Coronavirus

[Alex2507]

Maybe not something to joke about

I was gonna say, "time for a new g/f" ...

It's only funny about 98% of the time.

 

[Old Onkyo]

I still don’t understand why airlines are allowed to operate! why would anyone think the spread of the virus and its mutations can be stopped when I can fly from Los Angeles to Ne York in 6 hrs.

Nobody has the right to fly. If you want to travel drive. Covid numbers exploded as holiday travel ramped up.

 

[Swerd]

On to the subject of actually getting vaccinated. I'm told that my age group, 65-75 years, is next. In the vaccination jargon, that's called phase 1C. Phase 1B included people ≥75 years old.

The state of Maryland announced that phase 1C people become eligible for vaccination tomorrow, on Monday, 25 January. In their next sentence, they admit that only about 10% of people eligible under phase 1B have actually been vaccinated. Note the optimistic use of the word 'eligible' – without saying that vaccinations for 1C people can actually be scheduled starting Monday.

This weekend I began trying to learn just where vaccinations can be had. I'm not sure why I wanted to do that, because it wasn't fun. The state runs a website that purports to tell you all about this. But it's all bells & whistles, with little or no useful content. I spent about an hour downloading data and searching for what locations there are in my county. In Maryland, there are over 160 sites, but most are a long drive. It took me a while, but did I find 6 locations, one of them was only 4 miles away from me. My county has about 1 million people in it.

But the state's data had no useful contact info. I know the hospitals and health clinics don't want to be inundated with phone calls from people anxiously looking to get vaccinated, so I ignored the phone numbers. I started Googling each location until I found a usable URL for getting Covid-19 vaccinations. That took nearly another hour. Eventually, I found one where I could register online for future emailed info about when I could start the process of getting a vaccination appointment. That's the best I could do. That's like standing in line for the privilege of waiting in another line.

Two weeks ago, I had my annual physical exam, and my doctor has only received the 1st shot. The same is true for the resident who did the initial exam and took my recent history. I know only one person who has received both shots, and he works in a major hospital.

There is a quite lot of work to do before 80-90% of people in the US are vaccinated. So far, the supply of vaccine is far less than needed. With vaccines from two more manufacturers, J&J and AstraZeneca, soon to be approved, I hope to see increasing amounts of vaccine in the near future. The problem is that a public immunization apparatus (for lack of a better word) doesn't exist. And that's in Maryland, a state with good medical care. The state government is clearly inventing a large state-wide vaccination system at the same time as it's trying to get it up and running. That's like running a race while also trying to tie your shoes. Before the pandemic, we didn't even have plans for such a system. This is convincing evidence that we truly need a functional national health care system.

 

[Mr._Clark]

There is a quite lot of work to do before 80-90% of people in the US are vaccinated. So far, the supply of vaccine is far less than needed. With vaccines from two more manufacturers, J&J and AstraZeneca, soon to be approved, I hope to see increasing amounts of vaccine in the near future. The problem is that a public immunization apparatus (for lack of a better word) doesn't exist. And that's in Maryland, a state with good medical care. The state government is clearly inventing a large state-wide vaccination system at the same time as it's trying to get it up and running. That's like running a race while also trying to tie your shoes. Before the pandemic, we didn't even have plans for such a system. This is convincing evidence that we truly need a functional national health care system.

According to Reuters, there is a supply shortage of the "low dead space" syringes that are used to get 6 doses from 5 dose vials. It's amazing to me (in a bad way) that we have the know-how to produce sophisticated vaccines but we are dropping the ball on relatively simple things like syringes.

Exclusive: Scarce niche syringes complicate U.S. plan to squeeze more COVID shots from Pfizer vials

The U.S. government's effort to squeeze more doses from Pfizer Inc's COVID-19 vaccine vials is spurring unanticipated demand for specialized syringes that the world's largest syringe supplier says exceeds existing capacity.

www.reuters.com

 

[Mr._Clark]

