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.
Also, it would be nice if Mr @ARanganathan72 showed the same skepticism he shows for my article for Bharat Biotech's clam that Anvisa's report is a non-issue.

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More from @PriyankaPulla

16 Apr
[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.
Read 5 tweets
8 Apr
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)
Read 7 tweets
31 Mar
The 23 March 2021 COVID treatment guidelines of Maharashtra govt, as the state sees a huge surge. Vitamin D, Favipiravir and HCQ reccomended for mild cases
Convalescent plasma for moderate and severe
Favi, Vit C, Vit D, Zinc etc for moderate cases
Read 5 tweets
30 Mar
Seems like the Brazilian regulator rejected Bharat Biotech's request for GMP certification for its Covaxin facility.
From the translated version:
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.
Read 4 tweets
28 Mar
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...
Read 6 tweets

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