Statement
COVID-19 Vaccines Safety and Efficacy
by Dr Aseem Malhotra MD for Mika Vauhkala
Short Biodata:
Dr Aseem Malhotra is an NHS trained Consultant Cardiologist and an internationally renowned
expert in the prevention, diagnosis and management of heart disease. His areas of expertise
include evidence-based medicine and collaborative shared decision-making with patients.
From 2018 - 2023 he was visiting professor of evidence-based medicine at the Bahiana school of
medicine and public health, Salvador, Brazil. He is a founding member of Action on Sugar and was
the lead campaigner highlighting the harm caused by excess sugar consumption in the United
Kingdom, particularly its role in type 2 diabetes and obesity. In 2015 he helped co-ordinate theChoosing Wisely campaign by the Academy of Medical Royal Colleges as lead author in a BMJ
paper to highlight the risks of overuse of medical treatments. In the same year he became theyoungest member to be appointed to the board of trustees of UK health think tank, The King's
Fund that advises government on health policy. Aseem is a frequent expert commentator in print
and broadcast media and he has written scores of articles for a number of publications including
the BMJ, British Journal of Sports Medicine, BMJ Open Heart, JAMA Internal Medicine, Prescriber,
The Pharmaceutical Journal, European Scientist, The Guardian and Observer, BBC online,
Huffington Post, The Daily Mirror, Daily Mail, The Daily Telegraph and the Washington Post. He isserves on the editorial board of the Journal of Metabolic Health.
Aseem has appeared in the Health Service Journal’s list of top 50 BME pioneers, and has won a
number of awards for his work to raise awareness of diet-related illness both in the UK andinternationally. He is a pioneer of the lifestyle medicine movement in the UK and has had featurearticles written about him in the New York Times, The Guardian, The Telegraph, The i, andHealthcare Leader. In 2018 he was ranked by software company Onalytica as the number 1 doctor
in the world influencing obesity thinking.
In 2016 he was named in the Sunday Times Debrett's list as one of the most influential people inscience and medicine in the UK in a list that included Professor Stephen Hawking. His total
Altmetric score (measure of impact and reach) of his medical journal publications since 2013 isover 10,000 making it one of the highest in the World for a clinical doctor during this period. His
first book co-authored with Donal O' Neill, The Pioppi Diet, has become an international best seller.
His second book, the 21 day immunity plan is a Sunday Times best seller. During the first year of
the Covid pandemic he was asked by the Secretary of State for Health, Matt Hancock to advice on
the link between covid and obesity and how best to reduce population risk to infection. His
recently published third book A Statin Free Life is already a best seller.
Award winning American Science Journalist Gary Taubes describes Aseem as someone who has“probably done more in the UK to inject sanity in to nutrition science and the pharmaceuticalindustry debate than any human being alive”.
Sir Richard Thompson, Past President of the Royal College of Physicians and former personal
physician to her majesty The Queen said “Dr Aseem Malhotra is changing the face of medicine andhis revolutionary book the Pioppi Diet should be read by everyone”.
The Mayor of Manchester Andy Burnham said “ He’s really making people think differently about
what they eat and how they live their life. Through his work he’s going to change many thousandsof lives, millions of lives for the better”.
https://draseemmalhotra.co.uk/

1Summary
In response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several new
pharmaceutical agents have been administered to billions of people worldwide, including theyoung and healthy at little risk from the virus. Considerable leeway has been afforded in terms of
the pre-clinical and clinical testing of these agents, despite an entirely novel mechanism of action
and concerning biodistribution characteristics.
Re-analysis of randomised controlled trials using the messenger ribonucleic acid (mRNA)
technology suggests a greater risk of serious adverse events from the vaccines than being
hospitalised from COVID-19. Pharmacovigilance systems and real-world safety data, coupled withplausible mechanisms of harm, are deeply concerning, especially in relation to cardiovascularsafety. Mirroring a potential signal from the Pfizer Phase 3 trial, a significant rise in cardiac arrest
calls to ambulances in England was seen in 2021, with similar data emerging from Israel in the
16–39-year-old age group.
In parallel, authorities and sections of the medical profession have supported unethical,
coercive, and misinformed policies such as vaccine mandates and vaccine passports,
undermining the principles of ethical evidence-based medical practice and informed consent.
These regrettable actions are a symptom of the ‘medical information mess’: The tip of amortality iceberg where prescribed medications are estimated to be the third most common
cause of death globally after heart disease and cancer. Underlying causes for this failure
include regulatory capture – guardians that are supposed to protect the public are in fact
funded by the corporations that stand to gain from the sale of those medications.
To gain a better understanding of the true benefits and potential harms of the messenger
ribonucleic acid (mRNA) coronavirus disease (COVID) vaccines, I conducted a narrative
review of the evidence from randomised trials and real world data of the COVID mRNA
products with special emphasis on BioNTech/Pfizer vaccine1.
In a second published review, I identified the major root causes of these public healthfailures, it was found that the public health messaging has also resulted in wanton waste ofresources and a missed opportunity to help individuals lead healthier lives with relatively
simple – and low cost – lifestyle changes2.
Key aspects of these reviews for 2020-2021 will be developed here for the case of Mr Vauhkala.
I - Safety and Efficacy of the COVID-19 Vaccines up to end 2021
A doctor’s experience
Volunteering in a vaccine centre, I was one of the first to receive two doses of Pfizer’s
messenger ribonucleic acid (mRNA) vaccine, at the end of January 2021. Although I knew myindividual risk was small from COVID-19 at age 43 with optimal metabolic health, the main
reason I took the jab was to prevent transmission of the virus to my vulnerable patients.
During early 2021, I was both surprised and concerned by a number of my vaccine-hesitantpatients and people in my social network who were asking me to comment on what I
regarded at the time as merely ‘anti-vax’ propaganda.
But a very unexpected and extremely harrowing personal tragedy was to happen a few
months later that would be the start of my own journey into what would ultimately prove to
be a revelatory and eye-opening experience so profound that after six months of criticallyappraising the data myself, speaking to eminent scientists involved in COVID-19 research,vaccine safety and development, and two investigative medical journalists, I have slowly andreluctantly concluded that contrary to my own initial dogmatic beliefs, Pfizer’s mRNA vaccine
is far from being as safe and effective as we first thought.