Well, it looks like Civid-19 has hit home for me!
I just found out earlier today that both my daughter and my GF most likely have it.
Daughter went with roommate to get tested after finding out they had been exposed. Her roommate tested positive and my daughter tested negative, however, my daughter believes she got a false negative as she is having chills and has lost her sense of smell. Maybe it is a coincidental flu that happens to block her smell, but taht seems like a long shot.
GF is a police officer and got involved Thursday night (off duty) when an ambulance came to pick up a neighbor/friend who is on dialysis and in need of a kidney (which her son is willing to donate), but unable to lose enough weight to qualify for. GF masked up, but was not maintaining 6 feet. Friday, she got the word that the neighbor has Covid (which, as callous as it sounds, will likely be the neighbor's demise - she is not a healthy woman). GF went into quarantine due to her exposure. Today, my GF said that she was experiencing muscle soreness and she has no other easy explanation for that aside from Covid. Perhaps a positive is that she got the first dose of Moderna on Wednesday and gone through a period of fatigue on Thursday and half of Friday, so I am hoping her system has a leg up in gaining immunity.
Myself I spent Thursday night (after exposure) with the GF (not knowing that there was an exposure). Found out she was exposed Friday afternoon and she went into quarantine. So far, I have no symptoms. I am hoping that while the GF likely received a viral load that she did not carry a viral load to expose me (and she took a shower shortly after she returned). In my very limited understanding, I would expect that it would not be easy for a person to retain and transmit a viral load of the virus via second hand exposure, and expect she had not yet had enough time (less than 24 hours) to have replicated the virus enough to infect me.

I have a question for those of you with an advanced understanding of Covid 19. My GF works at Kennesaw State University. It has a well respected nursing school, so I would expect their HR department should have good access to medical expertise (if the CDC or Ga Dept of Health is not providing guidance).
For the sake of my question, forget that she is showing symptoms (soreness).
Their rule is:
If you've been exposed, you need to get a test on the 5th day. If the test is negative, then you can return to work after 7 days!

I don't understand this! If you test negative on day 5 (and don't have symptoms) why would you not return to work as soon as you got the test result?
If there is a chance you would get Covid on days 6 or 7, why wouldn't you want to wait until day 7 for the test?
The only explanation I can muster is that it is a hold-over from the earlier tests which required a 2 day wait before results were ready.

So my question is am I missing something? If not, they should allow return after a negative result of the test taken on the 5th day, right?

That is not good news. I certainly hope you, your family, and friends get through this without undue difficulty.

 

[Irvrobinson]

Supply of Covid vaccine doses held up by manufacturing delays

Oxford/AstraZeneca will rely on European plants for initial supplies after UK supply chain holdup

www.irishtimes.com

A rather messy picture of the manufacturing situation for the AstraZeneca vaccine. This type of vaccine, while being much easier to distribute than the Moderna and Pfizer vaccines, apparently has a 2-3x longer manufacturing time, which necessitates a deeper manufacturing pipeline. Deep pipelines are always more challenging, and the AZ pipeline is apparently about two months deep to produce a dose:

Inside Oxford’s coronavirus vaccine development

From a small discovery to producing at scale, photojournalist David Levene documents the groundbreaking work of the scientists of Oxford University during the development of a vaccine which is now poised for approval by medicines regulators

www.theguardian.com

The Johnson & Johnson vaccine is said to use similar technology to the AZ vaccine, and promises good efficacy in a single dose. Already I'm hearing that locally the two-dose requirement is going to cause uncertainty in initial dose distribution if the manufacturing objectives are not met, because second dose recipients will get priority over first dose recipients, naturally. Anybody reading the news lately knows that the distribution uncertainties are mucking up the vaccination process in many locales.

The Moderna and Pfizer mRNA vaccine doses apparently take about two weeks to manufacture, but then the distribution process is significantly hampered by the oft-reported and discussed cold storage requirements.

There's too little data available to know which vulnerabilities are worse.

Obviously, every step of the production process will improve with experience and refinement, but I wouldn't be surprised if we see ongoing significant hiccups in production, distribution, and the vaccination process for months. And lots of finger-pointing will be part of it too.

Merck just abandoned its vaccine candidates due to poor immune system responses:

Bloomberg - Are you a robot?

Very unfortunate.

 

[Irvrobinson]

Moderna is working on a booster shot for different COVID strains:

Moderna making booster shot to fight Covid-19 variants

New strains of the coronavirus have emerged in the United Kingdom, South Africa and Brazil.

www.politico.com

 

[Swerd]

Moderna has announced it's SARS-CoV-2 vaccine protects against the British & South African variants in lab tests. Antibody-containing blood serum, taken from people and monkeys who received the vaccine, were just as effective at blocking the British variant as the original strain of corona virus. Against the South African variant, the vaccine remained above the threshold for efficacy, but was less effective. As a precaution, Moderna has begun developing a new vaccine directed against the South African variant.

