Thread on testing & treatment research for COVID-19

[Cletus11]

so two questions.

1. When is the FDA supposed to give the go ahead for the two major vaccine candidates? At one point they were both expected by end of this year, but I get the feeling that will be delayed until maybe mid January for the first one and early February for the second one.

2. Obviously getting the vaccine out to the nursing home community with the first batch is the most important. That should be 'relatively' easy to do as everybody know where nursing homes are and just a matter of scheduling. Than the second batch, which I assume will be more in the March/April timeframe has to be for those over 70. Which means literally vaccinnating 10's of millions of people across the country which is the logistics nightmare. And I hear nothing at all of how this will be done. Vaccinating 300+ million americans in a short timeframe is like WWII D-Day like difficult in preparation and execution, it is mind boggling how that can be done quickly and effeciently. And the fact I read almost nothing about how that will be done makes me think that the execution of that is going to fall flat on it's face and push out the time to back to normalcy out to into the summer of 2022 timeframe.

 

[interrobang]

December 10 is the meeting for the Pfizer vaccine. Dec 17, if not before, for the Moderna vaccine. I believe I read between the two of them there'd be enough doses for 20 million people by the end of the year.

 

[83wuzme]

Yes

Fact check: Coronavirus deaths across continent of Africa are far less than in U.S.

An Instagram post by comedian Trevor Noah claims there have been fewer COVID-19 deaths in Africa, likely due to age. We rate this true.

www.usatoday.com

The death rates in most African countries have been much lower than Europe and the Americas. South Africa has been an exception to this. This lower rate has been determined to be the case, even allowing for the younger age demographics in Africa.
There have been a number of potential explanations for this, including : the high prevalence in the populations of BCG and MMR vaccinations, temperature, humidity, UV levels and exposure to an unknown native virus which may confer some level of immunity. The vaccine explanations have been getting a lot of traction lately.

 

[83wuzme]

I don't really think this is a surprise to many. Also a good probability that the Penn State report back in April saying that around 80 times as many people as they thought actually had covid is closer to being true than not.
Ask just about any school system what their attendance was from Thanksgiving through Valentine's Day, more days missed by kids and staff than ever before, most with similar symptoms to covid

Those estimates of high levels of community exposure, either from PSU or Stanford analysts, have been discredited. Population level serology put the number at around 12% of the US population back in October. It is also highly unlikely that the US and other countries would be experiencing the current case numbers if most of the population had been exposed by the end of the summer.

 

[Cletus11]

December 10 is the meeting for the Pfizer vaccine. Dec 17, if not before, for the Moderna vaccine. I believe I read between the two of them there'd be enough doses for 20 million people by the end of the year.

Don't both of them take 2 shots? So there is some numbers game being played I think we doses available that need to be cut in half for the actual people vaccinated.

And the second question of how do you administer 250 million doses to 125 million people by Memorial day? Not like you put up a sign at the CVS that says free flu shot and it works. I am amazed that the Army is not actually in charge of this. Only group I know of that has the logistics capability to handle something so massive. Talking multiple semi-permanent Army field hospitals in major metros (maybe in Mall parking lots considering they are centrally located, having ample parking and space). Traveling Army hospital tent set-up that spends a week or two in certain more remote areas and then picks up and moves on. National broadcasting of locations and times and who should go and when. More training of staff on how to give the shots (maybe a call for all retired nurses and doctors to come out of retirement to help man these stations as they really will require 24/7 operation to get it done quickly). Etc.....

 

[LCFP79]

I am amazed that the Army is not actually in charge of this. Only group I know of that has the logistics capability to handle something so massive.

Operation Warp Speed is primarily a DOD project, with a lot of help of course. The army is good at logistics, they say.

 

[bison13]

My 15 year old kid brought home whatever I had from school. She ended up in bed for a week in bad shape with a cough that lasted a month+ and I ended up in the hospital for a week and out of work for a month on oxygen.

There were school systems here in Maryland that had lower than 90% attendance rates which is about 5 to 8% lower than normal days. Combine that with the sick kids that came to school because they had mild or no symptoms and just in Montgomery County Maryland you probably have around 10000 kids. At least the same percentage of Faculty members missed as well

 

[interrobang]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[katchthis]

Those estimates of high levels of community exposure, either from PSU or Stanford analysts, have been discredited. Population level serology put the number at around 12% of the US population back in October. It is also highly unlikely that the US and other countries would be experiencing the current case numbers if most of the population had been exposed by the end of the summer.

The main Stanford researcher you are addressing , Jay Battacharya MD PhD now has seroprevalence numbers around 18% of the US population. He always welcomes anyone wanting to have a discussion or panel approach about COVID-19 and notes he wold be happy to participate. He is one of the key composers of the Great Barrington project which has many top docs on as endorsing its position on COVID-19. Jay along with the Harvard and Oxford composers have been apolitical in their approach which is quite refreshing.

