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Post Info TOPIC: SARS-CoV-2 / Covid-19 information


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RE: SARS-CoV-2 / Covid-19 information
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Tig wrote:

Next likely Covid19 vaccine looks to have many advantages.

Next Gen Vaccine


 I posted more information on the Johnson & Johnson trials in the 'Vaccine trials Information' section under Johnson

& Johnson / Janssen from New England Journal of Medicine (1-13-2021).



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NATIONAL STRATEGY FOR THE COVID-19 RESPONSE AND PANDEMIC PREPAREDNESS JANUARY 2021

Click HERE for .pdf file



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Next likely Covid19 vaccine looks to have many advantages.

Next Gen Vaccine



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U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca



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TWiV 696: Tear down that SARS-CoV-2 manuscript
December 20, 2020

TWiV explains that COVID-19 is not harmless for young adults, FAA approval for Pfizer mRNA vaccine, lack of justification for the claim of reverse transcription of SARS-CoV-2 RNA and integration into the human genome, and lack of evidence for increased transmission by new variants in the UK.

 

SARS-CoV-2 UK variant: Does it matter?



-- Edited by wmlj1960 on Monday 21st of December 2020 05:40:55 PM

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Watch Live - FDA panel discusses Moderna's Covid vaccine for emergency use 12/17/2020

 

FDA Briefing Document
Moderna COVID-19 Vaccine in .pdf format is HERE



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This is a huge step in the right direction but at $35 per test it will be almost useless in serving it's badly needed purpose. I hope they step up funding for this quickly, like yesterday!
 


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Tig wrote:

I found the Pfizer-Biontech-Covid-19 Monograph through Canada. The only mention of HCV, HBV and HIV that I can find thus far lies in Section 14.1 Clinical Trials. Patients were included in the trials with these health conditions, provided they met all other criteria. Mike and I will continue to look for any additional information and post it in the appropriate sections. 

Pfizer-Biontech-Covid-19 Monograph


 The FDA Document that I posted Dec. 8 in the 'Vaccine Trials Information' section (ADVISORY COMMITTEE
BRIEFING DOCUMENT download in .pdf format HERE) listed

("*Chronic condition (eg, hypertension; diabetes; asthma; pulmonary, liver, or kidney disease)
*
Autoimmune disease requiring therapeutic intervention (or history of)
*
Chronic HIV, HCV, or HBV infection that is stable and controlled
*
Vaping or smoking (or history of smoking within the prior year)
*
Resident in a long-term facility
*
Occupation with high risk of SARS-CoV-2 exposure (eg, healthcare, emergency response")

as being included in the study, but I don't see any results pertinent to those sub-groups in particular. I read somewhere that 127 HIV+ individuals were included in the trial, but results were not included in the final report.

From the 'Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine' report posted in the New England Journal of Medicine HERE;

"This report does not address the prevention of Covid-19 in other populations, such as younger adolescents, children, and pregnant women. Safety and immune response data from this trial after immunization of adolescents 12 to 15 years of age will be reported subsequently, and additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as immunocompromised persons".

 More results from a Phizer/Biontech "additional study" is certainly needed for these sub-groups.

 

Hopefully the Moderna Advisory Committee meeting December 17 will cover this topic in better detail. Information for that upcoming meeting is also linked in the 'Vaccine Trials Information' 'sticky' thread under the 'Moderna' section as well as the Briefing Document download. I read that it included 100 participants in the vaccine arm of the trial with chronic liver disease and 90 with HIV (although details of criteria such as cirrhosis or CD4 count were not mentioned).



-- Edited by wmlj1960 on Wednesday 16th of December 2020 01:36:56 AM



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American Liver Foundation statement and video presentation on COVID-19

Your Liver and COVID-19



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I found the Pfizer-Biontech-Covid-19 Monograph through Canada. The only mention of HCV, HBV and HIV that I can find thus far lies in Section 14.1 Clinical Trials. Patients were included in the trials with these health conditions, provided they met all other criteria. Mike and I will continue to look for any additional information and post it in the appropriate sections. 

Pfizer-Biontech-Covid-19 Monograph



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TWiV 693: Vax to the future
On this episode, FDA EUA for Pfizer mRNA vaccine, efficacy of AstraZeneca ChAdOx1 COVID-19 vaccine, and an orally administered drug that blocks SARS-CoV-2 transmission in ferrets.

