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Hi Saket, most things mentioned in this thread are normal and expected. There are many other reasons to question the vaccine approval process, but these have an explanation; documentation is present, data is available, and this thread is misleading.
All clinical trials in India *have* to be registered with CTRI, irrespective of whether ICMR is involved or not. It is the first place anyone checks for trial protocol and evaluating how trials are designed. https://twitter.com/SaketGokhale/status/1346664393682030595
This is adaptive phase 1/2 for 3 formulations: BBV152A, B, C vs placebo. Protocol says 1125 participants split up into 375 ph 1 & 750 phase 2. Ph 1&2 always have fewer participants as you’re checking for safety, tolerance, reactogenicity. https://twitter.com/SaketGokhale/status/1346664398631313411
This is Ph 1/2 to study safety & mainly immunogenicity for two different doses of formulation BBV152D without placebo. Primary outcomes, adverse reactions were measured at Day 7 for Ph1 and will continue to be measured for Ph2 until day 194 https://twitter.com/SaketGokhale/status/1346664404968849408
While non-pandemic Phase1/2 can take months or a couple of years, dates are an upper limit. Not unusual to see wide range. If endpoints/outcomes met, follow up will continue as everyone is (ideally) monitored. Outcomes defined clearly for both. https://twitter.com/SaketGokhale/status/1346664410798936065
