The risk of developing myocarditis following infection halved in the people who had received at least one dose of a COVID-19 vaccine, suggesting that the vaccines do protect against post-COVID myocarditis.

Iria Carballo-Carbajal, HealthFeedback.org, Published on: 06 Oct 2022

Reduction in COVID-19 and all-cause deaths by COVID-19 vaccines

Malhotra’s article stated that “The most objective determinant of whether the benefits of the vaccines outweigh the harms is by analyzing its effects on all-cause mortality”. He claimed that the results from clinical trials didn’t show a significant benefit in reducing “serious illness or COVID-19 mortality” over the six months of trial. Instead, he said, all-cause mortality was slightly higher in the vaccinated group (19 deaths) compared to the control group (17 deaths) during an additional follow-up period of around four months.

However, Malhotra misrepresented the conclusions of the clinical review memorandum by the U.S. Food and Drug Administration regarding all-cause mortality during Pfizer’s trial. Page 82 of this document, which Malhotra cited as a reference, clearly stated:

“Overall, deaths and SAEs were reported by similar proportions of participants in both treatment groups. A total of 38 deaths occurred in the reporting period (19 deaths in the BNT162b2 group, 17 in placebo and 2 in the placebo/BNT162b2 group). More deaths occurred in the older age group, as expected due to increased age and comorbidities. All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate. The frequency of non-fatal serious adverse events was low without meaningful imbalances between treatment groups.” [emphasis added]

As we explained above, the original trials observed a limited number of infections that made it difficult for researchers to accurately estimate the reduction in COVID-19 mortality. However, since then, several studies have used real-world data and showed that mRNA COVID-19 vaccines are highly effective at preventing severe disease and COVID-19 death[15-20].

In fact, recent research found that COVID-19 vaccines weren’t associated with an increased risk of mortality but instead with a lower all-cause mortality. The U.S. CDC evaluated all-cause mortality among 6.4 million vaccinated and 4.6 million unvaccinated persons and found that people who received any of the three COVID-19 vaccines authorized in the U.S. were up to three times less likely to die from any cause than those who didn’t receive a vaccine[21]. This finding is inconsistent with the claim that vaccinated people are more likely to die compared to unvaccinated people.

Iria Carballo-Carbajal, HealthFeedback.org, Published on: 06 Oct 2022

Changing Risks/Reward Ratio:

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So, while I sympathize with anyone who loses a father via an unexpected heart attack, it seems to me as though Dr. Malhotra has let this tragic personal loss cloud his judgment when it comes to correctly judging the benefit/risk analysis for the mRNA vaccines.
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This is also not to say that the benefit/risk ratio hasn’t changed during the pandemic.  It has changed, and is currently less clear-cut compared to when the mRNA vaccines first became available (Link). Note that the death rates for the vaccinated vs. the unvaccinated have significantly narrowed, since around April of 2022, ever since the omicron variants of COVID-19 have become dominant (Link):
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All Cause Death Rate vs. Vaccine/COVID-19 Timelines:

It is also very interesting to compare the timeline of the COVID-19 pandemic relative to the excess death rate from all causes in the United States that occurred during this time, relative to the rollout of the mRNA vaccines.  As Dr. Roger Seheult (a well-known pulmonologist) points out:
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“It’s pretty clear when you look at the excess mortality in the US and the daily # of infections and vaccinations (inverted). infections with SARS-CoV2 that is driving excess mortality not vaccinations. There are no confounders with diagnosis. These are the excess deaths from ANY cause over previous years. Notice that excess mortality follows the peaks of infection – just as we would expect given it takes time from infection to death. Notice that after each wave, there is a bump in vaccinations (human nature). Less so with Omicron. Also, notice that the Omicron infection amplitude was much higher than delta but the excess mortality from omicron was about the same as that from delta – less lethal?  Also note that the time with the highest excess mortality was prior to any vaccines being available (during the first surge). Never reached that peak again despite vaccinating up to 3 million people in a single day – with no peak in excessive mortality until the next surge. The other thing worth noting is that the magnitude of the first two graphs is scaled. As you can see we vaccinated far more people than were infected (albeit underestimated). Yet, we never had the surges after vaccination in the hospital like we did in early 2021.” (Link)
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Review by Dr. Susan Oliver (Back to the Science):

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Dr. Sean Pitman is a pathologist, with subspecialties in anatomic, clinical, and hematopathology, currently working in N. California.

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