This announcement generally resembles the results that Pfizer announced last week.

https://www.washingtonpost.com/health/2021/01/25/covid-vaccine-virus-variant/

 

[Verdinut]

FYI, the Montreal Heart Institute started using Colchicine for heart disease patients with positive results:

Bienvenue à l’Institut de cardiologie de Montréal

Bienvenue sur le site de l'Institut de Cardiologie de Montréal, centre dédié à la prévention, la recherche et le traitement des maladies cardiovasculaires.

www.icm-mhi.org

A January 22 follow-up report from the Montreal Heart Institute:

Colchicine is proven to reduce hospitalizations, need of mechanical ventilation and deaths:

Bienvenue à l’Institut de cardiologie de Montréal

Bienvenue sur le site de l'Institut de Cardiologie de Montréal, centre dédié à la prévention, la recherche et le traitement des maladies cardiovasculaires.

www.icm-mhi.org

 

[Mr._Clark]

This is not a huge surprise, but the Brazil variant has been detected in the U.S. (Minnesota).

First known case of Brazil COVID-19 variant in the U.S. found in Minnesota

The Minnesota Department of Health reports the patient recently returned from travel to Brazil.

www.kare11.com

 

[TLS Guy]

This is not a huge surprise, but the Brazil variant has been detected in the U.S. (Minnesota).

First known case of Brazil COVID-19 variant in the U.S. found in Minnesota

The Minnesota Department of Health reports the patient recently returned from travel to Brazil.

www.kare11.com

Yes, it has. Travel requirements are far too lax. Minnesota is going to start a lottery for those over 65 to get vaccinated starting at 5:00 AM tomorrow morning.
My wife and I have made the decision to wait until the vaccine will be available through our health system, Allina. They say they are hoping to get over 65 vaccinated by the end of next month. I have a feeling this may be over optimistic. Luckily we have comfortable house and are quite content. Even our five year old granddaughter knows how to message and Facetime us and send us pictures without assistance. I think she can do a lot of this better than I can!

A trade war is developing over vaccines.

Astrazeneca says it can not fulfill its obligations to the EU. The EU is reacting by threatening to ban all exports of vaccines produced in the EU. That would cut the UK out of obtaining the Pfizer vaccine. The largest Pfizer plant is in Belgium. I know the US supply is to some extent dependent on that Belgium plant.

Supply of the Oxford vaccine is described by the UK health minister, Matt Hancock as lumpy. There are real fears that the output is slowing and problems may worsen.
The UK has now vaccinated 75% of those over 80 and just over 10% of the population now.

It is clear to me that vaccine production is going to fall far short of requirements. I fear that the J & J vaccine will have the same production problems as the Astrazeneca vaccine, as it is also dependent on the culture of a live virus vector.

MSD who are a very large company have failed to produce two vaccines that are any use and given up. They bought a company registered in Austria with ties to the Pasteur Institute in Paris, Themis. They were going to use a live measles virus as a vector. On the face of it this sounds stupid, as humans would be pretty much certain to have antibodies to measles virus. Anyhow it is a bust. MSD also bought IAVI and Ridgeback Bio to jumpstart there vaccine program. Sounds like there needs to be a CEO and other top brass shown the door. This is a pity as it really reduces the prospect of getting to adequate production.

If either J & J or Novovax fail to get approval and come on stream soon, I think we are in serious trouble.

It looks as if Pfizer, Moderna, Astrazeneca, J & J and Novovax are our only contenders.

Meanwhile there are problems in Israel. They have the UK and South African variants now prevalent. They seem to think current vaccines are only partially effective against the South African variant. More disturbing they are seeing an alarming rise in pediatric cases especially adolescents. They seem to think that it is the UK mutation responsible for this and not the South African mutation. Anyhow they are moving ahead to vaccinate children over 12 without trial. This seems reasonable as children over 12 are immunologically very similar to adults. It would be more problematic to do this in younger children. Israel is also in hot water for not making vaccine available to Palestinians.

Moderna is doing an edit of its vaccine for the South African variant.

California now say its problems are being caused by a mutation that has arisen there. It seems to actually be very close to the UK mutation, and probably acts the same, which in itself is a big problem.

I think that a root cause of the Astrazeneca problem is likely pushing these cultures too hard in factories that are too small. The main Astrazeneca plant is in Wrexham Wales. It is currently surrounded by flood water which does not help. Due to heroic actions by emergency personnel they managed to keep water out of the plant, but it is surrounded by pumps. So there is disruption.

We need to use the war powers act to build factories under emergency orders round the clock with large work forces, and see if we can get the up in months rather than years.

