COVID-19 Outbreak Information Updates (Reboot) [over 150.000,000 US cases (est.), 6,422,520 US hospitilizations, 1,148,691 US deaths.] (10 Viewers)

[SaintJ]

Relax, don't worry about COVID. You might be immune.

 

[J.T.]

And....it has started.....

(This is still preliminary info, but very interesting that Pfizer thinks they have enough (positive) data to start this process.)

Pfizer has started to ask for a review of their vaccine candidate...in Europe. The request was made in Europe first. You can probably expect Pfizer to make an initial submission to the FDA shortly. (But the FDA normally requires more data at the beginning than Europe does, so it might be another couple of weeks.) This will then start the review process in the USA. Interesting that they submitted first in Europe, but understandable, given the slightly different regulatory framework.

The European equivalent of the FDA, the European Medicines Agency or EMA, has started to review data from Pfizer as part of their review process prior to a possible approval of the Pfizer vaccine.

Interesting line highlighted below....."encouraging preliminary results from pre-clinical and early clinical studies"... The last bit, I think is the most encouraging part of the whole thing.....encouraging preliminary results from.....early clinical studies. I think they just dropped a hint that they really think their vaccine works. The "early clinical" part is very interesting.

******

"Pfizer Inc. and BioNTech SE today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19. The EMA’s decision to start a rolling review follows the encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. ...BioNTech and Pfizer plan to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate the final Marketing Authorization Application (MAA)."

"As part of the rolling review, the CHMP has begun evaluating data generated in pre-clinical trials."

" Normally, all data on an investigational medicine’s efficacy, safety and quality and all required documents must be submitted at the start of the evaluation in a complete application for marketing authorization. In the case of a rolling review, the EMA’s CHMP reviews data as they become available from ongoing studies, before a complete application is submitted. Once the CHMP decides that sufficient data are available, the complete application should be submitted by the company. By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the investigational medicine or vaccine should be authorized. After a positive opinion, if adopted by the CHMP, it is the European Commission’s role to grant a Marketing Authorization. "

BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2

Rolling review accepted by the EMA based on available preclinical and clinical data for BNT162b2 to dateBioNTech and Pfizer will continue regular and open...

www.globenewswire.com

 

[Optimus Prime]

A man in New York state has been charged with criminally negligent homicide after allegedly shoving an 80-year-old man at a bar over a dispute about the suspect not wearing a face mask.

Donald Lewinski, 65, of West Seneca, was arrested in connection with the incident at the Pamp's Red Zone Bar and Grill in West Seneca on September 26 which left Rocco Sapienza dead.

Erie County District Attorney John Flynn said that Sapienza confronted Lewinski who was seen walking around the bar not wearing a mask to bring buckets of beer to a band playing outside.

During an argument, Lewinski is alleged to have shoved Sapienza "without warning," resulting in the victim falling back and hitting his head on the ground.

"The victim was not ready for the shove, he was not bracing himself for anything," Flynn said during a news conference.

Sapienza was unresponsive for four days at hospital before dying on September 30. An autopsy determined the cause of death was blunt force trauma to the head, reported The Buffalo News.

Flynn said that while there have been many examples of arguments or physical confrontations breaking out over the wearing of masks amid the coronavirus outbreak, this may be the first time someone has died over such a dispute in the country.................

Man Killed After Confronting Fellow New York Bar Patron For Not Wearing Mask

 

[Saint_Ward]

And....it has started.....

(This is still preliminary info, but very interesting that Pfizer thinks they have enough (positive) data to start this process.)

Pfizer has started to ask for a review of their vaccine candidate...in Europe. The request was made in Europe first. You can probably expect Pfizer to make an initial submission to the FDA shortly. (But the FDA normally requires more data at the beginning than Europe does, so it might be another couple of weeks.) This will then start the review process in the USA. Interesting that they submitted first in Europe, but understandable, given the slightly different regulatory framework.

The European equivalent of the FDA, the European Medicines Agency or EMA, has started to review data from Pfizer as part of their review process prior to a possible approval of the Pfizer vaccine.

