Monthly Archives: October, 2022

The crushing power of the pharmaceutical industry – a sorry tale

Here is a sorry tale about the power of the pharmaceutical industry to crush all dissent … dead. The key player is Dr. Aseem Malhotra, who some of you may know. He is a consultant cardiologist. Very bright, sparky, willing to take on the establishment when required. I get on well with him, we communicate on many different issues. He has his detractors – I am not one of them.

First, some background, to put this tale into some kind of context. It is part of an e-mail that I was sent, by Aseem. I I have modified it slightly. Basically, I changed it from first person and got rid of some typos. I have also checked with other independent witnesses, to ensure the accuracy of events:

‘Dr Aseem Malhotra was invited to deliver a keynote lecture/speech at the International Medical Graduates dinner by its organiser, Consultant Psychiatrist and Chair of the British Association of Physicians of Indian Origin (BAPIO) Dr JS Bamrah CBE. The event took place on Monday 27th June as a fringe event of the British Medical Association (BMA) Annual Representative Meeting (ARM).

Other chief guests included the Chair of the BMA (Dr Chaand Nagpaul) and the President of the BMA (Professor Nina Modi). The title of his talk was “Advocating for REAL evidence-based medicine”.

The talk was well received with excellent personal feedback including the Chair of BAPIO, Dr JS Bamrah. The event also commemorated Aseem’s late father Dr Kailash Chand Malhotra who died suddenly last year. He was honorary vice president of the BMA and on the BMA council.

The organiser of BMA education events Beryl De Souza also personally told Aseem it was a brilliant talk, and the next day sent him a text message asking him to present the same talk as an educational webinar to BMA members.

Aseem had also given a talk to over one hundred BMA members earlier in the year about heart disease, statins and cholesterol with excellent feedback. The Chairman of the British Egyptian Medical Association who was very complimentary about the talk also met Aseem the following day and asked if he would give the same talk to his members.’

It all sounded rather splendid, and mainstream, and suchlike.

But, gentle reader, beware. For there is a malignant ghost hovering over this feast. The ghost of ‘anti-vaxxer present’. Now it doesn’t take much to be accused of being an anti-vaxxer. The phrase ‘I have some concerns about mRNA vaccines’ is usually enough to be mercilessly attacked by the dementors, controlled by Facebook, Twitter and suchlike.

In this case, during his talk, Aseem presented data from a study called ‘Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials.’

It is a pre-print paper, at this point, and has not yet been peer-reviewed. It is due to be published in the Elsevier journal SSRN. You can see the full paper here 1.

The authors, from such places as Stanford, UCLA and Maryland, are of high academic standing. What they did was to look at serious adverse events associated with the Pfizer and Moderna vaccines. The Discussion section of the paper states the following:

‘The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes such as hospitalization or death.’

The ‘abstract’ further states, in the results section:

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8) respectively.

Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).’

Now, in English. According to this paper, the risk of a serious adverse event (caused by the vaccine) was greater than the reduction in hospitalisation from COVID-19 (prevented by the vaccine). Therefore, on this metric, the vaccine(s) may be doing more harm than good. [Please don’t hit me, I said ‘may’.]

Thus, Aseem committed the greatest sin imaginable today. He dared to mention a scientific study that asked questions about mRNA vaccines. And, of course, oops, I have now mentioned it too. Which clearly makes me an anti-vaxxer. Yes, quoting scientific papers is now, virtually, a crime. So, I have to strongly advise you … don’t look at the paper. Else you will become contaminated with impure thoughts and may have to be stomped on.

Oh, what a world we now live in.

Anyway. Back to Aseem’s story. Here he was, basking in glory. To top it all, he was then presented with an award. To quote … with some slight edits:

‘The next day Dr JS Bamrah informed Aseem that he was going to receive an award, to be presented by the BMA Chair, Dr Nagpaul. The award was “Champion of Preventative Medicine”. He had spoken to Dr Nagpaul on the phone who agreed.

The award was given in a break at the BMA conference. Dr Nagpaul was asked where he wants the photo to be taken of him presenting Aseem with the award. He suggested the main podium at the BMA conference hall, but the picture quality is poor, so they go elsewhere, and Dr Nagpaul was more than happy for Aseem to receive the award in front of a board in the main lobby with the BMA logo in the background. This was NOT Aseem’s suggestion.