1 Malhotra, A. (2022a). Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based

medicine - Part 1. Journal of Metabolic Health, 5(1), 8 pages. doi:https://doi.org/10.4102/jir.v5i1.71
2 Malhotra, A. (2022b). Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based

medicine - Part 2. Journal of Metabolic Health, 5(1), 10 pages. doi: https://doi.org/10.4102/jir.v5i1.72

2This critical appraisal is based upon the analytical framework for practicing and teachingevidence-based medicine, specifically utilising individual clinical expertise and/or experience
with use of the best available evidence and taking into consideration patient preferences andvalues.
A case study
Case studies are a useful way of conveying complex clinical information and can elicit usefuldata that would be lost or not be made apparent in the summary results of a clinical trial.
On 26 July 2021, my father, Dr Kailash Chand OBE, former deputy chair of the British Medical
Association (BMA) and its honorary vice president (who had also taken both doses of the
Pfizer mRNA vaccine six months earlier) suffered a cardiac arrest at home after experiencing
chest pain. A subsequent inquiry revealed that a significant ambulance delay likely
contributed to his death3. But his post-mortem findings are what I found particularly shocking
and inexplicable. 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. Given that he wasan extremely fit and active 73-year-old man, having walked an average of 10–15 000 steps/
day during the whole of lockdown, this was a shock to everyone who knew him, but most of
all to me. I knew his medical history and lifestyle habits in great detail. My father who had
been a keen sportsman all his life, was fitter than the overwhelming majority of men his age.
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.
I couldn’t explain his post-mortem findings, especially as there was no evidence of an actual
heart attack but with severe blockages. This was precisely my own special area of research.
That is, how to delay progression of heart disease and even potentially reverse it. In fact, inmy own clinic, I successfully prescribe a lifestyle protocol to my patients on the best available
evidence on how to achieve this. I’ve even co-authored a high-impact peer-reviewed paperwith two internationally reputed cardiologists (both editors of medical journals) on shifting
the paradigm on how to most effectively prevent heart disease through lifestyle changes4.We
emphasised the fact that coronary artery disease is a chronic inflammatory condition that isexacerbated by insulin resistance.
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 riskof heart attack, the mRNA vaccine was associated with significantly increasing thepredictive risk5 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

3 Gallagher P. The death of Dr Kailash Chand: How a lethal mix of NHS privatisation and lack of resources led to tragedy[Homepage]. iNews. 2021 [accessed 2023 Nov 17].
https://inews.co.uk/news/health/the-death-of-dr-kailash-chand-how-a-lethal-mix-of-nhs-privatisation-and-lack-ofresources-led-to-tragedy-1303449
4 Malhotra A, Redberg RF, Meier P. Saturated fat does not clog the arteries: Coronary heart disease is a chronic

inflammatory condition, the risk of which can be effectively reduced from healthy lifestyle interventions. Br J Sports Med.
2017;51(15):1111–1112. https://doi.org/10.1136/bjsports-2016-097285
5 Predictive risk: this study used the PULS Cardiac Test (Predictive Health Diagnostics Co., Irvine, CA) a clinically utilizedmeasurement of multiple protein biomarkers, which generates a score predicting the 5 year risk (percentage chance) of
a new Acute Coronary Syndrome (ACS) called the PULS Score. This clinic has been using the PULS Cardiac Test
(Predictive Health Diagnostics Co., Irvine, CA) a clinically utilized measurement of multiple protein biomarkers, which
generates a score predicting the 5 yr risk (percentage chance) of a new Acute Coronary Syndrome (ACS) called the PULS
Score.

