The MHRA Papers - Part 13

The heavily formatted secret minutes

SUMMARY: We report on the most common expressions used to examine and discuss the evidence. The most common was “The EWG heard,” but we do not know who told them what. Secrets are forever. Do not look for “analysed.” It’s not there.

Before continuing our review of the meeting minutes of the MHRA’s ​​Commission On Human Medicines (CHM) COVID-19 Vaccines Benefit Risk Expert Working Group, which took place on 29 January 2021, we would like to point out some interesting facts.

We searched the 19 EWG formerly secret minutes (but heavily redacted in places) relating to the content of the meeting from 25 August 2020 to 3 January 2021. This is the period leading up to the release of conditional market authorisation (CMA in EMA speak) on 21 December 2020 and its UK counterpart on 1 January 2021. This procedure is called mutual recognition in regulatory speak. In the case of biologics, all registrations are handled centrally by EMA.

This, however, is only the legal authorisation to market a produc…