Later that afternoon (Tuesday 28th) Aseem received the photo via text and put a tweet out (see below) in the evening with the three photos of Aseem receiving the award including with a larger group of people including the BMA president which read:

“Truly honoured to receive the “Champion of Preventive Medicine award from the Chair of the BMA @Cnagpaul. In my talk I said the science alone isn’t enough; opposition from vested interests needs to be overcome to save the #NHS. It’s time for REAL evidence-based medicine (fist bump emoji).’

But the all-seeing eye of Sauron had been ‘observing’ this unfortunate series of events. Grima Wormtongue was dispatched to whisper in the ears of those in power. ‘Yes, my precious (to mix my characters, stories, and metaphors, horribly), nasty hobbitses won’t be seen to criticise vaccines will they.’

Behind the scenes … all hell broke loose. Someone had dared to mention a study mildly critical of vaccines, and the BMA chairman GAVE HIM AN AWARD. Off with his head. ‘Whose head, please?’

‘Everyone involved in this treachery.

‘Yes boss, sure boss, right away boss….’

The tale continues:

‘The next morning, Aseem noticed a missed call and message from Dr Bamrah. “Please call Aseem. Need your tweet modified. Delete the bit about BMA council. Just say Chaand Nagpaul. Happy to explain.”

Aseem did as requested and sent another tweet specifically clarifying that it was an IMG forum award and was given to me by Chaand Nagpaul, without mentioning the BMA at all. Aseem also messaged Dr Bamrah in reference to Chaand which he also shared with him “He needs to stand his ground and not capitulate. We’ve compromised by deleting the tweet. My dad would say always stand up to bullies and cowards – that’s what he taught me.”

Chaand (CN) replies to me “Aseem the issue is who the award originated from. They’re questioning my governance – it was not an award “from me”. I know it’s semantics but real uproar”

AM: “Ok. I will delete the tweet altogether”

CN: “Much wider than this individual – within BMA too sadly – everything attributed to me has to be cleared with BMA comms while BMA chair”

AM: “Tweet deleted”

CN: “I’m going to get some sleep! It’s been incessant”

BMA releases a statement from the Chair that is read out at the conference essentially stating that the BMA does not endorse the views of Dr Aseem Malhotra and that Chaand had not actually given me the award but had “handed it over” due to politeness.

Why such a storm? Why the behind-the-scenes desperate machinations to ensure that the BMA could not, and would not be associated in any way with Aseem? Why the personal humiliations and climbdowns? Why the control over Chaand Nagpaul – who was stepping down as BMA chairman anyway? The incessant tweeting and criticism.

Was it because Aseem has always been critical of vaccines? I refer you to the fact that in early 2021 Aseem was asked to help promote the COVID-19 vaccine to the, so called, BAME (Black Asian Minority Ethnic) community. Yes, he promoted the vaccine to a particular vaccine hesitant community 2.

However, he has also, like me, been alert to the possibility of potential harm that the vaccines may cause. He is also, like me, well aware of the way that data from clinical studies can be, and is, manipulated and biased.

We both cast a highly sceptical eye over any ‘evidence’ that emerges from commercial organisations. Neither of us happily chants ‘two vaccines good, four vaccines better.’ We are both in the ‘but that man is wearing no clothes’ section of the audience. A rather smaller section, it must be said. Usually containing only two people. Him, and me.

Anyway, I thought it would be interesting to find out who, exactly, started the ‘bring me the head of Aseem Malhotra’ movement within the BMA. Could it be, I wondered, that they had a commercial conflict of interest? By which I mean, had they worked with a pharmaceutical company that made mRNA COVID19 vaccines.

Well, I have spoken to people within the BMA, at a high level, to find out exactly what went on. They confirm the details of Aseem’s story. But wish to remain nameless. It seems that a certain individual, who led the attack on Aseem, has close connections with Moderna. Surprise, surprise. As you can tell, I am treading on potentially libellous ground here, so I am not naming names. I am currently involved in a monstrously long, and complex libel suit, and I don’t want another one at present, thank you very much.

