"From Watchdog to Enabler?" Undertake urgent review into MHRA's approval of Covid vaccines.
#together urges you to co-sign this open letter to UK Government.
The MHRA (Medicines and Healthcare products Regulatory Authority), which is responsible for the safety and efficacy of medicines used in the UK, announced that it has morphed “from Watchdog to Enabler.”
Would anyone be concerned if the Office for Nuclear Regulation, the Civil Aviation Authority or the Defence Safety Regulator made the same statement?
It has become clear during the Covid-19 pandemic that the MHRA has failed to meet its responsibilities in multiple ways, despite prior warnings of inadequate regulation published in Government reports.
This has resulted in harm to individuals, who are currently struggling to get recognition, treatment and compensation.
Everyone is invited to co-sign the Open Letter to Health Secretary Steve Barclay below. We will be delivering a hard copy in April.
Open Letter to:
Steve Barclay, Secretary of State for Health & Social Care
cc Rishi Sunak, UK Prime Minister
We, the undersigned, have had increasing concerns over the poor record of the Covid-19 vaccines for both safety and efficacy.
Many of us have signed letters to the MHRA questioning various aspects, particularly regarding the use of these products in healthy children and have received no proper replies. The official response points to the ‘world class MHRA’, who can be trusted to have fully assessed that these vaccines are ‘Safe & Effective’ before providing any authorisation.
It has therefore been a revelation to read this detailed report of the inner workings of the UK’s regulatory authority.
The shortcomings outlined in the report, following on from the recent Cumberlege Report and coupled with the close relationship between the MHRA and the pharmaceutical industry, point to the need for an urgent reappraisal of the whole system of drug regulation.
The level of adverse events from the current vaccines, also requires urgent scrutiny.
We have no confidence in the process for ensuring ongoing safety of the Covid-19 vaccines and call for an immediate pause whilst an independent safety review is undertaken.
A very important letter to join in signing...the Chair of the MHRA, Stephen LightHouse, is standing down in July after 8 years in post....Raine should be indicted before she makes the decision to stand down. She made the unilateral decision for the MHRA to become an 'enabler', not the stringent regulator it should be for the nation's health. She has said at one of the MHRA's Board meetings that the 'vaccines' are "safe for most people".....how does that statement square with all the recorded adverse reactions and fatal outcomes ( post jab) on the MHRA'S Yellow Card reporting system? ( it is considered that the Yellow Cards capture only about 10% of actual harms and deaths).
Why was Pandemrix removed from market after far fewer recorded adverse reactions but these novel medications allowed to be rolled out indiscriminately, across the age ranges?
Such questions have already been posited and individual MPs contacted - apart from a few MPs the response is ' no response', or, the well worn and meaningless, "safe and effective". Under the leadership of June Raine, the MHRA is an unsafe and ineffective organisation. It is to be hoped this multi signed letter will initiate a forensic investigation of all those serving as Board members.
Thank you for posting this. Also please note that the report is the Perseus Paper, it is 36 pages, and very well organized.
https://togetherdeclaration.org/MHRA/
Here is the executive summary from that report :
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible
for ensuring the safety and efficacy of medicines used in the UK. It has become clear during the Covid-19 pandemic that the MHRA has failed to meet its responsibilities in multiple ways, despite prior warnings of inadequate regulation published in
Government reports:
● no requirement for manufacturers to demonstrate sufficient safety, before or after approvals;
● approvals for younger age groups and children in the absence of long-term safety
data, despite only negligible potential for benefit;
● failure to act promptly on evidence of adverse reactions, to rigorously assess safety evidence and to share it publicly to enable informed consent;
● failure to identify and address problems with manufacturing and quality control.
Bringing a new medicine to market typically takes around ten years but, under intense
political pressure, MHRA gave Conditional Marketing Authorisation for the Covid-19
vaccines after less than one year of clinical trials. It would appear that lessons have not been learned from the rushed Pandemrix Swine-Flu vaccine (2009) or from the report of the Cumberlege report (2020). There were 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.
Unforeseen 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 until JCVI advised that alternatives should be offered for under 40s.
Evidence of numerous vaccine-related side-effects has grown since approval. Serious
side-effects such as myocarditis, clotting problems, neurological problems and
immunosuppression have all been extensively reported.
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.
MHRA falls short of best practice safety management and governance seen in other safety critical sectors such as nuclear, aviation, defence and oil/gas. Shortcomings include:
● no process for investigating fatal/serious Yellow Card reports;
● no independent safety audits of MHRA;
● lack of accountability and no predetermined safety thresholds in stark contrast to regulators of other industries;
● close funding arrangements involving the pharmaceutical industry, creating serious
conflicts of interest.
The serious shortcomings identified raise grave concerns about the ability of MHRA to fulfil its statutory duty to protect the public from harm, by properly regulating the safety and effectiveness of medicines in the UK. Given the level of reported Covid-19 vaccine injuries and the excess deaths across all age groups, these products must be paused while they are properly investigated, and a full independent inquiry launched into MHRA’s regulatory processes and performance.