Friday, June 16, 2023

Has MHRA (UK equivalent of VAERS) Admitted That it Missed Covid Vaccine Safety Signals?

by Dr. Dickie Hart, 16 June 2023

While politicians deploy hyperbolic scaremongering about climate change, food shortages and the threat of nuclear war and set up anti - disinformation units (censorship bureaus,) while media ramp up threats of 'the next pandemic and stories about transgenderism, immigration or societal breakdown as they desperately try to deflect attention from the real threats of food shortages, economic meltdown and the destabilisation of the global economy, things are happening in the real world.

In Germany, Japan, the USA and here in UK rigorously conducted studies are revealing that with excess deaths running as truly alarming levels, stupendous numbers of people have suffered serious harm soon after receiving COVID shots, with heart disease (myocarditis,) blood clots and other serious conditions associated with the mRNA vaccines.

Ignored by the politicians and talking heads and unreported by both broadcast and print / text branches of mainstream media, the COVID killer pandemic narrative is slowly unravelling. The disease itself was no more serious a threat that the seasonal 'flu which comes around every winter and the infection to fatality rate (IFR) of COVID in people under retirement age is considerably lower than that of 'flu. People intent on holding the scaremongering narrative together (usually because they have financial links to vaccine manufacturers,) are quick to point out that the IFR for Covid was considerably higher among old people and those made vulnerable by prexisting health conditions, but the same coulfd be said for most diseases.

Also this week my attention was drawn to  minutes of meetings of the Commission on Human Medicines (here and specifically here), which reveal that MHRA (Medicines and Healthcare products Regulatory Agency had been concerned about the large numbers of Covid vaccine 'Yellow Card' (safety signal,) reports swamping the database and distorting the statistical analysis it relies on to detect safety concerns about healthcare and medical products. MHRA was concerned enough to conduct an investigation, write a report and consult the Commission on Human Medicines about it in June 2022. A  Freedom of Informations (FOI) requestas w submitted last December asking for a copy of MHRA’s report. This was all mentioned in the Perseus Report.

Nearly four months after the request, and after two complaints and the threat of legal action, MHRA eventually released its report. It’s quite technical but it makes very interesting reading.

It is  something of a shock to learn that MHRA’s safety monitoring of medicines doesn’t rely on investigating individual Yellow Card reports and assessing evidence of causality. Instead, it relies on statistical analysis called ‘disproportionality analysis’. This involves mining the database of Yellow Card reports looking for statistically significant differences in the frequencies of different types of side-effect between the drug of interest and other drugs. All medicine regulators use disproportionality analysis but there are differences in the algorithms (ROR, PRR, EBGM etc.) and the signal detection thresholds they use. This all sounds highly technical but although my only qualification in statistics is a fairly low level I can tel you these techniques can be summed up briefly as rigging the data. (An old saying in the computer business goes: "If you torture data enought it will give you the answer you want."

As its report says, MHRA was concerned about the effect on its own disproportionality analysis due to the very large proportion of COVID-19 vaccine reports in its Yellow Card database (by June 2022 it was over 80% of all vaccine-related Yellow Cards). Specifically, they were concerned that:

  • “With the majority of the vaccine dataset now comprised of reports for COVID-19 vaccines, these have the potential to unduly influence the disproportionality statistics for other vaccines.”
  • “If the safety/reporting profile for the COVID-19 vaccines differs significantly from other vaccines then this will impact disproportionality statistics and either mask potential signals or result in more false positive signals.”
  • “Additionally, there are potential issues with the large volume of COVID-19 vaccine reports impacting the disproportionality analyses for the COVID-19 vaccines themselves.”

The report concluded that the high number of Covid vaccine Yellow Cards was indeed suppressing signal detection for other vaccines. So the MHRA decided to remove Covid vaccine Yellow Cards from disproportionality analysis of other vaccines.  

For disproportionality analysis of Covid vaccine Yellow Cards, the investigation led MHRA to decide to assess Covid vaccines against other drugs (rather than other vaccines) and ditch the use of EGBM/EB05 based on RRR (relative risk ratio, used since 2006) and revert to just using the simpler PRR (proportional risk ratio) technique.

So what, I hear you say. It’s somewhat reassuring that MHRA spotted a potential problem with its safety signal detection methods and acted on it. But it’s the opposite of reassuring, for at least three reasons. First, it is evidence that potential safety signals for the Covid vaccine (and other vaccines) were being missed as the number of Covid vaccine Yellow Cards quickly mounted. Secondly, the Commission on Human Medicines seems to have just meekly accepted MHRA’s report and recommendations (here) without asking any probing questions – such as what about the missed signals, can signals still be missed, what are other regulators doing? Thirdly, it should have been (but wasn’t) a reminder to MHRA that it should also actively follow-up individual fatal and serious Yellow Card reports and not rely so heavily on statistical analysis.

On that last point, MHRA said here that “the MHRA carefully evaluates reports of serious suspected side-effects as soon as they are received to consider whether the medicine or vaccine may have caused the event, or whether the event was likely to be purely coincidental”.  

Just how many people have to die or suffer debilitating illness before these clowns realise it is far to many to be dismissed as coincidence?

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