This all comes hot on the heels of an article in the British Medical Journal by Maryanne Demasi. A medical journalist whose career was destroyed when she produced and presented programmes in Australia that were critical of the cholesterol hypothesis and the, potential, over-prescribing of statins. They even tried to get her PhD removed, to further destroy her reputation.

The BMJ article was called ‘From FDA to MHRA: are drug regulators for hire?’

‘Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate?’3

The short answer is no. Drug regulators have been bought and paid for by the companies that they are supposed to regulate. But the commercial influence spreads far wider than the regulators. Key opinion leaders (KOLs) who carry out the big clinical trials, who speak at conferences, and who appear at the top of influential medical organisations and write the guidelines – are often bought and paid for too.

There is virtually no area of the medical world that has not been lobbied, infiltrated and – in many cases – paid for and controlled by the pharmaceutical industry. We have a major crisis on our hands, that no-one is doing anything about.

Aseem’s tale is just one more example of the fact that anyone who dares to stand up to the relentless marketing of more and more drugs, and vaccines, will be attacked and crushed. In this case, under the banner of the British Medical Association. An organisation that I am increasingly unproud to be a member of. If the BMA can no longer support freedom of speech, then no-one can. The future looks bleak.

To quote George Orwell. ‘If you want a picture of the future, imagine a boot stamping on a human face, forever.’

1: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239

2: https://twitter.com/gmb/status/1357600088617611266?s=21&t=giXjno9w9ksPRjItQhC9_w

3: https://www.bmj.com/content/377/bmj.o1538

Source: https://drmalcolmkendrick.org/2022/07/18/the-crushing-power-of-the-pharmaceutical-industry-a-sorry-tale/ 18th July 2022

A Further Investigation into the Leaked EMA Emails & Confidential Pfizer-BioNTech COVID-19 Vaccine Related Docs

By Sonia Elijah

In June, Trial Site News published a bombshell investigative report on the leaked European Medicine Agency (EMA) emails and other Pfizer-related confidential reports, which exposed concerning facts in the run-up to the authorization of the Pfizer-BioNTech COVID-19 vaccine. It revealed:

  • A politically driven race between key regulators in their rush to authorize the vaccine.
  • By late November 2020, regulators including, US FDA, European Medicines Agency, Health Canada and the UK’s MHRA, were all aware of the significant loss of RNA integrity of the commercial batches (~55% mRNA integrity) of the Pfizer-BioNTech vaccine compared to the clinical ones (~78% mRNA integrity). This was classified by EMA as a “major objection” along with observed visible particles, which were classified as “impurities.”
  • A leaked 26 November PowerPoint presentation of a meeting between Pfizer-BioNTech and the EMA revealed how this major objection was shockingly ‘resolved’- the RNA integrity specification was simply lowered to 50%, therefore half of all mRNA molecules in the commercial batches were allowed to be truncated (not intact).
  • The potential implications of the RNA integrity loss in terms of safety and efficacy were unknown.

This report focuses on further leaked emails with specific reference made to the European Commissioner, Ursula von der Leyen and the unusual extent she was willing to go in corralling member states (MSs) in avoiding the use of Article 5 (2) (their national Emergency Use Authorization for the COVID-19 vaccines) but go with an EU Conditional Marketing Authorization (CMA). It shines light on other leaked EMA sensitive documents: the 24 November, 2020 Quality Office CMC observations presentation by the BWP (Biologics Working party) and Rapporteur’s Rolling Review assessment report, revealing more evidence which supports the ‘major objections’ discussed in the original Trial Site News report. It looks at unredacted versions of Pfizer vaccine contracts and the EC’s Advance Purchase Agreement signed in November 2020 with Pfizer and BioNTech ‘for the development, production, priority-purchasing options and supply of a successful COVID-19 vaccine for EU Member States.’

No stranger to scandal

Ursula von der Leyen has been under intense public scrutiny over her private negotiations of a multi-billion-euro vaccine deal (the EU’s biggest contract) via secret texts and phone calls made with Pfizer’s CEO, Albert Bourla, contravening the Commission decision for a steering board to ‘provide guidance throughout the evaluation process.’ Furthermore, she refused to grant public access to the secretive text messages exchanged between Bourla and herself, when called to do so. A European Court of Auditors published an alarming report, which stated ‘we asked the Commission to provide us with information on the preliminary negotiations for this agreement (scientific experts consulted and advice received, timing of the talks, records of the discussions, and details of the agreed terms and conditions). However, none was forthcoming.’

