With regards to #COVISHIELD which will be rolled out on 16th onward, the CDSCO SEC approval requires the recipient to be given a factsheet prior to the vaccination. Has this been prepared--has anyone seen it?
Was it distributed in the dry-runs? Available widely?#COVID19 #vaccine Image
So both these documents are indeed available (factsheet for recipient and the leaflet for the medical provider). Thanks to @Dr_Aqsa_Shaikh for pointing that these are available on the SIIL Website. Hope the factsheet will be available at all vaccine sites. Sharing here for info ImageImage
And this is the vaccine insert/leaflet for the medical providers/establishment
#Covishield ImageImage
You can find these both documents here: seruminstitute.com/product_covish…

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More from @AnantBhan

14 Jan
The government has announced an intent to go ahead with vaccination as of 16th Jan 2021 with both Covishield and Covaxin. There is going to be no choice. You will only be able to receive one of the two, whatever is allotted to you by the govt.
While you have an option of opt-out, it will put potential vaccinees in a tough situation. You have to decide for yourselves based on publicly available (or the lack fo it) information-- on safety, immunogenicity, and efficacy on both vaccines.
If you are allotted Covishield, you will follow the current protocol as described and practiced in the dry runs. Image
Read 22 tweets
8 Jan
The #COVID19 pandemic shows the need for building capacity within the country for critically evaluating ethical issues in health research
We @SangathIndia #Bhopal hub are delighted to have been funded by @thakurfdn to to create an online/digital course on health research ethics
The project is called DRISHTi (Developing capacity in health Research ethics Training) and the digital course will be targeted at health professionals as well as general public. The course is proposed to be 8-10 weeks long, completely digital in format and in the English language
The course has the potential to be a key contributor in developing capacity within India to conduct and evaluate health research from an ethics perspective.
Read 6 tweets
7 Jan
The ICMR DG and some other experts have argued that phase 1 and phase 2 data is enough for restricted emergency use approvals, and that phase 3 efficacy data is not necessarily required.
Dr T Jacob John also makes an argument in this regard, though also clarifying that there might have been some early safety data from those vaccinated in the phase 3 which is ongoing as well
BUT if we were going to base a regulatory decision on just phase1 and phase2 data, why did we have to wait till 02nd Jan 2021. That data was available a few weeks earlier, and in fact was considered in the 09th December CDSCO SEC meeting. Why not take the decision then itself?
Read 4 tweets
5 Jan
Have been in touch with Rachna for the last few weeks as we discussed issues with one of the #Bhopal #clinicaltrials site for #Covaxin. Lots of issues with trial conduct as documented in her thread below.
Issues with informed consent, care of trial participants, recruitment.
This issue needs to be highlighted more as it shows us what poor oversight could mean, especially because we are now talking about expanded use of vaccines "in clinical trials mode" (not that I am sure anyone really knows what that means)
Now this is probably just an issue with an inexperienced trial site and investigators who were eager to be part of a prestigious study, but faltered on some aspects of trial conduct. But imagine this happening at scale-- how are we going to ensure protection of the vaccinees?
Read 9 tweets
9 Nov 20
The 1st Prof MK Bhan Memorial lecture has started live streaming
Please watch at
The Lecture will be delivered by Prof. Vinod K Paul @NITIAayog on topic 'Science & Art of Influencing Health at Transnational Scale: How Visionary Physician Scientists Do it'
Dr @RenuSwarup, Secretary @DBTIndia announces the renaming of the @THSTIFaridabad- @unescorcb cluster auditorium after Prof MK Bhan
Dr @RenuSwarup also announces the launch of a #Fellowship Program to encourage young #researchers to continue their postdoctoral research in India.
The MKB-YRFP scheme @DBTIndia
Read 20 tweets

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