Coronavirus COVID-19 - Global Health Pandemic #97

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Thank you for sharing this article.
As a small restaurant owner in San Diego, California, I can attest.
Our patrons and our sales have taken a nose dive. Big time.
Stunning actually. People are afraid.
I so understand.
This virus is here. It's relentless as it tries to survive.
The mixed messages from our government can make anyone crazy.
I'm exhausted.
I honestly don't know what to think about going forward.
Looking forward, this winter, has me very worried as people go indoors.



Things have changed so fast!
Delta Surge Wipes Away Americans’ Optimism About Covid, Poll Shows—With Many Expecting Disruptions Through 2022

This marks a significant shift in opinion from June, when a record 89% believed the pandemic was getting better, and only 3% said it was getting worse.

It is also the first time since January that more U.S. adults have been pessimistic than optimistic about the Covid-19 pandemic (pessimism outpaced optimism for most of 2020).
Full article at link.
 
Drug companies cannot be held responsible for off label use.

But the doctor who prescribed it can.

Eta: Plus, the point is that it is safe and approved for its on label use, so the only "danger" is that it doesn't work for the off label use. Not that it's going to cause some harm no one knows about because it hasn't been thoroughly tested and in use for some time.
 
But the doctor who prescribed it can.

Eta: Plus, the point is that it is safe and approved for its on label use, so the only "danger" is that it doesn't work for the off label use. Not that it's going to cause some harm no one knows about because it hasn't been thoroughly tested and in use for some time.

(Getting back to how this topic originated) ...... If people don't want to get vaccinated, fair enough. But then they should all be following the protocol of wearing a mask to reduce any danger to themselves and (more importantly) to others, especially the danger to vulnerable children who cannot be vaccinated yet.

That obviously is not happening with many, many people ... according to observations by just about every US forum member here, and much MSM.
 
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Treating COVID-19—Off-Label and Compassionate Use and Clinical Trials During Pandemics

Although many drugs have in vitro activity against different coronaviruses, no clinical evidence currently supports the efficacy and safety of any drug against any coronavirus in humans, including SARS-CoV-2. Numerous drugs that have been highly promising in vitro for other infectious diseases have failed in clinical studies. If in vitro activity automatically translated into clinical activity, more antimicrobial drugs for all kinds of infectious diseases would be available. Yet, there are published case reports of old and new drugs with in vitro activity against SARS-CoV-2 that have been given to patients but without a comparison control group. The administration of any unproven drug as a “last resort” wrongly assumes that benefit will be more likely than harm. However, when a drug with unknown clinical effects is given to patients who have severe illness from a new disease (like COVID-19), there is no way to know whether the patients had benefited or were harmed if they were not compared to a concurrent control group. A common interpretation of off-label use and compassionate use of drugs is that is that if the patient died, they died from the disease, but if the patient survived, they survived because of the given drug. This is not true.
 
Treating COVID-19—Off-Label and Compassionate Use and Clinical Trials During Pandemics

Although many drugs have in vitro activity against different coronaviruses, no clinical evidence currently supports the efficacy and safety of any drug against any coronavirus in humans, including SARS-CoV-2. Numerous drugs that have been highly promising in vitro for other infectious diseases have failed in clinical studies. If in vitro activity automatically translated into clinical activity, more antimicrobial drugs for all kinds of infectious diseases would be available. Yet, there are published case reports of old and new drugs with in vitro activity against SARS-CoV-2 that have been given to patients but without a comparison control group. The administration of any unproven drug as a “last resort” wrongly assumes that benefit will be more likely than harm. However, when a drug with unknown clinical effects is given to patients who have severe illness from a new disease (like COVID-19), there is no way to know whether the patients had benefited or were harmed if they were not compared to a concurrent control group. A common interpretation of off-label use and compassionate use of drugs is that is that if the patient died, they died from the disease, but if the patient survived, they survived because of the given drug. This is not true.

