The subject expert committee of central drugs standards organisation (CDSCO) cleared Bharat Biotech’s coronavirus vaccine Covaxin for emergency use authorization (EUA), recommending the “clinical trial mode” condition be relaxed, which will bring it at par with the other dose, Covishield.
Covaxin was being administered as an extension to its clinical trial, with those receiving the dose required to provide informed consent and the company needed to make follow-up calls to check for adverse effects for at least some period. This was because the company was yet to determine efficacy at the time of the approval on January 3.
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Last week, the company determined it was 81% effective in preventing Covid-19 in an interim analysis.
“The company submitted the interim phase 3 trials data three-four days back,” confirmed a senior official in the know of things in CDSCO. The SEC looked into the phase 3 interim data before making its recommendation, which will now need to be cleared by the Drugs Controller General of India (DCGI). The change could give a further boost to the dose, helping address hesitancy concerns.