Malhotra Part 1

Summary of Dr Malhotra’s Article on mRNA COVID Vaccines

Using Pfizers Phase 2 Clinical Trial Data

Two of the most influential cardiologists in the world, Peter McCullough and Aseem Malhotra, have called for a halt of all COVID vaccinations.  Other medical experts around the world are also calling for a global pause of the shots.  February 5, 2021, Malhotra appeared on Good Morning Britain where he stated, “When you look at all the drugs combined…vaccines by far are the safest.”

Malhotra was one of the first to receive doses of the Pfizer vaccine.  Approximately a year and a half later, Malhotra, who previously received, supported, and promoted the COVID vaccines published two articles, deemed “the most important work of his career,” demanding a global stop to COVID vaccinations as they are “not completely safe and have unprecedented harms.” What changed?

This blog post will summarize Malhotra’s article published September 26, 2022, in the Journal of Insulin Resistance, entitled, “Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine – Part 1.” 

What Changed? A Personal Case Study

Malhotra’s investigation into the safety of the vaccines followed the sudden cardiac death of his “extremely fit and active” father within six months of vaccination whose previous heart scans from just a few years prior did not reveal problems. An autopsy found he had three major blocked arteries in his heart with no evidence of heart attack.

Given Malhotra’s cardiology experience and the unexplained findings on autopsy, he analyzed the COVID vaccination data over the course of 9 months to see if there could be a causation between the vaccine and his father’s sudden death.

In November 2021, Malhotra was made aware of a study of over 500 middle-aged patients reporting “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.” 

Low Risk and Unknown Short- and Long-Term Harms

Malhotra was surprised when a cardiologist colleague decided not to take the vaccine due to low risk of mortality and unknown vaccine harms. His colleague referenced data from Pfizer’s mRNA trial in The New England Journal of Medicine, showing one cardiac arrest in the placebo group and four cardiac arrests in the vaccine group.

While this did not reach statistical significance and could be a coincidental finding, without further studies evaluating this, there was no way to rule out vaccine as a cause of cardiac arrest. This was a safety signal overlooked and the push for vaccination continued.

Vaccine Effectiveness Vs. Efficacy

As COVID vaccines rolled out across the globe, news headlines published claims of 95% effectiveness and used the terms “efficacy” and “effectiveness” interchangeably.

Efficacy means how the vaccine performs under controlled and ideal circumstances. Effectiveness means how the vaccine performs in real-world conditions.

Even if a vaccine has a high efficacy in a controlled clinical trial, this does not translate into the same effectiveness in practice and the real world.

The reports of 95% effectiveness of the vaccines led both doctors and lay people to interpret this as, ‘if 100 people were vaccinated, 95 would be protected from getting the infection’. The original Pfizer trial revealed a vaccinated person was 95% less likely from catching the fall 2020 COVID variant. This is referred to as a relative risk reduction.  With emerging variants, the real-world effectiveness of the vaccines dropped towards 29% and below.

However, to truly determine how much a person’s individual risk is reduced by any intervention, the absolute risk reduction needs to be calculated.

What Was the Absolute Risk Reduction Using mRNA Vaccine in the Pfizer Clinical Trial? 

As stated, the true testament to the value of any treatment is the absolute individual risk reduction, meaning how much an individual’s risk is reduced by a treatment.

The results from the original Pfizer trial revealed an infection rate of 0.88% for the unvaccinated group and 0.04% for the vaccinated group.  This resulted in an absolute difference of infection rate between the two groups of 0.84%.  This is the absolute individual risk reduction: 0.84%.

What Does Absolute Individual Risk Reduction of Infection Rate Percentage Mean?

• 88 out of 10,000 unvaccinated would symptomatically test positive for COVID compared to 4 out of 10,000 vaccinated.
• 9,912 out of 10,000 or over 99% of the unvaccinated group would not have tested positive during the trial period
• 119 people would need to be vaccinated to prevent one symptomatic positive test

“This absolute risk reduction figure (0.84%) is extremely important for doctors and patients to know but how many of them were told this when they received the shot? Transparent communication of risk and benefit of any intervention is a core principle of ethical evidence-based medical practice and informed consent.”

