The World Council for Health (WCH) endorses Safe and Effective?, a new report released on 19 April 2023 produced by Perseus, a multidisciplinary team of experts from various fields including medicine, pharmaceutical regulation, and safety management.
The 36-page report is intended to widen the visibility of the UK’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) regulatory failures to Parliamentarians, the media, and the public, and details numerous systematic ongoing failures by the Medicines and Healthcare products Regulatory Authority (MHRA) in its responsibility to ensure the safety and efficacy of medicines in the UK.
Specifically, the report highlights how failures by the regulator resulted in the public being exposed to serious side effects such as myocarditis, clotting problems, neurological problems, and immunosuppression as a result of the Covid-19 vaccines.
Bringing a new medicine to market typically takes roughly ten years but, under intense political pressure, MHRA gave Conditional Marketing Authorisation for the Covid-19 injections following fewer than one year of clinical trials.
It would appear lessons have not been learned from the House of Commons Health Select Committee in 2004 on the influence of the pharmaceutical industry, the late withdrawal of the Swine Flu vaccine in 2009, and the damning Cumberlege Report in 2020. There were also numerous published reports and warnings about the risks of MHRA approving the Covid-19 vaccines on such limited evidence. Indeed, even the manufacturers claim to have been expecting to provide more safety evidence for the new vaccines before approval.
It is therefore not surprising that serious side effects emerged immediately. The AstraZeneca vaccine was suspended from use in young adults in many countries after only two months, but MHRA was still attesting to its safety months after this point until JCVI advised that alternatives should be offered for those under 40.
MHRA did not follow through on its promised ‘Proactive Vigilance’. This was supposed to have included population-level NHS data, segmented by vaccination status to look for any link between the vaccines and reported serious side effects.
The regulator also falls short on best practice safety management and governance that is seen in other safety critical sectors such as nuclear, aviation, defence and oil/gas. Shortcomings include:
- No process for investigating fatal or serious Yellow Card reports;
- No independent safety audits of MHRA have been carried out, despite this being required;
- A distinct lack of accountability;
- No predetermined safety thresholds, which is stark contrast to regulators in other industries;
- Funding arrangements that involve the pharmaceutical industry, which creates serious conflicts of interest.
World Council for Health co-founder Dr Tess Lawrie has this to say of the report’s revelations, “Most concerningly, these regulatory failings are common to regulatory agencies around the world that, having serious conflicts of interest, have taken on the role of drug industry enablers instead of public watchdogs. There is no doubt about it, they have put millions of people in harm’s way.”
Due to the significant number of reported injuries associated with Covid-19 vaccines and increased deaths across all age groups, the report authors believe it is imperative to withdraw these products until a thorough investigation is conducted. A comprehensive independent inquiry must be launched into the MHRA’s regulatory processes and performance. The agency must undergo an overhaul of its governance and accountability processes to restore public trust.
The harm done to the vaccine-injured and bereaved family members must also be recognised. Urgent measures must be put in place to ensure future victims are diagnosed and treated promptly and compassionately, and rapid action must be taken by the regulators to identify and reduce the risk of further injuries. In addition, we have a duty as a civilised society to recognise and make reparations for the significant price that many individuals and families have paid as a consequence of the failure of the MHRA to fulfill their duty of care to protect the public from dangerous products.
Rapid implementation of easy access to much-needed financial and practical support and compensation must be made a priority, to alleviate significant hardship and suffering currently being endured by the vaccine-injured and bereaved.
Every Member of Parliament in the UK has been sent a physical copy of the new report prepared by Perseus, as have many in the House of Lords. Those in the UK can help by writing to your MP to demand they read the report and act on its findings.
The report can be downloaded here: https://perseus.org.uk/main-report
Take Action
UK residents are asked to sign this petition demanding a Public Inquiry into the approval process for Covid-19 vaccines. At 100,000 signatures, the petition will be considered for debate in Parliament. The deadline is 24 May 2023.
#Together is intending to send this open letter to the UK government which references the Safe and Effective? report. If you agree that this is important, please consider adding your signature and sharing it with others.
