New Delhi, March 10
India’s indigenous COVID-19 vaccine COVAXIN is no longer to be used in clinical trial mode and has got the nod of national experts to be used under the normal restricted emergency use authorisation route, just like the Serum Institute manufactured Covishield.
The move entails a huge boost to the indigenous Covid vaccine sector and the ICMR and Bharat Biotech, the joint developers of COVAXIN.
The restricted emergency use authorisation to COVAXIN had been held up in early January as the vaccine’s phase 3 efficacy data was unavailable till then and its efficiency was yet to be established though the vaccine was safe and immunogenic in early phase 1 and 2 trials.
The drug regulator had at that time approved the use of COVAXIN in clinical trial mode until efficacy data came.
With Bharat Biotech presenting interim phase 3 data showing 81 per cent efficacy for COVAXIN and Lancet also declaring the vaccine safe and immunogenic with minimum side effects based on phase 2 trial data published yesterday, the subject experts at the Central Drug Standard Control Organisation today reviewed COVAXIN data for two hours and recommended that the vaccine be brought out of the use in clinical trial mode and placed in the category of restricted emergency use.
This means beneficiaries of COVAXIN would not need to be followed up closely after administration of the jab, something that was mandatory when the vaccine was permitted for use in clinical trial mode.
COVAXIN export will also get a boost with the move.
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