 

[katchthis]

Looks like the December number of planned vaccine doses already taking a big hit.

Pfizer will only ship HALF its planned 100m covid jab doses in 2020

Pfizer will only ship half as many doses of its coronavirus vaccine as it promised by the end of the year, cutting its planned global rollout from 100 million doses sources told the Wall Street Journal.

www.dailymail.co.uk

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[83wuzme]

The main Stanford researcher you are addressing , Jay Battacharya MD PhD now has seroprevalence numbers around 18% of the US population. He always welcomes anyone wanting to have a discussion or panel approach about COVID-19 and notes he wold be happy to participate. He is one of the key composers of the Great Barrington project which has many top docs on as endorsing its position on COVID-19. Jay along with the Harvard and Oxford composers have been apolitical in their approach which is quite refreshing.

No, I was thinking of Stanford’s Ionnaides. ( sp ? ).
Considering the 12% October figure, 18% seems reasonable.

 

[katchthis]

No, I was thinking of Stanford’s Ionnidis . ( sp ? ).
Considering the 12% October figure, 18% seems reasonable.

Same study multiple authors. Ioannidis has some of the most quoted research articles in medical research . Modeling numbers can jump off target easily with an incorrect assumption .

COVID-19 Antibody Seroprevalence in Santa Clara County, California

Background Addressing COVID-19 is a pressing health and social concern. To date, many epidemic projections and policies addressing COVID-19 have been designed without seroprevalence data to inform epidemic parameters. We measured the seroprevalence of antibodies to SARS-CoV-2 in a community...

www.medrxiv.org

 

[83wuzme]

Same study multiple authors

COVID-19 Antibody Seroprevalence in Santa Clara County, California

Background Addressing COVID-19 is a pressing health and social concern. To date, many epidemic projections and policies addressing COVID-19 have been designed without seroprevalence data to inform epidemic parameters. We measured the seroprevalence of antibodies to SARS-CoV-2 in a community...

www.medrxiv.org

Given the kinds of case numbers going on in CA, that would seem to invalidate their conclusion from the study about the level of community exposure in April.

 

[Cletus11]

Looks like the December number of planned vaccine doses already taking a big hit.

Pfizer will only ship HALF its planned 100m covid jab doses in 2020

Pfizer will only ship half as many doses of its coronavirus vaccine as it promised by the end of the year, cutting its planned global rollout from 100 million doses sources told the Wall Street Journal.

www.dailymail.co.uk

As I keep saying, best case scenario is that by Memorial Day people over 70 and the highly compromised double comorbidity under 60 group has been vaccinated by then. Will take remainder of 2021 to get the over 50 and under 50 with one co morbidity.

Supply chain to make billions of doses doesn’t exist and the logistics of getting that many doses into doctors and nurses hands and vaccinating that many people will prevent it from going much faster.

 

[LCFP79]

Pfizer CEO was bragging he never took any taxpayer money to develop his vaccine, and wasn't part of OWS. Maybe he shoulda let the logistics guys help.

 

[Tom McAndrew]

Pfizer CEO was bragging he never took any taxpayer money to develop his vaccine, and wasn't part of OWS. Maybe he shoulda let the logistics guys help.

development
phase I, II, and III testing
regulatory application
regulatory tracking
vaccine production
vaccine shipping & delivery

Those are all separate steps in the pharma process. Pfizer, as indicated earlier in this thread (or perhaps that was the separate Pfizer thread), and as mentioned in the NBC Dateline show that was broadcast this evening, did not take a penny from Operation Warp Speed for the development of their SARS-CoV-2 vaccine.

Production is totally separate from development. Pfizer is the largest drug company in the world. It has specialists in each of the aforementioned processes. And they produce several vaccines, so they know what they are doing.

Unless they have years of pharma vaccine production experience, "logistics guys" wouldn't be of any value to Pfizer, or any other drug company, for producing their respective vaccines.

FWIW, almost every new vaccine goes through production issues when its being introduced. Normally, that's a non-issue, as it simply means the vaccine won't be released until a month (or 2 or 3 or more) later than expected, or the supply will be limited when it's initially released.

Because of the severity of the pandemic, Pfizer (as well as Moderna) is attempting to produce an unprecedented number of vaccines for release as soon as they have FDA approval. They anticipated this issue, and started generating the vaccine while it was still being tested, and before they even made their regulatory application.