3disease, and more importantly heart attack risk, within months of taking the jab6. I wondered
whether my father’s Pfizer vaccination, which he received six months earlier, could havecontributed to his unexplained premature death and so I began to critically appraise the data.
Questioning the Data
I recalled a cardiologist colleague of mine informing me, to my astonishment at the time, that
he had made a decision not to take the vaccine for a number of reasons, including his
personal low background COVID-19 risk7,8 and concerns regarding unknown short- andlonger-term harms. One thing that alarmed him about Pfizer’s pivotal mRNA trial publishedin The New England Journal of Medicine,in December 2020, was the data in the
supplementary appendix, specifically that there were four cardiac arrests in those who took
the vaccine versus only one in the placebo group9.These figures were small in absolute terms
and did not reach statistical significance in the trial, suggesting that it may just be
coincidence, but 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 havethe effect of causing a surge in cardiac arrests once the vaccine was rolled out to tens of
millions of people across the globe. In terms of efficacy, headlines around the world madevery bold claims of 95% effectiveness, the interchangeable use of ‘efficacy’ and‘effectiveness’ glossing over the big difference between controlled trial and real-world
conditions10.
Contrary to popular belief, what the Pfizer pivotal efficacy trial did not show was any
statistically significant reduction in serious illness or COVID-19 mortality from thevaccine over the 6-month period of the trial, but the actual numbers of deaths(attributed to COVID-19) are still important to note. There were only two deaths fromCOVID-19 in the placebo group and one death from COVID-19 in the vaccine group. Looking
at all-cause mortality over a longer period, there were actually slightly more deaths11 in thevaccine group (19 deaths) than in the placebo group (17 deaths). Also of note was theextremely low rate of COVID-19 illness classified as severe in the placebo group (nine severecases out of 21 686 subjects, 0.04%), reflecting a very low risk of severe illness even inregions chosen for the trial because of perceived high prevalence of infection.
Now that we know what the published trial did and did not show in terms of the vaccine
efficacy, we can attempt to extrapolate what the effect of the vaccine would be in reducing
mortality or any other adverse outcome from the virus.
Clinical Harms
Concerns have already been raised about the under-reporting of adverse events in the clinical
trials for the COVID-19 vaccines. Investigative medical reporter Maryanne Demasi analysed

6 Gundry SR. Abstract 10712: Observational findings of PULS cardiac test findings for inflammatory markers in patients

receiving mRNA vaccines. Circulation. 2021;144(Suppl_1):A10712. https://doi.org/10.1161/circ.144.suppl_1.10712
7 Axfors C, Ioannidis JPA. Infection fatality rate of COVID-19 in community-dwelling elderly populations. Eur J Epidemiol. In

press 2022;37(3):235–249. https://doi.org/10.1007/s10654-022-00853-w
8 Axfors C,

Ioannidis JPA. Infection fatality rate of COVID-19 in community-dwelling populations with emphasis on theelderly: An overview. medRxiv, 2021.07.08.21260210; doi: https://doi.org/10.1101/2021.07.08.21260210

9 Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med.

2020;383(27):2603–2615. https://doi.org/10.1056/NEJMoa2034577
10 Burches E, Burches M. Efficacy, effectiveness and efficiency in the health care: The need for an agreement to clarify its

meaning. Int Arch Public Health Community Med. 2020;4:35. https://doi.org/10.23937/2643-4512/1710035
11 Wollersheim S, Schwartz A. BLA Clinical Review Memorandum* [Homepage]. 2021 [accessed 2023 Nov 17]. https://www.fda.gov/media/152256/download4

the various ways that the pivotal mRNA trials failed to account for serious harms12. Not only
were trial participants limited to the type of adverse event they could report on their digitalapps, but some participants who were hospitalised after inoculation were withdrawn from thetrial and not reported in the final results. After two months into the pivotal trials, the FDA
allowed vaccine companies to offer the vaccine to subjects in the placebo group, essentiallytorpedoing any chance of properly recording adverse events from that point on, forcing a
reliance of pharmacovigilance data.
Such data have shown that one of the most common mRNA COVID-19 vaccine-induced
harms is myocarditis. A study across several Nordic countries showed an increased risk frommRNA vaccination over background, especially in young males13. Authorities have repeatedly
maintained that myocarditis is more common after COVID-19 infection than after
vaccination14. However, trial data demonstrating that vaccination reduces the risk of
myocarditis in subsequent infection is elusive, and in fact the risks may be additive. Incidenceof myocarditis rocketed from spring 2021 when vaccines were rolled out to the younger
cohorts having remained within normal levels for the full year prior, despite COVID-1915, withthe most up-to-date evidence, a paper from Israel16 presented the results of a large
population-based retrospective cohort study of 196,992 adults after COVID-19 infection in
Clalit Health Services members in Israel between March 2020 and January 2021. The study
found that the infection itself, prior to roll-out of the vaccine, conferred no increase in therisks of either myocarditis or pericarditis from COVID-19, strongly suggesting that theincreases observed in earlier studies were because of the mRNA vaccines, with or without
COVID-19 infections as an additional risk in the vaccinated16.
Indeed, this reflects my own clinical experience of advising and managing several patients inthe community who presented with a clear suggestion from the history of myocarditis post
mRNA vaccination but aren’t necessarily unwell enough to require hospital admission. Manycase studies can be presented to demonstrate this.
II – Evidence-based Medical & Public Health Decision-Making in question
Health System Indicators
A number of reports and retrospective studies on 2020-2021 have produced concerning ratesof myocarditis, depending on age, ranging from 1 in 6000 in Israel17 to 1 in 2700 in a Hong