I regard the whole situation currently as highly critical and very worrying. If we don't take extraordinary measures then this crisis will drag on for years, and could easily spin totally beyond control.

 

[GO-NAD!]

Made-in-Canada coronavirus vaccine to begin human clinical trials Tuesday | CBC News

"A made-in-Canada vaccine to protect against COVID-19 is to begin human clinical trials Tuesday in Toronto, says the biotechnology company that developed the vaccine.

Toronto-based Providence Therapeutics said three shots will be given to 60 adult volunteers at a clinical trial site in Toronto in the first phase of the trial on Tuesday.

Fifteen of those volunteers will receive a placebo, and 45 will get the vaccine, called PTX-COVID19-B.

Brad Sorenson, the company's CEO, said it's the first time a vaccine designed and manufactured in Canada has begun clinical trials. The company has purchased a site in Calgary to mass produce the vaccine.

The vaccine is an mRNA vaccine — which triggers an immune response in the body — and is similar to the Moderna coronavirus shot being given to people across Canada.

Quebec-based pharmaceutical Medicago began clinical trials last July of its coronavirus vaccine that is based on another technology. Unlike Providence, a large portion of Medicago's vaccine doses will be manufactured outside the country, in North Carolina."

I had no idea these vaccines were in the works.

 

[Alex2507]

"A made-in-Canada vaccine to protect against COVID-19 is ...

... called Molsen.

 

[GO-NAD!]

... called Molsen.

Meanwhile, Molson is still making beer...

 

[Alex2507]

Meanwhile, Molson is still making beer...

Oof ... well, that's embarrassing.

 

[Trell]

Oof ... well, that's embarrassing.

poop happens

Edit: Poop is poop and poop is poop

 

[Swerd]

Meanwhile, Molson is still making beer...

It Labatt not Molson. They'll call it Labatt dix-neuf.

 

[Swerd]

A January 22 follow-up report from the Montreal Heart Institute: Colchicine is proven to reduce hospitalizations, need of mechanical ventilation and deaths:

Bienvenue à l’Institut de cardiologie de Montréal

Bienvenue sur le site de l'Institut de Cardiologie de Montréal, centre dédié à la prévention, la recherche et le traitement des maladies cardiovasculaires.

www.icm-mhi.org

I read that press release about the Colchicine clinical trial yesterday. As a low-dose oral treatment for PCR+ patients, it might be better tolerated than dexamethasone. I wonder if it's as effective as dex? If I remember, dex is given only to hospitalized patients by IV. Colchicine was given as an oral drug, at low dose, and was intended for infected people before they might need hospitalization. As someone with too much experience taking gluco-corticoids, I would be glad to have a choice other than dex.

After reading the press release, I focused on these words:

The Montreal Heart Institute (MHI) study results have shown that colchicine has reduced by 21% the risk of death or hospitalizations in patients with COVID-19 compared to placebo. This result obtained for the global study population of 4488 patients approached statistical significance. The analysis of the 4159 patients in whom the diagnosis of COVID-19 was proven by a naso-pharyngeal PCR test has shown that the use of colchicine was associated with statistically significant reductions in the risk of death or hospitalization compared to placebo. In these patients with a proven diagnosis of COVID-19, colchicine reduced hospitalizations by 25%, the need for mechanical ventilation by 50%, and deaths by 44%. This major scientific discovery makes colchicine the world’s first oral drug that could be used to treat non-hospitalized patients with COVID-19.

These are certainly interesting clinical results. However, whenever I see the words ‘approached statistical significance’, I groan because those words really mean ‘failed to achieve statistical significance’. It was close, but no cigar. The FDA will want to know what differences there were between the overall group of 4488 patients, and the PCR+ group of 4159 patients. Was the only difference the presence or absence of PCR confirmation of Covid-19? What about the placebo group? How many of them also had PCR-confirmed disease?

These statistical points do seem excessively picky, but they are essential for the FDA. I haven’t seen the data, but as a guess, the best outcome I can see is where the FDA tells the Montreal Heart Inst. to treat more PCR-confirmed patients until their data becomes both statistically and clinically significant.

The original protocol for the COLCORONA trial said it planned to enroll about 6,000 patients. But enrollment stopped at 4,500 patients.

• Why did the trial stop early at 75% of the planned enrollment? At Interim Analysis, were the results futile, or were they better than expected?
• Or, was it too difficult to find enough patients willing to enter the trial?

