Covid-19 (not gnr related)

[cineater]

Air travel over Thanksgiving is only down by 10 percent.

[pilferk]

Are you still in kore favor of the Pfizer one over Moderna?

I like the methodology behind the Pfizer one better, in terms of the actual chemistry and science, etc.

But they both work, with efficacy rates over 90%.  I recognize the Pfizer vax requires some additional storage considerations that make it hard to distribute and administer in more traditional settings (aka your local pharmacy).  At this point, I'd say I prefer the Pfizer vax (and it's the one I'll get via my employer), but I would say for the general public: Take what is available to you, of those two, as soon as you feel comfortable doing so.

So, Pfizer released their safety data today, and will seek FDA approval within the next couple days.  You heard it here first.

Yep saw the news about the emergency use authorization, definitely good news. I take it you are still under an NDA and can't say as much as you'd probably like to on the subject?

Yup, only whats been publically released. I posted what I did about 40 minutes after I got my alert the presser was out.   Hadn't even seen the news stations report it yet....

That NDA covers the next 20 years so.....but I will say this: I'm very hopeful.  Moderno will likely follow suit (and this is just based on shop talk) sometime within the next week or two. 

I am guessing we will have vaccines being distributed and administered before the new year, and maybe before Christmas.  That's a great first step.

I still think we are looking at spring before widespread vaccinations are widely available to the public.

[pilferk]

The FDA said Friday it has scheduled a meeting of its outside advisory panel to discuss Pfizer and BioNTech's application for emergency use authorization for a coronavirus vaccine for December 10.

WTF?  Why aren't they meeting next week?

Because they can't. While the FDA EUA process is MUCH faster than the "normal" process...there is still a process.  They need time to review all the data (and I can tell you, there's literal volumes of it), they need to allow a short period of peer review and comment, and they need time to do their due dilligence after all that is done.  FDA has set a docket EXACTLY 3 weeks from the date of application, basically.  I think that's pretty much the minimum time they are allowed.

The good news is, assuming the vaccine is approved on the 10th, you could see vaccinations being administered as soon as the 12th.  I'm not sure we will....but we could.

Thats less than 30 days from the filing of the application for approval.  That's an unheard of turn around time in terms of the FDA. 

[jarmo]

Covid-19: Oxford University vaccine is highly effective https://www.bbc.com/news/health-55040635



/jarmo

[cineater]

The FDA said Friday it has scheduled a meeting of its outside advisory panel to discuss Pfizer and BioNTech's application for emergency use authorization for a coronavirus vaccine for December 10.

WTF?  Why aren't they meeting next week?

Because they can't. While the FDA EUA process is MUCH faster than the "normal" process...there is still a process.  They need time to review all the data (and I can tell you, there's literal volumes of it), they need to allow a short period of peer review and comment, and they need time to do their due dilligence after all that is done.  FDA has set a docket EXACTLY 3 weeks from the date of application, basically.  I think that's pretty much the minimum time they are allowed.

The good news is, assuming the vaccine is approved on the 10th, you could see vaccinations being administered as soon as the 12th.  I'm not sure we will....but we could.

Thats less than 30 days from the filing of the application for approval.  That's an unheard of turn around time in terms of the FDA. 

In my mind, they should have been reviewing that data last month when it was announced they were close to submitting an application.  Really should have been reviewing it all along.  And maybe they were.  Give them the benefit of doubt.

This is the first round of vaccines, the round that goes to the people who have no choice but risk getting exposed because they are in there trying to save the lives of people who got it.  For the grandmas and grandpas.  Who doesn't love them?  And I can't help feeling the people we most value in all of this are going to be the guinea pigs for the whole population.  Yeah I want the FDA to do their process and keep them safe.

[pilferk]

In my mind, they should have been reviewing that data last month when it was announced they were close to submitting an application.  Really should have been reviewing it all along.  And maybe they were.  Give them the benefit of doubt.

Um, they can't.

Part of submitting the application is submitting all the data for review. That wasn't finished being compiled until a few days prior to the application.

Pfizer has been pretty much working 24/7 to compile all the safety data since Phase III of the trial ended.  That process isn't quick, trust me.

The FDA gets that data dump as part of the application process.

This is the first round of vaccines, the round that goes to the people who have no choice but risk getting exposed because they are in there trying to save the lives of people who got it.  For the grandmas and grandpas.  Who doesn't love them?  And I can't help feeling the people we most value in all of this are going to be the guinea pigs for the whole population.  Yeah I want the FDA to do their process and keep them safe.

Phase one, I believe, is HC workers.

Phase two is high risk.

Phase three is moderate risk.

Phase four is everyone else.

They might skip phase three, depending on production levels, and just roll it out to everyone.  A lot of that will depend on how many vaccine trials end up having high rates of efficacy.  If we can get 2 or 3 more that are around 90%, and are safe, that phase 3 will become less and less likely.

[tim_m]

Are you still in kore favor of the Pfizer one over Moderna?

I like the methodology behind the Pfizer one better, in terms of the actual chemistry and science, etc.

But they both work, with efficacy rates over 90%.  I recognize the Pfizer vax requires some additional storage considerations that make it hard to distribute and administer in more traditional settings (aka your local pharmacy).  At this point, I'd say I prefer the Pfizer vax (and it's the one I'll get via my employer), but I would say for the general public: Take what is available to you, of those two, as soon as you feel comfortable doing so.

So, Pfizer released their safety data today, and will seek FDA approval within the next couple days.  You heard it here first.

Yep saw the news about the emergency use authorization, definitely good news. I take it you are still under an NDA and can't say as much as you'd probably like to on the subject?

