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Indian Vaccinations per Capita Raises Questions About BJP Rhetoric on Giftaid to Neighbours

there is no such recognised legal concept in vaccine or drug administration as offering a therapeutic intervention "in clinical trial mode". One is either conducting a controlled trial with all the usual ethical and operational checkpoints in place, or one is offering a validated intervention. Otherwise we reduce ourselves to quackery.

I'm sure someone among India's highly educated medical establishment will ask Somani for further clarification on his usage of this highly suspect phraseology.
Oh yeah, it's smart to hang on to semantics. There may not be clinical trial "mode" but there is emergency use authorization. Maybe take time to read and understand instead of embarrassing yourself like this.
 
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The scientific knowledge displayed by few fanboys here seems to be tremendous.

Wonder, why this knowledge doesn’t go into developing a vaccine? All the aspects are on the fingertips of these experts. But development of a vaccine is no where to be seen. Please attempt at least. But naa ji.

Just wondering.

Indian vaccine is unproven and bad. Accepted.
 
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Oh yeah, it's smart to hang on to semantics. There may not be clinical trial "mode" but there is emergency use authorization. Maybe take time to read and understand instead of embarrassing yourself like this.
Is this all you ever say "oooohh masterchief don't embarrass yourself"?

Thanks for your concern but I don't need your advice on any matter of substance.


Emergency use is one thing - but to dish out a non-accredited vaccine on the same standing as an accredited one and not allowing the recipient to choose between the non-accredited one and the accredited one is flat out litigation waiting to happen.

In UK, Somani would have been sued to kingdom come by now by patients, doctors' associations and other healthcare workers.

This brings us back neatly to the original point of the thread.

IF Bharatistan had sufficient orders for accredited vaccines in place, why is it forcing people to take the non-accredited one without giving them choice?

Evidently, not enough doses are available of the Oxford vaccine because the clown in chief joined his hands together and said "you're most welcome Bhutan, Nepal, Maldives. We're happy to help you fellas. What are a few more dead ignorant Indians as long as we keep you guys smiling? We have plenty of them to spare."
 
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Thanks for your concern but I don't need your advice on any matter of substance.
I wasn't advising you lol. I was Just explaining your situation and suggesting a way out. Meh.

Emergency use is one thing - but to dish out a non-accredited vaccine on the same standing as an accredited one and not allowing the recipient to choose between the non-accredited one and the accredited one is flat out litigation waiting to happen.
Emergency use is the main thing. And no, you will not get sued for not allowing an option, you have two options, either get vaccinated or not get vaccinated. If you have co-morbidities then you will not be given covaxin and recipients can simply deny taking covaxin if they don't trust it, you are also required to sign a consent form. The data published in both phase 1 & 2 trials showed the vaccine is safe and we're only vaccinating frontline workers who on an average is young.

Evidently, not enough doses are available of the Oxford vaccine because the clown in chief joined his hands together and said "you're most welcome Bhutan, Nepal, Maldives. We're happy to help you fellas. What are a few more dead ignorant Indians as long as we keep you guys smiling? We have plenty of them to spare."
Lol! Did you not read what I already said? The vaccine has already been supplied to the states, 16.5 million doses were already supplied for frontline workers before we send to other countries. That is more than half of the requirement, and we are vaccinating nearly 3 Lakh people a day.

SII has already manufactured 100 million doses and still running production. You taking cheapshot and running around embarrassing yourself with old theories to show your typical Pakistani jealousy of being able to do zip-zilch-nada. We will give those countries vaccine for whatever reason, we may even end up sending you alms, if not make you buy from us. You should know 2/3rd of vaccines made in the world are from Serum Institute, you can take as many shots at them as you want, but they're the ones who will probably be going to end up vaccinating your sorry arse.
 
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I wasn't advising you lol. I was Just explaining your situation and suggesting a way out. Meh.


Emergency use is the main thing. And no, you will not get sued for not allowing an option, you have two options, either get vaccinated or not get vaccinated. If you have co-morbidities then you will not be given covaxin and recipients can simply deny taking covaxin if they don't trust it, you are also required to sign a consent form. The data published in both phase 1 & 2 trials showed the vaccine is safe and we're only vaccinating frontline workers who on an average is young.


Lol! Did you not read what I already said? The vaccine has already been supplied to the states, 16.5 million doses were already supplied for frontline workers before we send to other countries. That is more than half of the requirement, and we are vaccinating nearly 3 Lakh people a day.

SII has already manufactured 100 million doses and still running production. You taking cheapshot and running around embarrassing yourself with old theories to show your typical Pakistani jealousy of being able to do zip-zilch-nada. We will give those countries vaccine for whatever reason, we may even end up sending you alms, if not make you buy from us. You should know 2/3rd of vaccines made in the world are from Serum Institute, you can take as many shots at them as you want, but they're the ones who will probably be going to end up vaccinating your sorry arse.
 
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Giving away money is something Chinese can't think of. No wonder they are one of the least charitable nation, despite claiming to be rich and stronk.
 