12 Demasi M. Are adverse events in Covid-19 vaccine trials under-reported? [homepage]. Investigative Journalism. Nov

2021 [accessed 2023 Nov 17]. Available from https://maryannedemasi.com/publications/f/are-adverse-events-incovid-19-vaccine-trials-under-reported
13 Karlstad Ø, Hovi P, Husby A, et al. SARS-CoV-2 vaccination and myocarditis in a Nordic cohort study of 23 million

residents. JAMA Cardiol. 2022;7(6):600–612. https://doi.org/10.1001/jamacardio.2022.0583
14 Patone M, Mei XW, Handunnetthi L, et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with

COVID-19 vaccination or SARS-CoV-2 infection. Nat Med 2022;28:410422. .https://doi.org/10.1038/
s41591-021-01630-0
Note:the same authors had already warned about this risk earlier in 2021 https://www.phc.ox.ac.uk/publications/
1225727
15 Diaz GA, Parsons GT, Gering SK, Meier AR, Hutchinson IV, Robicsek A. Myocarditis and pericarditis after vaccination for

COVID-19. JAMA. 2021;326(12):1210–1212. https://doi.org/10.1001/jama.2021.13443
16 Tuvali O, Tshori S, Derazne E, et al. The incidence of myocarditis and pericarditis in post COVID-19 unvaccinatedpatients-a large population-based study. J Clin Med Res. 2022;11(8):2219. https://doi.org/10.3390/jcm11082219
17 Fronza M, Thavendiranathan P, Chan V, et al. Myocardial injury pattern at MRI in COVID-19 vaccine-associatedmyocarditis. Radiology. 2022;304(3):553–562. https://doi.org/10.1148/radiol.212559
Note: included In this retrospective cohort study, consecutive adult patients with myocarditis with at least one T1-based and at least one T2based abnormality at cardiac MRI performed at a tertiary referral hospital from December 2019 to November 2021.

5

Kong study in male children and adolescents aged 12–17 years18. Most of the epidemiology
studies that have been carried out have measured myocarditis cases that have been
diagnosed in a hospital setting, and do not claim to be a comprehensive measure of moremild cases (from which long-term harm cannot be ruled out). In addition, under-reporting ofadverse events is the scourge of pharmacovigilance data19.
It is instructive to note that according to ambulance service data, in 2021 (the year of thevaccine roll-out), there were approximately an extra 20 000 (~20% increase) outof-hospital cardiac arrest calls compared to 2019, and approximately 14 000 morethan in 2020. Data obtained under Freedom of Information laws from one of the largest
ambulance trusts in England suggest that there was no increase from November 2020 toMarch 2021, and thereafter the rise has been seen disproportionately in theyoung20. This is a huge signal that surely needs investigating with some urgency21.
Similarly, a scientific report published in Nature, comparing cardiovascular emergency events
during January–May 2021 with the years 2019–202022 on the basis of Israel Government
Data base Portal vaccination data revealed a 25% increase in both acute coronary
syndrome and cardiac arrest calls in the 16- to 39-year-old age groups significantly
associated with administration with the first and second doses of the mRNA
vaccines but no association with COVID-19 infection23.
The authors state that:“The findings raise concerns regarding vaccine-induced undetected severe cardiovascular side
effects and underscore the already established causal relationship between vaccines andmyocarditis, a frequent cause of unexpected cardiac arrest in young individuals”.
Reporting Systems Data
The United Kingdom relies on the Medicines and Health Regulatory Agency’s(MHRAs) ‘Yellow Card’ reporting system24, which is far from adequate to cope with arapid roll-out of a brand-new product. It only detected the clotting problems that resulted in
the withdrawal of the AstraZeneca product in April 2021 for younger people after 9.7 million

18 Chua GT, Kwan MYW, Chui CSL, et al. Epidemiology of acute myocarditis/pericarditis in Hong Kong adolescents following

comirnaty vaccination. Clin Infect Dis. 2021; ciab989. https://doi.org/10.1093/cid/ciab989
19 Gahr M, Eller J, Connemann BJ, Schönfeldt-Lecuona C. Underreporting of adverse drug reactions: Results from a survey

among physicians. Eur Psychiatry. 2017;41:S369. https://doi.org/10.1016/j.eurpsy.2017.02.377
20 Patients with heart conditions/strokes from 2017-present day [homepage]. WhatDoTheyKnow; 2022 [accessed 2023

Nov 17]. https://www.whatdotheyknow.com/request/patients_with_heart_conditionsst
21 HART. An epidemic of cardiac arrests [Homepage]. HART. HART Group; 2022 [accessed 2023 Nov 17].

https://

www.hartgroup.org/an-epidemic-of-cardiac-arrests/
22 Data on the vaccinations and COVID-19 cases were obtained from the online Israel Government Database Portal(https://info.data.gov.il/datagov/home/). These data include the number of daily administered 1st and 2nd vaccination
doses by age group, as well as the weekly number of new confirmed COVID-19 cases by age group, across all of Israel
23 Sun CLF, Jaffe E, Levi R. Increased emergency cardiovascular events among under-40 population in Israel during

vaccine rollout and third COVID-19 wave. Scientific Reports, Nature 2022;12(1):6978. https://doi.org/10.1038/
s41598-022-10928-z
24 Coronavirus vaccine – Weekly summary of Yellow Card reporting [Homepage]. GOV.UK. [accessed 2023 Nov 17].

