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Are vaccines the light at the end of the tunnel?


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2 hours ago, markeb said:

 

Yes, it will.

 

There's been the initial prioritization discussion, but I don't know how that will impact the different customers, such as the Military Healthcare System and the VA Healthcare System. There are agreements with BARDA for access to products in general, but we'll see how that plays out. And the MHS would generally favor readiness for any initial distribution they receive (as probably would Canadian Armed Forces, the UK MOD, etc.). And that all still assumes equivalence of the different candidates across populations...

 

Will there be a distribution to state, county, and city health departments? "Fencing" to Medicare recipients? School and/or college students and potentially first responders through health departments? Distribution directly to hospitals/clinics/etc. for health care providers? What about contracted health care providers versus employees? Contractors are usually responsible for any preventive medicine requirements for their contract employees, not the facility they're working in. Getting way inside baseball here, but those are unfortunately all very real potential conversations on who actually gets the distribution that impacts who gets the vaccine on initial distribution.

 

Note that nothing in this post includes delivery of vaccine to support leisure travel in the initial distribution if the recipient isn't otherwise in a priority population...

I suspect that things will be a bit different for this one.  Most of the existing systems are built around who is responsible for payment.  Thus the contractors vs the facility.  If the government eats the cost, then that becomes a non-issue and it becomes more a matter of priority and efficiency.  I would expect at the federal  you will see allocations to the various government agencies (DOD, VA, Indian Health Service, etc.) at least those that have the capability to actually deliver the Vaccine.

 

Public Health Service does not have the capabilities for executing such a program as existed back in the 60's and 70's.

 

So for actual delivery they will pretty much have to do like the vaccines programs were set up to do and that is to  allocate and deliver to the state and local agencies.  The problem then is who sets the priority the feds, who paid for and provided the vaccine or the states.  I can see this turning into a political mess with each state wanting set their own rules on prioritization.

 

Otherwise I would expect the government to start putting in place contracts with medical groups for vaccine distribution and there are no signs of that yet.

 

No matter how this is handled good, bad the amount of fighting that will be taking place and the corresponding real or manufactured blame will make what has gone on so far to be just the warm up.

 

Its been a few years, but I always was able to get pretty fast access to vaccines during my active duty air force time, and my Air National Guard time in 2 different states. For that matter same with medical and dental. Then again I always did feel that the Air Force got treated better.

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2 hours ago, cangelmd said:

Some of the county health debts in AL have very rudimentary facilities and low staffing. I’m sure they all can give vaccines, but don’t know what their storage abilities are. 
Actually, given all the marks against us - deep poverty, sheer bloody minded stubbornness, low education levels, very Hands off electorate - the state has done really well against Covid. The governor has provided leadership that I didn’t expect. Some of the national metrics make us look bad, but those tend to be the ones that include a measure of contact tracing, which I think has been only in SNFs and maybe some in prisons.

University of AL not withstanding, the mask ordinance has been successful, and we done better than our Eastern and Southern neighbors.

That is why they will need to do some kind of hub and spoke around key storage locations with courier or drop ship distribution.

 

The problem is you should be seeing some signs of either local, state or federal contracts starting to be put into place and that does not seem to be happening yet.

 

Without that planning the distribution will be kneecapped.  Also without that planning would not be surprised to see a lot of waste.

 

 

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3 minutes ago, npcl said:

No matter how this is handled good, bad the amount of fighting that will be taking place and the corresponding real or manufactured blame will make what has gone on so far to be just the warm up.

 

Ditto. Nothing really to add.

 

(And just to be clear, there have been generational changes over administrations of both parties going back to the smallpox eradication program and a general move from infectious disease to chronic disease management that have impacted the federal Public Health Service (a Uniformed Service but not an Armed Service) and it's ability to jump in like it did for polio and smallpox in the 50's through the 70's. Probably reasonable decisions at the time, but man I wish we had that capability today!)