The fire has also been heating up for Pfizer’s Bourla, when he was called to testify before the European Parliament’s Special Committee on COVID-19 to face questions over those secretive vaccine deals but last minute pulled out from facing the committee.

The leaked emails

The original Trial Site News investigative report highlighted the enormous pressure exerted by the EC (European Commission) on the EMA to grant CMA under a highly accelerated timeline. An email from Noel Wathion (EMA’s former deputy executive director) was published, which revealed a ‘rather tense’ TC (teleconference call) with the European Commissioner (Ursula von der Leyen) which was ‘at times even a bit unpleasant’.

A delay of several weeks..was not easily acceptable for the EC [European Commission]’ Wathion states. He also reveals ‘how political fall-out seems to be too high even if the “technical” level at the MSs could defend such a “delay” in order to make the outcome of the scientific review as robust as possible.’

Below is an email from Hilde Boone of the EMA, stating that ‘she [von der Leyen] will be prepared to call relevant health ministers personally to avoid the use of Art 5(2).’

Article 5 (2) vs CMA

 Article 5 (2) of Directive 2001/83 states ‘Member States may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.’ In other words, it’s the equivalent of an Emergency Use Authorization at the member state level. It can be done very quickly because the medicinal product doesn’t need to go through the standard national authorization process.

An expert on EU law explained to Trial Site News the downside of MSs using Art. 5 (2), is that it would have given rise to competition amongst member states, leading to an unequitable access/distribution of the COVID-19 vaccines, particularly for those MSs who preferred to wait for the EU’s CMA (which takes longer since it’s supposed to follow a controlled and robust framework providing safeguards). An EU CMA helped ensure that the vaccines would have been available to all members states, at the same time, which was one of the objectives of the EU COVID-19 strategy.

However, could there have been further reasons why von der Leyen was desperate for the MSs to avoid Art 5 (2) that she was willing to call every relevant health minister herself?

In the email below from Noel Wathion, he states ‘since the 1st option still is to aim for a CMA rather than an Art 5 (2) coupled or not with an Art 5 (3)..’

Article 5(3) states: ‘Member States shall lay down provisions in order to ensure that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product…’

The fact that Wathion points out that an Art. 5 (2) can be coupled or not with an Art. 5 (3), raises the important question whether member states would have had the option to not give indemnity to the marketing authorisation holders (in this case BioNTech) and manufacturers (BioNTech and Pfizer).

The Predatory Pfizer Contracts and Advance Purchase Agreements

Given what we know about the leaked Pfizer contracts made available by the non-profit consumer advocacy organization, Public Citizen; this pharmaceutical company has seemingly bullied countries into silence; can go after sovereign state assets (under the waiver of sovereign immunity) and enjoy full indemnity- exemption from legal liability that may result from their product- in fact it’s the Purchaser who is made liable on their behalf. This means governments have had to pay compensation to citizens who have suffered from a vaccine adverse event, not the vaccine manufacturer.

The screenshot below is taken from the unredacted version of the advance purchase agreement (APA) between the European Commission (EC), acting on behalf and in the name of member states, Pfizer Inc. and BioNTech (collectively ‘the Contractor’) signed in November 2020 (around the same time the leaked EMA emails were generated). It states ‘each Participating Member State shall indemnify and hold harmless the Contractor, their Affiliates..from and against any and all liabilities incurred..relating to harm, damages and losses..arising from or relating to the use and deployment of the Vaccines..’

However, information posted on the EC’s website states that under an EU Conditional Marketing Authorisation (CMA), liability is with the holder of the marketing authorisation’ (which in this case is BioNTech). This directly conflicts with the APA that the EC signed with Pfizer and BioNTech (for 200 million vaccine doses priced at 15.50 Euros per dose excl VAT), a month before CMA was granted. It’s noteworthy that the EC published a heavily redacted version of the identical APA, any section related to indemnity/liability or simply considered ‘sensitive’ has been censored.  