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccinesummary-of-yellow-card-reporting6

doses had been given in the United Kingdom25; in contrast, Denmark detected the problem
after only 150 000 doses had been administered26.
In the United Kingdom, since the vaccine roll-out there have been almost 500 000 adverse
event reports recorded (via the Yellow Card system) in association with the mRNA COVID-19
vaccinations involving over 150 000 individuals. In terms of the number of reports per person(i.e. having received at least one dose), the MHRA figures show around 1 in 120 suffering alikely adverse event that is beyond mild27. However, the MHRA are unclear about the rate andfurthermore do not separate out the serious adverse events. Nevertheless, this level ofreporting is unprecedented in the modern medical era and equals the total number of reports
received in the first 40 years of the Yellow Card reporting system (for all medicines – not justvaccines) up to 202028. In comparison, for the measles, mumps and rubella (MMR) vaccine,the number of reports per person vaccinated was around 1 in 4000, more than thirty times
less frequent than the 1 in 120 Yellow Card reports for COVID-19 vaccine recipients28.
Norway does separate out the reported serious adverse reactions and has shown a rate of
approximately 1 in 1000 after two doses of BioNTech/Pfizer mRNA product that result in
hospitalisation or are life changing29.
Another, and more useful, source of information (because of the level of detail for each report
made available to the public) is the United States (US) Vaccine Adverse Effect
Reporting System (VAERS). As with the UK’s system, the level of reports – including
serious ones – associated with COVID-19 vaccines is completely unprecedented. For example,
over 24 000 deaths had been recorded in VAERS as of 02 March 2022; 29% of these occurred
within 48 h of injection, and half within two weeks. Earlier as of 15 October 2021, 17’128
deaths had already been recorded, of which 818’044 injuries cases and 26’199 permanent
disabilities. An analysis published on 8 September 2021 by Hoeg et al.30 from this databaseshows that young people aged 12 to 17 are exposed to a higher cardiac risk (myocarditistype) than the risk of hospitalisation for COVID-19. The group with the most severe risk ofheart problems after experimental vaccination is the youngest group of 12-15 year olds.
The average reporting rate prior to 2020 was less than 300 deaths per annum. One
explanation often given for this is that the COVID-19 vaccine roll-out is unprecedented inscope; however, this is not valid, since (for the last decade at any rate) the United States has
administered 150 million – 200 million vaccinations annually. Another criticism of VAERS isthat ‘anyone can make an entry’, yet, in fact, an analysis of a sample of 250 early deaths

25 Yellow Card reports compared for Oxford/AstraZeneca and PfizerBioNTech product (2021). Covid-19: European countries

suspend use of Oxford-AstraZeneca vaccine after reports of blood clots. BMJ:372:N699 - doi: https://doi.org/10.1136/
bmj.n699 (Published 11 March 2021)
26 BBC News. AstraZeneca vaccine: Denmark stops rollout completely. BBC [serial online]. 2021 [accessed 2023 Nov 17];

https://www.bbc.co.uk/news/world-europe-56744474
27 Coronavirus vaccine – Weekly summary of Yellow Card reporting [Homepage]. GOV.UK. [accessed 2023 Nov 17].

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccinesummary-of-yellow-card-reporting
28 Medicines and Healthcare products Regulatory Agency. All spontaneous suspected UK Adverse Drug Reaction (ADR)

reports associated with the MMR vaccine in 2020 [homepage]. 2021 [accessed 2023 Nov 17]

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1041736/FOI_21-877-4.pdf

29 Norwegian Medicines Agency. Reported suspected adverse reactions to COVID19 vaccines as of 04.01.2022[Homepage]. 2022 [accessed 2023 Nov 17]. https://legemiddelverket.no/Documents/English/

Covid-19/20220107%20Reported%20suspected%20adverse%20reactions%20coronavirus%20vaccines%20%20updated%2020220113.pdf
30 Hoeg T.B., Krug A., Stevenson J. and Mandrola J. (2021). SARS-CoV-2 mRNA Vaccination-Associated Myocarditis inChildren Ages 12-17: A Stratified National Database Analysis, medRxiv 2021.08.30.21262866; doi: https://doi.org/