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I wasn't advising you lol. I was Just explaining your situation and suggesting a way out. Meh.


Emergency use is the main thing. And no, you will not get sued for not allowing an option, you have two options, either get vaccinated or not get vaccinated. If you have co-morbidities then you will not be given covaxin and recipients can simply deny taking covaxin if they don't trust it, you are also required to sign a consent form. The data published in both phase 1 & 2 trials showed the vaccine is safe and we're only vaccinating frontline workers who on an average is young.


Lol! Did you not read what I already said? The vaccine has already been supplied to the states, 16.5 million doses were already supplied for frontline workers before we send to other countries. That is more than half of the requirement, and we are vaccinating nearly 3 Lakh people a day.

SII has already manufactured 100 million doses and still running production. You taking cheapshot and running around embarrassing yourself with old theories to show your typical Pakistani jealousy of being able to do zip-zilch-nada. We will give those countries vaccine for whatever reason, we may even end up sending you alms, if not make you buy from us. You should know 2/3rd of vaccines made in the world are from Serum Institute, you can take as many shots at them as you want, but they're the ones who will probably be going to end up vaccinating your sorry arse.
Such an indiot, pretending to know what you're talking about for your little fanboy brigade.

"recipients can simply deny taking covaxin if they don't trust it, you are also required to sign a consent form. The data published in both phase 1 & 2 trials showed the vaccine is safe "

I have demonstrated with references that Indian citizens cannot choose the Oxford vaccine over the Bharat vaccine. If your grandma declines the Bharat vaccine, correctly citing a lack of confirmatory data on immunogenicty (never mind safety, a vitamin shot is bloody safe but it isn't going to work against Covid....so your comment about safety IGNORES the absence of immunogenicty data published, hence - as is your SOP - you try to deflect the reader with talk of shafffteee), then she will not be given the Oxford vaccine.

Why should they be ordered to "trust" a vaccine without published phase 1 and 2 data on efficacy?

What police state is this where the media is told to shut up, regulators decide on a whim if a vaccine is safe, and individuals who complain about side effects get taken to court?
However many you've manufactured and stockpiled, I don't care. Why are people being ordered to take the incomplete Bharat vaccine if you have these stocks available? You haven't explained this.

Regarding 3 lakh per day, again, that is irrelevant as a raw number. It's like saying 3000 in India get infected per day vs 300 in Madagascar. Numbers per day per FIXED number of overall population can be compared, hence the data presented by the BBC article is most appropriate for making conclusions about whether India is up to scratch with other vaccine producers.
 
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I have demonstrated with references that Indian citizens cannot choose the Oxford vaccine over the Bharat vaccine. If your grandma declines the Bharat vaccine, correctly citing a lack of confirmatory data on immunogenicty (never mind safety, a vitamin shot is bloody safe but it isn't going to work against Covid....so your comment about safety IGNORES the absence of immunogenicty data published, hence - as is your SOP - you try to deflect the reader with talk of shafffteee), then she will not be given the Oxford vaccine.
Pindiots seem not to understand, my grandma is not a frontline worker. You playing slippery slope when in fact emergency use approval allows medicines as well as vaccine to be used after completion of Phase 1 & 2 trials. Instead of repeating new stupidity pretending you know what you are talking about read some simple facts. It already showed an effective immune response in Phase 1 and 2 trials. That's how they got approval to start Phase 3 trials. How do you think this works really? I like to know what you think.


Why should they be ordered to "trust" a vaccine without published phase 1 and 2 data on efficacy?

What police state is this where the media is told to shut up, regulators decide on a whim if a vaccine is safe, and individuals who complain about side effects get taken to court?
However many you've manufactured and stockpiled, I don't care. Why are people being ordered to take the incomplete Bharat vaccine if you have these stocks available? You haven't explained this.
And hilarious that you don't care how much vails we have stockpiled then what's the point of this stupid thread and you whining here? Your entire thread is about India giving priority to neighbours instead of its own people and now you're saying you don't care. So, I'm right, you're just salty about the whole thing lol.

People are not ordered to take any vaccine, the covaxin was given emergency approval to keep the vaccination up and not just rely on one SII maybe. Whatever that be, it is perfectly legal. And double blind sided covaxin trial data will be published as soon as trials are completed.
What police state is this where the media is told to shut up, regulators decide on a whim if a vaccine is safe, and individuals who complain about side effects get taken to court?
However many you've manufactured and stockpiled, I don't care. Why are people being ordered to take the incomplete Bharat vaccine if you have these stocks available? You haven't explained this.

Regarding 3 lakh per day, again, that is irrelevant as a raw number. It's like saying 3000 in India get infected per day vs 300 in Madagascar. Numbers per day per FIXED number of overall population can be compared, hence the data presented by the BBC article is most appropriate for making conclusions about whether India is up to scratch with other vaccine producers.
It's interesting that you didn't cry or whine when China approved emergency use authorization.
The 3 Lakh number is very relevant because there are 30 million frontline workers that are getting vaccinated on a priority basis. We haven't started mass vaccination yet. It will take months for that to happen.
 