Another important point to consider when it comes to Art 5 (2) vs an EU CMA- is that given some European countries mandated the vaccine for adults, at-risk age groups and certain job sectors – it’s highly unlikely those MSs would have been able to do that with an unauthorised medicinal product, which these vaccines would have been classified under Art 5 (2).

The CMC issues

Wathion’s November 20, 2020 email raises several concerning points -‘there are still issues with both (CMC seems to be a concern for the Pfizer/BioNTech and the rolling review for Moderna just started giving less time to review) so it needs to be seen if all this can be sorted out on time, whilst not compromising the robustness of the review.

The original Trial Site News report discussed what those CMC (Chemistry Manufacturing and Controls) issues were with Pfizer/BioNTech, particularly the loss of RNA integrity in the commercial batches and the unknown visible particles observed. Wathion tellingly states, ‘there are still issues’ speaks to the notion these ‘issues’ were not solved but had been ongoing. Wathion’s concern of ‘compromising the robustness of the review’ because of the need to authorise ‘on time’ is emphasized. This worry of speed over safety is reflected in other leaked emails, particularly by Wathion.

The report also contained a leaked email from Veronika Jekerle, EMA’s Head of Pharmaceutical Quality Office, where she outlined the 3 agreed major objections and the conclusion of the BWP (Biologics Working Party) regarding the Pfizer-BioNTech vaccine. Her email was sent on the November 24th the same day as the BWP presentation. Below, are a series of screenshots of the actual leaked BWP power point presentation (which Jekerle references in her email), entitled ‘EMA Quality Office CMC Observations.’ At the end of her email she thanks, ‘Ton, Brian and Claudio.’ Ton van der Stappen and Brian Dooley are named in the screenshot of the slide below.

The screenshot below presents wide-ranging data, which backups one of the major EMA objections in reference to the significant drop in %RNA integrity between the clinical and commercial batches. It’s noteworthy that batches from Pfizer’s Andover, USA (~62%) and Puurs, Belgium (~55%) sites were reported as having significantly lower %RNA integrity than batches provided by BNT (BioNTech) and Polymun.

The screenshot below is taken from the unredacted APA signed by the EC. It specifies that the majority of Europe’s vaccine supply will ‘come from Pfizer’s manufacturing site in Puurs, Belgium.’ This is concerning given the data shows that the %RNA integrity of batches from that site were the lowest at 55%, compared to other sites.

The screenshot below shows the acceptance criteria of various BNT 162B2 Drug Product lots. Drug Product refers to ‘medication in its marketed form, including its fillers, coloring agents, and other active or inactive agents.’ The acceptance criteria for Emergency Supply is greater or equal to 50%, which happens to be just below the batches with the lowest %RNA integrity supplied by Pfizer, Puurs. For some reason the acceptance criteria for the clinical Drug Product Lots differs and is set higher at greater or equal to 60%.

CMC (Chemistry, Manufacturing and Controls) ‘involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches.’ Given the data shown above, it’s evident there were significant CMC issues regarding the inconsistency of the %RNA integrity between batches, which is reflected in the leaked EMA emails and documents. What’s concerning is that the manufacturer (Pfizer/BioNTech) claimed, “The efficacy of the drug product is dependent on the expression of the delivered RNA, which requires a sufficiently intact RNA molecule.”

It’s baffling how lowering the specification down to 50% was potentially how this major objection was ‘solved.’ According to a leaked Rapporteur’s Rolling Review Assessment (revised report date: 25 November, 2020) compiled by the CHMP and PRAC rapporteurs- they found the ‘current acceptance criteria’ particularly troubling. The report states, ‘no characterisation data on RNA integrity and truncated forms is presented and the potential safety risks associated with truncated RNA isoforms are not addressed. This is especially important considering that the current DS and DP acceptance criteria allows for up to 50% fragmented species.’

Truncated (shortened by missing either top or end section) RNA is defined as a ‘product-related impurity’ and the fact that potential safety risks arising from this fragmented species ‘are not addressed’ is highly alarming.