Personal Analysis Validating Malhotra’s Pfizer Statistics

The efficacy of the vaccine was determined by looking at the total number of COVID cases from the original Pfizer trial (170), cases per placebo (162), and cases per vaccinated (8) gathered from July 2020 to December 2020.

Vaccine efficacy can be calculated as follows: risk of COVID among unvaccinated (0.88) – risk of COVID among vaccinated (0.04) / risk of COVID among unvaccinated (0.88). This is 0.88 – 0.04 / 0.88. This gives the 95% efficacy rate.

Pfizer data also revealed a surprisingly low infection rate for both the placebo and vaccinated groups as there were only 170 total infections out of the 36,523 trial participants.

To clarify Malhotra’s stated infection rate for the placebo arm or unvaccinated from the original Pfizer data of 0.88%, it was found the statistics were taken from an article entitled “COVID-19 Evidence Bites” in which the original Pfizer trial data was evaluated.  After participant drop outs and exclusions, the total remaining enrollment population for evaluation in the trial for efficacy was 36,523 (18,198 vaccinated, 18,325 placebo).

Infection rates are found by dividing the number of infections by the population at risk.

• Infection rate of vaccinated: 8/18,198 = 0.04%
• Infection rate of placebo: 162/18,325 = 0.88%

Do COVID Vaccines Stop Transmission or Prevent Infections?

The CDC director stated in an interview she was initially optimistic and hoping the vaccine would stop transmission and infection upon hearing the initial reports by CNN it was 95% effective.  It has since been revealed COVID vaccines do not stop transmission nor prevent infection.  Why are professional medical authorities in charge of matters of public health quoting CNN rather than quoting the science.

Survival Rate

Many were led to believe they needed to take the vaccination in order to survive COVID infection. The survival rate of COVID pre-vaccination by age remained above 99.4% for all age groups below 69 years. The survival rate remained quite high but dropped for the over 70 group to 97.6%.

Did the Vaccines Reduce Serious Illness or Mortality?

Contrary to popular belief and what was reported in the media, there was no statistically significant reduction in serious illness or mortality from the vaccine over the 6-month period of the Pfizer’s clinical trial.

There was one death from COVID in the vaccine group and two deaths from COVID in the placebo group. When analyzing all-cause mortality over a longer period, there were slightly more deaths in the vaccine group (19) than in the placebo group (17).

It is important to note the rate of severe COVID infection in the placebo group was extremely low, with 9 severe cases out of 21,686 – a rate of 0.04%.

Protection Against Death

The public was led to believe the vaccines protect people from dying, however, the Pfizer trial only showed the relative risk reduction. Malhotra attempted to deduce the vaccine’s effect on reducing mortality though there are limitations. He states, estimates are “likely an overestimate of the individual benefit of vaccination; the open and frank discussion of such uncertainties is an essential component of shared decision-making.”

For any person considering taking the shot, Malhotra suggests the following should be part of the shared decision-making informed consent:

“Depending on your age, several hundreds or thousands of people like you would need to be injected in order to prevent one person from dying from the Delta variant of COVID-19 over a period of around three months. For the over 80s, this figure is at least 230, but it rises the younger you are, reaching at least 2600 for people in their 50s, 10000 for those in their 40s, and 93 000 for those between 18 and 29 years. For omicron, which has been shown to be 30% – 50% less lethal, meaning significantly more people would need to be vaccinated to prevent one death. How long any protection actually lasts for is unknown; boosters are currently being recommended after as short a period as 4 months in some countries.”

