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)
Third: a slide for high prevalence regions, like Mumbai today. Here, *all* age groups are better off taking the vaccine, because risk of ICU admission from disease has risen for everyone (4)
Of course, India's AEFI surveillance program hasn't even acknowledged that the vaccine comes with risks. The very low incidence of DICS in India after Covishield likely has to do with poor reporting and slow rate of causality analyses. (5)
So, I believe Serum Institute must issue a warning with the vaccine, *and* issue a treatment guidance for blood clots. Government must ask them to do so. Let's not pretend that poor reporting = no AEFIs. There are lives at stake here (6)
CORRECTION: The UK recommendation to offer an alternative vaccine to under 30-year-olds was made by the Joint Committee on Vaccination and Immunisation (JCVI), not MHRA.

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More from @PriyankaPulla

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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