Reference is made to ‘the current DS and DP acceptance criteria,’ this implies that it was not always set at that level and perhaps it had been changed (lowered). The question is why? Could it have been that process 2 (the manufacturing of the commercial batches) was just not replicable at the same specification level to the clinical batches (small scale) of process 1, therefore a lower standard was set in order for CMA to be granted?

Trial Site News communicated with the EMA regarding the content of the leaked emails and documents. The EMA press office’s prompt response has been published below in its entirety.

“The investigation of the published material revealed that the correspondence was manipulated by the perpetrators prior to publication. Not all of the documents were published in their integral, original form and may have been taken out of context. Whilst individual emails were authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes were created and additional titles were added by the perpetrators.

 These documents do not present a full picture of the assessment of Comirnaty, the COVID-19 vaccine developed by BioNTech/Pfizer. They show the situation up to the beginning of December 2020, when the hack was discovered, but do not mention the considerable amount of additional data, information and clarifications submitted by BioNTech/Pfizer up to 21 December 2020, the day when EMA’s committee for human medicines (CHMP) gave its recommendation to grant a marketing authorization for this vaccine.

 Comirnaty works because the mRNA it contains provides instructions for producing a spike protein which triggers an immune response. Its efficacy therefore depends on the presence of suitable amount of intact mRNA, which is known to be relatively unstable. What the documents show is how the assessment of any medicine works: following scrutiny of the data submitted by the company, the CHMP had questions about the integrity of mRNA and raised them formally as a ‘major objection’. This is an integral part of the assessment of any medicine. If major objections remain unresolved, they preclude the granting of the marketing authorisation. In this case, the company addressed the issues raised satisfactorily and subsequently supplied the required information and data after beginning of December 2020, which allowed EMA to move towards a positive opinion for this vaccine.

 The public assessment report of Comirnaty summarises the conclusions of the CHMP on this issue and details the steps taken during the marketing authorization procedure of Comirnaty as well as the obligations placed on the marketing authorisation holder to carry out additional studies to closely monitor the pharmaceutical quality of vaccine. These obligations were also included in the Product Information published at the time of the CHMP opinion.

 Even in a public health emergency as COVID-19, there has always been consensus across the EU not to compromise standards and to base any recommendation on the available scientific evidence on a vaccine’s safety, pharmaceutical quality and efficacy, and nothing else. Authorizations are only granted when the evidence shows convincingly that the benefits of vaccination are greater than any risks posed by a vaccine.”

Originally published in Trial Site News.

UK Doctor Turns Against Messenger RNA COVID-19 Vaccines, Calls for Global Pause

A doctor who promoted COVID-19 vaccines is now calling for health authorities around the world to pause the administration of two of the most-widely utilized COVID-19 vaccines, saying that the benefits from the vaccines may not outweigh the risks.

Epoch Times – By Zachary Stieber and Jan Jekielek September 26, 2022 Updated: September 28, 2022

Dr. Aseem Malhotra. (Courtesy of Dr. Aseem Malhotra)

“There is more than enough evidence—I would say the evidence is overwhelming—to pause the rollout of the vaccine,” Dr. Aseem Malhotra, a British cardiologist and evidence-based medicine expert, told The Epoch Times.

A paper from Malhotra detailing the evidence was published on Sept. 26.

Among the citations is a recent reanalysis of the Pfizer and Moderna clinical trials that concluded that vaccinated trial participants were at higher risk of serious adverse events. He called the study a “smoking gun.”

Malhotra also pointed to the lack of reduction in mortality or severe disease in the trials, which were completed in 2020.

Taking into account death rates and other figures since then, the number of people who need to be vaccinated to prevent a single COVID-19 death ranges from 93,000 for people aged 18–29 to 230 for people aged 80 and older, according to an analysis of UK safety and effectiveness data by the Health Advisory & Recovery Team.

The author also noted that serious side effects have been detected after the trials, such as myocarditis, a form of heart inflammation.

Overall, looking at the absolute benefits and drawbacks of the vaccines, it’s time to halt their usage and allow authorities and other experts to closely examine the data to see if the vaccines should be used again down the road, according to Malhotra.

The paper was published in the Journal of Insulin Resistance in two parts following peer review.

Pfizer and Moderna didn’t return requests for comment.