10.1101/2021.08.30.21262866.
7

suggested that the vast majority are hospital or physician entries31, and knowingly filing a
false VAERS report is a violation of Federal law punishable by fine and imprisonment32. Given
that VAERS was set up to generate early signals of potential harm for new vaccines,
and was instrumental in doing so for several products, it seems perverse to only
now criticise it as unreliable when there seem to have been no changes in the way
it operates.
It has been estimated that serious adverse effects that are officially reported are actually agross underestimate, and this should be borne in mind when the above comments in relation
to VAERS reports are considered. For example, a paper by David Kessler (a former FDA
Commissioner) cites data suggesting that as few as 1% of serious adverse events arereported to the FDA33. Similarly in relation to the Yellow Card scheme in the United Kingdom,
it has been estimated that only 10% of serious adverse effects are reported34,35. A pre-print
publication co-authored by some of the most trusted medical scientists in the world in
relation to data transparency adds validity to pharmacovigilance data. Accessing data fromthe FDA and Health Canada websites and combining results from journal articles thatpublished the Pfizer and Moderna trials, the authors concluded that the absolute risk of aserious adverse event from the mRNA vaccines (a rate of one in 800) significantly exceeded
the risk of COVID-19 hospitalisation in randomised controlled trials36,37.
What VAERS and other reporting systems will miss are potential medium to longer term
harms that neither patients nor doctors will automatically attribute to the drug. For example,
if the mRNA vaccine increases the risk of a coronary event within a few months (in what wasa likely contributory factor in my father’s sudden cardiac death), then this would increase
event rates well beyond the first few weeks of the jab yet linking it back to the vaccine, andthus reporting it is highly unlikely to occur later on.
Biological mechanism of harm
For ‘conventional vaccines’, an inert part of the bacteria or virus is used to ‘educate’ the immune
system. The immune stimulus is limited, localised and short-lived. For the COVID-19 vaccines,
spike protein has been shown to be produced continuously (and in unpredictable amounts) for atleast four months after vaccination38 and is distributed throughout the body after intramuscular

31 McLachlan S, Dube K, Osman M, Chiketero PP. (June 2021). Analysis of COVID-19 vaccine death reports from the

Vaccine Adverse Events Reporting System (VAERS) Database: Interim Results and analysis. ResearchGate. https://doi.org/10.13140/RG.2.2.26987.26402
32 VAERS. Report an adverse event [homepage]. [accessed 2023 Nov 17]. https://vaers.hhs.gov/reportevent.html
33 Kessler DA. Introducing MEDWatch. A new approach to reporting medication and device adverse effects and productproblems. JAMA. 1993;269(21):2765–2768. https://doi.org/10.1001/jama.1993.03500210065033
34Rawlins MD. Pharmacovigilance: Paradise lost, regained or postponed? The William Withering Lecture 1994. J R

Coll Physicians Lond. 1995;29(1):41–49.
35 Yellow Card: Please help to reverse the decline in reporting of suspected adverse drug reactions [homepage]. GOV.UK;

2019 [accessed 2023 Nov 17]. https://www.gov.uk/drug-safety-update/yellow-card-please-help-to-reverse-the-declinein-reporting-of-suspected-adverse-drug-reactions
36 Fraiman J, Erviti J, Jones M, et al. Serious adverse events of special interest following mRNA COVID-19 vaccinationin randomized trials in adults. Vaccine. 2022 Aug 30:S0264-410X(22)01028-3.
37 Note for clarity: “the results of both studies reported all data at the time of data cutoff (14 Nov 2020 for Pfizer, 25

Nov 2020 for Moderna)” cited from above reference by Fraiman et al.
38 Bansal S, Perincheri S, Fleming T, et al. Cutting edge: Circulating exosomes with covid spike protein are induced by

BNT162b2 (Pfizer-BioNTech) vaccination prior to development of antibodies: A novel mechanism for immune activation
by mRNA vaccines. J Immunol. 2021;207(10):2405–2410. https://doi.org/10.4049/jimmunol.2100637

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injection39. For the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, thespike protein was chosen, possibly because it enables cell entry. However, this protein is not inert,
but rather it is the source of much of the pathology associated with severe COVID-19, including
endothelial damage40, clotting abnormalities41 and lung damage. It is instructive to note that prior
to roll-out of the mRNA products, the WHO endorsed a priority list of potential serious adverse
events of special interest that may occur as a direct result of COVID-19 vaccines. The list was
based upon the specific vaccine platform, adverse events associated with prior vaccines in general,
theoretical associations based upon animal models and COVID-19-specific immunopathogenesis42.
Evidence-based medicine and COVID-19 vaccine roll-out
Neither the drug regulators nor the vaccine manufacturers have yet to share all the raw datafrom the pivotal trials for the COVID-19 vaccines43. The raw data from clinical trials comprisethousands of pages that have yet to be released for independent scrutiny. This is importantbecause historically when independent researchers have on occasion gained access to thisdata then it can completely overturn the conclusions of the published trials: A case in point is
Tamiflu44. Getting access to clinical case reports for Tamiflu ultimately revealed that the drug
was no more effective than paracetamol for influenza and also came with small but significant
harms. The UK government had spent half a billion dollars stockpiling a drug that in effectproved to be useless despite claims by the manufacturers (Roche, Basel, Switzerland) that itshortened the duration and severity of the illness. The independent researchers who wereable to analyse the data concluded that all industry-sponsored research should be consideredmarketing until proven otherwise.
It is against this backdrop that transparency advocates sued the Food and Drug
Administration (FDA) to gain access to the data upon which the Pfizer (BNT162b2) vaccine
was granted emergency use authorisation45. The FDA wanted a US Federal court judge toallow the agency 55 years to release this data46. Why would the FDA – ‘which is responsible
for the oversight of more than $2.7 trillion in consumption of food, medical products, andtobacco47’ – do this? Secrecy should never surround any public health intervention. The
lawyer acting on behalf of the plaintiff Aaron Siri reported that:

39 Seneff S, Nigh G, Kyriakopoulos AM, McCullough PA. Innate immune suppression by SARS-CoV-2 mRNA vaccinations:

The role of G-quadruplexes, exosomes, and MicroRNAs. Food Chem Toxicol. 2022;164:113008. https://doi.org/10.1016/
j.fct.2022.113008
40 Lei Y, Zhang J, Schiavon CR, et al. SARS-CoV-2 spike protein impairs endothelial function via downregulation of ACE 2.