Respectfully, I don't really care about the alternative drugs that can be used off label to treat Covid. As I've said a few times, I'm not afraid of getting it, strongly believe I've already had it, I don't want the vaccine because I've had anaphylaxis from medication before and am FAR more afraid of that, and if I'm wrong and I die of Covid, so be it. I'm going out one way or another eventually. It's just not something that concerns me or ever crosses my mind. That's how I got involved in this thread in the first place -- because it so incongruous to my personal daily life experience where Covid is irrelevant. And I'm going to step out of this thread now for that same reason. Good health to all :)
 
Treating COVID-19—Off-Label and Compassionate Use and Clinical Trials During Pandemics

Although many drugs have in vitro activity against different coronaviruses, no clinical evidence currently supports the efficacy and safety of any drug against any coronavirus in humans, including SARS-CoV-2. Numerous drugs that have been highly promising in vitro for other infectious diseases have failed in clinical studies. If in vitro activity automatically translated into clinical activity, more antimicrobial drugs for all kinds of infectious diseases would be available. Yet, there are published case reports of old and new drugs with in vitro activity against SARS-CoV-2 that have been given to patients but without a comparison control group. The administration of any unproven drug as a “last resort” wrongly assumes that benefit will be more likely than harm. However, when a drug with unknown clinical effects is given to patients who have severe illness from a new disease (like COVID-19), there is no way to know whether the patients had benefited or were harmed if they were not compared to a concurrent control group. A common interpretation of off-label use and compassionate use of drugs is that is that if the patient died, they died from the disease, but if the patient survived, they survived because of the given drug. This is not true.
I think human nature makes it very difficult to do NOTHING when a loved one is literally dying if the mere possibility exists that doing SOMETHING might help.

Yes, that SOMETHING might turn out to be a bad thing, resulting in more death than if NOTHING had been done.

But it’s hard to sit back and choose NOTHING over SOMETHING. I can see how, in the middle of a crisis in the middle of a pandemic, one might choose SOMETHING over NOTHING, even when both are unproven.
 
Thank you for sharing this article.
As a small restaurant owner in San Diego, California, I can attest.
Our patrons and our sales have taken a nose dive. Big time.
Stunning actually. People are afraid.
I so understand.
This virus is here. It's relentless as it tries to survive.
The mixed messages from our government can make anyone crazy.
I'm exhausted.
I honestly don't know what to think about going forward.
Looking forward, this winter, has me very worried as people go indoors.



Things have changed so fast!
Delta Surge Wipes Away Americans’ Optimism About Covid, Poll Shows—With Many Expecting Disruptions Through 2022

This marks a significant shift in opinion from June, when a record 89% believed the pandemic was getting better, and only 3% said it was getting worse.

It is also the first time since January that more U.S. adults have been pessimistic than optimistic about the Covid-19 pandemic (pessimism outpaced optimism for most of 2020).
Full article at link.
 
Not before long, we might encounter vaccine overdose cases if accurate records are not maintained. If some people literally drank bleach to kill Covid, what would stop them from getting 5 more shots in addition to the 2 already received. Worried.

Its hard to stop crazy people from doing crazy things. Inthose cases, they're not a threat to others, only themselves. There's not a lot others can do. Fortunately, those cases will be a very small percentage of the general public.
 
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Novavax is almost ready to join the fight against covid. (This is one of the four vaccines that Australia bought into before the vaccines were ready, so I have been watching its progress.)


... the Gaithersburg, Md.-based firm’s vaccine has done so well in clinical trials against the Covid-19 virus that its Thursday report on the quarter looked confidently ahead to the authorizations it expects from governments around the world.

With studies showing its shots to be more than 90% effective at preventing Covid, even from worrisome virus variants

Applications for emergency use authorization have been filed by the company’s manufacturing partner, the Serum Institute of India, in India, Indonesia, and the Philippines. Novavax expects to make similar filings in the U.K. during the September quarter, with European and U.S. filings in the months that follow.

Novavax Readies Its Vaccine to Fight Covid World-Wide
 
I don't know why the border force are allowing the migrants in.

With the number of migrants crossing the southern border surging and the pandemic proving to be far from over, the Biden administration has decided to leave in place for now the public health rule that has allowed it to turn away hundreds of thousands of migrants, officials said.

Despite the public health rule, many migrant families have been allowed to enter the United States this year. The administration has been able to enforce the rule in some areas of the border but not others, such as South Texas
Biden Administration to Keep Using Public Health Rule to Turn Away Migrants

The Border Patrol says it has insufficient time and space to conduct coronavirus testing at crowded processing stations.
Covid on the Border: Migrants Aren’t Tested on Arrival in U.S.


We're not nearly as on-top of this pandemic as you guys are, and the migrant issue is highly political.

A massive number of migrants--in the hundreds of thousands--are flowing over our southern border and there should be some sort of mandatory quarantine in place--longer than 2 days--to ensure they're virus-free before they're released into the general public.

And, I don't think it's wrong to require a Covid vaccine in order to enter the country either. Well, after it's FDA approved, anyway.

But, it's not just the migrants, it's the whole attitude here. It's a bike rally that's expected to host 700,000 participants, it's huge indoor weddings, it's schools where children don't wear masks.

