I actually have sympathy for @BharatBiotech's scientists and the volunteers who took part in their clinical trials so far. They have been let down by bad science and poor regulatory processes. The company should never have submitted #Covaxin for regulatory approval w/o Ph 3 data
That mistake -the original sin, if you like- has led to a series of mis-steps, errors, cover-ups, linguistic contortions, and lack of clarity. The regulator shd have held the #Covaxin approval request and said, "we'll look at it when you have at least some preliminary ph 3 data"
Instead, they clubbed their approval of 3 separate products into one press release. That was Mistake No 3, driven I suspect by the desire to have a wholly Indian offering (Covishield though made in Pune was already labelled, don't forget as an #Angrez product.
But the regulators had this problem: How do you conjure of an efficacy number in the absence of ANY Ph 3 data? They could not and so they didn't. Instead they gave it a half-arsed approval, underwent a linguistic contortion to come up with "Clinical Trial Mode".
The trouble with #AliceInWonderland words and novel phraseology is this: people ask, as indeed they should, "But what does it mean?". Here's the difficulty: No one knows. Not the CEO of @BharatBiotech, not anyone in @MoHFW_India nor indeed anyone in @ICMRDELHI.
Health journalists have been asking Questions. Their investigations on the ground led to uncovering some damning and damaging facts in #Bhopal. Was it research misconduct or was it #researchfraud? Who knows but it does not smell nice.
Instead of taking on all these questions and dealing with the issues with integrity, someone in New Delhi thought it would be a good idea to get a few dozen worthies to put their signatures to a statement condemning those who raised the Questions. "Antinational, Anti-India"!!
But science and vaccine policy cannot be determined on the basis of who can rent a bigger mob to drown out the quiet insistent critics asking uncomfortable Questions. Now on #VaccinationDay, they unveil a ConsentForm, presumably specific for those centres offering #Covaxin.
This form repeats the "Clinical Trial Mode" obfuscatory phrase. So people coming for the vaccine are entitled to ask further Questions.
"Am I taking part in a trial?"
"If so is this a registered trial
"What is the efficacy of this vaccine?"
"Why not no-fault compensation scheme?
You couldn't have created a bigger fiasco if you had deliberately tried, to mark the start of what was to be the largest immunisation programme of any country ever. And instead of taking accountability the authorities and their #loyal #apologists are blaming the journalists!!!
@FaheemYounus may have the answer. India may have lost sight of this aphorism.
Typo corrected:

• • •

Missing some Tweet in this thread? You can try to force a refresh

Keep Current with JayEnAar

JayEnAar Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!


Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @GorwayGlobal

16 Jan
Having said what I did in this tweet thread linked below, it may well be the case that #Covaxin would have proved itself in a proper trial. But we'll never know now.
If the phase 3 trials do come up with an efficacy estimate it will be tainted by the #Bhopal trial centre irregularities. Hopefully they will scrap that centre and sequester all the trial data from Bhopal. If they start including data from this "clinical trial mode" roll-out...
They'd have a problem judging whether any protective effect is due to #Covaxin or due to the low number of cases reported from India anyway. That is the fundamental reason why efficacy can only ever be measured in placebo RCTs anyway.
Read 4 tweets
13 Jan
In one of my earliest columns in 2020 I looked critically at the 30 patient trial of Itolizumab in severe Covid-19 and found it scientifically statistically deficient. It is here: science.thewire.in/the-sciences/b…
I concluded that Op-Ed piece as follows: "The irony is that Itolizumab may well be a breakthrough. If it is and if its real effects can be shown conclusively in a large trial, then Biocon would be able to boast of an unbeatable product."
and with the last sentence: "As things stand, it is unlikely to make that breakthrough without much greater rigor in the science of clinical trials. India’s pharmaceutical industry cannot become world-class on the back of shoddy clinical trials."
Read 13 tweets
9 Jan
Here is the text of the Resolution of impeachment of #DonaldTrump in the US Congress. - 4 pages in 4 tweets.
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
4 Jan
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.
Read 8 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: pib.gov.in/PressReleseDet…
Read 7 tweets

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!