Agree. I don't think the indemnity itself is the problem, as is Pfizer's demand for indemnity against compensation for *negligence* (that's different from indemnity against compensation for AEFI)
Indemnity against negligence potentially includes manufacturing negligence, storage negligence. That's a whole different world, and I don't get why a manufacturer should have no liabilities on that front.
As far as indemnity against compensation for AEFI goes, if it gets people like SII to acknowledge there are AEFIs, and helps recipients get paid for AEFIs (like thrombosis) that have actually been linked to the vaccine, I don't see why every manufacturer shouldn't get it.
There is little doubt that as more vaccines get commercialised, new (and hopefully, rare) AEFIs *will* emerge.

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More from @PriyankaPulla

4 Jun
Important story that throws light on the confused mess of a trial that led to the approval of 2DG. It is such criminality to push these drugs on people.
More importantly - isn't there a single person in this country whom the Dr Reddy's, Biocons or Glenmarks of the world can hire to design a decent trial for them?
Is it so bloody hard to design ONE trial that can properly test a hypothesis, carry it out cleanly & transparently, and report the results asap? Seems like it is truly impossible in this country.
Read 4 tweets
25 May
I find this article really problematic…
It frames the early approvals of the Russian and Chinese vaccines, without phase 3 trials, as some sort of a vague perception problem, and not of real consequence.
Simultaneously, makes some vague jabs at "problems" with the western vaccines.
Read 6 tweets
18 May
Dear doctors who are telling everyone that Covaxin is as good as any other vaccine, please also raise your voice about these horrendous violations in the clinical trial that was used to develop the vaccine are promoting. This is your job too.
The investigators in the trial of the vaccine you are promoting are refusing to give an informed consent form to the family of a deceased participant. You have a responsibility to protest this.
"the vaccine you are promoting", I meant.
Read 4 tweets
18 May
Many people are finding out the hard way that when vaccine manufacturers claim 100% efficacy against severe disease in a clinical trial, this doesn't translate to deal life. Vaccine efficacy against severe disease is probably very high, but not 100%.
And effectiveness - in real life - where people who have been excluded from clinical trials (the immunocompromised, for instance), is probably even lower. That's why we needed effectiveness studies for this country.
That's why we *saw* effectiveness studies done for vaccines like AZ and Pfizer. It matters. It's not just some fun academic exercise.
Read 4 tweets
8 May
Primary outcomes of the phase 3 trial of the just approved drug, 2-DG. What's the point of CTRI if investigators report primary outcomes like this? This doesn't mean anything!!!
How exactly is CTRI accepting such nonsensical descriptions of primary outcomes?
Read 4 tweets
8 May
Why is the world's most vaccinated nation seeing a surge… (59% of the vaccinations in Seychelles were the poorly characterised Sinopharm vaccine, which has not published Phase 3 data yet)
I suspect that those who are confidently saying today that all approved vaccines across the world are the same will regret it at some point in future (it's an argument of expedience, just like the argument, a year ago, that everyone doesn't need masks)
My point is not that a vaccine with a lower efficacy estimate in a clinical trial is worse than one with a higher estimate(these estimates aren't comparable across trials). My argument is that poorly characterised vaccine is an unfair gamble to subject individuals/populations to.
Read 4 tweets

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