Writing a column, 12-15 00 words is never easy. especially if you want to be factual, comprehensive, fair, and logical. And especially if you want it to be read widely. I faced this difficulty in rising to the challenge posed by @1amnerd when he invited me to explian this:
This was the Lancet paper of 21 Jan from an @BharatBiotech and @ICMRDELHI team reporting their phase 1 trial of BBV152 (#Covaxin). Ordinarily, a technical paper of this kind would excite interest only among PhDs and others in the same field of science.
The reason there was a story in it at all was that it was widely misrepresented on both social and mainstream media. The subliminal suggestion was that the 03 jan decision to authorise #Covaxin was after all vindicated.
Mere mortals wouldn't give a monkey's about the technical minutiae of CD4/CD8 and IgG1/G4 ratios. Who cares what an RBD is? (it is a Receptor Binding Domain, if you really must know). Charts like this are not designed to excite, are they?
The mainstream media took the easy route, It was a much easier story to report if you took the line that here at last was a prestigious foreign journal finally succumbing to the sheer weight of science and acknowledging the Indian breakthrough by publishing the results.
But Indian science stands up to the best in the world. Indian scientists have a well-earned reputation for frugal innovation. If they are let down at all it is not by the studied indifference of Western journals but by needless homegrown jingoism. science.thewire.in/health/dcgi-cd…
Explaining this takes domain knowledge, a love for writing, and an ability with language. Too technical loses you readers, too simple loses you scientific accuracy. There's no right or single middle path. Too critical and the pseudo-national trolls latch on like piranhas
It helps to have a good editor who understands the readership. But even before it got to that stage, I had rapidly to catch up with the advances in immunology that had, over the years, passed me by. In the final finished article as it appeared on the web: science.thewire.in/the-sciences/c…
And so it was gratifying to have a medical scientist like @chatterbox7916 not only read the article but read it closely enough to spot an error. This line "The other kind of T-cell mediated immune response, Th-2, is associated with cytokines.", was wrong, misleading she said.
And true enough, it was misleading. Both Th1 and Th2 immune responses are mediated by cytokines. What are cytokines and what are Th1 and Th2 immune responses. I found this an excellent primer on the subject. bmj.com/content/321/72…
"Cytokines are the hormonal messengers responsible for most of the biological effects in the immune system, such as cell-mediated immunity and allergic-type responses."
"Although they are numerous, cytokines can be functionally divided into two groups: those that are proinflammatory and those that are essentially anti-inflammatory but that promote allergic responses"
Specifically in relation to vaccine development, Soumya Chatterjee referred me to this very helpful and relatively easy to understand paper in PNAS from April 2020. pnas.org/content/pnas/1…
And I found another nice review paper in Science from May 2020 that gives a thorough account of the need for caution and careful testing to ensure that a vaccine intended to prevent disease does not result in even worse disease. science.sciencemag.org/content/sci/36…
The new terms to come up to speed with, are
#ADE or Antibody-mediated disease Enhancement
#VAERD vaccine-associated enhanced respiratory disease. And here is a nice summary of the risks.
There is far more in these two papers than can be summarised meaningfully in a Tweet thread. If you're interested you'll have to follow the links and read them. But back once one last time to the practical significance of #ADE and #VAERD
We need to proceed carefully, but that does not mean delay. We need effective vaccines, and fast, but cutting corners risks a setback as happened before with other epidemics like SARS. We need to carry the public with us and that means transparency.


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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
16 Jan
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
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

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