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I am hoping that initial vaccine distribution is well defined in the guidelines by the CDC does not get caught in Red vs Blue state BS.😕.  Yes I can at least try to be optimistic about this.  Not at all trying to be political and not taking sides.  Just sadly realistic.

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8 hours ago, npcl said:

That is why they will need to do some kind of hub and spoke around key storage locations with courier or drop ship distribution.

 

The problem is you should be seeing some signs of either local, state or federal contracts starting to be put into place and that does not seem to be happening yet.

 

Without that planning the distribution will be kneecapped.  Also without that planning would not be surprised to see a lot of waste.

 

 

 

Total inside baseball now:

 

I wonder if the contract actually delivers the vaccine to the Strategic National Stockpile and it's distributed from there? There are mechanisms for that to state and local health departments. Even if that's really direct vendor shipped and it never hits the SNS warehouse (seems most likely), it would use the distribution system in place for the SNS. Most of that was for local disaster/bioterrorism event, but there is a plan for widespread distribution of smallpox vaccine. Just not on this scale.

 

If you start seeing state and local health departments contracting for lab freezers...

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7 hours ago, markeb said:

 

Total inside baseball now:

 

I wonder if the contract actually delivers the vaccine to the Strategic National Stockpile and it's distributed from there? There are mechanisms for that to state and local health departments. Even if that's really direct vendor shipped and it never hits the SNS warehouse (seems most likely), it would use the distribution system in place for the SNS. Most of that was for local disaster/bioterrorism event, but there is a plan for widespread distribution of smallpox vaccine. Just not on this scale.

 

If you start seeing state and local health departments contracting for lab freezers...

What I have been watching has been some signs (contract announcements) that they are trying to put mechanisms in place for specialty (frozen product storage and transport).  The standard GSA contracts might have the capacity, but I would doubt it.

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16 hours ago, npcl said:

That is why they will need to do some kind of hub and spoke around key storage locations with courier or drop ship distribution.

 

The problem is you should be seeing some signs of either local, state or federal contracts starting to be put into place and that does not seem to be happening yet.

 

Without that planning the distribution will be kneecapped.  Also without that planning would not be surprised to see a lot of waste.

 

 

Excellent point. Maybe in the next few weeks since the meetings on who is in a priority group seem to be completed? They have ramped up manufacturing and bought up all the special glass, you would think they would be working this part of the distribution chain too.

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On 8/27/2020 at 3:02 PM, markeb said:

 

We all have. It's been discredited by every reputable reviewer who has looked at it, as have pretty much every other study looking at hydroxychloroquine. The only real effect of studying HCQ has been that those of us who use it to control RA and lupus (actually long standing indications with good data) now have to jump through hoops to actually get our med.

 You are totally incorrect. There are links to 70+ scientific studies at the website: c19study.com from journals such as International Journal of Microbiology, Journal of Infectious Diseases, Virology journal, etc. with many of these studies showing positive results for this medication for Covid in the pre-hospital phase. The studies not showing effectiveness (also linked on this website) were on patients already hospitalized and and 2 of those studies widely reported in the mainstream media were subsequently retracted. Also, the Association of American Physicians and Surgeons have filed a federal lawsuit against the FDA regarding restrictions on this medication.

https://aapsonline.org/hcqsuit/ 

A recently published study in the Journal of Electrocardiology (also linked on c19study.com) showed no significant adverse cardiac effects from this medication in non-ICU patients. Again, look at the actual research.

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"The Association of American Physicians and Surgeons (AAPS) is a conservative non-profit association founded in 1944. The group was reported to have about 5,000 members in 2014. The association has promoted a range of scientifically discredited hypotheses, including the belief that HIV does not cause AIDS, that being gay reduces life expectancy, that there is a link between abortion and breast cancer, and that there is a causal relationship between vaccines and autism. It is opposed to the Affordable Care Act and other forms of universal health insurance."

 

From Wikipedia. They're too small and insignificant for even Snopes to bother with.

 

Just stop. The adverse effects study was withdrawn as the data sources could not be verified. 

