I am deeply disappointed at T Jacob John. It is a smear to say that everyone who asked Qs of #DCGI when they 'approved' #Covaxin was anti-Indian is such patent nonsense as to be unworthy of rebuttal. To bring 'nationalism' into science is disgraceful. deccanherald.com/national/much-…
I now learn that the "emergency-use approval" of Covaxin means, iot cannot be generally used but if someone desperately needs it then he can get it under trial conditions. This is disingenuous and garbled nonsense. No one desperately needs a vaccine except PEP in HepB or rabies
PEP is post-exposure prophylaxis. @BharatBiotech has in fact completed its planned recruitment of 26k subjects and within 12 weeks we will have the first cut efficacy data. Where was the need to rush with this spurious disingenuous play on words?
Even Kishna Ella, the CEO of Bharat Biotech said he had no idea what 'clinical trial mode' means. It is an unholy mess where nobody comes out a winner, while Indian science takes a knock. science.thewire.in/health/dcgi-cd…
And now we hear (thanks to @pash22 and @AnantBhan for tweeting abt this) that even @ICMRDELHI has no clue what "clinical trial mode" means.
There are times in any project (cooking a new dish, or making a great painting, or writing your magnum opus) when things get so messy that the best course is to chuck it all away, take a walk, come back, and start all over again. Clean slate, #KoraKagaz. This' one of those times
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The shambles and confusion about the regulatory approval for @BharatBiotech's #Covishield#vaccine will have serious consequences for the #Indian#biopharma industry. The real tragedy is NOT that an unsuitable or ineffective vaccine has been approved.
The real tragedy has been that the scientific process of basing decisions on data has been ruptured. Today nobody has any idea of the efficacy (as judged in field trials) of the efficacy of #Covaxin. This is as much a slap in the face for the scientists in @BharatBiotech
as it is a betrayal of the 22,000 subjects who had been enrolled in the as yet on-going phase 3 clinical trials. Their altruism in volunteering for the trial has been trashed, as has the painstaking work of the trial doctors been devalued.
For Covishield:
"restricted emergency use of vaccine, subject to multiple regulatory conditionalities"
For Covaxin
"restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains
One interpretation of the Covaxin approval is that it is essentially approval to continue their phase 3 trial. In which case, what's new?
Then, a day later, i.e. today we learn: pib.gov.in/PressReleseDet…
Memo
Re Bharat Biotech Covaxin. 1. We have a rregulatory approval process that approves vaccines on the basis of data demonstrating safety and efficacy. 2. The trustworthiness of this process is shown when approval is NOT granted in the absence of such data.
Memo (continued) 3. We trust a licensed vaccine not because it has been approved by the regulator.
We trust it when the regulator and the manufacturer are open and transparent with the data on which the approval is based.
4. We should no more accept an opaque regulatory process that we would accept a kangaroo court that delivers its verdict in a closed court.
The one great genius of the #Hindutva#RightWing in India is their capture of the mind of the average Hindu. That there was a time when Hindu civilisation was the greatest, when India was a land of milk and honey, that India's decline in fortune was entirely the fault
Of marauding foreigners -mostly Islamic, but latterly European (but they are white-skinned and probably Aryan, so let's not be hard on them); that therefore by association, anything Islamic is bad and must be rooted out of India. They have further convinced the Hindu mind that
All we need to do to return to the pole position we once enjoyed in the world, is to return to anything that is Ancient. Hence, Sanskrit, Ayurveda, social structures based on caste, outmoded gender roles, an imagined vegetarianism, cow-worship, cow-pathy.
A thread.
After the #PunjabFarmers protesting at the #ModiGovt's AgriMarket bills complained that the mainstream media TV were either ignoring them or mischievously showing them in a bad light, lets look at how the World's press is reporting it.
Londo's @guardian first. On 30 Nov they carried this big story: