Meanwhile, a few days ago the EMA published its EPAR (public assessment report) on the Moderna vax (HT @pajz_) https://t.co/LHW4rGgFwV It's 169 pages ...1/n

...There was "a major objection" to the US manufacturing sites, so they were withdrawn. Complete transfer for Europe to Swiss manufacturing due to conclude soon. (There have been Qs in the US about a batch there https://t.co/g573j7uFNQ)...2/n
...If you're interested in the chemical & biological aspects of this vaccine, there are pages for you to dig into - not an area I have any expertise in. Small amount of detail of reproductive toxicity study (in rats): no cause for concern....3/n
...The clinical trial data is from November, as for the FDA data. There's more detail than in the FDA report, though, of the phase 2 study, which hasn't been published. 600 people: a lot of data on immunogenicity (but not cell-mediated immunity)...4/n
...More methodological data on blinding etc for the phase 3 trial & *a lot more data* than in the FDA report. And take a moment to appreciate this: 30,000 people enrolled in less than 3 months. Giant thank you's due all round ...5/n
...In my posts, I've pointed to FDA report someone with apparent severe Covid-19 not adjudicated or in Moderna's analyses. Now we know why: no cases before dose 2 & not all suspected ones were adjudicated. That's not reassuring, though they conclude "no substantial bias" ... 6/n
...Like FDA, EMA point to person with severe Covid-19 in the vaccine group. Overall, data on severity reassured them, but "the cases overall seem mostly mild, which is a limitation of the dataset". "No definitive conclusion on clinical efficacy after one dose can be drawn" ...7/n
...They also conclude the definition of severe Covid-19 "could have been more stringent from a clinical
perspective". They say open questions remain about the lower bound for the confidence interval of efficacy, partly because of the case ascertainment issue, so... 8/n
...they want more data in a final report by December 2022 before considering approval. Serious adverse events seem similar to FDA's conclusions (but I haven't cross-checked case by case). Apropos today's other discussion: 7,520 people were aged 65+...9/n
...Conclusion? This is a far better report than the FDA's one on this vaccine: it's the "go to". Not comfortable that the unadjudicated person with severe Covid signals a bigger issue, but very glad the EMA is on it. 10/10

More from Government

This article by Jim Spellar for @LabourList misses the point about why Labour needs to think seriously about constitutional reform - and have a programme for it ready for government.


The state of our constitution is a bit like the state of the neglected electric wiring in an old house. If you are moving into the house, sorting it out is a bit tedious. Couldn’t you spend the time and money on a new sound system?

But if you ignore the wiring, you’ll find that you can’t safely install the new sound system. And your house may well catch fire.

Any programme for social democratic government requires a state with capacity, and a state that has clear mechanisms of accountability, for all the big and all the small decisions that in takes, in which people have confidence.

That is not a description of the modern UK state.

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हिमालय पर्वत की एक बड़ी पवित्र गुफा थी।उस गुफा के निकट ही गंगा जी बहती थी।एक बार देवर्षि नारद विचरण करते हुए वहां आ पहुंचे।वह परम पवित्र गुफा नारद जी को अत्यंत सुहावनी लगी।वहां का मनोरम प्राकृतिक दृश्य,पर्वत,नदी और वन देख उनके हृदय में श्रीहरि विष्णु की भक्ति अत्यंत बलवती हो उठी।


और देवर्षि नारद वहीं बैठकर तपस्या में लीन हो गए।इन्द्र नारद की तपस्या से घबरा गए।उन्हें हमेशा की तरह अपना सिंहासन व स्वर्ग खोने का डर सताने लगा।इसलिए इन्द्र ने नारद की तपस्या भंग करने के लिए कामदेव को उनके पास भेज दिया।वहां पहुंच कामदेव ने अपनी माया से वसंतऋतु को उत्पन्न कर दिया।


पेड़ और पौधों पर रंग बिरंगे फूल खिल गए और कोयलें कूकने लगी,पक्षी चहकने लगे।शीतल,मंद,सुगंधित और सुहावनी हवा चलने लगी।रंभा आदि अप्सराएं नाचने लगीं ।किन्तु कामदेव की किसी भी माया का नारद पे कोई प्रभाव नहीं पड़ा।तब कामदेव को डर सताने लगा कि कहीं नारद क्रोध में आकर मुझे श्राप न देदें।

जैसे ही नारद ने अपनी आंखें खोली, उसी क्षण कामदेव ने उनसे क्षमा मांगी।नारद मुनि को तनिक भी क्रोध नहीं आया और उन्होने शीघ्र ही कामदेव को क्षमा कर दिया।कामदेव प्रसन्न होकर वहां से चले गए।कामदेव के चले जाने पर देवर्षि के मन में अहंकार आ गया कि मैने कामदेव को हरा दिया।

नारद फिर कैलाश जा पहुंचे और शिवजी को अपनी विजयगाथा सुनाई।शिव समझ गए कि नारद अहंकारी हो गए हैं और अगर ये बात विष्णु जी जान गए तो नारद के लिए अच्छा नहीं होगा।ये सोचकर शिवजी ने नारद को भगवन विष्णु को ये बात बताने के लीए मना किया। परंतु नारद जी को ये बात उचित नहीं लगी।