Links for this episode:

FDA advisory committee votes in favor of EUA for Pfizer vaccine (NY Times)

Sanofi/Glaxo subunit vaccine steps back (Stat)

Efficacy of ChAdOx1 COVID-19 vaccine (Lancet) - (.pdf File is HERE)

Oral antiviral blocks SARS-CoV-2 transmission in ferrets (Nature Microbiology)

Letters read on TWiV 693

 



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Healio: UK advises against giving Pfizer vaccine to patients with history of allergic reactions.

Vaccine Update on Anaphylaxis



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F.D.A. Advisory Panel Gives Green Light to Pfizer Vaccine

nytimes.com

More information in the 'Vaccine Trials Information' 'sticky' thread at the top of this section.



-- Edited by wmlj1960 on Sunday 13th of December 2020 09:28:36 PM



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Coronavirus Vaccine Update With Anthony Fauci (JAMA Network)  12-11-2020

Coronavirus (COVID-19) Q&As (JAMA Network)



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Tig wrote:

Thanks, Mike! That's going to take a while to review, lol! You GO, Brother   This is a treasure trove of information!


 He covers most of it in the video, but the references are there for further investigation where needed.



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Thanks, Mike! That's going to take a while to review, lol! You GO, Brother   This is a treasure trove of information!



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Vitamin D and COVID 19: The Evidence for Prevention and Treatment of Coronavirus (SARS CoV 2)

 

REFERENCES:

The National Human Activity Pattern Survey (NHAPS)... (J. of Exposure Analysis and Environmental Epidemiology)

Aging decreases the capacity of human skin to produce vitamin D3 (The J. of Clinical Investigation)

Racial differences in the relationship between vitamin D... (Osteoporosis Int.)

Decreased bioavailability of vitamin D in obesity (The American J of Clinical Nutrition)

Vitamin D Insufficiency and Deficiency and Mortality from Respiratory Diseases ... (Nutrients)

Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis... (BMJ)

Randomized trial of vitamin D supplementation to prevent seasonal influenza A... (The American J.of Clinical Nutrition)

Vitamin D and SARS-CoV-2 infection... (Irish J. of Medical Science)

Factors associated with COVID-19-related death... (Nature)

Editorial: low population mortality from COVID-19 ... (Alimentary Pharm. & Therap.)

The role of vitamin D in the prevention of coronavirus ... (Aging Clinical & Experimental Research)

25-Hydroxyvitamin D Concentrations Are Lower in Patients with ... SARS-CoV-2 (Nutrients)

Vitamin D deficiency in COVID-19: Mixing up cause and consequence (Metabolism)

Low plasma 25(OH) vitamin D level... increased risk of COVID-19... (The FEBS J.)

The link between vitamin D deficiency and Covid-19...

SARS-CoV-2 positivity rates... with circulating 25-hydroxyvitamin D levels (PLOS One)

Vitamin D status and outcomes for... COVID-19 (Postgrad Medical J.)

Vitamin D Deficiency and Outcome of COVID-19... (Nutrients)

Effect of calcifediol treatment... (The J. of Steroid Bio. and Molec. Bio.)

Vitamin D and survival in COVID-19 patients... (The J. of Steroid Bio. and Molec. Bio.)

Effect of Vitamin D3 ... vs Placebo on Hospital Length of Stay...: A Multicenter, Double-blind, Randomized Controlled Trial

Short term, high-dose vitamin D... for COVID-19 disease: a randomized, placebo-controlled, study [SHADE study] (Postgraduate Medical Journal)

Association of Vitamin D Status... With COVID-19 Test Results (JAMA Network Open)

Vitamin D Fortification of Fluid Milk ... A Review (Nutrients)

Analysis of vitamin D level among asymptomatic and critically ill COVID-19 patients... (Scientific Reports from the Journal Nature)

 

 

 

 



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The HIV/AIDS virus was viewed as a 'gay' disease and the stigma attached prevented aggressive funding for research etc. And yes it was not an aerosolized contagion, therefore it was viewed as not a threat unless you were engaged in sexual activity with a "gay" person. Once it started affecting a wider segment of the population interest and funding for a solution increased. This Covid-19 pandemic affects all people and affects the economy, therefore it has received much more immediate attention and FUNDING.
 Also, HIV is a different animal due to several things including it's high mutation factor. It's like a moving target for an effective cure. And due to a source of a latent reservoir in the host cell's genome where it can hide out quietly in lymph nodes and lymphoid organs. Because of this drugs have nothing to disrupt, and these cells remains latent for extended periods until periodically becoming reactivated.
 I pray they go full steam ahead too Tig. But for the time being HIV research and development efforts are being hampered by SARS-CoV-2/Covid-19, as are many other health concerns. When we get through this pandemic I hope more attention is given to funding scientific research and development and we'll eventually have a cure for all the known viruses, and also have an effective plan for dealing with future novel viruses that will inadvertently arise.