Interesting line highlighted below....."encouraging preliminary results from pre-clinical and early clinical studies"... The last bit, I think is the most encouraging part of the whole thing.....encouraging preliminary results from.....early clinical studies. I think they just dropped a hint that they really think their vaccine works. The "early clinical" part is very interesting.

******

"Pfizer Inc. and BioNTech SE today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19. The EMA’s decision to start a rolling review follows the encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. ...BioNTech and Pfizer plan to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate the final Marketing Authorization Application (MAA)."

"As part of the rolling review, the CHMP has begun evaluating data generated in pre-clinical trials."

" Normally, all data on an investigational medicine’s efficacy, safety and quality and all required documents must be submitted at the start of the evaluation in a complete application for marketing authorization. In the case of a rolling review, the EMA’s CHMP reviews data as they become available from ongoing studies, before a complete application is submitted. Once the CHMP decides that sufficient data are available, the complete application should be submitted by the company. By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the investigational medicine or vaccine should be authorized. After a positive opinion, if adopted by the CHMP, it is the European Commission’s role to grant a Marketing Authorization. "

BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2

Rolling review accepted by the EMA based on available preclinical and clinical data for BNT162b2 to dateBioNTech and Pfizer will continue regular and open...

www.globenewswire.com

All of the early clinical stuff was positive. The question, at this phase, is if it's safe for people, and does it actually make those who take it less likely to get the virus vs others. If not enough people get exposed to the virus, they may not be able to prove its effectiveness.

 

[Infoman]

The median age of people who have died with Covid is 71 among Hispanics, 72 among non-whites and 81 among whites, according to the report.

Coronavirus (COVID-19) Overview

COVID-19 is a new type of coronavirus that causes mild to severe cases. Here’s a quick guide on how to spot symptoms, risk factors, prevent spread of the disease, and find out what to do if you think you have it.

www.webmd.com

This overall - all things considered - means that the average person that dies from Covid is ~75 years old. Not taking any of the millions of details that go into that into consideration... that's the average overall age of death for Covid. Roughly 75.

U.S. Life Expectancy 1950-2024

Chart and table of U.S. life expectancy from 1950 to 2024. United Nations projections are also included through the year 2100.

www.macrotrends.net

The overall U.S. Life Expectancy age is.... ~78 years old....

In short, the average person that dies of from contracting Covid is 75 years old, and the average person that dies of being old or literally anything else under the sun is.... 78 years old...

Think on that for a while, and then realize what we are being put though because of this. It's Insane!

And to be clear, as I have been from the beginning...

I am not saying we shouldn't take this seriously, we should. We should do all we can to protect the elderly and people most at risk. We should do what we can that makes sense to limit the spread. We should make sure hospitals can handle spikes in patients, and are equipped to handle treatment and don't get overwhelmed.

But the rest of this craziness needs to stop, and healthy people that have less than %.1 of being impacted by this need to be allowed to live their lives, and stop being feed fear and lies.

Again, the average age of Covid death is 75... the average age of death in general is 78. (US)

What the hell are we doing here?

 

[Saint by the Bay]

Death is not the only thing that matters. There are many other factors than just death.

 

[buzd]

Death is not the only thing that matters. There are many other factors than just death.

And also, assuming some sort of bell curve distribution, that means >100,000 are dead who are under 75. And plenty over 50.. And a good bit over 40..

And, at this point, what is there to really complain about? No bars? Concerts? Mask mandates? Social distancing? I understand the economic pain of restaurant and bar owners, for sure, but other than that what is really being restricted at this point?

 

[Infoman]

Death is not the only thing that matters. There are many other factors than just death.

Understood... I addressed them. Our hospital system is not overwhelmed. We must take the humane steps to shield the elderly and people most at risk. We can continue to do what we can to limit the spread among people with less then a .1% chance of death.

We don't know what the long term effects are for sure, because there is no long term data with a new (novel) virus.

We need to start being smart, and stop being scared. The smart data says the chance of anyone dying of old age at 78 - and dying from this virus at 75... are roughly the same.

Is that really enough reason to kill entire lively-hoods, shudder our most productive cities, wipe out industries, destroy our children's education, watch people lose their homes, watch suicide rates skyrocket, etc...?

I fell like I am taking crazy pills over here....

