Leading doctors have joined a call to suspend all COVID-19 mRNA vaccines until serious side-effects are fully investigated and the raw trial data from Pfizer’s COVID-19 vaccine trial are released for independent analysis to help determine the true benefits and potential harms for different age groups.
Writing in the peer-reviewed Journal of Insulin Resistance, one of the U.K.’s most eminent Consultant Cardiologists Dr. Aseem Malhotra, who was one of the first to take two doses of the vaccine and promote it on Good Morning Britain on TV, says that since the rollout of the vaccine the evidence of its effectiveness and true rates of adverse events has changed.
In a two-part research paper entitled “Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine”, real-world data reveal that in the non-elderly population the number needed to vaccinate to prevent one death from COVID-19 runs into thousands and that re-analysis of randomised controlled trial data (that first led to approval of the vaccines for Pfizer and Moderna) suggests a greater risk of suffering a serious adverse event from the vaccine than being hospitalised with COVID-19.
Dr. Malhotra writes: “Pharmacovigilance systems and real-world safety data, coupled with plausible mechanisms of harm, are deeply concerning, especially in relation to cardiovascular safety.”
Mirroring a potential signal from the Pfizer Phase 3 clinical trial, a significant rise in cardiac arrest calls to ambulances in England was seen in 2021 (an extra 14,000 compared to 2020) with similar data emerging from Israel in the 16-39 year old age group where there was a 25% increase in heart attacks or cardiac arrests associated with the Pfizer vaccine administration but not associated with COVID-19.
Citing the FDA’s own website he also highlights that testing positive for antibodies is an unreliable marker for immunity or protection against Covid post-vaccination.
It cannot be said that the consent to receive these agents was fully informed, as is required ethically and legally. 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 informed consent. These regrettable actions are a symptom of the ‘medical misinformation mess’: The tip of a mortality 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 very corporations that stand to gain from the sale of those medications. A failure of public health messaging has also resulted in wanton waste of resources and a missed opportunity to help individuals lead healthier lives with relatively simple – and low cost – lifestyle changes. The unprecedented rollout of an emergency use authorisation vaccine without access to the raw data, with increasing evidence of significant harms, compounded by mandates that appear to serve no purpose other than to bolster the profits of the drug industry, have highlighted modern medicine’s worst failings on an epic scale, with additional catastrophic harms to trust in public health. There is a strong scientific, ethical and moral case to be made that the current Covid vaccine administration must stop until all the raw data has been subjected to fully independent scrutiny. Looking to the future, the medical and public health professionals must recognise these failings and eschew the tainted dollar of the medical-industrial complex. It will take a lot of time and effort to rebuild trust in these institutions, but the health of both humanity and the medical profession depend on it.
We must use this as an opportunity to transform the system to produce better doctors, better decision making, healthier patients and restore trust in medicine and public health. Until all the raw data on the mRNA COVID-19 vaccines have been independently analysed, any claims purporting that they confer a net benefit to humankind cannot be considered to be evidence based.
Professor of Vascular Surgery and President of the International Vascular Society Dr. Sherif Sultan said:
Doctor Aseem Malhotra’s literature review and analysis is a cause for global concern. 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. These 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. Surveillance of potential vaccine side-effects and COVID-19 outcomes to identify public health trends and promptly investigate potential underlying causes needs immediate attention.
Professor of Medicine and Epidemiology at the University of Stanford Jay Bhattacharya said:
Dr. Aseem Malhotra has written detailed narrative review of the literature on the uses and abuses of the mRNA Covid vaccines. Dr. 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. He 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. Malhotra’s paper calls for a pause in the use of the vaccine in younger people, such as the one recently adopted by Danish public health authorities and the Florida department of public health in the United States. He calls for investigation of side-effect profiles of mRNA vaccines and for a halt to any vaccine mandate programmes involving Covid vaccines. These papers should be considered carefully by all public health authorities who seek to adopt principles of evidence based medicine in their recommendations to the public regarding the Covid mRNA vaccines.
