The MHRA Papers - Part 2
We have some questions, but there is no formal obligation to reply
We continue reviewing the minutes of the three meetings of the MHRA’s Commission On Human Medicines (CHM) COVID-19 Vaccines Benefit Risk Expert Working Group, which took place between 28 October and 18 November 2020.
During the first meeting, the EWG reviewed the non-clinical and clinical evidence from trial BNT162b2 (Pfizer Biontech). As you may recall from our series on Comirnaty, manufacturers started running two studies in April 2020.
The first is BNT16201, divided into b1 and b2—abbreviated to BNT162b1 (120 participants) and BNT 162b2 (96). The trial is a phase 1 dose-ranging study that was run in Germany.
The first odd thing we noticed is the following statement: “3.2 The EWG agreed that the pharmacokinetics posed no particular concerns.” This is inconsistent with the statement immediately following:
Oddly, parenteral vaccine content stays mainly at the injection site, eliciting a reaction from our immune system (as in the job description). In this case, the stuff went just about …
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