Coronavirus

[renim]

I'm surprised at what seems like a low level of testing in the US so far, and taking a long time to organise test kits.

My impressions are Australia may have done a much better job on testing...

What Went Wrong with Coronavirus Testing in the U.S.

I'm not surprised

America seems to have multiple agencies that can say NO to expedient progress in anything medical related.
basically giant bureaucratic that is self-reinforcing more bureaucracy.

the same bureaucratic process that is required to stop dodgy medical outcomes, swings the other way and stops expedient Covid19 outcomes.

Australia is smaller population and southern hemisphere, so even without stating it, we also proportionally have a LOT of medical competence from Hong Kong and Singapore/Malaysia, so its more natural to enact an expedient choices. More to the point, ASX20 is Australia's top 20 companies, CSL is within ASX20 https://medicalhistorymuseum.mdhs.u...Australia-The-Legacy-of-antvenom-research.pdf is a serum specialist with deep expertise in flu vaccines Products. We have basically the 2nd largest flu vaccine company in the world listed in Australia.

whoever is advising Scott Morrison, is doing so from a position of deep understanding of realities from flu vaccine experience and understands the difficulties in implementing a SARS/Covid19 vaccine in the real world.

 

[linux-works]

adapt or be left behind.

stickers on the floor, at stores (norway) to keep people .1" spaced - er, I mean, 2 meters away from each other.

I think this gives "hey, could you save my spot?" a renewed meaning.

 

[nwdiver]

I have not followed this in detail - but is the president suggesting thowing $1k at each of us, and that will 'make it all ok' ?

or is that a starter amount?

do people really think that $1k is going to fix anything??

$1k is probably a starting point. Most people have <$400 and will soon be tapped out. I've heard as much as ~$20k over the rest of the year. Something has to be done to prevent a depression. Not a recession but a depression.

This is the perfect economic storm and the economy WILL be crippled without SIGNIFICANT stimulus from the bottom up. I live in the permian basin. With oil soon to be <$20 unemployment here will almost certainly be >20% in a few months.

 

[linux-works]

I don't know where the $1k figure came from, but it seems unwise to even mention a number, right now. just tell people (if you were the leader) that 'we wont let you down and we will support the working class'. just be supportive; don't throw some stupid fixed lowball number at people.

yet another bonehead move. I wish he'd let adults handle this.

 

[EVNow]

Not yet -> Likely won't bottom out for 2-3 weeks.

Why ?

The problem is we are seeing really slow drip-drip bad news. And then some action by the government. So a cycle of down, a bit up and another down day.

Let me rephrase it. What bad news and interventions are priced in now ?

 

[nwdiver]

I don't know where the $1k figure came from, but it seems unwise to even mention a number, right now. just tell people (if you were the leader) that 'we wont let you down and we will support the working class'. just be supportive; don't throw some stupid fixed lowball number at people.

yet another bonehead move. I wish he'd let adults handle this.

It may have started with Romney.

Romney wants government to send $1K to every American adult amid coronavirus crisis

 

[shootformoon]

I have a question for medical/vaccine experts. From the timeline of H1N1 flue vaccine, it took about 2 months from clinical trial to FDA approval. Why we expect 12-18 months for COV19 since the first clinical trials already started?

 

[ohmman]

I have a question for medical/vaccine experts. From the timeline of H1N1 flue vaccine, it took about 2 months from clinical trial to FDA approval. Why we expect 12-18 months for COV19 since the first clinical trials already started?

Good question, I just have a clarification - it took 5 months.

 

[gerebgraus]

Geez such nonsense.

If you’ve followed the press conferences both Dr Birx and Dr Fauci are data oriented.

Some of the comments are just not productive and belong on the political thread.

Dr. Birx and Dr. Fauci seem first rate scientists. It is not their fault that they have to operate from much more limited data than desirable.
In fact that they have finally proper roles will get us finally proper data.
My criticism was directed to other infectious disease specialists quoted in these forums who made claims not supported by data.

A bit OT: It is a standard political joke that although Dr. Fauci at 79 is older than the remaining 3 presidential candidates running but he is much sharper than all of them.

 

[Cosmacelf]

Can anyone recommend another blog/news source/reddit that has current and updated coronavirus information where people aren't attacked and childish partisan attacks are unwelcome?

 

[EinSV]

University of Washington has decided to start using hydroxychloroquine with all patients admitted for COVID-19, based primarily on the in vitro data, and recognizing that clinical data supporting treatment does not exist yet (details in the Twitter thread for anyone interested).

Arun Sridhar on Twitter

 

[bkp_duke]

I have a question for medical/vaccine experts. From the timeline of H1N1 flue vaccine, it took about 2 months from clinical trial to FDA approval. Why we expect 12-18 months for COV19 since the first clinical trials already started?

Because H1N1 is a variant of the flu. We already had in place flu vaccines that we knew conferred relatively good immunity against the seasonal influenza virus. We simply had to swap out the H and the N genetic codes for the new virus, run it through the already MASSIVE production setup that was already in place, and deploy the vaccine.

Unfortunately, coronaviruses are a totally different kind of virus. They are as related to influenza as you are to . . . a lizard (i.e. not very).

We have to identify parts of the coronavirus genome that encode proteins we can use to make a potential vaccine (this part has been done). Then we have to take those candidate proteins and mass produce them enough to start Phase 1 clinical trials (those are ONLY for SAFETY and EFFICACY). Historically, only one in 100 Phase 1 candidates makes it to Phase 2 (the expansion of testing to get better data on efficacy and potential side effects). If that then succeeds, you can bet we will skip Phase 3 and go straight to mass production and population innoculation.