Circ Res. 2021;128(9):1323–1326. https://doi.org/10.1161/CIRCRESAHA.121.318902
41 Ryu JK, Sozmen EG, Dixit K, et al. SARS-CoV-2 spike protein induces abnormal inflammatory blood clots neutralized by

fibrin immunotherapy. bioRxiv 10.12.464152 (2021). https://doi.org/10.1101/2021.10.12.464152
42 Yellow Card: Please help to reverse the decline in reporting of suspected adverse drug reactions [Homepage]. GOV.UK;

2019 [accessed 2023 Nov 17]. https://www.gov.uk/drug-safety-update/yellow-card-please-help-to-reverse-the-declinein-reporting-of-suspected-adverse-drug-reactions
43 Doshi P, Godlee F, Abbasi K. Covid-19 vaccines and treatments: We must have raw data, now. BMJ. January2022;376:o102. https://doi.org/10.1136/bmj.o102
44 BMJ. Tamiflu campaign [homepage]. [accessed 2023 Nov 17]. https://www.bmj.com/tamiflu
45 Demasi M. FDA to release Pfizer data but the devil could be in the detail [Homepage]. Investigative Journalism. 2022

[accessed 2023 Nov 17]. https://maryannedemasi.com/publications/f/fda-to-release-pfizer-data-but-the-devil-could-bein-the-detail?blogcategory=COVID-19
46 Public Health and Medical Professionals for Transparency vs Food and Drug Administration. Civil Action No. 4:21-

cv-01058-P public health and medical professionals for transparency [homepage]. 2021 [accessed 2023 Nov 17].
https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-StatusReport-8989f1fed17e2d919391d8df1978006e.pdf
47 US Food and Drug Administration (FDA) Fact sheet: FDA at a glance [Homepage]. Silver Spring, MD: FDA; 2019[accessed 2023 Nov 17]. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance

9The government also sought to delay full release of the data it relied upon to license thisproduct until almost every American alive today is dead. That form of governance isdestructive to liberty and antithetical to the openness required in a democratic society48.
Instead, the judge ordered the FDA to release the data over a period of eight months after allcommercially sensitive information has been redacted.
A major risk factor for failure to protect the public from such harms is lack of independence ofthe regulator. The FDA’s Centre for Drug Evaluation Research (CDER) receives 65% of its
funding from the pharmaceutical industry (mainly in the form of user fees)49. For example, aspart of the approval process for its COVID-19 vaccine, Pfizer made a wire transfer to the FDA
of $2 875 842 million in May 202150 under the Prescription Drug User Fee Act of 199251. Full
FDA approval for Pfizer’s COVID-19 injection duly followed in August 202152 despite evidence
emerging a few months later that the original RCT data suggested a greater risk of serious
adverse events from the vaccine than from hospitalisation because of COVID-19.
Shortcomings of informed decision making in the medical profession
According to Professor Carl Heneghan and urgent care General Practitioner, the director of the
University of Oxford’s Centre of Evidence-Based Medicine: ‘with every intervention you do as
a doctor you must ask yourself two questions: how much difference does it make? How do I
know this?53’
Building on the Academy of Medical Royal Colleges Choosing Wisely campaign54, it isinstructive to note that the General Medical Council in 2020 issued guidance on the duty of
doctors to engage in Shared Decision Making with patients, underpinned by informed
consent55.
There are six components essential to informed decision making:(1) description of the nature of the decision;(2) discussion of alternatives;(3) discussion of risks and benefits (in absolute terms);(4) discussion of related uncertainties;(5) assessment of the patient’s understanding; and48 Demasi M. FDA to release Pfizer data but the devil could be in the detail [Homepage]. Investigative Journalism.8

January 2022 [accessed 2023 Nov 17]. https://maryannedemasi.com/publications/f/fda-to-release-pfizer-data-but-thedevil-could-be-in-the-detail?blogcategory=COVID-19
49 Gagnon MA, Lexchin J. The cost of pushing pills: A new estimate of pharmaceutical promotion expenditures in the

United States. PLoS Med. 2008;5(1):e1. https://doi.org/10.1371/journal.pmed.0050001
50 Pfizer. BLA 125742 COVID-19 mRNA vaccine (BNT162/PF-07302048) part 1 of the original submission – Rolling

Biologics License Application (BLA) request for priority review designation [Homepage]. 2021 [accessed 2023 Nov 17].
https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_cover.pdf
51 CONGRESS.GOV. Prescription Drug User Fee Act of 1992 [homepage]. 5952 Sep 24, 1992 [accessed 2023 Nov 17].

http://www.congress.gov/
52 US Food and Drug Administration (FDA). FDA approves first COVID-19 vaccine [Homepage]. U.S. Food and Drug

Administration. FDA; 2021 [accessed 2023 Nov 17]. https://www.fda.gov/news-events/press-announcements/fdaapproves-first-covid-19-vaccine
53 Heneghan C, Mahtani KR, Goldacre B, Godlee F, Macdonald H, Jarvies D. Evidence based medicine manifesto forbetter healthcare. BMJ. 2017;357:j2973. https://doi.org/10.1136/bmj.j2973
54 Malhotra A, Maughan D, Ansell J, et al. Choosing Wisely in the UK: The Academy of Medical Royal Colleges’

initiative to reduce the harms of too much medicine. BMJ. 2015;350:h2308. https://doi.org/10.1136/bmj.h2308
55 General Medical Council. Shared decision making is key to good patient care – GMC guidance [Homepage].

