Bharat biotech will be conducting clinical trials Phase -4 for Covaxin to check the real world effectiveness of the Vaccine . full licensure will be applied for Covaxin only after it gets final result of the Phase -3 studies , Said Bharat Biotech on wednesday
Phase -4 trails will not only help to check the real world effectiveness of the Covaxin vaccine but also confirms that ‘’ its a vaccine met every rigorous scientific standard for safety ,effectiveness , and manufacturing quality needed to support emergency use authorization (EUA)’’ said the manufacturer of Covaxin
Full data of Phase 3 of covaxin is to be submitted to the Central Drug Standard Control (CDSCO), first then it will be made public during July , said the manufacturer of covexin.
‘’ it is important to note, the inoculation which began in mid -january and with several million doses administration , will have credible and sizable data soon , they added
Slamming the comparative study as defective Bharat Biotech on covaxin said ‘’this is not a peer reviewed publication , nor statistically design study , the study design and conduct reflect an ad hoc analysis , rather than a predetermined hypothesis ‘