The Hyderabad based covid 19 vaccine , Covaxin manufacturing company submitted its phase iii clinical trial data to DCGI, according to Govt. sources.
Bharat Biotech’s Covaxin is one of the three vaccines being used in India . The efficacy of Covaxin was under radar as it had not submiited the stage 3 clinical trial data. The data is expected to get published within a week. It was scheduled to be published in June earlier.
Under the phase 3 clinical trial, investigators keep track of participants for at least six months after the last vaccine dose is administered . The data of those falling sick among the vaccinated and unvaccinated participants helps calculate the efficacy of the vaccine.
The trial also helps to highlight the possible adverse affects of a vaccine. Favourable phase 3 results of the vaccine’s efficacy and side-effects leads to the vaccines being approved for general human use.