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The Coronavirus Thread Part 2


Big Boss

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17 minutes ago, playstationdude said:

Just imagine, if someday, your wife gets hand of your phone and the pics you post on IVG. Just imagine:rofl:


Live by the sword & die by it. I swear I heard that line in Ghost of Sushma. 
 

TBH, she’s accepted I’ve gone senile ages ago. iPhones are unhackable no? FBI jo na kar paaya woh kambakht ek aurat kya karegi :fear1:

Edited by Jigsaw
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42 minutes ago, Big Boss said:

Bull shitry to downplay a vaccine.

 

But this is nothing than the Bull Shitry our own people do to downplay vaccine made by our Country. 

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1 minute ago, hope said:

Bull shitry to downplay a vaccine.

 

But this is nothing than the Bull Shitry our own people do to downplay vaccine made by our Country. 

That guy is pissed that Serum guy called the vaccine as water and government person called it as backup :lol:

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https://www.moneycontrol.com/news/trends/health-trends/covaxin-approval-beyond-the-emotional-outburst-heres-what-bharat-biotechs-krishna-ella-said-about-the-vaccine-6304551.html

 

Quote

“We are under pressure as we are developing vaccines at such a fast pace… hence we haven’t got time to publish our data in the public domain,” Ella said.

 

Ok.

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4 hours ago, Bird Bird Bird said:

It has been hard to keep up with the vaccine updates. From this article, it seems like they were only criticising Covaxin being approved. Is the approval of Oxford's vaccine safer/non-controversial/less controversial by comparison? 

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13 hours ago, Ph3N0M said:

It has been hard to keep up with the vaccine updates. From this article, it seems like they were only criticising Covaxin being approved. Is the approval of Oxford's vaccine safer/non-controversial/less controversial by comparison? 

There are multiple issues with Covaxin approval. 

 

No P3 data in public - to some extent, understandable IF the data is out in the next 2-3 weeks AND considering it's already been accepted in a journal. BUT it seems they haven't even got their P1/2 data published anywhere except as a pre-pint, which...anyone can do without oversight. All other vaccines also received approval after submitting P3 data to regulators, but the data was out in public within 2-3 weeks of approvals (since that is likely the smallest publishing cycle with most journals, and even if there was no peer review, there must be an editorial review). 

 

They clubbed animal safety data with P1/2 human data, and that was considered for safety purpose, which, frankly, is pretty bullshit. 

 

The way these trials were conducted, while not surprising, cast a dubious shadow over any data generated. No ICF, patients paid for AE management etc. 

 

Ella is saying they have given Covaxin to 23000 volunteers. AFAIR, they were supposed to recruit 23000 or 26000 volunteers for their P3 trial, so that means none or only a small proportion of the volunteers got placebo. How the heck can you compare results from such vastly different sample sizes, specially efficacy ? How come the protocol was changed midway (protocol said 1:1 randomization for vaccine and placebo) ? The early press releases said they showed interim data of around 190 patients to DCGI. Ella is shouting they showed data of 23000 volunteers to DCGI. What is the truth ? Where is the data ? Currently Ella is saying the data will likely get published by Feb 2021. Let's see. 

 

Govt stating that Covaxin is approved for "CT Mode". WTF is a CT mode ? Either you are approved as experimental drug for P3 trials - meaning everyone taking that vaccine HAS to be informed of risk, benefits and HAS to sign an ICF,  HAS to be monitored regularly, HAS to have their AE managed by the PI, HAS to have a compensatory policy, and a data interpretation has to be generated after a predefined time period - OR you are approved as a vaccine to be administered in mass AFTER robust P3 data has been submitted, and you do a P4/PMS study to look at other data points, primarily long term safety (observational trial). 

 

SII has 2 benefits - their interim data has shown 70% efficacy, and their base data is also helped by global AZ data which shows 62% (full dual dose) or 90% (half dual dose mode) efficacy. So they do have a base to stand on. 

 

Both Pfizer and Moderna similarly followed up with publicly published data for anyone to dissect. I know for a fact that one of my relatives (NHS, UK) who got a shot of vaccine (I don't remember if this was Pfizer or AZ) had VERY severe headache for 2-3 days, and had to hit high NSAID doses for relief. His wife was fine though. Every vaccine is a live experiment to some extent now.

 

 

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