As the data seems from the press release, I doubt if it would get FDA approval. I hope this colchicine result gets attention from people on Anthony Fauci’s staff. Their opinion will matter, as they know how to press the buttons of the right people at the FDA.

To me, this study reinforces the stark truth I learned after my time with clinical trial design for anti-cancer drugs. Selection of patient population characteristics and planning of statistical analysis often end up making-or-breaking phase 3 clinical trials. At the time this study was planned, PCR tests to confirm Covid-19 diagnosis were not readily available, so it wasn’t required for patients. Later in 2020 it became the standard for confirming Covid-19 diagnosis. This may have been the reason why data were not available from enough PCR-confirmed patients to allow a statistically significant conclusion.

Colchicine can always be used off-label. I wonder what the side effects of 30 days of oral low-dose Colchicine are? @TLS Guy?

 

[TLS Guy]

I read that press release about the Colchicine clinical trial yesterday. As a low-dose oral treatment for PCR+ patients, it might be better tolerated than dexamethasone. I wonder if it's as effective as dex? If I remember, dex is given only to hospitalized patients by IV. Colchicine was given as an oral drug, at low dose, and was intended for infected people before they might need hospitalization. As someone with too much experience taking gluco-corticoids, I would be glad to have a choice other than dex.

After reading the press release, I focused on these words:
These are certainly interesting clinical results. However, whenever I see the words ‘approached statistical significance’, I groan because those words really mean ‘failed to achieve statistical significance’. It was close, but no cigar. The FDA will want to know what differences there were between the overall group of 4488 patients, and the PCR+ group of 4159 patients. Was the only difference the presence or absence of PCR confirmation of Covid-19? What about the placebo group? How many of them also had PCR-confirmed disease?

These statistical points do seem excessively picky, but they are essential for the FDA. I haven’t seen the data, but as a guess, the best outcome I can see is where the FDA tells the Montreal Heart Inst. to treat more PCR-confirmed patients until their data becomes both statistically and clinically significant.

The original protocol for the COLCORONA trial said it planned to enroll about 6,000 patients. But enrollment stopped at 4,500 patients.

• Why did the trial stop early at 75% of the planned enrollment? At Interim Analysis, were the results futile, or were they better than expected?
• Or, was it too difficult to find enough patients willing to enter the trial?

As the data seems from the press release, I doubt if it would get FDA approval. I hope this colchicine result gets attention from people on Anthony Fauci’s staff. Their opinion will matter, as they know how to press the buttons of the right people at the FDA.

To me, this study reinforces the stark truth I learned after my time with clinical trial design for anti-cancer drugs. Selection of patient population characteristics and planning of statistical analysis often end up making-or-breaking phase 3 clinical trials. At the time this study was planned, PCR tests to confirm Covid-19 diagnosis were not readily available, so it wasn’t required for patients. Later in 2020 it became the standard for confirming Covid-19 diagnosis. This may have been the reason why data were not available from enough PCR-confirmed patients to allow a statistically significant conclusion.

Colchicine can always be used off-label. I wonder what the side effects of 30 days of oral low-dose Colchicine are? @TLS Guy?

You need the toilet handy. The trouble with oral covid-19 given orally is diarrhea in almost 100% of cases. It can also cause bone marrow suppression. That is why I used to treat acute gout with one dose of IV cochinine. The other problem is that an avaricious equity firm managed to patent a drug used for hundreds of years and hold everyone to a king's ransom for it. Dexamethasone is a much better, safer and cheaper drug. It is one of the cheapest drugs in the hospital pharmacy.

 

[TLS Guy]

I have just entered the great Minnesota lottery! I'm not making this up, Minnesota decided last week to turn the distribution of Covid-19 vaccines into a state lottery.
After researching it, it became clear these mega vaccines centers are going to have priority over your usual provider. So I felt I would pretty much have to sign the two of us up. Registration closes at 5:00 AM tomorrow morning. You have to be 65 or older to sign up, unless you are a frontline worker, which here includes teachers, or a high risk category individual. This has been controversial, especially as the over 80 group do not have preference. So I will be randomized, and about one in 12 who register are expected to get a place. Now there are few of these centers. The nearest one to us is 30 miles the other side of the metro. However many rural residents will have a round trip of hundreds of miles.

I would have thought that Minnesota could have done better than this Dog's Dinner. I think there needs to be a strong Federal program for this roll out. If not the weird patchwork of programs the states are coming up with, and implementing, will make to US a bigger laughing stock than it is already on the world stage.