Dr. Amir Hannan MBE, General Practitioner and Chairman of the West Pennine Local Medical Committee, Greater Manchester said:
Dr. Aseem Malhotra should be congratulated for putting this all together to help inform the public, the medical profession, the regulators, Government, the pharmaceutical industry and wider society. Drug treatments and vaccinations can be an important part of helping to overcome disease and prevent illness but we must remain vigilant against over-reliance on the benefits and minimising or even suppressing the harms. Greater scrutiny of the data and those overseeing medical practice is needed to ensure the public and the profession remain safe. An urgent review is needed of the materials and information provided on the COVID-19 vaccines to help inform the public so that informed consent is gained through a shared decision-making process with education and training in light of the new evidence emerging.
Dr. Campbell Murdoch, General Practitioner and Clinical Advisor to the Royal College of General Practitioners said:
Provision of safe and effective healthcare sits at the heart of medical services. As a GP this is central to every action I take with patients. The healthcare regulator in England, the Care Quality Commission, requires this from all providers of medical care. As Dr. Malhotra describes, to be able to provide safe and effective care all healthcare professionals must practice evidence-based medicine. This is a combination of using the best available scientific evidence, the patient’s preferences, and the healthcare professional’s expertise. The combination of these three factors allows the patient to make an informed choice about what is best for their health. In the case of the COVID-19 vaccination Dr Malhotra describes multiple systemic failures in the provision of safe and effective evidence-based medicine. Consequently, it has been impossible for patients and the public to make an informed choice about what is best for their health and life. High quality healthcare requires organisations and individuals to act with complete integrity. Without this the delivery of safe and effective healthcare will always fail. Errors in healthcare can provide an opportunity to improve. It is now time to reflect and learn from the experience of the COVID-19 vaccination. Healthcare must always help, not harm.
Dr. Bob Gill, General Practitioner, activist and producer of documentary “The Great NHS Heist” said:
This important two-part review of the impact of the international rollout of mRNA vaccination programme highlights significant concerns about the overstated benefits of vaccination especially in low-risk populations and the under-reporting of adverse events. Public information and consent to vaccination has not been balanced, neglecting discussion of individual risk versus benefit of having the shot. The quality of evidence provided by vaccine producers and lack of openness from the pharmaceutical industry risk long-lasting damage to confidence in public health interventions. Part two of the review sets out how regulatory capture by pharmaceutical corporations and their immense financial power influences politicians and media to promote products at the expense of scientific scrutiny and unfettered access to research on which decisions of immense impact are made. Bias and conflicts of interest abound in the medical-industrial complex with well-documented adverse outcome for patients from over-medicalisation and prescription drugs. Coercive vaccine mandates based on biased and short trials with unpublished raw data are the culmination of the unchecked power of the pharmaceutical industry to the exclusion of effective lifestyle-factor risk reduction, which was ignored by media and politicians alike. Given the declining virulence of the infection and mounting evidence of vaccine-related harms, there can be no justification to continued mass roll-out of booster programmes, given the short-term risks from the vaccine likely outweigh the benefits for the majority of the population and we remain ignorant of the long-term risk to health.
Dr. Renee Hoenderkamp, General Practitioner, writer and broadcaster said:
This is an important paper from Aseem. As a GP in a small practice I have two young patients with post-vaccine heart conditions confirmed. They were not counselled on the risk of this as part of an informed consent process. Surely any medical professional should want their patients to fully understand the risks and benefits of a medication they take, and welcome that discussion? As the evidence evolves and we see clearly that the risk from both COVID-9 and the vaccine designed to protect against it differs massively by age, sex, co-morbidity and previous infection, it becomes ever more important to give patients the information they need to make an informed decision. This important paper brings those risks and benefits into sharp focus and should allow the desperately needed discussion that has thus far been sorely missing from any examination of vaccination benefit and harms. Aseem opens up the discussion around both the harms and the ability to have a healthy discourse and I welcome it.