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JayEnAar

@GorwayGlobal

16 Jan

@BharatBiotech

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.

Read 13 tweets

JayEnAar

@GorwayGlobal

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

JayEnAar

@GorwayGlobal

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

JayEnAar

@GorwayGlobal

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.
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

@BharatBiotech

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

JayEnAar

@GorwayGlobal

4 Jan

@BharatBiotech

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.

@BharatBiotech

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

JayEnAar

@GorwayGlobal

3 Jan

@MoHFW_INDIA

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
pib.gov.in/PressReleseDet…

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

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