MHRA verdict reportedly coming any day for the Oxford/AstraZeneca vaccine. I've been asked if I think their process is comparable to FDA's. Good question, post-Brexit. So I looked at 3 regulator reports for Tozinameran (BNT/Pfizer): FDA, MHRA, EMA (Europe) ...1/6
...2 agencies have unequivocal advantages:
1) Only the EMA did manufacturing inspections, which is a very big deal;
2) FDA had greater transparency: they're the only 1 releasing manufacturer briefing, released reports pre-committee, live-streamed committee discussion ...2/6
1) Only the EMA did manufacturing inspections, which is a very big deal;
2) FDA had greater transparency: they're the only 1 releasing manufacturer briefing, released reports pre-committee, live-streamed committee discussion ...2/6
... FDA assessment report: 92 pages, almost all clinical data/issues, extensive data analysis - released days before their decision;
MHRA: 51 pages, not as much analysis - released 2 weeks after decision;
EMA: 140 pages, extensive data analysis, wide coverage ...3/6
MHRA: 51 pages, not as much analysis - released 2 weeks after decision;
EMA: 140 pages, extensive data analysis, wide coverage ...3/6
...I'm collecting regulators' reports here zotero.org/groups/2528572…
I think FDA might have edge on clinical data analysis over EMA, but my analysis wasn't thorough. We can't know what went on behind the scenes obviously, but the MHRA *report* is lighter on detail/analysis...4/6
I think FDA might have edge on clinical data analysis over EMA, but my analysis wasn't thorough. We can't know what went on behind the scenes obviously, but the MHRA *report* is lighter on detail/analysis...4/6
..FDA & EMA reported detailed serious adverse events (SAEs), with verdicts which differed from the manufacturers' take. FDA raised issues re lymphadenopathy & Bell's palsy; so did EMA, plus acute peripheral paralysis. MHRA detailed none & "No significant concerns are raised"..5/6
... Overall? The scope of what the EMA is reporting seems closer to a full assessment, not just an emergency use one. However, given the FDA reportedly undertook complete data re-analysis, that's a major strength. 6/6
PS: Left out a detail in the thread ⬆️: the EMA assessment report was released 2 days after their decision.
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