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20 hours ago, cangelmd said:

Some of the county health debts in AL have very rudimentary facilities and low staffing. I’m sure they all can give vaccines, but don’t know what their storage abilities are. 
Actually, given all the marks against us - deep poverty, sheer bloody minded stubbornness, low education levels, very Hands off electorate - the state has done really well against Covid. The governor has provided leadership that I didn’t expect. Some of the national metrics make us look bad, but those tend to be the ones that include a measure of contact tracing, which I think has been only in SNFs and maybe some in prisons.

University of AL not withstanding, the mask ordinance has been successful, and we done better than our Eastern and Southern neighbors.

County health departments in Arizona have excellent storage facilities.  They have set up inoculation clinics using shopping centers and schools in the past.  The county did a measles clinic for the local.school districts.  Local nurses and docs came together to cover the whole school community in a week after an outbreak.  I would expect clinics to be set up.  We have some 4 dozen Walgreens and 2 dozen pharmacies in Grocers but doing mass innoculations there difficult.  Our local Air Force Base could easily do a clinic either for retirees or active duty or both.

With the manufacturing facilities in place and ready to go would expect those most at risk could all be processed in a matter of days in Tucson.

I fully understand some will refuse vaccination.  They then will receive the same consequences as those who are refused International travel if cruiseline require a vaccination.  Cruising, like travel to say the DRC - Congo - is a choice and not a required activity.

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14 hours ago, K.T.B. said:

Yes everything is in planning and starting to come together.  The controversial part of this initial guidance is that prisoners/prisons will get high priority in the first group.  I guess from the standpoint that they are institutionalized in close quarters.  But I also see how it might be hard to explain how prisoners get priority over working (non-senior) healthy adults.  I see this becoming a lightening rod issue. 

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5 minutes ago, TeeRick said:

Yes everything is in planning and starting to come together.  The controversial part of this initial guidance is that prisoners/prisons will get high priority in the first group.  I guess from the standpoint that they are institutionalized in close quarters.  But I also see how it might be hard to explain how prisoners get priority over working (non-senior) healthy adults.  I see this becoming a lightening rod issue. 

Did I miss something? Where did it say healthy 65 or old seniors get any form of priority? When I read it, no mention of healthy seniors was noted other than being grouped at the end with everyone else.

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5 minutes ago, Ken the cruiser said:

Did I miss something? Where did it say healthy 65 or old seniors get any form of priority? When I read it, no mention of healthy seniors was noted other than being grouped at the end with everyone else.

Sorry- I did not mean to imply that in my previous post.  But lots of details being worked out.

 

See this for more info:

https://www.nationalacademies.org/news/2020/09/national-academies-release-draft-framework-for-equitable-allocation-of-a-covid-19-vaccine-seek-public-comment

 

Here is a quote:

As of Aug. 1, nearly 80 percent of all COVID-19 deaths in the U.S. have occurred in people over the age of 65, and a significant proportion of these deaths were individuals living in long-term care facilities.  It is clear that directly protecting older adults — particularly those living in congregate or overcrowded settings — will have substantial impact on COVID-19-related severe outcomes, the draft framework says, and it gives higher priority to these groups.

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11 minutes ago, TeeRick said:

Sorry- I did not mean to imply that in my previous post.  But lots of details being worked out.

 

See this for more info:

https://www.nationalacademies.org/news/2020/09/national-academies-release-draft-framework-for-equitable-allocation-of-a-covid-19-vaccine-seek-public-comment

 

Here is a quote:

As of Aug. 1, nearly 80 percent of all COVID-19 deaths in the U.S. have occurred in people over the age of 65, and a significant proportion of these deaths were individuals living in long-term care facilities.  It is clear that directly protecting older adults — particularly those living in congregate or overcrowded settings — will have substantial impact on COVID-19-related severe outcomes, the draft framework says, and it gives higher priority to these groups.

No big deal. We'd rather be healthy and in the back of the line than have underlying conditions which hopefully won't come to our door step anytime soon.

