Google bug,Govt daily update has mortality data of daily basis.
We all know how drug trials are run in india and their regulatory compliance also we have seen Alekh.
no surprise in this.
I know how things work. I have been in front of DCGI and SEC over 10 times for multiple approvals, but I haven't seen things getting approved without any efficacy(yes, data can be fudged; CRFs overwritten etc). BB merged preclinical animal data with P1/2 data and called it safe and effective. There P3 interim data is based on 190 volunteers instead of >20000 volunteers.
Among the >20k volunteers, they were supposed to do 1:1 randomization b/w vaccine and placebo, whereas their press release says 20k+ volunteers have been vaccinated. So only 3k were given placebo ? How do compare with such a sizable difference in samples ?
None of their data has been peer reviewed or published, only pre-printed.
I understand how many (not most) CTs happen here, but Dr HV announced Covaxin is approved in CT Mode (WTF is that if not just a CT approval ?) only, and everyone will be tracked. Well, will everyone be informed that they are given an experimental vaccine with no useful data ? Will an ICF be signed ? Will a CRF be filled ? Will AEs be monitored ? Who will managed the AEs ? Will volunteers be compensated towards an accident ?
This is blatantly unethical, whatever angle we look at. Worst of all, this is happening by the GoI, basically conducting an unapproved, unconsented trial on their populace. Unprecedented in modern times.