 

[buzd]

Understood... I addressed them. Our hospital system is not overwhelmed. We must takes the humane steps to shield the elderly and people most at risk. We can continue to do what we can to limit the spread among people with less then a .1% chance of death.

Are you familiar with the state of health insurance/health care in this country?

Is that really enough reason to kill entire lively-hoods, shudder our most productive cities, wipe out industries, destroy our children's education, watch people lose their homes, watch suicide rates skyrocket, etc...?

Cities are not shuddered. (sic)

 

[Infoman]

Are you familiar with the state of health insurance/health care in this country?



Cities are not shuddered. (sic)

I am... Not sure how this virus changes the absolute price gauging, and lack of price controls from the medical industry and Big Pharma...

Also... anytime you want, just have a look at these...

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Maybe "shuttered" is a strong word... but it's not that far off.

 

[superchuck500]

The median age of people who have died with Covid is 71 among Hispanics, 72 among non-whites and 81 among whites, according to the report.

Coronavirus (COVID-19) Overview

COVID-19 is a new type of coronavirus that causes mild to severe cases. Here’s a quick guide on how to spot symptoms, risk factors, prevent spread of the disease, and find out what to do if you think you have it.

www.webmd.com

This overall - all things considered - means that the average person that dies from Covid is ~75 years old. Not taking any of the millions of details that go into that into consideration... that's the average overall age of death for Covid. Roughly 75.

U.S. Life Expectancy 1950-2024

Chart and table of U.S. life expectancy from 1950 to 2024. United Nations projections are also included through the year 2100.

www.macrotrends.net

The overall U.S. Life Expectancy age is.... ~78 years old....

In short, the average person that dies of from contracting Covid is 75 years old, and the average person that dies of being old or literally anything else under the sun is.... 78 years old...

Think on that for a while, and then realize what we are being put though because of this. It's Insane!

And to be clear, as I have been from the beginning...

I am not saying we shouldn't take this seriously, we should. We should do all we can to protect the elderly and people most at risk. We should do what we can that makes sense to limit the spread. We should make sure hospitals can handle spikes in patients, and are equipped to handle treatment and don't get overwhelmed.

But the rest of this craziness needs to stop, and healthy people that have less than %.1 of being impacted by this need to be allowed to live their lives, and stop being feed fear and lies.

Again, the average age of Covid death is 75... the average age of death in general is 78. (US)

What the hell are we doing here?

A couple questions for you: (1) Do you think that death is the only adverse result of Covid?

The median (national) age of Covid-related emergency room visits is about 48. With a few exceptions, this means that the person was ill enough to decide that the ER was their next step. The idea that because the ill person doesn't die, that it's not concern is pretty silly - particularly when it is clear that we are learning more and more about long-term implications of Covid illness among those who survived.



source below

(2) Do you understand that for averages across large populations, every data point over the average means that there is data below the average . . . it's a curve, mostly likely a bell curve, but the zone of significance is much larger than the single numeric average.

Of the 194K American Covid deaths through September 24, there were almost as many deaths between the ages of 45 and 64 (36,161) than there were 65 and older (41,866)(source below). This idea that if the average age of death is 75 and life expectancy is 78, so it's really just an old person thing is a substantial mischaracterization of the data and what it means. By comparison, in the 2018-19 flu season, 5,676 Americans between the ages of 50 and 64 died from it, so Covid kills pre-seniors (Americans between 45 and 65) by an significant order of magnitude compared to viral illness that we just "live with".


I think there is a sweet spot of sensible mitigation and, admittedly, in some regions there's too much mitigation and likely not enough in others. But it seems to me that "allowed to live their lives" is code for "I'm not going to do anything to help mitigate the risk of Covid for me, my family, and the community I live in" and that just continues to strike me as quite selfish. I think we could have an honest discussion about what mitigation measures are sensible and low impact (e.g. masks and limitations on indoor gatherings of high density that last for a significant length of time) and what mitigation measures are overkill. But we can't have that conversation if people aren't being honest about this illness and what it does. And I think that cuts both ways - it's not the black death, but nor is it just a geriatric disease.

Changing Age Distribution of the COVID-19 Pandemic ...

