sohamn wrote:GoI kept insisting on bridging trials and not allowing for indemnity.
Which is still the right thing to do. When one makes comments in hindsight, always normalize it against the factors that weighed upon the decisions in that situation.
* Sputnik back in Dec/Jan was as much, if not much more controversial than Covaxin. Sample: Sputnik V vaccine rushed out to wary Russians
. Yes it's the BBC, and their attitudes vs Russia are known. But that also means Govt had no clear idea what was going on, unlike Covaxin, for which ICMR could offer expert guidance. So they did the right thing - asked for phase 3 trials.
* Normal Phase 3 trials take 7-12 months. During Covid, they were compressed to 1-2 months. Technically the 'phase 3' data everyone's releasing is just phase 3a, with repeated updates as they track the patients longer. Companies fund the trials.
* Covishield Phase 3 trials were requested in late Sept 2020, given clearance in Oct, volunteers recruited by Nov and trials done by mid Dec 2020. AZ separately funded EU phase.3 trials during the same timeframe, giving multiple sets of data.
* Sputnik was asked to complete trials as requested, and they did so by end Feb 2021. Completion was announced in March 2021 and got EUA in early April.
* Pfizer was asked to do trials in November, at the same time AZ was doing phase 3 trials in India. They declined - they demanded orders and EUA before discussing trials. They spent 3 months (Dec-Feb) trying to argue that they are special. They are not.
The DCGI's job is to maintain a careful risk/reward balance. In Dec/Jan pretty much no one had a significant record of vaccine use yet. It paid to be cautious. In April, multiple candidates have a longer known recorded with updated EUAs. Therefore Govt liberalized the approval process. It's important to not presume conditions in Dec/Jan were the same as in Apr. There is FAR more real world data now than back then.
Cautious and organized regulatory process matters. It ensures institutionally driven stability in the process. Let's look at what happened in EU - they rushed in with AZ, there was the blood clot scandal however 'real' it was, pause, reuse, withdrawal, some swearing by it and some swearing at it. Australia altogether dropped its vaccination plans based on AZ. Japan has been producing AZ vaccines since end Feb but not a single dose used because they haven't approved it after the scandal in EU.
Other side of the ocean, J&J which only last year got done with its massive asbestos-in-talc lawsuit, got embroiled in another bloot clot scandal associated with its vaccine, allegedly because Pfizer tried to undermine it. May or may not be true, but the very fact that anyone alleges such things causes loss of confidence in the regulatory process.
The point is not whether or not AZ/JJ blood clot risk is minimal. The point is that such a dysfunctional process is extremely harmful to ensuring public confidence in the whole process. It is FAR harder to rebuild credibility than cautiously go about it properly the first time out. Otherwise it sets everything back.
Is that what we want ? 3-4 different companies allegedly trying to undermine each other in the vaccine sweepstakes like the mess we saw in UK/EU and US ? The west is a horrible example here - they played too heavy on the risk side of the risk/reward balance and paid for it with multiple vaccine rollout pauses and reexaminations. Imagine the Indian headlines if the same happened with Indian vaccines.
People need to stop with the 'if my aunty had ba11s back in January...' arguments. Go do it elsewhere if you must. It's just noise here.