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Just now, square_25 said:

Yes, and it looks like they found similar stuff via tissue samples from autopsies? Not conclusive, obviously. Just worrisome.

I got down a cardiologist twitter trail because of the other day, and some were very skeptical about the in vitro stuff because you could expose heart tissue cells to a lot of otherwise innocuous  things in a test tube that would cause damage. Maybe it was even that same guy?

I am becoming increasingly wary of preprints that either show Very Bad or Very Good things.

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33 minutes ago, Pen said:

 

https://medicalxpress.com/news/2020-06-astrazeneca-track-virus-vaccine-september.html

 

It looks like AstraZeneca Oxford is expected  to finish expedited phase 3 shortly.

 

(i don’t know if I see the same twitter thread you do.  What I see seems like a bunch of conspiracy theory and politics and nothing about virus trials. )

Weird

im going to post the text from the individual tweets in the thread then

“Some have responded to my tweet thinking that I am opposed to issuing an EUA for a vaccine AT ALL. That's not true. I strongly oppose issuing an EUA for a vaccine before we have any information about whether or not it actually works.

Here's how phase 3 clinical trials work: they enroll a lot of people (tens of thousands). Some randomly get the experimental vaccine, some get another unrelated, already-approved vaccine. These people then go about their normal lives.

In the course of those normal lives, some will be exposed to #SARSCoV2 and become infected. The trials follow up with participants periodically and tally up who has become infected and obtain data about their course of #COVID19.

After enough people from both the experimental and control groups become infected, you can use statistics to assess if there is a significant difference. Did fewer people receiving the experimental vaccine become infected? Of those who did, was their disease less severe?

If a significantly lower number of people receiving the experimental vaccine were infected and/or had less severe disease, that suggests the vaccine is effective at preventing infection (fewer infections) and/or ameliorating disease severity (less severe COVID-19).

Again, this is dependent on how long it takes for trial participants in both experimental and control groups to be exposed in the course of their normal lives. This may happen more quickly in places with high community transmission, but also depends on a lot of other things.

If participants are taking precautions to reduce exposure risk (which hopefully they are), that could also increase the amount of time it takes to get sufficient data to assess efficacy, but that's okay. We shouldn't tell participants to behave recklessly to speed up the trial!

Similarly, safety is also evaluated in phase 3 trials. How many participants have to withdraw because of adverse events? For some vaccines administered in a prime-boost regimen (2 shots spaced out over time), these might not be apparent until after booster shots. So...more time.
 

Some people may think phase 1 and 2 trials already look at safety. They do. But that still needs to be part of a phase 3 trial, since some rare adverse events may not be observed in smaller trials with fewer patients. Obviously safety is as critically important as efficacy.
 

So BOTH safety and efficacy are crucial to establish before a vaccine is authorized for public use, even for limited groups as Dr. Hahn suggested. Why? If a vaccine gets EUA and it either doesn't work or is a significant safety risk, it would cause tremendous harm.

If a vaccine isn't safe, it could harm all the people who take it. Even if it is safe, but isn't effective, it could indirectly harm people by giving them a false sense of security that they are protected. Both situations would be extraordinarily damaging to public health.

Issuing an EUA for a vaccine without safety and efficacy data to support that would deal a catastrophic blow to public confidence in both vaccines and the regulatory mechanisms in place for evaluating their safety and efficacy.

Vaccine skepticism and refusal are already huge public health problems. Providing public access to an unsafe or ineffective vaccine would discourage huge numbers of people from getting other vaccines that we already know ARE safe and effective.

(sorry this but is slightly political but I think the info is valuable enough to hopefully overlook that). Furthermore, if an EUA were issued for non-scientific reasons (like, say, a candidate's desire to have an edge in an upcoming election), it would destroy public trust in medical science as an evidence-based enterprise. We cannot let that happen.

Finally, it is unethical to conduct trials without the informed consent of participants. Scientists and physicians are trained in bioethics to ensure that they design trials to minimize harm to participants. Trials undergo ethical review at multiple stages.

