Revealed: Why Britain’s regulator missed the link between the AstraZeneca jab and rare blood clots telegraph.co.uk/global-health/…
2/ We confirmed the first three cases of CVST+H happened in Jan and Feb. Two life-changing events and one death. The first Yellow Card came in, say the MHRA, on 8 Feb - the day the vax launched in Europe. Why were these and other early signals missed?
3/ We identified three reasons. First, the "sensitivity" of the algorithms/processes used by MHRA were lower than in parts of Europe. We tracked against background rates, while others turned the sensitivity dial up to 11...
4/ This is, in part, a function of resources. More sensitivity = more leg work. Observers say this should be seen in the context of the “operational and logistical challenges” the MHRA faced in becoming a sovereign regulator on Jan 1 - bang in the middle of a pandemic...
5/ Which points to a second point: The MHRA lost access to Eudravigilance, the vast European database into which all adverse drug reactions are reported, at the same time - the very point we needed it most. See quote below from EMA....
6/ The old tension between transparency and paternalism may also have played a part. EU regulators took a very modern and open approach, the MHRA really didn't. Those first reports of early mid Feb were not mentioned until 18 March. We have since identified 100 CVST+H cases...
7/ The reason all this is important has less to do with the jab itself than good comms and regulation. Even at a 1/100k incidence, the risk is tiny. As @d_spiegel points out, you have about the same chance as guessing the last five digits of a stranger's mobile phone number....
8/ The real question is this: Had the MHRA been quicker and more open, might it have been better able to shape reaction and policy towards the AZ globally? For make no mistake, the AZ vaccine remains vital for fighting #COVIDー19 around the world, esp in developing countries...
9/9 The full story is here. Ii is OPEN and FREE to read 🔓🔓🔓 @TelGlobalHealth
telegraph.co.uk/global-health/…
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