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14 minutes ago, Ken the cruiser said:

Did I miss something? Where did it say healthy 65 or old seniors get any form of priority? When I read it, no mention of healthy seniors was noted other than being grouped at the end with everyone else.

From a CNN article https://www.cnn.com/2020/09/01/health/coronavirus-vaccine-allocation-nas/index.html on the National Academies of Sciences, Engineering, and Medicine committee's draft framework:

 

The 115-page report recommends allocation in four phases. 
 
In the first phase, vaccines would go to first responders, high-risk workers in health care facilities as well as people of all ages with conditions that put them at significantly higher risk of bad outcomes and older adults living in dense settings.
 
In the second phase the vaccine would be distributed to critical risk workers — workers who are both in industries essential to the functioning of society and at substantially high risk of exposure as well as teachers and school staff.
 
The second phase would also include people of all ages with conditions that put them at moderately higher risk; all older adults not included in Phase 1; people in homeless shelters or group homes for individuals with physical or mental disabilities or in recovery; and people in prisons, jails, detention centers, and similar facilities, and staff who work there.
 
Phase one and two combined would cover approximately 45% to 50% of the US population, the report notes.
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17 minutes ago, Fouremco said:

From a CNN article https://www.cnn.com/2020/09/01/health/coronavirus-vaccine-allocation-nas/index.html on the National Academies of Sciences, Engineering, and Medicine committee's draft framework:

 

The 115-page report recommends allocation in four phases. 
 
In the first phase, vaccines would go to first responders, high-risk workers in health care facilities as well as people of all ages with conditions that put them at significantly higher risk of bad outcomes and older adults living in dense settings.
 
In the second phase the vaccine would be distributed to critical risk workers — workers who are both in industries essential to the functioning of society and at substantially high risk of exposure as well as teachers and school staff.
 
The second phase would also include people of all ages with conditions that put them at moderately higher risk; all older adults not included in Phase 1; people in homeless shelters or group homes for individuals with physical or mental disabilities or in recovery; and people in prisons, jails, detention centers, and similar facilities, and staff who work there.
 
Phase one and two combined would cover approximately 45% to 50% of the US population, the report notes.

Thanks for highlighting that! I completely jumped over that sentence. This will make my DW much happier! 

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5 minutes ago, Ken the cruiser said:

Thanks for highlighting that! I completely jumped over that sentence. This will make my DW much happier! 

Now DW and I just need to keep our fingers crossed that the Canadian approach will be similar. 😷

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For those that are concerned over comments concerning early approval of a vaccine, this article describes very nicely the considerations involved and the conditions under which it might take place. It gives a good description of the role of the Data and Safety Monitoring Board.

 

https://www.cnn.com/2020/09/01/health/coronavirus-vaccine-trials-early-fauci/index.html

 

The Data and Safety Monitoring Board could say, "'The data is so good right now that you can say it's safe and effective,'" Fauci said. In that case, researchers would have "a moral obligation" to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions.

 

Fauci, director of the National Institute of Allergy and Infectious Diseases, said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.

 

The safety board periodically looks at data from a clinical trial to determine if it's ethical to continue enrolling volunteers, who are randomly assigned to receive either an experimental vaccine or a placebo shot. Neither the volunteers nor the health workers who vaccinate them know which shot they're receiving.

 

 

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14 minutes ago, npcl said:

For those that are concerned over comments concerning early approval of a vaccine, this article describes very nicely the considerations involved and the conditions under which it might take place. It gives a good description of the role of the Data and Safety Monitoring Board.

 

https://www.cnn.com/2020/09/01/health/coronavirus-vaccine-trials-early-fauci/index.html

 

The Data and Safety Monitoring Board could say, "'The data is so good right now that you can say it's safe and effective,'" Fauci said. In that case, researchers would have "a moral obligation" to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions.

 

Fauci, director of the National Institute of Allergy and Infectious Diseases, said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.

 

The safety board periodically looks at data from a clinical trial to determine if it's ethical to continue enrolling volunteers, who are randomly assigned to receive either an experimental vaccine or a placebo shot. Neither the volunteers nor the health workers who vaccinate them know which shot they're receiving.

