MHRA Papers - Part 17
Nothing to see here - move on please.
SUMMARY: No trial evidence in pregnant women and more excuses not to asses reports of possible harms
After the great interest shown by the UK Parliament, our readers and the enablers at the MHRA, we continue reviewing the minutes of the 2 and 9 March 2021 meetings of the MHRA’s Commission On Human Medicines (CHM) COVID-19 Vaccines Benefit Risk Expert Working Group.
Oops…. the Minutes have been withdrawn in the interests of transparency, silly us. Never mind, here are the pdfs.
In the 2 March meeting, the three vaccines (Oxford Astra Zeneca, Moderna and PfizerBioNTech) were discussed, especially their use in pregnant women.
“Pfizer have announced a trial in pregnant women to compare the data to that from their pivotal trial, but as yet this will not involve the UK.”
UK or not, as we have already reported, the trial results are still unavailable. Pregnant women were and continue to be exposed to vaccination without a shred of evidence, as pregnancy was an exclusion criteria in all the trials. So, the discussion must have been one of the shortest on record.
On the 9 March, the secret squirrels “heard” about a clutch of reports of possible nasty harms, including recognised ones such as Guillain Barre’ Syndrome (GBS) included in thousands of reports to the Yellow Card System (the one the Secretary of State knew nothing about) Platform.
We ran a series on systems for reporting adverse drug reactions, highlighting the cost to the health system is substantial and that failure to act will only lead to more harm.
The MHRA said it took all reports with a fatal outcome in patients who have received a COVID-19 vaccine very seriously, and every report with a fatal outcome is reviewed carefully, which we have recently reported not to be the case.
Evidence was mounting of possible harms which needed investigating given that by that point in England alone, 45% of the population had already been exposed at least once to the vaccines:
But:
“The EWG stated that there was the potential of an increased signal of GBS, particularly with the AstraZeneca vaccine and that reports of GBS should be closely monitored but that a formal epidemiological study was not yet indicated at this stage” (our emphasis).
TTE would like to know what would it take to launch a formal epidemiological study?
This post was written by two old geezers who wonder what it takes to launch a formal epidemiological study. They also wonder what happened to the precautionary principle given that most recipients were healthy.
My daughter had a reaction to AstraZeneca- the symptoms were those of GBS. Unfortunately her GP was of no help, just called it a reaction to Covid (she didn’t get Covid until after the jab). She was sent to hospital where she received no treatment at all, there were no doctors available! She discharged herself after 4 days. Also, sadly, our daughter had swallowed the Kool Aid so we couldn’t discuss it with her. We were beside ourselves with worry but luckily the symptoms subsided after a week or so.
Thanks again for pointing out the ominous omission of tests in pregnant women!
I suggest - tongue firmly in cheek! - the reason for that omission can be found in this latest statement by Ms Pritchard:
“Ms Pritchard insisted that women’s health was a “priority” for the health service but said that the health service had been “built by men and doesn’t always have the needs of women at its heart”."
Sadly, I'm not aware of her or any other women's health advocates pushing for tests in pregnant women before the vaccine was rolled out, but then, being an old geezerette, my memory is probably failing ....