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When will this shit end?


Chrisp1986

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2 hours ago, kalifire said:

At the same time, aren’t you the fish pushing for Boris to act on easing restrictions as soon as possible? If football fans are causing a problem, then isn’t there a problem (regardless who it is)? If they’re not, why target them? 

It wasn't a serious post lol 

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2 hours ago, Toilet Duck said:

Normally, Phase 3 RCT data is what is used for initial approval or registration of a new drug/vaccine (to be supplemented with real world use data and ongoing pharmacovigilance data at specified timepoints to hold onto the approval)...for the EUA submissions that all the vaccines have used, Phase 3 RCT data was what was required by the regulators (and in the EU, that approval converts to full approval within 12 months if they add in the extra data requested from additional trials in new cohorts that the vaccine wasn't approved for in the first place (adolescents and kids for example)). AZ did submit their Phase 3 data to the FDA, but they f*cked it up and sent in data that was out of date and gave an inaccurate view of performance (and they were hauled in to explain it). So, they are re-doing the submission with a new endpoint last I heard. I think they were looking at skipping EUA altogether and just going for full approval from the FDA since they now have enough endpoints for that and also have real world use data from elsewhere to bolster that submission. Pfizer have already gone ahead with their full approval submission too. The AZ issue in terms of accepting it for travel etc was flagged to me by mates in the NIH a while back (they suggested if I had a choice, take one of the FDA approved ones to avoid any hassle). The general feeling is that eventually, either AZ will get full approval from the FDA, or the US will loosen it's stance on which vaccines it will accept (likely to happen once the travel corridor with the EU opens up again later in the summer, since there are EU citizens vaccinated with AZ and the EU won't agree to letting US citizens into the EU but excluding some EU citizens from entry to the US simply on the basis that they had an EMA approved vaccine but not an FDA approved one....reciprocity is their buzzword!). So, unless you need to go now (when travel to the US is a pain in the arse anyway), it should be fine I'd expect. 

Feb 2022 I 100% have to go...  can put it off to then 😜

Thanks for that explanation 

Edited by Barry Fish
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1 hour ago, Barry Fish said:

Feb 2022 I 100% have to go...  can put it off to then 😜

Thanks for that explanation 

No worries! I reckon you’ll be grand by then. I have to go to Texas in December and I’m assuming that’ll be fine (well, I hope it will!)…

Edited by Toilet Duck
Stoopid autocorrect!
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