Circumventing clinical trials by issuing an EUA without safety or efficacy would place huge numbers of people at risk for massive potential harm. It makes a mockery of the very serious protections put in place to conduct clinical research ethically.

We absolutely cannot tolerate or accept an EUA for any #SARSCoV2 #COVID19 #coronavirus vaccine without reliable safety and efficacy data from phase 3 clinical trials.

 

 

 

 

 

 

 

 

 

 

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Regarding the preprint about heart damage, I am not aware of ways to test actual patients. Maybe there is something. I’m not sure.

Possibly most people, especially asymptomatics, will be okay and the sickest will struggle but there might be drugs they could use. A senolytic, maybe.

At this point and because the virus isn’t fully understood yet, it’s best not to get infected. Too many unknowns.

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Although I agree that preprints should be taken with a grain of salt, there are several aspects of this study that, to me, add credibility:

(1) There is no doubt that Covid is causing heart damage in a significant number of patients, even those who were asymptomatic or had very mild cases, but the how/what/why have not been understood. This research provides a clear, specific, elegant (in the scientific sense) explanation of not only the nature of the damage and how it happens, but why the evidence has been missed until now.

(2) These guys specialize in research on cardiovascular disease, virology, and immunology using a type of stem-cell derived tissue that was developed there at Gladstone (and for which the developer won a Nobel prize). They are experts in this area, and the lead investigator said that in his entire career of looking at cardiomyocytes he had "never seen anything like it before." If this was the sort of damage that could easily be caused by in vitro treatment with many types of toxins or viruses or whatever, then they would presumably have seen it, or at least something similar, before.

(3) The in vitro results were confirmed by examination of autopsy tissue from three patients, only one of whom had been diagnosed with myocarditis. "[E]xamination of myocardium specimens from COVID-19 patients revealed striking similarities to our in vitro findings, including localized regions of severely disrupted sarcomeric structure and numerous cells lacking nuclear DNA."

The full paper can be downloaded here: https://www.biorxiv.org/content/10.1101/2020.08.25.265561v1.full.pdf+html

 

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11 hours ago, EmseB said:

I got down a cardiologist twitter trail because of the other day, and some were very skeptical about the in vitro stuff because you could expose heart tissue cells to a lot of otherwise innocuous  things in a test tube that would cause damage. Maybe it was even that same guy?

I am becoming increasingly wary of preprints that either show Very Bad or Very Good things.

Right...but the guy, who is doing this as a career, has never seen this particular effect before. And then the autopsy samples showed pretty much the same thing. 

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In addition to factors you mention, People I have heard interviewed in Taiwan (and possibly similar in a lot of Asian countries) sound like they have a tendency to behave in ways toward trying to protect community well being.   Not a “personal freedom” first attitude. 

 

32 minutes ago, Bagels McGruffikin said:

What’s even more interesting though is comparing the stringency of the lockdown and integration scores. Travel and ability to genuinely isolate borders has been an enormous factor in changing how a country handles spread. And population density too. It’s really a huge mixed bag, and this one actually tries to consider more variables than just the straight count, to give better context. This is a metric I’m totally keeping my eye on.

 

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48 minutes ago, Bagels McGruffikin said:

What’s even more interesting though is comparing the stringency of the lockdown and integration scores. Travel and ability to genuinely isolate borders has been an enormous factor in changing how a country handles spread. And population density too. It’s really a huge mixed bag, and this one actually tries to consider more variables than just the straight count, to give better context. This is a metric I’m totally keeping my eye on.

I don't understand the stringency of lockdown chart.  New Zealand had very stringent lockdown, but there's was yellow.  The United States has had very limited lockdown throughout most of it, and we're red?  

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3 minutes ago, Terabith said:

I don't understand the stringency of lockdown chart.  New Zealand had very stringent lockdown, but there's was yellow.  The United States has had very limited lockdown throughout most of it, and we're red?  

