When will this shit end?

[steviewevie]

[Toilet Duck]

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). 

[Toilet Duck]

59 minutes ago, steviewevie said:

Covid-19 antibodies reduce faster in men than women – study

https://www.theguardian.com/world/2020/nov/18/covid-19-antibodies-fall-faster-in-men-than-women-study-suggests

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!). 

[Fuzzy Afro]

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?

[Fuzzy Afro]

@mattiloy to explain why he reddie’d that? ^^^

[DickButkis]

26 minutes ago, Fuzzy Afro said:

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

Because that story is obviously bollocks. Why would her parents and grandparents need to leave the country?

[Fuzzy Afro]

21 minutes ago, DickButkis said:

Because that story is obviously bollocks. Why would her parents and grandparents need to leave the country?

Because of an anti-Semitic government 

[steviewevie]

17 minutes ago, DickButkis said:

Because that story is obviously bollocks. Why would her parents and grandparents need to leave the country?

maybe they don't feel safe living in a country governed by a political party with an antisemitism problem?

[DickButkis]

Just now, Fuzzy Afro said:

Because of an anti-Semitic government 

She just cried tears of joy because a blatent racist government got in instead. Yeah okay mate.

[worthyraver]

2 hours ago, steviewevie said:

ahem.

https://www.theguardian.com/society/2020/nov/18/binge-drinking-among-over-50s-rising-amid-pandemic-says-uk-charity

[xxialac]

4 bottles a day is an awful lot. Sad.

[squirrelarmy]

2 minutes ago, xxialac said:

4 bottles a day is an awful lot. Sad.

Equivalent of 12 pints of average strength ale or lager.

[Fuzzy Afro]

11 minutes ago, DickButkis said:

She just cried tears of joy because a blatent racist government got in instead. Yeah okay mate.

She’s Jewish. Makes sense that she’d be more concerned about anti semitism than other forms of racism that the government may inhibit 

[topmarksbri]

24 minutes ago, worthyraver said:

Given she's regularly going on binges I would say that maybe this is indicative of a wider problem with drinking?

 

[Crazyfool01]

6pm delays again !!!

[Gingerfish79]

 

[SheffJeff]

27 minutes ago, worthyraver said:

If she's drinking that much I'd recommend boxes rather than bottles from a filling your wheely bin perspective if nothing else.    

[Crazyfool01]

Just now, SheffJeff said:

If she's drinking that much I'd recommend boxes rather than bottles from a filling your wheely bin perspective if nothing else.    

something you'd like to tell us ?  

[JoeyT]

Edited November 18, 2020 by JoeyT

[SheffJeff]

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.

[DickButkis]

12 minutes ago, Fuzzy Afro said:

She’s Jewish. Makes sense that she’d be more concerned about anti semitism than other forms of racism that the government may inhibit 

Who do you work with, Rachel Riley?

[Cherry Tree]

The Government are considering a five day relaxation of restrictions from the 24th December. The Hanukkah celebrations last for eight nights from the 22nd, is it reasonable to conclude that’s the government are a little anti-semitic.
 

https://www.bbc.co.uk/news/uk-54984297

[Chapple12345]

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 

[Guest]

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. 

[steviewevie]

18 minutes ago, DickButkis said:

Who do you work with, Rachel Riley?

bet you love a Rachel Riley pile on.