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


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CDC - Updated Mar. 8, 2021
Interim Public Health Recommendations for Fully Vaccinated People



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

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How Do COVID-19 Vaccines Compare?

A side-by-side look at the three vaccines authorized in the U.S. Note the 21-28 day second dose information of the mRNA vaccines. I've heard stories of people being denied such requirements and have been forced to wait 6 weeks for the second dose. Make sure you ask for that in writing and schedule the second dose knowing it's an important part of the vaccine protocol.

 

Vaccine Comparisons/Medpage

 



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Thanks everyone, I am following this thread.

Cheddy, it's good to hear you managed well with both doses.



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Gt:1a-36yrs .Started Intron-A in 96' for 2.5mo-VL still too high.taken off. Labs on 3.6.18:. A1 activity.  f3@60: fibrosur bloodtst. AFP=norm. enz=mostly norm.VL=3.9 million.sot=5.1.18>Harvoni>[8wks]: 4WEEKS=UND. Eot 6/25=L.J*13weeks=UND * 6 m =UND: CLUB ZERO.1yr.=0



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Yes, Mike, thanks for the info and perspective.

I have had both doses of Moderna. I had a sore arm and was tired after the first shot, for a day. The second day after the second shot was tougher. It's kind of curious though, to watch yourself experiencing flu symptoms and feel good about it. By day 3, I was okay and have felt nothing but good since then. 

Even though caution is still in order, it's very liberating, and definitely a mental health boost

We've got to get this thing over with. I hope everybody who wants a vaccine gets one soon. 



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Thanks for the info and advice Mike



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 Both Pfizer and Moderna have been used widely and long enough for me to feel comfortable about taking either. I like the way the mRNA does not need to infiltrate our cell structure in order to produce the 'spike' target for our immune system to react to in order to produce the needed antibodies to fight the Covid-19 virus when/if introduced to it. Also, the mRNA vaccines code can be easily modified to be more specifically effective against variants of SARS-CoV-2 if needed.
 AstraZeneca (ChAdOx1) uses an adenovirus vector, a weakened version of a common cold virus. So this vaccine may cause cold symptoms but is incapable of causing an actual cold which, even if it did, I'm sure you will agree is much better than being infected with SARS-CoV-2.
 Novavax is a Nanoparticle vaccine that starts with modified spike gene which is inserted into a baculovirus (baculoviruses have been tested and used extensively in influenza and HPV vaccines). This gene is used to instruct cells to produce spike proteins, therefore initiating an immune response similar to the other vaccines. Like the AstraZeneca causing cold symptoms, the Novavax vaccine may cause influenza-like symptoms, but will not cause the flu virus.
 Johnson and Johnson/Jannsen uses the non-replicating viral vector Ad26 and essentially does the same as other viral vector vaccines - this modified adenovirus is injected into someones arm, it enters the persons cells. The cells then read the genetic instructions needed to make the spike protein and the vaccinated cells make and present the spike protein on their own surface. The persons immune system then notices these foreign proteins and makes antibodies against them that will protect the person if they are ever exposed to SARS-CoV-2 in the future
 The efficacy of the viral vector vaccines has been reported to be less than that of the mRNA vaccines, but effective enough to prevent serious infection and/or death.
 Bottom line for me is that I do not want to contract the Covid-19 virus. So, even my being severely immunocompromised, I may take either of the vaccines when available, especially considering the fact that in my area, rollout has been rather slow and when given the opportunity I doubt I will have a choice between which vaccine I prefer. If given the choice I would prefer one of the mRNA vaccines.
If your life situation will allow you to remain isolated or at least well protected against infection, you may opt to wait and see how all of the vaccines do in the longer term. For me, living by myself, my mental health has taken a toll and I am so ready to return to some version of normalcy soon. smile
 



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Hi Mike Newzealand has contracted four suppliers for COVID-19 vaccines. These are Pfizer and BioNTech, Janssen Pharmaceutica, Novavax and AstraZeneca. The vaccinations are being rolled out a the moment in Newzealand, border workers and Medical staff have a priority first. Then at risk community's.



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Mikaere wrote:

Hi has there been any covid 19 vaccines that are harmful to people who have had long term Hep c and those who used Generic drugs to overcome the Hep c


 Hi Mikaere.
Which vaccines are available in your area?
 As far as 'long term' I suspect you are concerned with how much liver damage occurred as a result of Hep C and your current liver condition.
I'm in the USA. I had Hep C long term which finally caused ascities, portal hypertension, bleeding varacies, etc. and resulted in decompensated cirrhosis. I achieved SVR 1-2016 after my 2nd 24 week Tx (with Harvoni) (1st Tx was sofosbuvir / ribavirin). Since SVR my condition has vastly improved to compensated cirrhosis without those symptoms. I still visit my Gastroenterologist every 6 months for liver checkup (blood work and MRI or Ultrasound). I also have had HIV long term and although my viral load stays 'undetectable' due to me taking my medications, my immune system is weak with a CD4 of only 221. Taking all of that into consideration, both my gastroenterologist and my infectious disease doctors advised me to take either of the vaccines available in my area, which are Pfizer or Moderna.
 So if my situation is any indicator for you then I suspect you may also take the vaccine depending on what is available in your area and depending on approval from your doctor.
 Also, if you have any history of an allergic reaction to other vaccines or you have allergy issues in general, you should be sure your doctor knows this and also that the facility administering the vaccine to you also knows this.



