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The Coronavirus Thread Part 2


Big Boss

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13 hours 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.

 

 

Thanks for your detailed explanations. Just to make this more understandable for everyone, could you expand the following acronyms that I have been confused with on this thread lately?

CT Mode 

ICF

AE (after effects?)

PI (Principal Investigator?)

PMS

 

So, it seems overall the SII Astra-Zeneca vaccine seems more trustworthy than Covaxin so far? Any idea whether someone can know beforehand which vaccine they will get or will it be any of the two at random?

 

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26 minutes ago, Ph3N0M said:

Thanks for your detailed explanations. Just to make this more understandable for everyone, could you expand the following acronyms that I have been confused with on this thread lately?

CT Mode 

ICF

AE (after effects?)

PI (Principal Investigator?)

PMS

 

So, it seems overall the SII Astra-Zeneca vaccine seems more trustworthy than Covaxin so far? Any idea whether someone can know beforehand which vaccine they will get or will it be any of the two at random?

 

CT mode - Clinical Trial mode 

PMS - Premenstruation Syndrome

 

These are the only 2 I know. 

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1 minute ago, sobbii said:

Off topic but crazy scenes happening right now at us capitol building


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Lol Trump is a terrorist urging other terrorists to act. Enough OT.

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7 hours ago, Ph3N0M said:

Thanks for your detailed explanations. Just to make this more understandable for everyone, could you expand the following acronyms that I have been confused with on this thread lately?

CT Mode 

ICF

AE (after effects?)

PI (Principal Investigator?)

PMS

 

So, it seems overall the SII Astra-Zeneca vaccine seems more trustworthy than Covaxin so far? Any idea whether someone can know beforehand which vaccine they will get or will it be any of the two at random?

 

 

CT  = Clinical Trial. What is CT Mode ? I bet even Bharat Biotech does not know (Ella said the same in a recent interview). Acc. to Harshvardhan, Covaxin injections will be monitored as a CT, but seems BB is also surprised by this decision (since they need high preparedness if this is going to be a CT). Also, nobody calls anything in "CT Mode". :mellow:

 

ICF = Informed Consent Form. You need to know you are a part of a CT, what the vaccine/drug will do to your body, what are the potential side effects, what  are your rights throughout the trial, what compensation you are eligible to etc. ICF is a MUST before enrolling any volunteer in any CT. Ideally it has to be translated into local languages too since many trial volunteers might not understand English. Every trial is ethically overseen by an ethical committee, which is made up of healthcare professionals, lawyer(s) and 1 person from general population. The Ethical Committee can ideally audit the trial anytime and ask for ICF, CRF (Case record forms) etc and check if the trial is running by rules or not. 

 

AE = Adverse Events aka side effects.

PI = Principal Investigator. Overall responsible for conducting the trial, making sure the protocol is followed to the T, everything is recorded etc. 

PMS = Post Marketing Study/Trial aka Phase 4 study. More or less observational trial launched AFTER approval of a drug to monitor safety/AEs. 

 

From HV's statement, Covaxin is a "backup" plan, main is SII's candidate. But no idea which will be rolled out, and how the process will happen. I believe some people have started getting Covaxin already. 

 

6 hours ago, sobbii said:

Off topic but crazy scenes happening right now at us capitol building


Sent from my SM-N960F using Tapatalk
 

 

I just got up, and the NYT was blowing up. Went through the news quickly, and holy f**king hell - Capitol breached. :blink:

 

Trump's Twitter and FB suspended. :lol:

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9 hours ago, playstationdude said:

No wonder Akhilesh doesnt want the vaccine yet. Ulta Pradesh no doubt, but this is gonna happen everywhere in the North thanks to greedy f**ks saving a few bucks

 

Yeah, same sh*t will happen across most North and NE states. Very low trust in govt maintaining cold chain. 

 

Edit: Not blaming the centre for this. It's the local bodies and people executing the vaccine drives who will f**k it up. 

 

Is anybody here from Varanasi ? I have a work colleague there and he told me some days back that no one wears any mask. If you wear a mask, everybody looks at you like a COVID patient, and don't serve you (say at shops etc.). He also stopped wearing masks in Varanasi. 

 

8 hours ago, Walker said:

I'm not surprised. I've seen enough of corners cut in my time dealing in PPE (different industry no doubt but the mentality is the same).

 

Same sh*t, man. 

Edited by Bird Bird Bird
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1 hour ago, Bird Bird Bird said:

 

Yeah, same sh*t will happen across most North and NE states. Very low trust in govt maintaining cold chain. 

 

Edit: Not blaming the centre for this. It's the local bodies and people executing the vaccine drives who will f**k it up. 

 

Is anybody here from Varanasi ? I have a work colleague there and he told me some days back that no one wears any mask. If you wear a mask, everybody looks at you like a COVID patient, and don't serve you (say at shops etc.). He also stopped wearing masks in Varanasi. 

 

 

Same sh*t, man. 

Not Varanasi but when I went to Mathura, no one was wearing a mask and some were taunting me for wearing one. I bet its the same in all of North India. Heck even in Mumbai, barely anyone wears a mask *properly*. Those who are wearing wear it below the nose or some sh*t. Even mom started wearing cloth mask even though I have a stockpile of N95s at home. 

No one gives a sh*t at this point. 

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