Yup, only whats been publically released. I posted what I did about 40 minutes after I got my alert the presser was out.  Hadn't even seen the news stations report it yet....

That NDA covers the next 20 years so.....but I will say this: I'm very hopeful.  Moderno will likely follow suit (and this is just based on shop talk) sometime within the next week or two.  

I am guessing we will have vaccines being distributed and administered before the new year, and maybe before Christmas.  That's a great first step.

I still think we are looking at spring before widespread vaccinations are widely available to the public.

Ok that's great news, question i think you should be able to answer. I have tickets to a rescheduled concert August 13th. Odds of it happening?  What can you tell us about the Oxford vaccine who just released their findings of it being 70% effective?

[cineater]

We have the wedding rescheduled for June 4th.  I'm thinking if we can get the old folks vaccinated it's a go.  Might push the reception off a few months.

My entire family is doing Thanksgiving with groups.  They better not get sick and leave me here all alone.  I could be the end of the line.  I already have their Christmas presents.  Not wrapped but their names are on it in case I check out.

[tim_m]

Hope they all stay safe.

[pilferk]

Ok that's great news, question i think you should be able to answer. I have tickets to a rescheduled concert August 13th. Odds of it happening?  What can you tell us about the Oxford vaccine who just released their findings of it being 70% effective?

I think August probably looks good.  70/30 for?  I think anything after July 1 will probably be a go.

I don't know a lot about AstraZeneca's "Oxford" vaccine.  What we had heard in the pipeline was that it was less effective (less than 70%) than the Pfizer or Moderno versions.  It sounds like they've done a dosage modification (with a LOWER dosage being more effective? half initial dose and a full dose 2 weeks later) that gets it up to around 90%?  I do know it's using a different method of production (not rDNA but using an adenovirus found in chimp stool to create the proper spike protein), costs about $5 a dose to make, and doesn't need as much cold storage as the P and M vaccines.

Again, if it's my choice, I'd choose the P or M vaccine simply because I trust and understand their methodologies a bit more. That dosage/efficacy change gives me pause, too.  There's some good scientific theory as to why the dosage reduction gave rise to increased efficacy, but it's all theorycrafting as far as I know. 

All that being said: Sometimes beggars can't be choosers, so we'll see how it goes.

[tim_m]

Ok that's great news, question i think you should be able to answer. I have tickets to a rescheduled concert August 13th. Odds of it happening?  What can you tell us about the Oxford vaccine who just released their findings of it being 70% effective?

I think August probably looks good.  70/30 for?  I think anything after July 1 will probably be a go.

I don't know a lot about AstraZeneca's "Oxford" vaccine.  What we had heard in the pipeline was that it was less effective (less than 70%) than the Pfizer or Moderno versions.  It sounds like they've done a dosage modification (with a LOWER dosage being more effective? half initial dose and a full dose 2 weeks later) that gets it up to around 90%?  I do know it's using a different method of production (not rDNA but using an adenovirus found in chimp stool to create the proper spike protein), costs about $5 a dose to make, and doesn't need as much cold storage as the P and M vaccines.

Again, if it's my choice, I'd choose the P or M vaccine simply because I trust and understand their methodologies a bit more. That dosage/efficacy change gives me pause, too.  There's some good scientific theory as to why the dosage reduction gave rise to increased efficacy, but it's all theorycrafting as far as I know. 

All that being said: Sometimes beggars can't be choosers, so we'll see how it goes.

Thanks for the reassurance, i was hoping i could salvage that one show. I'm still pissed GNR couldn't reschedule the Dallas show because the rangers have a homestead that week.

[cineater]

Instead of going to see her kids for Thanksgiving, my sister is waiting to get a covid test.  Sucks but you just never know who you've been around who might have it and not know.  Her exposure was over 11 days ago but she's being safe.

And my niece announced she's expecting at dinner.  Missed it.

[tim_m]

Instead of going to see her kids for Thanksgiving, my sister is waiting to get a covid test.  Sucks but you just never know who you've been around who might have it and not know.  Her exposure was over 11 days ago but she's being safe.

And my niece announced she's expecting at dinner.  Missed it.

That really sucks, hopefully next year will be better.

[cineater]

Instead of going to see her kids for Thanksgiving, my sister is waiting to get a covid test.  Sucks but you just never know who you've been around who might have it and not know.  Her exposure was over 11 days ago but she's being safe.

And my niece announced she's expecting at dinner.  Missed it.

That really sucks, hopefully next year will be better.

Covid hasn't struck my family and friends so it's pretty good.

[tim_m]

Instead of going to see her kids for Thanksgiving, my sister is waiting to get a covid test.  Sucks but you just never know who you've been around who might have it and not know.  Her exposure was over 11 days ago but she's being safe.

And my niece announced she's expecting at dinner.  Missed it.

That really sucks, hopefully next year will be better.

Covid hasn't struck my family and friends so it's pretty good.

That is certainly something to be thankful for.

[pilferk]

As I had thought, Moderna filed for Emergency use with the FDA today.

So, within the next month, if everything goes well, we should have 2 good vaccine candidates available.

[jarmo]

They also filed for for coronavirus vaccine authorization with the European Medicines Agency (EMA).




/jarmo

[tim_m]

As I had thought, Moderna filed for Emergency use with the FDA today.

So, within the next month, if everything goes well, we should have 2 good vaccine candidates available.

Very good news, i saw an article today that the hope is that by June everyone who wants one of the vaccines will be able to get it.

[jarmo]

The UK has approved the Pfizer/BioNTech vaccine.

They could start vaccinating people next week.




/jarmo

[cineater]

The UK has approved the Pfizer/BioNTech vaccine.

They could start vaccinating people next week.




/jarmo

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?