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.
The creative use of language to justify the approval of #Covaxin ("restricted emergency use".. in "clinical trial mode") is at best disingenuous, at worst devious. No one in an official capacity is able to explain what the practical implications of thesse terms are. Image
Accusations of working against India's national interests levelled at those who asked questions are diabolical, as indeed are specious appeals to #AatmaNirbharBharat or to #desi vs #Angrez #vaccines. India has long since gone beyond the self-reliance of #Gandhi's #swadeshi ImageImage
#India cannot be both the World's premier supplier of pharmaceutical drugs and vaccines and at the same time have an approach to new drug and vaccine regulatory approvals process that reeks of political expediency. Image
The sad part of it is that in all likelihood #Covaxin will probably turn out to be an effective vaccine. But in the absence of phase 3 trial data we'll never know how efficacious it is. Without the trial data, @BharatBiotech will not be able to market their vaccine to the World.
Senior Govt Ministers in India have been pressed into service to tweet such nonsense.
Asking for a transparent regulatory process is NOT cynicism. It is not anti-national. Expecting India to have high standards is patriotic. Condoning low standards is the real anti-national act. Image

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More from @GorwayGlobal

9 Jan
Here is the text of the Resolution of impeachment of #DonaldTrump in the US Congress. - 4 pages in 4 tweets. Image
Read 4 tweets
8 Jan
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.…
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?
Read 6 tweets
3 Jan
Will @MoHFW_INDIA or @CDSCO_INDIA_INF put out an explanatory note to deal with all the questions about the differences in approval for
a) @SerumInstIndia's #Covishield
b) @BharatBiotech's #Covaxin…
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:…
Read 7 tweets
3 Jan
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.
Read 8 tweets
2 Dec 20
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.
Read 10 tweets
1 Dec 20
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:
The story reported:
Read 14 tweets

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