I'm coming to the conclusion that the US is simply too big and too diverse in agenda to stop this virus. And, the saddest part is that it's going to mutate and mutate, and those mutations will find their way to your shores, even though you guys have set the stage for a healthy response. You should not be put at risk for my nation's behavior.
 
We're not nearly as on-top of this pandemic as you guys are, and the migrant issue is highly political.

A massive number of migrants--in the hundreds of thousands--are flowing over our southern border and there should be some sort of mandatory quarantine in place--longer than 2 days--to ensure they're virus-free before they're released into the general public.

And, I don't think it's wrong to require a Covid vaccine in order to enter the country either. Well, after it's FDA approved, anyway.

But, it's not just the migrants, it's the whole attitude here. It's a bike rally that's expected to host 700,000 participants, it's huge indoor weddings, it's schools where children don't wear masks.

I'm coming to the conclusion that the US is simply too big and too diverse in agenda to stop this virus. And, the saddest part is that it's going to mutate and mutate, and those mutations will find their way to your shores, even though you guys have set the stage for a healthy response. You should not be put at risk for my nation's behavior.

I couldn't agree with you more. The law currently says that the Border Force should not be allowing the migrants in, and yet .....

I know that I personally can't plan on visiting the US , as I usually do, when I am allowed to travel (which should be by your next summer, if our projections hold up). Instead, I am hoping that I can visit my best friend in Canada - if Canada can keep itself relatively safe, now that they are opening the border.
 
Novavax is almost ready to join the fight against covid. (This is one of the four vaccines that Australia bought into before the vaccines were ready, so I have been watching its progress.)


... the Gaithersburg, Md.-based firm’s vaccine has done so well in clinical trials against the Covid-19 virus that its Thursday report on the quarter looked confidently ahead to the authorizations it expects from governments around the world.

With studies showing its shots to be more than 90% effective at preventing Covid, even from worrisome virus variants

Applications for emergency use authorization have been filed by the company’s manufacturing partner, the Serum Institute of India, in India, Indonesia, and the Philippines. Novavax expects to make similar filings in the U.K. during the September quarter, with European and U.S. filings in the months that follow.

Novavax Readies Its Vaccine to Fight Covid World-Wide


This looks interesting! I just pulled up the latest, though, and now, they're not looking to submit the vaccine for emergency use until Q4. Originally, it was going to be submitted in Q3.

It almost seems as though the US government is slowing them down.

"The U.S. government has recently instructed us to prioritize alignment with the FDA on our analytic methods before conducting additional U.S. manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made."
Story here.

Again, this could be politics in play. Or crony capitalism, whereby some drug research companies are prioritized over others.

I don't mean to be so full of doom and gloom today. I need to get to work, which is probably good, since I'm being a wet blanket. Catch up with you later!
 
This looks interesting! I just pulled up the latest, though, and now, they're not looking to submit the vaccine for emergency use until Q4. Originally, it was going to be submitted in Q3.

It almost seems as though the US government is slowing them down.

"The U.S. government has recently instructed us to prioritize alignment with the FDA on our analytic methods before conducting additional U.S. manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made."
Story here.

Again, this could be politics in play. Or crony capitalism, whereby some drug research companies are prioritized over others.

I don't mean to be so full of doom and gloom today. I need to get to work, which is probably good, since I'm being a wet blanket. Catch up with you later!

Novavax's manufacturing partner is Serum Institute of India (who make lots and lots of worldwide meds), so I don't think the US manufacturing stance will really affect them in manufacturing their vaccine.

I read a little while ago that Novavax was having difficulty getting all of the components it needed for production. Hopefully that hurdle will soon be overcome, if it hasn't already been, because I know the first countries that it plans to service are desperately in need of vaccines. (India, Indonesia, Phillipines.)
 
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Novavax's manufacturing partner is Serum Institute of India (who make lots and lots of worldwide meds), so I don't think the US manufacturing stance will really affect them in manufacturing their vaccine.

I read a little while ago that Novavax was having difficulty getting all of the components it needed for production. Hopefully that hurdle will soon be overcome, if it hasn't already been, because I know the first countries that it plans to service are desparately in need of vaccines. (India, Indonesia, Phillipines.)
Novavax is a protein based vaccine and is expected to have fewer side effects (it doesn't involve either DNA or RNA). Too bad that it's taking them so long to ask for approval. I wonder if it's going to be a good option for little kids, but again they haven't done clinical trials with little kids, so that won't be any time soon.
 
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