-- Edited by wmlj1960 on Thursday 10th of December 2020 01:21:09 AM



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I haven't been able to sit down and review all the Big Pharm data, so it's likely you've already answered that question. It makes me wonder, why wasn't this same call to arms made with the Aids/HIV virus? I imagine since it wasn't an aerosolized contagion, it didn't seem as threatening. They have proven they can do it now, and I would place that at the top of needed vaccines. As you know, the treatments have improved greatly, but they need to work on a cure for those living with it now. We are on the precipice of great advances. I pray they go full steam ahead!



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Technology has come a long way lately. I think a big help was that the gene sequencing data was known globally after it's release from China in early January. From that point it was all hands on deck and adequate funding was made available. Additionally, mRNA technology has been 'in the works' for many years and SARS-CoV-2 and the resulting pandemic and need for a solution quickly was right down it's alley. An mRNA vaccine be rapidly created and deployed on a large-scale. Also overlapping the trial phases sped up the process considerably without sacrificing either phase since they were still separate.



-- Edited by wmlj1960 on Sunday 13th of December 2020 09:55:53 PM

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I do have a question. What kind of information is out there providing insight into how they were able to develop not one, but 3 potential RNA vaccines so quickly? It took decades to develop the HBV vaccine. This was light year fast!

 



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Tig wrote:

Mike's desire to get involved as our "Covid-19 Czar" has already proven to be a most excellent decision! Well done, my thanks for doing such a good job!


 I don't know about the "Czar" part, but I'm glad to contribute what I can. smile



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Mike's desire to get involved as our "Covid-19 Czar" has already proven to be a most excellent decision! Well done, my thanks for doing such a good job!



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The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH. If you would like to attend this meeting (virtually) it will be streamed at either of the following links Thursday from 9am until 6pm ET:

Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.

Speaker presentations will be available by 8 AM on Dec 10, 2020

The online web conference meeting will be available at either of the following:
https://youtu.be/owveMJBTc2I
https://twitter.com/US_FDAExternal Link Disclaimer (Supported in Chrome browser)
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d

PFIZER-BIONTECH COVID-19 VACCINE (BNT162, PF-07302048)
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
BRIEFING DOCUMENT
MEETING DATE: 10 December 2020

Download document in .pdf format HERE.

 



-- Edited by wmlj1960 on Wednesday 9th of December 2020 01:27:56 PM

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Iris Dragonfly wrote:

What a great resource. thanks Mike!


 My pleasure Iris. I hope it will be useful for the members of this group that helped save my life.



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What a great resource. thanks Mike!



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TWiV 683: Two COVID-19 mRNA vaccines

 

Efficacy  Moderna

Efficacy PFizer

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

Prothrombotic autoantibodies in serum from patients hospitalized with COVID-19

On the whereabouts of SARS-CoV-2 in the human body: A systematic review

 



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"Here, we present crystallographic and inhibition kinetics evidence for SARS-CoV-2 3CL Mpro inhibition by three hepatitis C clinical NS3/4A serine protease inhibitors, telaprevir / Incivek, Vertex Pharmaceuticals, boceprevir / Victrelis, Merck, and narlaprevir / Arlansa, R-Pharm, and a naturally occurring microbial peptide aldehyde, leupeptin, Appleyard and Tisdale."

Potential of Hepatitis C Drugs to Treat COVID-19 by Stopping the Virus From Spreading

DOI: 10.1016/j.str.2020.10.007

 



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Discussions about long-term COVID, cross-reactive memory to SARS-CoV-2, common mucosal surfaces, the risky business of peptide mega-pools, immunodominant epitopes and much more.

 

Reflections of a COVID-19 Long Hauler

Severe immunosuppression and not a cytokine storm characterizes COVID-19 infections

 



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 Reviewing the difficulties in predicting species susceptibility to SARS-CoV-2 infection by only examining the ACE2 protein, and the olfactory mucosa as a portal of entry into the central nervous system in COVID-19 patients.

