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Authors Dinesh S. Thakur

7 days 30 days All time Recent Popular
Dinesh S. Thakur
Dinesh S. Thakur
@d_s_thakur
This is a limited point about availability of efficacy data for vaccines under development in the context of the approval for CovidShield and Covaxin in India.

There have been many so-called experts on the idiotbox opining about apparent availability of P III data which 1/n

2/n apparently the SEC had access to based on which it "supposedly" approved Covaxin. Another argument that is prevalent is other regulators (US FDA and MHRA) also approved vaccines based on P II data alone. Let me give you a few facts so that you can make your own decision.

3/n The protocols for both mRNA vaccines are publicly available. You can check. Both protocols *define* when the interim analysis will be done. This is not subjective. They clearly define how many infections need to be documented before the Data Safety Monitoring Board meets.

4/n Find the protocols for the bridging study for CovidShield and Covaxin and look for a similar milestone.

Here is one set of efficacy data post the interim analysis of a mRNA vaccine.

Source:
https://t.co/BAPnP3PxEb


5/n This data was analyzed post the interim analysis where the blind was broken by the DSMB. Now ask yourself this question:
How does the SEC, or the sponsor of these studies, or the experts who are offering their opinion liberally on the idiotbox know what the efficacy is
HEALTH
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