Underreporting of Adverse Events in Clinical Trials

Concerns about the underreporting of adverse events in the clinical trials have come to light:

• Trial participants were limited to specific types of adverse events they could report
• Some participants were hospitalized after vaccination and were withdrawn from the trial and not reported in the results
• Participants in the placebo group of the trial were offered the vaccine after 2 months

Safety in Question

One of the most prevalent concerns following vaccination is myocarditis. The incidence of myocarditis “rocketed” after vaccines were offered to younger individuals in the spring of 2021. The incidence remained stable for the entire year prior to vaccine roll out. A study from Israel found no increase in the risk of myocarditis from COVID infection itself prior to vaccine roll-out though authorities maintained the risk of myocarditis is more common after infection than vaccination.  This paper strongly suggests increases in myocarditis and pericarditis in earlier studies were because of the vaccines with or without infection as an additional risk among the vaccinated. 

Though concerning rates of myocarditis have come to light, ranging from 1 in 6000 to 1 in 2700 in children aged 12-17, it subsequently became downplayed as “most recover from it.” However, MRI scans reveal approximately 80%  admitted to the hospital with myocarditis have some degree of myocardial damage. “It is like suffering a small heart attack and sustaining some – likely permanent – heart muscle injury.”

A recent blog post reviewed current data available for safety of the vaccinations, including government databases for adverse event reporting around the globe. The United Kingdom Yellow Card system (MHRA) showed 1 in 120 individuals is suffering an adverse event considered beyond mild. Malhotra reports the total number of reports received is unprecedented and equals the number of reports received in the first 40 years of the MHRA up to 2020.

Comparing the reported events from COVID vaccination to measles, mumps and rubella (MMR) vaccination, the numbers were more than thirty times less frequent than for COVID vaccinated individuals. The MHRA does not sort out serious adverse events though Norway does, revealing an approximate rate of 1 in 1000 experiencing a serious event after two doses of the Pfizer vaccine.

Risk of Serious Adverse Event Exceeds Risk of COVID Hospitalization

Supporting the data reported to VAERS and MHRA, a recent study authored by some of the most trusted medical scientists in the world concluded there was a rate of 1 in 800 for a serious adverse event, exceeding the risk of COVID hospitalization in randomized controlled trials.

The reporting systems will miss potential moderate and longer-term harms neither doctors nor patients will attribute to the vaccine.

Recent publications also raise a huge safety signal. Data from the largest ambulance trusts in England showed a disproportionately rise in cardiac arrest calls with a 20% increase in calls in 2021 compared to 2019. Similarly, a study out of Israel on volumes of cardiovascular calls in the 16-39 age group to EMS during the vaccine rollout showed an increase of calls by over 25% compared to the year before the pandemic.

“The disturbing findings in this paper have resulted in calls for a retraction. In the past, scientists with a different view of how data should be analysed would have published a paper with differing assumptions and interpretation for discussion. Now they try to censor.”

Many other concerns have been raised about the potential mid- to long-term harms from the vaccines. While some remain hypothetical, the current safety signal is alarming and many are silencing this signal and continuing to push the vaccines. Why?

Misleading Picture of Efficacy vs Death

Many have been analyzing data for all-cause mortality since the vaccine rollout. Pfizer’s trial showed slightly more deaths in the vaccine group than the placebo group and vaccines provided no statistically significant reduction in all-cause mortality.

One study was published showing an unusual increase in mortality in the unvaccinated population of each age group. Of concern is various authorities counting vaccinated deaths as unvaccinated deaths. Confirmed from a freedom of information act in Sweden, those who died within 14 days of receiving vaccination were categorized as being unvaccinated.

A Reckless Gamble?

Malhotra concludes, given the observations and data, it is difficult to argue the vaccines produce a net benefit in all age groups. While vaccines may have saved lives in vulnerable and elderly groups, the evidence is weak and questionable.

It is imperative the risks of adverse events and harms from the vaccine are acknowledged as the risks remain constant while the benefits reduce over time. It cannot be stated that full shared decision-making and informed consent has been received by vaccine recipients.

When the possible harms and established safety signal are considered, “the roll-out into the entire population seems, at best, a reckless gamble.”

Have an awesome day.  Dr D