I'm also very confused about what the lockdown numbers represent, and also the global integration.  If that's how many people are allowed in/out, wouldn't New Zealand be highest (or lowest?).

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34 minutes ago, Terabith said:

https://elemental.medium.com/a-supercomputer-analyzed-covid-19-and-an-interesting-new-theory-has-emerged-31cb8eba9d63

Have we heard about this before?  I'm honestly losing track, but bradykinin sounded familiar.  

 

I posted a link to a DrBeen video explaining Bradykinin Storms a few days ago.

 

Another problem is SARS2 can use CD147 Receptor sites not just ACE2.

 

and it can direct infect immune system cells and hijack them

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1 hour ago, Terabith said:

https://elemental.medium.com/a-supercomputer-analyzed-covid-19-and-an-interesting-new-theory-has-emerged-31cb8eba9d63

Have we heard about this before?  I'm honestly losing track, but bradykinin sounded familiar.  

 

40 minutes ago, Pen said:

 

I posted a link to a DrBeen video explaining Bradykinin Storms a few days ago.

 

Another problem is SARS2 can use CD147 Receptor sites not just ACE2.

 

and it can direct infect immune system cells and hijack them

The Bradykinin storm is interesting.  From the supercomputer Bradykinin article, 

"Vitamin D as a potentially useful Covid-19 drug." 

"If indeed the vitamin proves effective at reducing the severity of bradykinin storms, it could be an easy, relatively safe way to reduce the severity of the virus."
 

 

 

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1 hour ago, Terabith said:

https://elemental.medium.com/a-supercomputer-analyzed-covid-19-and-an-interesting-new-theory-has-emerged-31cb8eba9d63

Have we heard about this before?  I'm honestly losing track, but bradykinin sounded familiar.  

 

40 minutes ago, Pen said:

 

I posted a link to a DrBeen video explaining Bradykinin Storms a few days ago.

 

Another problem is SARS2 can use CD147 Receptor sites not just ACE2.

 

and it can direct infect immune system cells and hijack them

The Bradykinin storm is interesting.  From the supercomputer Bradykinin article, 

"Vitamin D as a potentially useful Covid-19 drug." 

"If indeed the vitamin proves effective at reducing the severity of bradykinin storms, it could be an easy, relatively safe way to reduce the severity of the virus."
 

 

 

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8 minutes ago, ElizabethB said:

 

The Bradykinin storm is interesting.  From the supercomputer Bradykinin article, 

"Vitamin D as a potentially useful Covid-19 drug.

"If indeed the vitamin proves effective at reducing the severity of bradykinin storms, it could be an easy, relatively safe way to reduce the severity of the virus."
 

 

 

 

If “they” class Vitamin D as a “drug” we may become blocked from being able to obtain it. 

 

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29 minutes ago, Pen said:

 

If “they” class Vitamin D as a “drug” we may become blocked from being able to obtain it. 

 

I think that's very unlikely to happen.  It would take a lot of paperwork to reclassify it, and it has a long history of safe usage as an over the counter supplement.  

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17 minutes ago, Terabith said:

I think that's very unlikely to happen.  It would take a lot of paperwork to reclassify it, and it has a long history of safe usage as an over the counter supplement.  

There is Also a history of people fighting to keep vitamins and supplements accessible OTC 

 

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1 minute ago, Plum said:

I just had an emergency alert on my phone totally scare me. 😳 It was to tell me they are doing free testing! 👍 They must be desperate to blast it over the emergency alert system. I wish they were doing antibody testing, too. Then I might go. It's part of a huge surveillance campaign. Something like 60k tests.

Weren't you just trying to get tested?  Or did I get you confused with someone else? 

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32 minutes ago, Ausmumof3 said:

Bno:  “Florida says it is cutting ties with Quest Diagnostics after the company failed to report nearly 75,000 COVID-19 test results, some as far back as April. It includes 3,870 positive cases.”