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Pindiots seem not to understand, my grandma is not a frontline worker. You playing slippery slope when in fact emergency use approval allows medicines as well as vaccine to be used after completion of Phase 1 & 2 trials. Instead of repeating new stupidity pretending you know what you are talking about read some simple facts. It already showed an effective immune response in Phase 1 and 2 trials. That's how they got approval to start Phase 3 trials. How do you think this works really? I like to know what you think.



And hilarious that you don't care how much vails we have stockpiled then what's the point of this stupid thread and you whining here? Your entire thread is about India giving priority to neighbours instead of its own people and now you're saying you don't care. So, I'm right, you're just salty about the whole thing lol.

People are not ordered to take any vaccine, the covaxin was given emergency approval to keep the vaccination up and not just rely on one SII maybe. Whatever that be, it is perfectly legal. And double blind sided covaxin trial data will be published as soon as trials are completed.

It's interesting that you didn't cry or whine when China approved emergency use authorization.
The 3 Lakh number is very relevant because there are 30 million frontline workers that are getting vaccinated on a priority basis. We haven't started mass vaccination yet. It will take months for that to happen.
The data isn't published. It may be there somewhere on some lab worker's flash drive but it isn't published as others have done.

BMJ and a number of Indian doctors echo this sentiment.


"Health officials have defended India’s decision to approve a homegrown covid-19 vaccine without efficacy data—a move that triggered criticism amid speculation that regulators may have buckled under a government wish for an Indian vaccine alongside those now authorised in other countries.."

India is a very simplistic majoritarian state where critics are silenced, due diligence is short circuited for petty nationalism, and common folk simply aren't educated enough to know not to automatically trust someone in a white coat sticking a needle in you.

In response to the above BMJ article:

"Dear Editor

Indian COVID-19 vaccine trials have become further mired in controversy relating to alleged violations of ethical principles at the People’s College of Medical Sciences and Research Centre, Bhopal. When the death of a participant came to light through the media rather than the regulator and sponsors, broader concerns quickly emerged as to the conduct of the study. These included recruitment of vulnerable people with medical problems related to the 1984 gas disaster; questions over adequacy of informed consent; financial inducement to participate; lack of documentation; failure to monitor trial participants.

Bhopal based civil society organisations have called for an immediate end to the trial for Bharat Biotech’s COVAXIN; a full and independent investigation of the concerns; responsible parties to be punished if found negligent; officers of the institutional ethics committee to be held accountable; an audit of scientific and ethical standards in the Research Centre; data gathered so far to be excluded from the trial analysis; access to free medical care and compensation for any participants injured; transparency over the death of the participant. Support for these demands is being requested from individuals and organisations, and in particular from those with a medical background "
 
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Why threaten to take the victim of an adverse event to court, instead of behaving in a mature manner as trial coordinators would anywhere else in the world? Pause the trial, investigate fully and reassure the participants. But no! In India, blame the victim, sue him and carry on with the nationalist agenda!

That letter in post 71 was from another UK retired doctor. People are literally aghast at the lack of professionalism spewing forth from Amateuristan.
 
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Let's Not stop with BMJ though. Let's ask the Lancet, who published India's initial paper a couple of weeks ago.

They are equally concerned by a lack of transparency over Bharat vaccine adverse events and possible incorrect trial protocol in Bhopal.


"“I went to the nearby hospital in December and was given an injection. I was told it is the COVID-19 vaccine'', said Ramesh. ‘'I did not know it was a trial. The people at the hospital did not give me any time to see what I was told to sign. I did not know that I could refuse the injections.”"

That isn't informed consent for a trial. That is deception, tricking some poor sod into being a guinea pig when he believes he has received a vaccine.

@Chhatrapati
 
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Instead of repeating new stupidity pretending you know what you are talking about read some simple facts. It already showed an effective immune response in Phase 1 and 2 trials. That's how they got approval to start Phase 3 trials. How do you think this works really? I like to know what you think.
In specific response to this, I refer you back to the original Bharat vaccine paper submitted to the Lancet. This is the summary of findings:

"BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted."

Tolerable safety - check.

An immune response of some sort to the jab - check, partially, with phase 2 data incomplete.

ACTUAL VERIFIABLE "IMMUNITY" I.E. ACCEPTABLE EFFICACY OF RESPONSE - NOPE.

The authors themselves refer to their study as INTERIM.

"Because this is an interim report, we are not reporting any data on the persistence of vaccine-induced antibody responses or long-term safety outcomes. The results reported here do not permit efficacy assessments. The analysis of safety outcomes requires more extensive phase 2 and 3 clinical trials. "

Phase 2 is incomplete. Phase 3 is non-existent. Yes the Bharat vaccine is safe, safe as a vitamin shot. Will it be effective? We have no clue whatsoever.
 
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