Thread by @GorwayGlobal

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.

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

#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.

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.