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The Coronavirus Thread Part 2


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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

 

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“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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3 minutes ago, Bird Bird Bird said:

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.

 

 

 

Oh god no.. not this DLC with the already frequent cluster migraine i have. 

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Lol Goa cops can be freaking cool. Was on my way to town and every car was being checked to make sure everyone is wearing a mask. I'm not sure why a lone traveller in their own car needs to wear a mask but thats what it is. I get stopped, and one uncle behind me as well. I was wearing a mask under my helmet anyway. While I'm showing my papers, uncle is full on pissed. Young cop is telling him that the mask is for his own protection. Bc uncle shouts "You wear condom full day or what?". The cops, me and everyone else nearby were laughing :lol:. I swear I think he got off lucky. Any other cop might have given him a quick slap or danda. Good to know that some still have a sense of humor.

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3 hours ago, Walker said:

Lol Goa cops can be freaking cool. Was on my way to town and every car was being checked to make sure everyone is wearing a mask. I'm not sure why a lone traveller in their own car needs to wear a mask but thats what it is. I get stopped, and one uncle behind me as well. I was wearing a mask under my helmet anyway. While I'm showing my papers, uncle is full on pissed. Young cop is telling him that the mask is for his own protection. Bc uncle shouts "You wear condom full day or what?". The cops, me and everyone else nearby were laughing :lol:. I swear I think he got off lucky. Any other cop might have given him a quick slap or danda. Good to know that some still have a sense of humor.


Dare the oldie to try this in Mumbai. Soda bottle technique ke baad kabhi akele mein bhi mooh nahi kholega :lol:

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11 minutes ago, Jigsaw said:

Is there any consensus on distribution of the vaccine? One video says chemist availability by april... another says mass scale program by administration. 

 

 

What bro? Atmanirbhar and Vaccine is BS  havent you heard :P

 

Some guys surely wont be going for vaccination here in India. So where UK?US?Canada? Kaha ja rahe ho :P

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6 minutes ago, hope said:

What bro? Atmanirbhar and Vaccine is BS  havent you heard :P

 

Some guys surely wont be going for vaccination here in India. So where UK?US?Canada? Kaha ja rahe ho :P


Arre apna toh jab aana ho aa jayega. But for parents and the maid. She’s precious. :D

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37 minutes ago, hope said:

What bro? Atmanirbhar and Vaccine is BS  havent you heard :P

 

Some guys surely wont be going for vaccination here in India. So where UK?US?Canada? Kaha ja rahe ho :P

Abe abhi tak sulag rahi hai kya :rofl:

 

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