Irvrobinson

Irvrobinson

Audioholic Spartan
As stated above, the UK is taking the same line and moving to emergency approval. Under the circumstances this is entirely reasonable.
I'm a strong supporter of vaccines, but I think the procedures are probably there for a reason. I'll wait.

Already this pandemic has extracted a dreadful cost, in death, misery, disability, economically and educationally. Attempts to reopen schools, sporting events, and especially universities are not going well. The UK in particular has reached the barriers of what it can do financially to prevent extreme misery to the population.

In addition, many feel that the worst is yet to come without a more aggressive approach. As the weather cools people will come inside, and Covid-19 infections coincide with influenza infections. A paper published in JAMA Saturday, looking at co-infection in China, showed this not to be rare at all, and increased mortality by 18%. So everyone should get their flu vaccine as soon as it is released.
I plan to get a flu vaccine when they're available in my area.

I think as soon as there are signals that the vaccine has a low incidence of side effects, and is effective, then this needs to be rolled out quickly on an emergency basis.
I'll wait, not that I think it'll make much difference. Vaccinating first-responders, healthcare professionals, and active military people will probably consume all of the vaccine that can be produced before the formal process comes to a readiness conclusion. I'm not in any of those groups.

I do see there may be some conflicts between practicing physicians, and academic/regulating ones. However practicing physicians are used to balancing difficult risk/benefits throughout their careers. Certainly I had to make these calls in occasions and take unapproved lines of action.

The fact is that as soon as there a clear signals, and I strongly suspect that those signals are there, that a vaccine presents far lower risk to health than the virus it should be rolled out.

At that point then clear guidance should be given, with as accurate a time line as possible. If a vaccine can start rolling out in quantity within two months say, then I think it would quell risky behavior like the reopening of universities and schools when the R value is too high to safely do so.
School-age people are probably going to end up being lowest on the priority scale. Teachers, especially those over 55 years old, might be higher, but I think in-person education is probably compromised or out the window for the 2020-2021 school year, and perhaps even for Fall 2021.

As soon as it is clear that rolling out the vaccine is less risk than the virus, then it needs to rolled out promptly. This is not a normal vaccine roll out. These are not ordinary times, so following established protocols will lead to greater disaster.
I'm less convinced.
 
Swerd

Swerd

Audioholic Spartan
However Astrazeneca is a UK company and as far as I know have no US production facilities.
Astra Zeneca has significant R&D as well as manufacturing facilities in the USA.
I live about a mile away from this in Gaithersburg, MD. It was previously an independent biotech company, MedImmune, Inc. It was the company HQ as well as all their R&D labs. My wife worked there for 17 years. AZ bought MedImmune about 15 years ago, for $15 billion. That included a manufacturing facility in Frederick, MD.
1598885158014.png
 
Swerd

Swerd

Audioholic Spartan
As stated above, the UK is taking the same line and moving to emergency approval. Under the circumstances this is entirely reasonable. … …

I think as soon as there are signals that the vaccine has a low incidence of side effects, and is effective, then this needs to be rolled out quickly on an emergency basis.
This is in reference to the recent announcement that the FDA is willing to fast track the approval process for corona virus vaccines.

The FDA does have a fast track approval procedure, and it has done that in the past. I'm not familiar with all the details, but it usually involves temporary approval while the large clinical trials are being completed. Most of these trials are designed with an interim analysis when the data from roughly half of the test subjects is available. That data is made available, unblinded, to the data review team. If the data shows enough efficacy, the trial can be stopped early, and the drug can be approved with the existing data. Likewise, if the data shows no efficacy or shows significant safety issues, the trial can be stopped early for futility.

These options after interim analysis always exist. With 'fast tracking', a drug can be temporarily approved, while the clinical trial proceeds. When the trial data becomes available, a final analysis is done, allowing final approval or disapproval for a drug. This process is done only when there is an unmet medical need. I certainly think COVID-19 qualifies as an unmet need.

The major problem I see with fast track approval, is not the procedure, but with the contaminated political appointees at the FDA who answer to Trump's unreasonable requests irrational demands. I don't trust them to follow the normal fast track approval process.
 
TLS Guy

TLS Guy

Audioholic Slumlord
This is in reference to the recent announcement that the FDA is willing to fast track the approval process for corona virus vaccines.

The FDA does have a fast track approval procedure, and it has done that in the past. I'm not familiar with all the details, but it usually involves temporary approval while the large clinical trials are being completed. Most of these trials are designed with an interim analysis when the data from roughly half of the test subjects is available. That data is made available, unblinded, to the data review team. If the data shows enough efficacy, the trial can be stopped early, and the drug can be approved with the existing data. Likewise, if the data shows no efficacy or shows significant safety issues, the trial can be stopped early for futility.