As of September 21, 2020, the coronavirus disease 2019 (COVID-19) pandemic had resulted in more than 6,800,000 reported U.S. cases and more than 199,000 associated deaths.

www.cdc.gov

Estimated Flu-Related Illnesses, Medical visits, Hospitalizations, and Deaths in the United States — 2018–2019 Flu Season | CDC

CDC calculates estimates of disease burden in the United States using surveillance data and modeling to adjust for sources of under-detection. Burden estimates for the 2018-2019 season found here.

www.cdc.gov

 

[Saint by the Bay]

I know I've said it before, but I'm not a fan of the mandatory closures and restrictions. I think as a community and society we need to be responsible.

The problem is there are too many people who simply won't be because of the politicization of the virus and they look at the circumstances through a narrow view or of it as an election year hoax. It makes it hard to rely on society to be responsible citizens because society is so fundamentally broken.

The truth is this thing has proven to be incredibly contagious and in many cases has some very long effects. Even if you get better many don't get better for weeks or months. The mask mandates and gathering restrictions have proven to work. I don't know of any industry still facing mandatory closures. I still don't like the mandatory restrictions and I have watched one restaurant I loved close under it, but I also can't propose a better alternative considering where we are as a society.

Just let it spread isn't a viable option for me. It's devastating, well beyond just the death rate. The only reason we aren't seeing Spanish Flu-like numbers has been the seriousness this has been approached with by many (certainly not all). I don't know the right answer, but I do believe "just let it happen and don't be scared" is the wrong answer.

 

[Infoman]

I get your point Chuck... I addressed the other factors already....

Some people will be have to be hospitalized, and treated... That is happening anyway. As long as we can handle the volume and don't overwhelm the system... that will be unavoidable until there is a vaccine that is widely deployed.

I don't want to hear about long term effects, until there is literally long term data that supports any conclusion one way or the other.

I am not one of those people that are like - "open everything up".... that's equally crazy....

But we are treating this virus like it's the kiss of death, and it just isn't... you literally have near the same life expectancy whether you contract this or you don't....

I am asking for reasonable decisions here, and stopping the fear campaign on this... because I think it's doing just as much (if not more) damage than the virus is doing at this point.

 

[superchuck500]

I get your point Chuck... I addressed the other factors already....

Some people will be have to be hospitalized, and treated... That is happening anyway. As long as we can handle the volume and don't overwhelm the system... that will be unavoidable until there is a vaccine that is widely deployed.

I don't want to hear about long term effects, until there is literally long term data that supports any conclusion one way or the other.

I am not one of those people that are like - "open everything up".... that's equally crazy....

But we are treating this virus like it's the kiss of death, and it just isn't... you literally have near the same life expectancy whether you contract this or you don't....

I am asking for reasonable decisions here, and stopping the fear campaign on this... because I think it's doing just as much (if not more) damage than the virus is doing at this point.

I don't think you addressed my point at all - if your primary contention is that Covid death is primarily a problem for those near the average life expectancy, how do you account for the fact that approximately 1 in 5 (21 percent) Covid deaths is under the age of 65? That's tens of thousands of Americans since February, who were nowhere near the average life expectancy.

But so as not to get hung up, what exactly, then, are your grievances an proposed resolutions to more appropriately fit this presentation?

 

[DaveXA]

And also, assuming some sort of bell curve distribution, that means >100,000 are dead who are under 75. And plenty over 50.. And a good bit over 40..

And, at this point, what is there to really complain about? No bars? Concerts? Mask mandates? Social distancing? I understand the economic pain of restaurant and bar owners, for sure, but other than that what is really being restricted at this point?

Well, to be fair, it's much more than that. Airline travel is still down over 70%. Cruise lines are essentially non-existant. Large numbers of businesses have filed for bankruptcy or shuttered. And massive layoffs are starting to happen because the Cares act funding is starting to run out.

So, a good bit of this stems not just from restrictions, but also from people changing their behavior and travel plans. I'm actually surprised the economy hasn't been hit harder. We're not out of the woods yet, not by a long shot imo.

We do need to remain vigilant, yet, at the same time, find a way to go on living in the new normal.