Floridas data will look a bit weird today

 

 

as of when I checked the state report at noon, those numbers were not included in our count. They may just not include them?

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On 8/30/2020 at 9:09 PM, Ausmumof3 said:

Finally, it is unethical to conduct trials without the informed consent of participants. Scientists and physicians are trained in bioethics to ensure that they design trials to minimize harm to participants. Trials undergo ethical review at multiple stages.

Circumventing clinical trials by issuing an EUA without safety or efficacy would place huge numbers of people at risk for massive potential harm. It makes a mockery of the very serious protections put in place to conduct clinical research ethically.

We absolutely cannot tolerate or accept an EUA for any #SARSCoV2 #COVID19 #coronavirus vaccine without reliable safety and efficacy data from phase 3 clinical trials.

 

 

I am confused about several things:

1) how does USA EUA affect Australia?  

2) wouldn’t Australia be part of the AstraZeneca/Oxford vaccine that is in Stage 3 already?

3)  China and Russia have already started widescale vaccine programs as I understand it- without Phase 3.   I don’t know that that was wise, but It is  *already happening, Isn’t it? 

 

 

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1 hour ago, Ausmumof3 said:

Bno:  “Florida says it is cutting ties with Quest Diagnostics after the company failed to report nearly 75,000 COVID-19 test results, some as far back as April. It includes 3,870 positive cases.”

Floridas data will look a bit weird today

 

 

 

So what's their backup plan for running tests?  Who else do they have that can take up the slack? 

The cynic in me wonders if firing Quest is just an excuse to slow down testing in Florida.

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10 minutes ago, Pen said:

 

 

I am confused about several things:

1) how does USA EUA affect Australia?  

2) wouldn’t Australia be part of the AstraZeneca/Oxford vaccine that is in Stage 3 already?

3)  China and Russia have already started widescale vaccine programs as I understand it- without Phase 3.   I don’t know that that was wise, but It is  *already happening, Isn’t it? 

 

 

I don’t think it will affect Australia that I know of.  I just assumed people here would be interested - I will often share stuff that’s more US based than Aus relevant.  Maybe it will help someone making a decision about whether to go for a vaccine or not at some point. For a couple of months there was no COVID here in my state but I’m still sharing what I can.  That said it could affect us in some way because anything the US does affects us.  Because we’re small I guess and you’re our biggest ally.  
 

re China and Russia Norman Swann had some good stuff about the Russia vaccine. Basically he said the type of vaccine they are using sounds good and may be good but because they’re not doing proper trials we may never actually know if it’s any good or not.  If you have a 1 in 1000 safety event it won’t be picked up in the smaller trials but when you apply it over millions of people you end up hurting quite a few people.  I personally don’t think following China and Russia in this is really a great idea.  The other problem is if it’s ineffective often research stops on other vaccine trials once one is approved meaning you may miss out on finding one that is effective.  
 

Edited to add re astra Zeneca as I understand it we have paid for the rights to manufacture if for ourselves if it passes phase 3.  Really hope it happens.  We also have some local research that may potentially lead to something.  

Edited by Ausmumof3
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Just now, Ausmumof3 said:

I don’t think it will affect Australia that I know of.  I just assumed people here would be interested - I will often share stuff that’s more US based than Aus relevant.  Maybe it will help someone making a decision about whether to go for a vaccine or not at some point. For a couple of months there was no COVID here in my state but I’m still sharing what I can.  That said it could affect us in some way because anything the US does affects us.  Because we’re small I guess and you’re our biggest ally.  
 

re China and Russia Norman Swann had some good stuff about the Russia vaccine. Basically he said the type of vaccine they are using sounds good and may be good but because they’re not doing proper trials we may never actually know if it’s any good or not.  If you have a 1 in 1000 safety event it won’t be picked up in the smaller trials but when you apply it over millions of people you end up hurting quite a few people.  I personally don’t think following China and Russia in this is really a great idea.

