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When will this shit end?


Chrisp1986

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44 minutes ago, phimill said:

@Toilet Duck sorry if this has been asked already!

Do we know what the turnaround time is from the FDA once Bio-n-tech and/or Moderna submit their safety data to give the approval of their vaccine?

Howdy,

Normally it would take a few weeks (at least), however, normally the company would do their interim analysis, see if they are on to something, continue with the trial, and analyse the full trial, prepare their submission to the regulators and then the regulators would comb through the data (only seeing it for the first time after the trial is completed). This time, the company have been providing the data in real time to the regulators, so they have already been looking at it. They are waiting for key signals on efficacy and safety, and once these reach significance, then they can approve for emergency use. The will keep looking at the data and will analyse the final result before they fully approve the vaccine, but since we are in the middle of a pandemic, emergency use allows for it to be widely used. Even after it is approved, for years to come, safety data will be collected to see if there are any unforeseen, really rare side effects that could be avoided. One of the hurdles Pfizer had when they released their interim data was that nobody on the trial had had a severe case of COVID. The FDA had inserted a requirement for at least 5 cases of severe disease in their criteria for granting EUA. However, the trial didn't stop when the interim analysis was performed, and today, Pfizer released more data showing even better protection against disease and now have 10 cases of severe disease in their trial (9 in the placebo arm, 1 in the vaccinated group). This, along with the safety data is enough to file for EUA. November 21st is the first day the FDA can authorise it (if they stick to their own timeline of 2 months minimum safety data), however, it's important to remember that these are the Phase 3 trials...people got the same vaccines in the Phase1/2 trials and we have much longer follow up safety data for those participants (even though there are fewer of them). In fact, there are now hundreds of thousands of participants in COVID vaccine trials all over the world, and off the top of my head, I can only think of 5 serious adverse events (and they are all big news, so get reported pretty quickly). 1 of those was unfortunately in the placebo arm of the Oxford trial, one unfortunately was suicide, one wasn't fully reported (but the trial is up and running again, so must be unrelated) and the other 2 were autoimmune reactions (which occur at a similar or greater frequency from natural infection...in fact one of them was reported to have been an undiagnosed underlying condition anyway). So, it looks like the various vaccines are safe and they work in so far as they stop you getting disease (the sterilising immunity claims that were made when the Pfizer data was released remain unsubstantiated in my view). 

Long story short, we're in uncharted territory in terms of regulatory approval as (like everything else in the development of drugs and vaccines) it usually takes longer when they don't have a global pandemic to try to control!. But, I'd expect it to be on or very soon after November 21st (for Pfizer). 

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59 minutes ago, steviewevie said:

If we go back to the paper we were discussing yesterday from Shane Crotty's lab (the most comprehensive analysis of the immune response to this virus to date), they found huge variation in antibody responses (not just between men and women, but between people with hospitalised cases and asymptomatic cases...some completely asymptomatic cases had huge antibody responses that were really durable). The most important thing though was that the durable immunological memory didn't vary (no difference between men and women) and didn't correlate at all with antibody levels, suggesting that losing circulating antibodies has little or no bearing on what our immunological memory to this infection is like and how we might deal with a subsequent one (someone in the Grauniad should really read the papers they are publishing about rather than just regurgitating copy from elsewhere!). 

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6 hours ago, Fuzzy Afro said:

On the Corbyn stuff, I voted Labour in the last election and knew by approximately 10:04pm that I’d made the wrong decision.

 

I was at my office Christmas party and was drinking with a colleague of mine who I’m fairly close with, but we hadn’t really discussed politics before. She’s also fairly strict Jewish. As the exit poll dropped, she burst into tears and told me how relieved she was that her parents and grandparents wouldn’t have to leave the country. At that point, I realised I was wrong to vote for that version of the Labour Party. 
 

I hope Corbyn doesn’t get the whip back. 

@DickButkis care to elaborate on why you reddie’d this?

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6 hours ago, Copperface said:

Maybe something might result from this. I would imagine a lot of squirming going on .

https://www.bbc.co.uk/news/business-54978460

Thanks for the link mate.  I saw something on newsnight last night and Kier mentioned it today so at least questions are now being asked.  Time will tell if anything comes of it.

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7 minutes ago, JoeyT said:

I'm pleased to see we're seeing a fall in the cases and hoping this will pay off soon... but I'm absolutely heartbroken by the deaths in the last few weeks. So many of them could have been avoided if Boris and co had co-operated with Starmer with earlier action but no, it's awful to see 

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8 minutes ago, Chapple12345 said:

I'm pleased to see we're seeing a fall in the cases and hoping this will pay off soon... but I'm absolutely heartbroken by the deaths in the last few weeks. So many of them could have been avoided if Boris and co had co-operated with Starmer with earlier action but no, it's awful to see 

Quite right, history will remember them badly for the poor decisions they made a month ago. 

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