The MHRA Papers - Part 10
The antibody two-step
SUMMARY: We secretly discussed the types and quantities of antibodies produced by vaccination in trial participants. The only trouble is that we do not know how antibodies correlate to effectiveness, but all is well and secret, of course.
We continue reviewing the minutes of the MHRA’s Commission On Human Medicines (CHM) COVID-19 Vaccines Benefit Risk Expert Working Group meeting, which took place on 29, 31 December 2020, and 3 January 2021.
These secret meetings were devoted to the Oxford Astra Zeneca product, dealing with sensitisation issues. The minutes are tedious and complicated and relate to a vaccine that is no longer available. We will move on to the 13 January meeting, but those interested in each meeting can access the relevant files through the hyperlink.
On 13 January, the EWG examined safety data in those with prior COVID-19 infection recipients of mRNA COVID-19 vaccines, the risk of anaphylaxis with Pfizer/BioNTech and Moderna COVID-19 vaccines, and got an update on the Safety Data for the Pfizer/BioNTech COVID-19 vaccine.
“[For Comirnaty] The EWG were assured that low levels of lymphadenopathy were observed, and this event is listed in Section 4.8 of the SmPC. The EWG heard there were no cases of appendicitis”.
The text does not mention lymphopenia, C-reactive protein (CRP—an aspecific marker of inflammation), or thrombocytopenia. This does not mean the two were not discussed, but the minutes did not record them.
Perhaps the most interesting statement can be found on page 4 of the document and para 2.5:
Two points stick out:
First, this statement applies to all respiratory virus vaccine trials that rely on antibody response as a surrogate marker for field protection and, hence, effectiveness. Regulators have been well aware of this problem for decades but have primarily done nothing to address it.
Second, readers will see the interminable discussions around antibody responses if they go through the minutes. The validity of these discussions is only relevant to potential harms, as the statement we reported above undermines the significance of antibody responses in vaccines as a marker of effectiveness.
The MHRA were informed that 500 yellow cards concerning the AZ vaccine had been received, which they stated did not indicate any signals. While future steps ‘indicated that the content of the papers and proceedings of the meeting were strictly confidential and should not be disclosed,’ not one person around the virtual EWG table bothered to ask about the inadequacies of the Yellow Card System.
This post was written by two old geezers who understand why they are never invited to safety meetings.
Hi John and Vivian thank you for your excellent comments. Its is not by chance that EBM has been marginalised and infiltrated - just think of the onslaught on the Cochrane review A122 which we have documented many times. The onslaught is based on the fact that the review does not reach the "right” conclusions.
One more. Everyone in vaccinology knows that antibodes are a hit and miss correlate of protection. I once asked a PHE (now UKHSA) grandee what the serological correlates were and she answered (referring to antibodies): "the more the better".
These EWG guys (or at least the vaccinologists among them) knew the problem very well, but there is no trace of discussion as we shall show in Part 13.
Keep supporting us please, we need you.
Best, Tom.
Hi Keith, It’s not they do not look for them, they are very rare as we showed in the F word and Connecting the Dots series.
In addition most trials are underpowered and the influenza vaccines registration trials have dubious surrogate outcomes (antibody responses).
Best wishes, Tom