Okay, having read a translation of the report on Anvisa's website about Covaxin and @hildabast's useful thread, here is my quick take. This is not a reversal of the previous decision of Brazil to import 20 mn doses gov.br/anvisa/pt-br/a…
The translated report contains the phrase "partial authorisation", and talks about only 4 million doses, not 20 million, as earlier. And there are several caveats.
Based on the corrective actions Bharat Biotech agreed to take, and also accounting for "information gaps", Brazil will import the vaccine, as long as 1) BB implements the GMP changes promised 2) presents a certificate of potency (thanks @hildabast for the translation)
3) Provides two months of safety data from the phase 3 clinical trial (presumably, this safety data is from post second dose of vaccine. One of the conditions of the US FDA EUA's is that the sponsor provides 2 months safety data for half the trial participants, before approval)
4) Each batch is tested for quality by a Brazilian national lab. Only after Bharat Biotech meets these conditions, will the decision to import more doses be made.
The "certificate of potency" requirement is interesting. My guess is this: when Anvisa refused GMP certification to BB last time, they said BB was using a non-specific measure for the potency of each dose, i.e total protein.
The worry was that, if a non-specific measure is used, one dose of vaccine is not as potent as another. A US GMP expert I spoke to agreed with this assessment, because even degraded antigen counts as protein. And you need active antigen for vaccine to work.
My guess is that Bharat Biotech has either shifted to a different method of measuring potency of each dose, or has validated total protein as measure. Either way, they have to prove the potency of each dose.
What would really useful for Indians is to see the corrective action Bharat Biotech has taken before Brazil allowed import of 4 mn doses under specific conditions.
Brazil has also asked for data which BB may not have ye, i.e the two months of safety data. Also, it looks like Brazil will monitor adverse events in the recipients of the 4 million doses to take any further decision to import Covaxin. End.

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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
2 Jun
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.
Read 4 tweets
25 May
I find this article really problematic nytimes.com/2021/02/05/opi…
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

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