Wed, 9 Jun 2021

Phase-4 trials for Covaxin

Phase-4 trials for Covaxin

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 

Phase-4 trials for 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