Wathion assumes the FDA (and the MHRA’s) EUA would be issued before the EMA granted its own CMA, which turned out to be correct. What’s interesting is his concern to address the ‘damage limitation’ resulting from the probable outcome of the EMA finishing last in this regulatory race and his fear that this would result in public opinion and the media turning against the agency. Speed seemingly superseded concerns of quality based on a careful review of these emails.
In a November 19 email, Wathion reveals a ‘rather tense’ TC (teleconference call) with the European Commissioner (Ursula von der Leyen) which was ‘at times even a bit unpleasant.’ This reflects the mounting pressure which the EMA staff were under to issue CMA quickly following an EUA granted by the FDA/MHRA for the Pfizer-BioNTech vaccine. Von der Leyen is implicated in potentially being responsible for this tense environment with ‘a delay of several weeks…not easily acceptable for the EC [European Commission].’
In early 2022, Trial Sites News reported how von der Leyen was embroiled in scandal when a group of independent MEPs demanded her immediate resignation and full disclosure of a series of private text messages between her and Pfizer’s CEO, Albert Bourla. Only a small portion of these texts were ever disclosed. Of the ones that were, they revealed her negotiating portions of a European-wide vaccine deal, unilaterally with Bourla via a series of texts! Clearly standard protocols in Europe were thrown out the window in favor of expediency and this seemingly was tied to a unified competitive pressure on all three regulatory agencies.
Wathion lays bare his reflections after this particular TC, and shockingly writes how ‘the political fall-out seems to be too high even if the “technical” level at the MSs [Member States] could defend such a delay in order to make the outcome of the scientific review as robust as possible.’ Put another way the continuous broadcast of science first appeared as a cover for politics first.
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