 

 

Just now, Ausmumof3 said:

 

 

 The other problem is if it’s ineffective often research stops on other vaccine trials once one is approved meaning you may miss out on finding one that is effective.  

 

Bold part a huge problem. I think they should stop having a single approved or EUA treatment. 

 

 

Was the part I quoted like “we can’t accept” etc part of the twitter thread or your own comments? 

 

USA has 3 vaccines currently in phase 3 trials.  I don’t think the current plan is to have a vaccine released with no phase 3 trials at all. And a lot of us are suspicious of new vaccines for a while even if there’s full phase 3, while other people would like a vaccine ASAP even without full trials.    

 

There’s substantial differences in the various types of vaccines and it makes no sense to give up on one even if another is first. 

 

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3 minutes ago, Pen said:

 

 

Bold part a huge problem. I think they should stop having a single approved or EUA treatment. 

 

 

Was the part I quoted like “we can’t accept” etc part of the twitter thread or your own comments? 

 

USA has 3 vaccines currently in phase 3 trials.  I don’t think the current plan is to have a vaccine released with no phase 3 trials at all. And a lot of us are suspicious of new vaccines for a while even if there’s full phase 3, while other people would like a vaccine ASAP even without full trials.    

 

There’s substantial differences in the various types of vaccines and it makes no sense to give up on one even if another is first. 

 

No that was copied and pasted from the Twitter bread.  

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6 minutes ago, Pen said:

 

 

Bold part a huge problem. I think they should stop having a single approved or EUA treatment. 

 

 

Was the part I quoted like “we can’t accept” etc part of the twitter thread or your own comments? 

 

USA has 3 vaccines currently in phase 3 trials.  I don’t think the current plan is to have a vaccine released with no phase 3 trials at all. And a lot of us are suspicious of new vaccines for a while even if there’s full phase 3, while other people would like a vaccine ASAP even without full trials.    

 

There’s substantial differences in the various types of vaccines and it makes no sense to give up on one even if another is first. 

 

No it was all part of the twitter thread.  I should have put quote marks or italics.

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10 minutes ago, Pen said:

 

 

Bold part a huge problem. I think they should stop having a single approved or EUA treatment. 

 

 

Was the part I quoted like “we can’t accept” etc part of the twitter thread or your own comments? 

 

USA has 3 vaccines currently in phase 3 trials.  I don’t think the current plan is to have a vaccine released with no phase 3 trials at all. And a lot of us are suspicious of new vaccines for a while even if there’s full phase 3, while other people would like a vaccine ASAP even without full trials.    

 

There’s substantial differences in the various types of vaccines and it makes no sense to give up on one even if another is first. 

 

https://www.ft.com/content/f8ecf7b5-f8d2-4726-ba3f-233b8497b91a
 

there’s some discussion about it.  Sorry this is a twitter link but the web link is paywalled.  There’s probably other sources but apparently these guys did the original interview.  Would be nice if there was full text transcript of it so we can see that comments aren’t being taken out of context.

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6 minutes ago, Ausmumof3 said:

https://www.ft.com/content/f8ecf7b5-f8d2-4726-ba3f-233b8497b91a
 

there’s some discussion about it.  Sorry this is a twitter link but the web link is paywalled.  There’s probably other sources but apparently these guys did the original interview.  Would be nice if there was full text transcript of it so we can see that comments aren’t being taken out of context.

 

For me it’s a link that Financial Times - Which is paywalled.

I have seen a fair bit about FDA saying they are wanting to fast track a vaccine, and release it without completion of phase 3. 

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3 minutes ago, Pen said:

 

For me it’s a link that Financial Times - Which is paywalled.

I have seen a fair bit about FDA saying they are wanting to fast track a vaccine, and release it without completion of phase 3. 

Yes that was what the article was about.  The FDA rep Dr Stephen Hahn saying that they wouldn’t rule out issuing an emergency use approval for a vaccine before phase 3 Trials are complete.  That was what the post I shared further up was in response to, I believe.