[accessed 2023 Nov 17]. https://www.gmc-uk.org/news/news-archive/shared-decision-making-is-key-to-goodpatient-care---gmc-guidance10(6) elicitation of the patient’s preference.
If the administration of the vaccine did not adhere to these principles (which islikely widespread, consistent with historical evidence56), then it is also a significant
breach of General Medical Council duties of a doctor to ‘give patients theinformation they want or need in a way that they can understand’57.

56 Braddock CH 3rd, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient

practice: Time to get back to basics. JAMA. 1999;282(24):2313–2320. https://doi.org/10.1001/jama.282.24.2313
57 Duties of a doctor registered with the General Medical Council [Homepage]. Royal College of Surgeons. [accessed

2023 Nov 17]. https://www.rcseng.ac.uk/standards-and-research/gsp/duties-of-a-doctor-registered-with-thegeneral-medical-council/

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In conclusion
There was never any evidence justifying any COVID-19 vaccine mandates, passports or anyof the other coercive measures adopted by various governments worldwide. Every patient
who was offered any COVID-19 vaccine should have been made aware of what their risk fromCOVID-19 is according to age and risk factors. In keeping with ethical medical practice,doctors should have informed patients of their absolute risk reduction for infection fromprevious more lethal variant being approximately 0.84% or 1 in 119 (based on nontransparent data) and that this level of protection only lasts for a few months. They should
also have provided more precise and robust data on what the actual absolute individual risk
reduction of COVID-19 death from the vaccine is, what the true rates of serious adverse
events (such as permanent disability, hospitalisation or death) are. It is only when doctors
and patients have all this information that they can then be empowered to have frankdecision making conversations on whether any treatment – including this vaccine – is rightfor them. The profession must explain that optimising metabolic health will give patients thebest chance for ensuring they are not just resilient to infection but reducing their risk ofchronic disease including heart disease, cancer and dementia.
The time has come to stop misleading evidence flowing downstream into media reporting andclinical decision making and resulting in unethical and unscientific policy decisions. It’s time
for real evidence-based medicine58
The most objective determinant of whether the benefits of the vaccines outweigh the harms
is by analysing its effects on ‘all-cause mortality’. This gets round the thorny issue as to whatshould be classified as a COVID-19 death, and also takes full account of any negative effectsof the vaccine. It would be surprising – to say the least – if during an apparently deadly
pandemic, an effective vaccine could not clearly and unequivocally be shown to reduce allcause mortality.
Pfizer’s pivotal mRNA trial in adults did not show any statistically significant
reduction in all-cause mortality, and in absolute terms there were actually moredeaths in the treatment arm versus in the placebo.
There is also a strong scientific, ethical and moral case to be made that the current mRNA vaccine
administration must stop until Pfizer releases all the raw data for independent scrutiny59.This willallow a more accurate understanding of which groups are more likely to potentially benefit fromthe vaccine versus those who are more likely to be harmed. A pause and reappraisal of
vaccination Policies for COVID-19 is long overdue60.
The above reviews of data and studies conducted in 2020-2021 present the evidence that therisks of adverse events from the vaccine remain constant, whereas the benefits reduce over time,
as new variants are (1) less virulent and (2) not targeted by an outdated product.
From my medical experience and the review of sound data and scientific basis, I canconfirm that in December 2021 the medical and scientific communities should have
known that COVID-19 vaccines were proven to be far from safe or effective and far
from preventing transmission of COVID-19 or severe form of COVID-19. Most of them
did not know. Although the results were available and showed early on in 2021 a higher
risk of deleterious reactions such as cardiovascular events. The COVID-19 vaccine
study should have ethically been halted and reconsidered.
Looking to the future the medical and public health professions must recognise these failings andeschew the tainted dollar of the medical-industrial complex. It will take a lot of time and effort to58 Greenhalgh T, Howick J, Maskrey N, Evidence Based Medicine Renaissance Group. Evidence based medicine: A

movement in crisis? BMJ. 2014;348:g3725. https://www.bmj.com/content/348/bmj.g3725
59 BMJ. Tamiflu campaign [Homepage].[cited in Malhotra 2022, accessed 2023 Nov 17]. https://www.bmj.com/tamiflu
60 Malhotra, A. (2022a). Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based

medicine - Part 1. Journal of Metabolic Health, 5(1), 8 pages. doi:https://doi.org/10.4102/jir.v5i1.71

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rebuild trust in these institutions, but the health – of both humanity and the medical profession –depends on it61.

Dr Aseem Malhotra MD
29th of November 2023

61 Malhotra, A. (2022b). Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based

medicine - Part 2. Journal of Metabolic Health, 5(1), 10 pages. doi:https://doi.org/10.4102/jir.v5i1.72

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