 

New York City will create pandemic response institute to prepare for future outbreaks

Olfactory transmucosal SARS-CoV-2 invasion as a port of central nervous system entry in individuals with COVID-19

Broad host range of SARS-CoV-2 predicted by comparative and structural analysis of ACE2 in vertebrates

 

 



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Clinical update with Dr. Daniel Griffin

 

Analysis of vitamin D level among asymptomatic and critically ill COVID-19 patients and its correlation with inflammatory markers

New York City will create pandemic response institute to prepare for future outbreaks

How CDC Is Making COVID-19 Vaccine Recommendations

When to Quarantine

 

 



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Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52 = SVR

Mike

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 I'm going to try to keep this all focused on proven science based information, and since scientist still have a lot that is unproven at this point, some will be hypothesis, and some theoretical, but that will be noted where applicable.

First, I'd like to link to some videos by Dr Roger Seheult, MD, who no longer has time to do many videos at Medcram.com since he is covered up in the ICU in California treating patients with Covid-19. So these 1st videos are older, and some of the information has been superseded, but they are very informative for a basic understanding of this virus and this disease.

A link to the playlist of ALL of the Medcram 'Coranavirus' updates is HERE.

Here are some videos I selected to condense pertinent information since going back through all the updates would take much time:

How Viruses Work - Molecular Biology Simplified (DNA, RNA, Protein Synthesis)

The ACE-2 Receptor - The Doorway to COVID-19 (ACE Inhibitors & ARBs)

COVID-19 and Oxidative Stress (Prevention & Risk Factors)

Blood Clots & COVID-19 - New Research & Potential Role of NAC

Widespread Clotting on Autopsy

So let's switch to testing and how our current testing system is failing miserably, and a test that will be more effective - the home rapid test. Vaccines are already being administered in some parts of the world and may start being distributed here in the US after likely EUA approval following FDA advisory committee meeting that will convene Thursday and issue its recommendations for the Pfizer Biontech mrna vaccine, and scheduled to do the same for the Moderna mrna vaccine December 17. The vaccines will take time (months) to get widely administered. So there will still be a need for a rapid test for some time to come if we have any hope of curving the current spike in infections and transmission which will likely get worse before getting better in the upcoming winter months.

 Dr Michael Mina from the Harvard School of Public Health has been pushing for advancing this technology for months and although this 'antigen' testing approach has been widely adopted, it has not been produced as a rapid, home-use test to test yourself to see if you are currently 'infectious' (currently shedding the virus). This will be as quick and simple as using a home pregnancy test with results in minutes, which is the major advantage over PCR diagnostic test, which take much more time to receive results, which makes the test almost useless to use as a public awareness tool.

I watched a clip this morning on 'CBS This Morning' TV show which highlighted one of the company's working to make this happen. That link is HERE.

For a better understanding of how this test can be used watch the following interview with Michael Mina on the video podcast, 'This Week in Virology" a very educational podcast with virologist, Professor Vincent Racaniello, 2 other virologist and an immunologist (skip to time point 1:46 to bypass the intro and political comments): Test often, fast turnaround, with Michael Mina

Ct Values: How They Should be Assessed for SARS CoV 2 (COVID 19 PCR Testing vs. Rapid Antigen Tests)

Dr Seheult explains CT Values etc. on 'Rapid Test'

Demonstration with explanation of how a rapid lateral flow assay test works for antigen or for antibody

Real-life validation of the Panbio COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection

SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis

As far as vaccine availability and distribution, the media has that covered pretty well on TV and I'll post a link to the 'Regulatory Affairs Professional Society' (RAPS) Vaccine Tracker. Also, more vaccine trials information is listed in the 'Sticky' thread, ' Information Source Links and Vaccine Information' at the top of this section.

But to understand more about the top 3 vaccines currently in phase 3 trials likely soon to be approved in the US (one of which is already approved in the UK and Canada) Dr Seheult has these 3 videos with great information:

Pfizer / Biontech Vaccine

Moderna Vaccine

AstraZeneca - Oxford Vaccine

 To see details on all of the ongoing vaccine clinical trials, see the 'stickied' "Information Source Links - Vaccine Information" post at the top of this section.

 



-- Edited by wmlj1960 on Saturday 12th of December 2020 05:28:05 AM

__________________

60 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52 = SVR

Mike

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