Reversal of Opinion

Malhotra received the Pfizer primary series in January 2021. He became a promoter of the vaccine, even appearing on “Good Morning Britain” to advise Indian film director Gurinder Chadha to get the vaccine. Chadha did so shortly after.

Malhotra said he began digging into vaccine data after his father, Dr. Kailash Chand, suffered a cardiac arrest at home approximately six months after receiving Pfizer’s vaccine.

The post-mortem showed two of Chand’s major arteries were severely blocked, even though Malhotra described his father as a fit person who didn’t have any significant heart problems.

Malhotra began reading about post-vaccination issues, including a study abstract in the journal Circulation that identified a higher risk of a heart attack following vaccination with the Pfizer and Moderna vaccines and a study from Nordic countries that identified a higher risk of myocarditis.

While authorities have claimed that myocarditis is more common after COVID-19 than vaccination, many studies have found otherwiseat least for certain age groups. Some papers have found no increased incidence of heart inflammation for COVID-19 patients.

Malhotra has come to believe that his father’s death was linked to the vaccine.

“I’ve always approached medicine and science with uncertainties because things constantly evolve. And the information I had at the time is completely different to the information I have now,” Malhotra told The Epoch Times. “And in fact, it is my duty and responsibility as the information has changed to act on that information. And that’s what I’m doing.”


HALIFAX, ENGLAND – JULY 31: Dr Lisa Pickles draws up the Pfizer-BioNTech COVID-19 vaccine at a new ‘Pop Up’ vaccination centre in the Big Top of Circus Extreme in Shibden Park on July 31, 2021 in Halifax, England. The pop-up clinic will be situated just outside the UKs largest circus Big Top so even people who do not have tickets to the show will still be able to get their vaccine. All adults in England have been able to book a first dose since June 18, but the latest figures show that nearly a third of young adults (aged 18 to 29) in the country have still not had one. A doctor prepares the Pfizer-BioNTech COVID-19 vaccine at a vaccination center in Halifax, England, on July 31, 2021. (Photo by Ian Forsyth/Getty Images)

Response to Criticism

After the new paper was published, critics noted that Malhotra is a board member of the Journal of Insulin Resistance.

He acknowledged the position but said the article went through an independent peer review process and that he has no financial links to the journal.

The doctor encouraged people to view his publication history, which includes articles in the British Medical Journal and the Journal of the American Medical Association.

He said he chose to submit the paper to the insulin journal for several reasons, including it being “one of the few journals that doesn’t take money from the pharmaceutical industry.”

“I don’t think that there’s any validity to question the integrity of the piece,” he said. “People can argue I’ve got an intellectual bias. We all have intellectual biases, but there’s certainly no financial bias for me.”

Paper Gains Support

Leading scientists say the new paper is important.

“We fully believe that vaccines are one of the great discoveries in medicine that has improved life expectancy dramatically, however, mRNA genetic vaccines are different, as long-term safety evaluation is lacking but mandatory to ensure public safety,” Sherif Sultan, president of the International Society of Vascular Surgery, said in a statement.

Sultan also noted that the findings “raise concerns regarding vaccine-induced undetected severe cardiovascular side effects and underscore the established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals.”

Dr. Jay Bhattacharya, a professor of medicine and epidemiology at the University of Stanford, said that Malhotra “makes a good case that there is considerable heterogeneity across age groups and other comorbid conditions in the expected benefits and expected side effect profiles of the vaccine” and “finds that while there may be a case for older people to take the vaccine because the benefits may outweigh expected harm that may not be the case for younger people.”

Dr. Campbell Murdoch, who advises the Royal College of General Practitioners, said the study “describes multiple systemic failures in the provision of safe and effective evidence-based medicine” and the situation has made it “impossible for patients and the public to make an informed choice about what is best for their health and life.”

Some others criticized the paper, including Dr. Victoria Male, an immunologist at Imperial College London.

Male wrote on Twitter that the table in the paper outlining the number of people in each age group estimated to need a vaccination to prevent a COVID-19 death “is quite in favour of vaccination.”

Zachary Stieber : REPORTER & Jan Jekielek : SENIOR EDITOR

Source: Epoch Times

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