Here's hoping the data is so good on all of the ongoing stage 3 trials that they can one day soon say they're all safe and effective, and open the blinds so all volunteers can get the vaccine! Again, I'm an optimist and always full of hope!

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2 hours ago, Fouremco said:

From a CNN article https://www.cnn.com/2020/09/01/health/coronavirus-vaccine-allocation-nas/index.html on the National Academies of Sciences, Engineering, and Medicine committee's draft framework:

 

The 115-page report recommends allocation in four phases. 
 
In the first phase, vaccines would go to first responders, high-risk workers in health care facilities as well as people of all ages with conditions that put them at significantly higher risk of bad outcomes and older adults living in dense settings.
 
In the second phase the vaccine would be distributed to critical risk workers — workers who are both in industries essential to the functioning of society and at substantially high risk of exposure as well as teachers and school staff.
 
The second phase would also include people of all ages with conditions that put them at moderately higher risk; all older adults not included in Phase 1; people in homeless shelters or group homes for individuals with physical or mental disabilities or in recovery; and people in prisons, jails, detention centers, and similar facilities, and staff who work there.
 
Phase one and two combined would cover approximately 45% to 50% of the US population, the report notes.

 

My wife and I would be in the second phase.  She's over 70 and diabetic and I'm diabetic.

 

And everything that's mentioned is pretty much how I saw things happening with who gets the vaccine first, etc.

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20 hours ago, markeb said:

"The Association of American Physicians and Surgeons (AAPS) is a conservative non-profit association founded in 1944. The group was reported to have about 5,000 members in 2014. The association has promoted a range of scientifically discredited hypotheses, including the belief that HIV does not cause AIDS, that being gay reduces life expectancy, that there is a link between abortion and breast cancer, and that there is a causal relationship between vaccines and autism. It is opposed to the Affordable Care Act and other forms of universal health insurance."

 

From Wikipedia. They're too small and insignificant for even Snopes to bother with.

 

Just stop. The adverse effects study was withdrawn as the data sources could not be verified. 

Why would you believe wikipedia and snopes rather than looking at the actual scientific research studies? This article just came  out in the American Journal of Medicine and further proves my point: 

Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection

https://www.sciencedirect.com/science/article/pii/S0002934320306732

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12 minutes ago, K.T.B. said:

 

My wife and I would be in the second phase.  She's over 70 and diabetic and I'm diabetic.

 

And everything that's mentioned is pretty much how I saw things happening with who gets the vaccine first, etc.

According to the American Diabetes Association:

 

People with diabetes have much higher rates of serious complications and death than people without diabetes—and generally we believe that the more health conditions someone has (for example, diabetes and heart disease), the higher their chance of getting serious complications from COVID-19. Older people are also at higher risk.

 

https://www.diabetes.org/coronavirus-covid-19/how-coronavirus-impacts-people-with-diabetes

 

Whether people with diabetes fall within the first phase, which includes "people of all ages with conditions that put them at significantly higher risk of bad outcomes" or second phase "people of all ages with conditions that put them at moderately higher risk" remains to be seen. The ADA's statement that diabetics "have much higher rates of serious complications and death" certainly suggests that they may need to be included in the first phase.  

 

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11 minutes ago, OceanCruise said:

Why would you believe wikipedia and snopes rather than looking at the actual scientific research studies? This article just came  out in the American Journal of Medicine and further proves my point: 

Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection

https://www.sciencedirect.com/science/article/pii/S0002934320306732

 

What IS your point?  That paper basically doesn't say much.

 

Yes, treatment for COVID is getting better, but treatment for viral illnesses never really does much good in the big picture.  Statistically relevant risk reduction does not mean cure.  Also, the long term effects of surviving of COVID is beginning to look pretty bad.

 

It seems like the side effects of getting COVID >>>>>>>> worse than side effect profile of any vaccine.

 

Go push your anti-vaccine and flat earth science somewhere else.

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