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Hi has there been any covid 19 vaccines that are harmful to people who have had long term Hep c and those who used Generic drugs to overcome the Hep c



-- Edited by Mikaere on Wednesday 3rd of March 2021 02:05:28 AM

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FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine



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 FDA panel recommends authorization of Johnson & Johnson single-shot vaccine

More information in the Vaccine Trials Information thread.

 



-- Edited by wmlj1960 on Saturday 27th of February 2021 06:43:19 PM

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Paul Offit joins TWiV to discuss all things vaccine, including how COVID-19 vaccine development was accelerated, whether the vaccines are safe and efficacious, the difference between an EUA and a licensed vaccine, sterilizing immunity, herd immunity, and much more.



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COVID-19 clinical update - Dr Daniel Griffin 2-13-21

Links for this episode:

Resurgence of COVID-19 in Brazil (Lancet) 7:41

Pfizer vaccine reduces viral load (medRxiv) 10:34

EUA for bamlanivimab plus etesevimab (pdf) 12:58

Tocilizumab in hospitalized patients (medRxiv) 14:54

Bacterial superinfections in COVID-19 (Open For Inf Dis) 17:08

Download TWiV 719 (17 MB .mp3, 28 min)



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I found some information that might interest you. There are a number of Covid 19 discussions and recommendations by the Infectious Disease Society of America the IDSA. We have followed them for years for their current recommendations for HCV. Take a look and soak up all the news!

https://www.idsociety.org/

 



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COVID-19 clinical update #48 with Dr. Daniel Griffin

https://youtu.be/PWVPytcsvg4

Links for this episode:

Resistance of variants to mAb neutralization (bioRxiv)

Safety and efficacy of Sputnik V (Lancet)

Increased vaccine reactogenicity in seropositives (medRxiv)

Single dose vaccination in seropositive health care workers (medRxiv)

Update on vaccine intervals (CDC)

Single dose AZD1222 results (Lancet preprints)

Three RCT on anticoagulants (NIH)



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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

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TWiV 713: COVID-19 clinical update #47 with Dr. Daniel Griffin
1-30-2021

Sources:

Novavax vaccine phase 3 results

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE TriaL

(CDC) - COVID-19 Cases and Transmission in 17 K12 Schools Wood County, Wisconsin, August 31November 29, 2020
Weekly / January 29, 2021 / 70(4);136140
On January 26, 2021, this report was posted online as an MMWR Early Release.

This article was published on October 28, 2020, at NEJM.org.
SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

January 26, 2021 at 7:00 AM EST
Regeneron Reports Positive Interim Data with REGEN-COV Antibody Cocktail used as Passive Vaccine to Prevent COVID-19

January 25, 2021
COLCORONA topline results: Colchicine reduces hospitalization, death in COVID-19

 

 

 



-- Edited by wmlj1960 on Sunday 31st of January 2021 01:40:22 AM

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Tig wrote:
I'm curious and haven't found out one way or another, is the Janssen product also a mRNA vaccine?

 No, the JNJ/Janssen vaccine is not mRNA. It uses a 'non-replicating viral vector'. Several viruses, including adenovirus, adeno-associated virus, measles virus, and human parainfluenza virus, are widely used as viral vectors. Viral vectors that are genetically modified to make replication-defective are called non-replicating vectors.

Thanks for posting the Ad26.COV2.S (JNJ-78436735) information!



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

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Hey Mike,

Thanks for the continued updates, they're very helpful. I added one link to the bottom of the J&J information. I came across it while looking at your other data.

I'm curious and haven't found out one way or another, is the Janssen product also a mRNA vaccine? I'm one that will wait for the next generation of vaccines. I'm not convinced they have ironed all the bugs out of the first gen drugs. Consider me skeptical of any RNA vaccine, modified or not. I do like the J&J (Janssen) vaccine single inoculation protocol though. One and done. We've got so many distribution problems down here, it's ridiculous. We have a lot of seasonal residents here and many are from Canada. It has thrown a wrench into the roll-out. People are fighting over who should be first, and then residency requirements come into play. Some get the first round, get refused for the second (over residency requirements missed the first time) and it has resulted in wasted products. If you can't get the second inoculation, the first one is useless. Hopefully they'll get it figured out, sooner than later.

I appreciate all of your research, it's top notch!



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Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial (1-29-20201)

More information in the 'Vaccine Trials Information' thread under Johnson and Johnson / Janssen



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Iris Dragonfly wrote:

There was something about the hand sanitizer, a warning I missed. Is this the methanol problem? or was there something else?

It dawned on me the alcohol in the sanitizers might be absorbed and have to be processed by the liver. Does anyone know if that may be an issue?

Thanks, Iris


 All hand sanitizers are not created equally. Here are some updates from the FDA about what to avoid:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use



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There was something about the hand sanitizer, a warning I missed. Is this the methanol problem? or was there something else?

It dawned on me the alcohol in the sanitizers might be absorbed and have to be processed by the liver. Does anyone know if that may be an issue?

Thanks, Iris



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4 weeks=UND, 8 weeks=UND, 12 weeks=UND (EOT= 09-23-2018)



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Tig wrote:

Thanks Mike! The vaccine changes are almost constant. I appreciate you doing the research as we make our way through this.


 Yes there have been some setbacks like yesterday when Merck halted development of both of it's vaccine candidates, V590 and V591. Hopefully Johnson & Johnson Ad26.COV2.S, Novavax NVX-CoV2373 and/or AstraZeneca AZD1222 can take up that slack soon.



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Thanks Mike! The vaccine changes are almost constant. I appreciate you doing the research as we make our way through this.



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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 can 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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