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It's great some universities are identifying Covid outbreaks early by testing sewage from dorms, but that only reinforces my sense that public restrooms are potential sources of spread--

https://www.washingtonpost.com/opinions/2020/09/01/its-time-talk-about-how-toilets-may-be-spreading-covid-19/?hpid=hp_save-opinions-float-right-4-0_opinion-card-c-right%3Ahomepage%2Fstory-ans#comments-wrapper

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https://www.nejm.org/doi/full/10.1056/NEJMoa2026116
 

nejm study shows antibodies are still stable after four months except in a few cases and more severe illness equals higher antibody level.  They calculate a 0.3pc IFR, which is significantly lower than I’ve seen yet.  I haven’t read it right through to see what inclusion criteria etc were.

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56 minutes ago, Ausmumof3 said:

Yes that was what the article was about.  The FDA rep Dr Stephen Hahn saying that they wouldn’t rule out issuing an emergency use approval for a vaccine before phase 3 Trials are complete.  That was what the post I shared further up was in response to, I believe.

I'm quite sure Trump is going to order one released before the election, regardless of phase 3 trials.  

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6 minutes ago, Terabith said:

I'm quite sure Trump is going to order one released before the election, regardless of phase 3 trials.  

the fda guy did say it wouldn’t be approved for political reasons so I hope he stands by that.  A lot of doctors and scientists seem concerned about the idea of it being approved at all for any reason though.  The one I quoted up thread was just one of the most detailed responses.

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1 hour ago, Ausmumof3 said:

What do we know about the different kinds of vaccines?  I know that some are based on the spike protein added to a chimpanzee virus (adenovirus?).  I think the Russian one is like this.  

 

DrBeen has reviewed the main types—but I know you don’t like videos.

 I am sure there are Twitter threads on it, but I don’t usually use twitter. 

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52 minutes ago, Pen said:

 

DrBeen has reviewed the main types—but I know you don’t like videos.

 I am sure there are Twitter threads on it, but I don’t usually use twitter. 

Yeah sorry... I will watch a bit but it’s hard to get uninterrupted time to get through them.  I listen to the coronavirus podcast in the shower 😆.

 

 

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37 minutes ago, Ausmumof3 said:

Yeah sorry... I will watch a bit but it’s hard to get uninterrupted time to get through them.  I listen to the coronavirus podcast in the shower 😆.

 

 

 

I tend to listen while washing dishes or that sort of thing.  

He puts lots of drawings, but usually I can follow without the visuals and just look when I need to with a back 15 seconds if need be.

Once going, His doesn’t tend to be interrupted by tons of ads, another plus. 

Edited by Pen
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3 hours ago, Ausmumof3 said:

No it was all part of the twitter thread.  I should have put quote marks or italics.

 

There were quotes at start, but I got confused by the part that apologized that it was getting political, thinking that was then your own comments from that point and an apology related to board rules. 

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Just now, Pen said:

 

There were quotes at start, but I got confused by the part that apologized that it was getting political, thinking that was then your own comments from that point and an apology related to board rules. 

Oh no!  I don’t think that I can even talk that coherently!

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@Ausmumof3  John Campbell updated vaccine progress in his latest video.  Dr Been gives more medical and in depth on the science.  He also has personal experience with CV19 patients in CA (has had good patient responses to HCQ and Ivermectin btw afaik).  Campbell is less scientific based, tends to go with mainstream views (for example was on the anti HCQ bandwagon till this past week), possibly is easier to understand (speech clarity, accent, lay person explanation level...) - especially if using audio only. 

 

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Antiviral surfaces in Brisbane study show no viable Covid after 6 hours

https://pubs.acs.org/doi/10.1021/acsbiomaterials.0c01091#

 

I thought that most surfaces weren’t showing viable Covid just fragments so I’m a bit surprised by this study.  Haven’t read all through yet 

edited to add looks like the study is paywalled

Edited by Ausmumof3
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