Still, the aforementioned normal rollout production problems are magnified by:
1. this being a mRNA vaccine, which has never before been released, and thus never before been produced
2. the severity of the pandemic
3. the world-wide need for the vaccine
4. and Pfizer's vaccine being a 2-shot vaccine

 

[Cletus11]

development
phase I, II, and III testing
regulatory application
regulatory tracking
vaccine production
vaccine shipping & delivery

Those are all separate steps in the pharma process. Pfizer, as indicated earlier in this thread (or perhaps that was the separate Pfizer thread), and as mentioned in the NBC Dateline show that was broadcast this evening, did not take a penny from Operation Warp Speed for the development of their SARS-CoV-2 vaccine.

Production is totally separate from development. Pfizer is the largest drug company in the world. It has specialists in each of the aforementioned processes. And they produce several vaccines, so they know what they are doing.

Unless they have years of pharma vaccine production experience, "logistics guys" wouldn't be of any value to Pfizer, or any other drug company, for producing their respective vaccines.

FWIW, almost every new vaccine goes through production issues when its being introduced. Normally, that's a non-issue, as it simply means the vaccine won't be released until a month (or 2 or 3 or more) later than expected, or the supply will be limited when it's initially released.

Because of the severity of the pandemic, Pfizer (as well as Moderna) is attempting to produce an unprecedented number of vaccines for release as soon as they have FDA approval. They anticipated this issue, and started generating the vaccine while it was still being tested, and before they event made their regulatory application.

Still, the aforementioned normal rollout production problems are magnified by:
1. this being a mRNA vaccine, which has never before been released, and thus never before been produced
2. the severity of the pandemic
3. the world-wide need for the vaccine
4. and Pfizer's vaccine being a 2-shot vaccine

there has been discussion just the shear number of needles and vaccine bottles and stoppers, etc...production all has to ramp way up to support the vaccine itself. like the PPE issues, cannot just go from producing X to 1000 times X in a couple of months. So a lot of moving parts besides just the vaccine itself.

 

[ThePennsyOracle]

development
phase I, II, and III testing
regulatory application
regulatory tracking
vaccine production
vaccine shipping & delivery

Those are all separate steps in the pharma process. Pfizer, as indicated earlier in this thread (or perhaps that was the separate Pfizer thread), and as mentioned in the NBC Dateline show that was broadcast this evening, did not take a penny from Operation Warp Speed for the development of their SARS-CoV-2 vaccine.

Production is totally separate from development. Pfizer is the largest drug company in the world. It has specialists in each of the aforementioned processes. And they produce several vaccines, so they know what they are doing.

Unless they have years of pharma vaccine production experience, "logistics guys" wouldn't be of any value to Pfizer, or any other drug company, for producing their respective vaccines.

FWIW, almost every new vaccine goes through production issues when its being introduced. Normally, that's a non-issue, as it simply means the vaccine won't be released until a month (or 2 or 3 or more) later than expected, or the supply will be limited when it's initially released.

Because of the severity of the pandemic, Pfizer (as well as Moderna) is attempting to produce an unprecedented number of vaccines for release as soon as they have FDA approval. They anticipated this issue, and started generating the vaccine while it was still being tested, and before they event made their regulatory application.

Still, the aforementioned normal rollout production problems are magnified by:
1. this being a mRNA vaccine, which has never before been released, and thus never before been produced
2. the severity of the pandemic
3. the world-wide need for the vaccine
4. and Pfizer's vaccine being a 2-shot vaccine

You're burning the midnight oil, Tom.

Jokes aside--have you come across any studies or articles about the efficacy of mRNA vaccines after just a single dose? Scott Gottleib mentioned in a recent CNBC interview that some individuals may develop some degree of protection after a single dose, but that two were required for full efficacy. I keep trying to find something about this, but am coming up empty.

 

[Agoodnap]

there has been discussion just the shear number of needles and vaccine bottles and stoppers, etc...production all has to ramp way up to support the vaccine itself. like the PPE issues, cannot just go from producing X to 1000 times X in a couple of months. So a lot of moving parts besides just the vaccine itself.

Cletus, you clearly have never developed any product and taken it to high volume in a short amount of time. You should just be quiet and watch it happen.

 

[katchthis]

Cletus, you clearly have never developed any product and taken it to high volume in a short amount of time. You should just be quiet and watch it happen.

As a medical provider, I anticipate a shortage of things like the medical glass, needles, stoppers etc. just like Cletus proposed creating a bottle neck in the delivery system. WSJ has had a lot of articles on this very subject over the past few months. It will happen, but it won't always be smooth. Todays WSJ has an article on dry ice manufacturers needing to ramp up production in anticipation of the vaccine delivery.
Everyday there is a shortage of over 100 drugs, such as Lasix ( a generic and long in production) and other med supplies like IV fluids., Vaccine production and delivery won't be any different in experiencing its share of logistical hiccups.
Pfizer just cut its expected delivery of doses for December in half.