This is a crap-ton of work, but fortunately we have a slight head start because some companies were working on the previous SARS and MERS coronaviruses and trying to develop a vaccine against them (in case they came out of their biological reservoirs and caused a pandemic). This is the only reason you are seeing Phase 1 clinical trials starting now, and the end result is that this may wind up saving millions of lives.

This entire pandemic is what we are taught in medical school to *sugar* our pants about. A novel virus where no one has immunity and that there is no vaccine for. This is almost the perfect storm. The only saving grace is that the fatality rate of this virus is not higher.

If the stars align, we will have several candidate vaccines emerge from Phase 2 testing by the fall. And that is as rosey a timeline as possible. More likely, not till a year from now.

 

[DanCar]

Can anyone recommend another blog/news source/reddit that has current and updated coronavirus information where people aren't attacked and childish partisan attacks are unwelcome?

You might have fun at: https://www.reddit.com/r/Wuhan_Flu/

 

[shootformoon]

July 22

• Clinical trials testing the 2009 H1N1 flu vaccine began.

September 15

• The FDA announced its approval of four 2009 H1N1 influenza vaccines.

Good question, I just have a clarification - it took 5 months.

 

[S4WRXTTCS]

Why ?

The problem is we are seeing really slow drip-drip bad news. And then some action by the government. So a cycle of down, a bit up and another down day.

Let me rephrase it. What bad news and interventions are priced in now ?

I'm fully expecting the cycle to be more dialed in with better data. Normally the stock market prices things really well. Now I don't know if it's 3-4 weeks or 6 weeks. But, I expect it to be sooner than later.

Or maybe I just want it to because this bouncy bouncy is really annoying.

 

[renim]

Coronavirus update: Australian Government Deputy Chief Medical Officer | ABC News

worth a view, Australian context

 

[ohmman]

July 22

• Clinical trials testing the 2009 H1N1 flu vaccine began.

September 15

• The FDA announced its approval of four 2009 H1N1 influenza vaccines.

My mistake, I misread your comment. I didn't think we were in US clinical trials yet; are we? I saw that JNJ's clinical trials won't start until November.

Either way, apologies for the confusion.

 

[shootformoon]

If we only comparing the clinical trial timeline, do you mean H1N1 vaccine candidate back then did not need a P1 because H1N1 was just a variant of flu?

Also, even when we run p1 for cov19 vaccine with the primary end point as safety, that does not preclude the secondary end point as efficacy? i.e. If p1 sample is large enough suppose we have enough volunteers, is it possible we can approve it once the statistical significance is reached?

Because H1N1 is a variant of the flu. We already had in place flu vaccines that we knew conferred relatively good immunity against the seasonal influenza virus. We simply had to swap out the H and the N genetic codes for the new virus, run it through the already MASSIVE production setup that was already in place, and deploy the vaccine.

Unfortunately, coronaviruses are a totally different kind of virus. They are as related to influenza as you are to . . . a lizard (i.e. not very).

We have to identify parts of the coronavirus genome that encode proteins we can use to make a potential vaccine (this part has been done). Then we have to take those candidate proteins and mass produce them enough to start Phase 1 clinical trials (those are ONLY for SAFETY and EFFICACY). Historically, only one in 100 Phase 1 candidates makes it to Phase 2 (the expansion of testing to get better data on efficacy and potential side effects). If that then succeeds, you can bet we will skip Phase 3 and go straight to mass production and population innoculation.

This is a crap-ton of work, but fortunately we have a slight head start because some companies were working on the previous SARS and MERS coronaviruses and trying to develop a vaccine against them (in case they came out of their biological reservoirs and caused a pandemic). This is the only reason you are seeing Phase 1 clinical trials starting now, and the end result is that this may wind up saving millions of lives.

This entire pandemic is what we are taught in medical school to *sugar* our pants about. A novel virus where no one has immunity and that there is no vaccine for. This is almost the perfect storm. The only saving grace is that the fatality rate of this virus is not higher.

If the stars align, we will have several candidate vaccines emerge from Phase 2 testing by the fall. And that is as rosey a timeline as possible. More likely, not till a year from now.

 

[shootformoon]

No worries. It seems at least two already started?

AP Exclusive: Coronavirus vaccine test opens with 1st doses
Daily briefing: First coronavirus vaccine clinical trials begin in United States

My mistake, I misread your comment. I didn't think we were in US clinical trials yet; are we? I saw that JNJ's clinical trials won't start until November.

Either way, apologies for the confusion.

 

[bkp_duke]

If we only comparing the clinical trial timeline, do you mean H1N1 vaccine candidate back then did not need a P1 because it is just a variant of flue?

Also, even when we are running p1 for cov19 with the primary end point is safety, that does not preclude the secondary end point as efficacy? i.e. If p1 sample is large enough if we have enough volunteers, is it possible we can approve it once the statistical significance is reached?

Correct, it only needed a Phase 2 trial which could be modified for efficacy testing because the overall process of an influenza vaccine was well established.

Phase 1 trials always look at both safety and efficacy. Both are included.

Safety - any adverse reactions, specifically looking for allergic reactions or unexpected side effects (i.e. the old Polio vaccine gave some kids a life-threatening condition called Guillain Barre Syndrome).

Efficacy - in this case, we have to wait about 2 weeks (my guess) and then draw blood from the candidates given the vaccine and check antibody titers to the virus.


Longer term, likely Phase 2, we will have to see what the infection rate is in people that got vaccinated. But that takes a lot of people to tease out (i.e. how efficacious is the vaccine).


I read this morning, but for the life of me cannot find the source now, that there were over 300 Phase 1 candidates that are in the pipeline for approval. That is reassuring and I hope that we can get 3-4 really good candidates to push into Phase 2 trials from that large a number.