Hyderabad-based Bharat Biotech said it will be carrying out clinical trials in the United States to support the marketing application for Covaxin.
Earlier, the US Food and Drug Administration (USFDA) had decided not to give Emergency Use Authorisation (EUA) to Bharat Biotech’s Covaxin. The regulator had recommended Ocugen, the US partner for Bharat Biotech’s Covid-19 vaccine, to pursue Biologics License Applications (BLA) path for Covaxin.
Bharat Biotech said, “The USFDA had earlier communicated that no new emergency use authorisation would be approved for new Covid-19 vaccines… Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN®, which is full approval.”
Bharat Biotech also added that the data from both efficacy and safety follow-up of Covaxin’s phase-three trial was currently being analysed and compiled. The company said that they will make phase-three trials data from the final analysis public soon.
Bharat Biotech added that, “Once data from final analysis of phase-III studies are available, Bharat Biotech will apply for full licensure for Covaxin.”
The company pointed out that phase-III data will be first submitted to the Central Drugs Standard Control Organisation (CDSCO), after which it will be published in peer-reviewed journals.
Bharat Biotech is seeking emergency use listing (EUL) for Covaxin and the data of the phase-three trial is needed for the World Health Organisation’s prequalification.
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