The report’s findings about systemic failures in MHRA’s regulation of medicines include :

  • it assesses the safety of a medicine relative to its benefit, not its safety in absolute terms.  It’s like the Nuclear Regulator saying “your nuclear power station is safe because it has fewer contaminated water leaks than theirs”;
  • it does not define the tolerable rate of fatal and serious side-effects of new medicines.  If it did, it would have a clear threshold for action if subsequent evidence of reduced benefit or increased risk emerges after Authorisation.  This probably explains MHRA’s slowness to act when subsequent problems emerge, as has happened with many medicines not just the Covid vaccines;
  • it has no process for fully investigating Yellow Card reports of fatal/serious adverse events potentially linked to a medicine;
  • it has serious manpower shortfalls;
  • it has less robust safety management systems and processes than exist in other safety critical sectors (eg aviation, defence, nuclear, oil & gas, rail); and
  • There have been no safety audits of MHRA.

And in relation to the Covid vaccines in particular :

  • it licensed the vaccines based on limited short term data and no long term data
  • it licensed the novel Covid mRNA therapies as vaccines (which have lower regulatory requirements);
  • it failed to identify and address problems with manufacturing and quality control.  This led to batch quality problems;
  • it tacitly allowed promotion of the Covid vaccines based on relative percentage benefit (a large number), not absolute benefit (a small change in a very small number).  This compromised informed consent;
  • it consults the Commission on Human Medicines about the risk/benefit of all medicines and the minutes are published – all except those relating to the Covid vaccines.  Again, this compromised informed consent;
  • it did not act on problems with the AstraZeneca Covid vaccine despite other national Regulators suspending and withdrawing it for certain age groups;
  • it did not follow through on its promised ‘4 strand Proactive Vigilance’; and
  • it seems to be ignoring ever increasing evidence of Covid vaccine risks, notably blood clotting, heart inflammation, neurological conditions, immune downgrading, and menstrual disorder.

Patrick Vallance summed up the whole problem in 2014 : 

“In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.”

Given the level of reported Covid-19 vaccine injuries and the excess deaths across all age groups, these products must be suspended while they are properly investigated, and a full independent inquiry launched into MHRA’s regulatory processes and performance.

Download Report

This report is intended to widen visibility of MHRA’s regulatory failures to Parliamentarians, the media and the public.

We’ve sent a copy to all MPs. If you share our concerns we’d be grateful if you would:

Source – https://perseus.org.uk/main-report