These options after interim analysis always exist. With 'fast tracking', a drug can be temporarily approved, while the clinical trial proceeds. When the trial data becomes available, a final analysis is done, allowing final approval or disapproval for a drug. This process is done only when there is an unmet medical need. I certainly think COVID-19 qualifies as an unmet need.

The major problem I see with fast track approval, is not the procedure, but with the contaminated political appointees at the FDA who answer to Trump's unreasonable requests irrational demands. I don't trust them to follow the normal fast track approval process.
There is a fine line between interference, and putting some stick about to work with dispatch.
 
mtrycrafts

mtrycrafts

Audioholic Slumlord
Where is the Kodak lab? Isn't $3/4 billion enough to put them on the map and start producing?
 
davidscott

davidscott

Audioholic Field Marshall
83000 dead as of today. Saw a study that says under 40 almost no deaths. 40 to 50 a few. 60s and above maybe 5 out of 1000. I'm 65 and I don't like those odds.
 
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Mikado463

Mikado463

Audioholic Field Marshall
83000 dead as of today. Saw a study that says under 40 almost no deaths. 40 to 50 a few. 60s and above maybe 5 out of 1000. I'm 65 and I don't like those odds.
I hear 'ya, I'm 66 and an A-fib patient so I totally understand
 
M

Mr._Clark

Full Audioholic
Here's a question for the group.

Do "comorbidities" in Table 3 of the recent CDC report include both preexisting conditions and conditions that are caused by COVID-19?

It seems to me that answer is "yes" but I may be missing something?

I've seen quite a few news reports that seem to conflate preexisting health conditions with contributing conditions. This appears to be caused, at least in part, by the CDC's confusing use of the term "underlying medical conditions" to describe preexisting issues, and the use of the somewhat similar term "comorbidities" to refer to all conditions that caused death, including both preexisting conditions and conditions that are caused by COVID-19.

Here's an example of a news article that (to my mind) conflates the issues:

Headline: "CDC data shows significance of underlying health concerns in COVID-19 deaths"


From the news report:


>>>The top comorbidities, or underlying medical conditions in a COVID-19 death include:
  • Influenza and pneumonia
  • Respiratory failure
  • Hypertensive disease
  • Diabetes
  • Vascular and unspecified dementia
  • Cardiac arrest
  • Heart failure
  • Renal failure
  • Intentional and unintentional injury, poisoning and other adverse events<<<

The CDC uses the term "underlying medical conditions" to describe preexisting issues:


Taking respiratory failure as an example, this is listed as a "comorbidity" in Table 3 of the recent CDC report:


I can't see how respiratory failure (or heart failure) could be a preexisting condition? In other words, it seems to me that respiratory failure was caused by COVID-19 in these patients (the person didn't have respiratory failure prior to contracting COVID-19). However, hypertension is also listed as a comorbidity in Table 3, and this does appear to be a preexisting condition.

It seems to me that some of the 94% who had a comorbidity probably did NOT have a preexisting condition.

In other words, there appears to be 2 different mistaken interpretations of Table 3 of the CDC report. The first is that only 6% of the deaths were caused by COVID-19. The second is that 94% of people who die from COVID-19 were already in a weakened state of health.

Am I missing something?
 
Swerd

Swerd

Audioholic Spartan
Here's a question for the group.

Do "comorbidities" in Table 3 of the recent CDC report include both preexisting conditions and conditions that are caused by COVID-19?
I've also wondered about this term, in the past. I got used to hearing it, often as a one-word shortcut for more complex things. There is a tendency in medicine, as in various other branches of science, to create one-word hybrids that stand for something too complex to explain each time it's used. It really falls under the category of shop-talk jargon. The more complex the phenomena, the less we actually understand it, the more often the one-word monstrosity is used. Usually plain English words, such as "underlying conditions', work better, but using shop-talk jargon becomes habit forming. A good scientific or medical journal will often eliminate terms they consider as jargon.

Presently there is no agreed-upon terminology of comorbid. I looked it up (see the Wikipedia link below) and found these definitions:
  1. to indicate a medical condition existing simultaneously but independently with another condition in a patient (this is the older and more "correct" definition)
  2. to indicate a medical condition in a patient that causes, is caused by, or is otherwise related to another condition in the same patient (this is a newer, nonstandard definition and less well-accepted).
  3. to indicate two or more medical conditions existing simultaneously regardless of their causal relationship.
https://en.wikipedia.org/wiki/Comorbidity

The term 'pre-existing' or 'previous history' suggests that a condition was previously known in a patient, such as heart or kidney disease. When that patient contracted Covid-19 and died, the pre-existing condition became a co-morbidity. At least, that's how I understand it. Of course, there can easily be such co-morbid conditions in a patient, that may have previously existed but were never previously identified or diagnosed. Determining an official cause of death can be very complex because it's rarely just one cause.
 