Pfizer will only ship HALF its planned 100m covid jab doses in 2020

Pfizer will only ship half as many doses of its coronavirus vaccine as it promised by the end of the year, cutting its planned global rollout from 100 million doses sources told the Wall Street Journal.

www.dailymail.co.uk

 

[Agoodnap]

As a medical provider, I anticipate a shortage of things like the medical glass, needles, stoppers etc. just like Cletus proposed creating a bottle neck in the delivery system. WSJ has had a lot of articles on this very subject over the past few months. It will happen, but it won't always be smooth. Todays WSJ has an article on dry ice manufacturers needing to ramp up production in anticipation of the vaccine delivery.
Everyday there is a shortage of over 100 drugs, such as Lasix ( a generic and long in production) and other med supplies like IV fluids., Vaccine production and delivery won't be any different in experiencing its share of logistical hiccups.
Pfizer just cut its expected delivery of doses for December in half.

Medical provider? Are you in sales? As a guy that has taken products from concept to high volume production production I can assure you that although not trivial the problems that you mentioned all have straight forward solutions.

 

[KnightSlayer]

As a medical provider, I anticipate a shortage of things like the medical glass, needles, stoppers etc. just like Cletus proposed creating a bottle neck in the delivery system. WSJ has had a lot of articles on this very subject over the past few months. It will happen, but it won't always be smooth. Todays WSJ has an article on dry ice manufacturers needing to ramp up production in anticipation of the vaccine delivery.
Everyday there is a shortage of over 100 drugs, such as Lasix ( a generic and long in production) and other med supplies like IV fluids., Vaccine production and delivery won't be any different in experiencing its share of logistical hiccups.
Pfizer just cut its expected delivery of doses for December in half.

Pfizer will only ship HALF its planned 100m covid jab doses in 2020

Pfizer will only ship half as many doses of its coronavirus vaccine as it promised by the end of the year, cutting its planned global rollout from 100 million doses sources told the Wall Street Journal.

www.dailymail.co.uk

So why didn't we ramp up production of these items over the last 9 months knowing we were going to need them to eventually distribute the vaccine to hundreds of millions of people?

 

[bdgan]

development
phase I, II, and III testing
regulatory application
regulatory tracking
vaccine production
vaccine shipping & delivery

Those are all separate steps in the pharma process. Pfizer, as indicated earlier in this thread (or perhaps that was the separate Pfizer thread), and as mentioned in the NBC Dateline show that was broadcast this evening, did not take a penny from Operation Warp Speed for the development of their SARS-CoV-2 vaccine.

Production is totally separate from development. Pfizer is the largest drug company in the world. It has specialists in each of the aforementioned processes. And they produce several vaccines, so they know what they are doing.

Unless they have years of pharma vaccine production experience, "logistics guys" wouldn't be of any value to Pfizer, or any other drug company, for producing their respective vaccines.

FWIW, almost every new vaccine goes through production issues when its being introduced. Normally, that's a non-issue, as it simply means the vaccine won't be released until a month (or 2 or 3 or more) later than expected, or the supply will be limited when it's initially released.

Because of the severity of the pandemic, Pfizer (as well as Moderna) is attempting to produce an unprecedented number of vaccines for release as soon as they have FDA approval. They anticipated this issue, and started generating the vaccine while it was still being tested, and before they event made their regulatory application.

Still, the aforementioned normal rollout production problems are magnified by:
1. this being a mRNA vaccine, which has never before been released, and thus never before been produced
2. the severity of the pandemic
3. the world-wide need for the vaccine
4. and Pfizer's vaccine being a 2-shot vaccine

I think we need a better explanation than this.

First of all, the U.S. made a $1.95 billion deal with Pfizer for 100 million doses. Money is fungible and can be used to pay scientists, buy equipment, or purchase raw materials. Who's to say that this deal didn't help spur development?

I thought Pfizer was supposed to start production before approval knowing that they were getting paid either way. The deal wasn't to wait and start production after FDA approval.


P.S. Pfizer's own announcement mentioned project warp speed. I think there's some political posturing going on here.

"NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021."

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Tom McAndrew]

 

[Art]

I think we need a better explanation than this.

First of all, the U.S. made a $1.95 billion deal with Pfizer for 100 million doses. Money is fungible and can be used to pay scientists, buy equipment, or purchase raw materials. Who's to say that this deal didn't help spur development?

I thought Pfizer was supposed to start production before approval knowing that they were getting paid either way. The deal wasn't to wait and start production after FDA approval.


P.S. Pfizer's own announcement mentioned project warp speed. I think there's some political posturing going on here.

"NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021."

Pfizer's deal was contingent on it developing an FDA-approved vaccine. It was no fronted any money.

 

[Tom McAndrew]