Frankly, I find this surprising. Dr Udwadia said this in Glenmark's press release. He was on the task force that recommended favipiravir for mild Covid. How does he now say the use of the drug for mild Covid was unwarranted? What changed?
For reasons that are not fully understood, all state drug regulators of this country consider a dissolution/disintegration failure to be a minor one, while active ingredient less than 70% of labelled claim is a major failure.
They also believe dissolution failure can be caused by storage conditions (hence, minor), but drop in content of active ingredient cannot be caused by poor storage conditions. God knows what this even means.
Actually, even active ingredient less than 70% of labelled claim is not considered a major failure by many (except on paper)
Thread and new story: We were all shocked at the sudden rise of mucormycosis cases in India this year. Yesterday, the government said we had touched a whopping 45,000 cases by July 15 (possibly starting May 19, but starting date unknown) (1) livemint.com/science/health…
How did this fungal disease pop out of seemingly nowhere? Of course, mucormycosis existed before: a rare disease, seen predominantly in people with uncontrolled diabetes. Why did the Covid pandemic make its numbers jump through the roof? (2)
The primary hypothesis today is that the use of steroids for Covid was so unprecedented (they were used in both irrationally high doses+very widely), that they made patients vulnerable to mucormycosis. Steroids were also a mucormycosis risk-factor earlier, along with diabetes (3)
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)
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.
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.
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.
Why is the world's most vaccinated nation seeing a surge bloomberg.com/news/articles/… (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.
While being an advisor to Biocon, he was also on Mumbai's Covid task force, which continues to prescribe Itolizumab.
How does one appear in a company's press conference for the launch of a drug, claim it is wonderful, and then also be a part of a state task force that prescribes the drug? Same applies to another noted pulmonologist.
It seems like some of the unused doses of the AZ vaccine in USA were made in the Emergent Biosolutions plant, which was later found to have mixed up ingredients between AZ and J&J vaccine nytimes.com/2021/03/11/us/…
Kinetics of inactivation and validation of proof of inactivation happen at multiple stages - during development and while scaling to manufacture. The jump in scale from development to manufacture is huge, and the whole process *must* be repeated
Simple example: The kinetics of inactivation that Jonas Salk plotted while developing the vaccine didn't work when it was scaled to manufacture. *A lot changes* during large scale production, including methods of inactivation. Repeated validation is *required*
So, *no*. The kinetics of inactivation you see in the Cell paper cannot be extrapolated to commercial manufacturing. And yes, I did see that paper.
[New story] Two weeks ago, the Brazilian regulator Anvisa published a report listing a number of quality control problems with Covaxin, including that the company hadn't "validated the method to prove complete inactivation of the virus". thequint.com/coronavirus/ex…
The report looked pretty serious at first look. And yet, some commentators said the Anvisa's complaints were just a "bureaucratic" issue, or "just a documentation problem".
I spoke to Good Manufacturing Practices experts (people who routinely see such reports) to understand exactly what each term in the Anvisa report meant.
Many in India may be confused about MHRA's decision yesterday to offer an alternative to the AZ vaccine in under-30 year olds. What does this mean for Covishield and you? The following three slides should help understand things more clearly (1)
First: a slide shared at MHRA PC comparing benefits and risks of vaccine in low prevalence regions. Explains most clearly why the vaccine may not be the best choice for under 30 y.o. *when transmission is low*. For everyone else, benefit>risk (2)
Second: a slide of benefit/risk comparison in a region with medium prevalence. Here, already, the benefits for even under 30 y.o start to outweigh risk of clots. For everyone else, the ratio is even more favourable (3)
For those who don't know, GMP is Good Manufacturing Practices - sterility, hygiene, documentation and control of production processes etc. Compliance to GMP is a prerequisite for manufacturing any drug/vaccine. India has similar requirements under Drugs & Cosmetics Act.
I recall some discussions on Twitter on how Covaxin may be effective, even though the clinical trial was botched up in Bhopal. Sure - but how would you KNOW, unless you *addressed* the botch-up? Read below to understand what a non botched-up trial looks like @RachnaDhingra
I can hear, in my mind, some people asking: so what if a site with 1700 participants was not managed properly. By *how much* can that throw efficacy/safety estimates off?
...after all, the total trial size is 26000 people? I don't know the answer to that. But my concerns are different: if ICMR denies, point blank, the egregious protocol deviations in India's flagship vaccine/flagship trial...