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M

Mr._Clark

Full Audioholic
Here's a news blurb about how the coronavirus affects hearts cells:

>>>"The sarcomere disruptions we discovered would make it impossible for the heart muscle cells to beat properly," explains Conklin, who is also a professor of medicine, cellular and molecular pharmacology, and ophthalmology at UCSF.

The scientists also noted that the nuclear DNA seemed to be missing from many of the heart cells. Without DNA, cells can no longer perform any normal functions.

"It's the cell equivalent of being brain dead," adds Conklin. "Even after scouring scientific literature and conferring with colleagues, we cannot find these abnormal cell features in any other cardiac disease model. We believe they are unique to SARS-CoV-2 and could explain the prolonged heart damage seen in many COVID-19 patients." . . .

Moreover, these findings shed light on the long-term ramifications of COVID-19. Unlike some other tissues in the body, the heart does not regenerate. So, it's possible that someone who becomes infected with COVID-19, even a mild case, could recover and then develop heart disease years later. <<<



I know quite a few people who continue to repeat the mantra "it's just the flu!" This seems bizarre to me, but I've come to realize that this belief is impervious to facts.
 
Swerd

Swerd

Audioholic Spartan
Interesting post about long term cardiac damage after corona virus infection. Thanks.
I know quite a few people who continue to repeat the mantra "it's just the flu!" This seems bizarre to me, but I've come to realize that this belief is impervious to facts.
They suffer from watching too much Faux News. This is also known among medical professionals as Cranial / Colonic Inversion, sometimes confused with Early Onset Dementia.
 
Swerd

Swerd

Audioholic Spartan
I read more news on vaccine clinical trial progress.
https://abcnews.go.com/Business/wireStory/virus-vaccine-reaches-major-hurdle-final-us-testing-72750503

"AstraZeneca announced Monday its vaccine candidate has entered the final testing stage in the U.S. The Cambridge, England-based company said the study will involve up to 30,000 adults from various racial, ethnic and geographic groups."​

This is the same vaccine as the Oxford Adenovirus vaccine that TLS Guy often mentions.

The ABC News article has a good summary of all the various types of vaccines in clinical trials.

It also discusses preliminary draft plans from a US advisory panel for how to ration the early doses of an approved vaccine. Initial supplies are expected to be limited to as many as 15 million people.
  1. First to receive vaccination are high-risk health care workers and first responders.
  2. Next priority will be older residents of nursing homes and other crowded facilities, as well as people of all ages with health conditions that put them at significant danger.
  3. In following waves of vaccination, teachers, other school staff, workers in essential industries, and people living in homeless shelters, group homes, prisons and other facilities would get the shots.
  4. Healthy children, young adults and everyone else would not get the first vaccinations, but would be able to get them once supplies increase.
These plans are a draft. The National Academies of Science and Medicine will solicit public comments on the plan through Friday.

The article also quoted NIH Director Francis Collins, who commented that the NIH
"is supporting several vaccine trials, since more than one may be needed. We have all hands on deck."​

I've often said that myself. I'm gratified to know that sound minds think alike ;).
 
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M

Mr._Clark

Full Audioholic
Interesting post about long term cardiac damage after corona virus infection. Thanks.
They suffer from watching too much Faux News. This is also known among medical professionals as Cranial / Colonic Inversion, sometimes confused with Early Onset Dementia.
As far as I can tell, the source of this was Trump's comparison of COVID-19 to the flu back in February as a way to minimize COVID-19. For the believers he is infallible, so this position must be maintained.
 
Mikado463

Mikado463

Audioholic Field Marshall
This is also known among medical professionals as Cranial / Colonic Inversion, sometimes confused with Early Onset Dementia.
LOL, a buddy of mine that I shoot clays with refers to it as 'cranial rectal inversion' whenever he(or me for that matter) has a bad day.
 
panteragstk

panteragstk

Audioholic Spartan
83000 dead as of today. Saw a study that says under 40 almost no deaths. 40 to 50 a few. 60s and above maybe 5 out of 1000. I'm 65 and I don't like those odds.
All jokes aside, but they call this "boomer remover" for a reason.

It's the main reason my kids don't get to see their grandparents and vice versa. I'm not going to risk their health just because. I want my kids to have their grandparents around as long as I have. It's nice to be able to still talk to my grandma when I'm approaching 40.

We need to protect our older generation. Don't get mad at the fact that your the "older generation". You guys got to see way better concerts than me. There's a thread about it.
 

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