Bharat Biotech said Wednesday that they will release the data from the third phase of Covaxin’s trial to the public in July.
According to Bharat Biotech, they will apply for Covaxin’s full license when they have all the data.
Bharat Biotech said, “As soon as the data from the final analysis of the Phase III studies are available, Bharat Biotech will apply for full approval for Covaxin.”
The company added that Phase 3 trial data will be submitted to the Central Drugs Standard Control Organization (CDSCO) first, followed by peer-reviewed journals.
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“It is important to understand that Phase 3 data will be submitted to CDSCO first, followed by peer-reviewed journals, with a timeframe of (approx.) 3 months for publication, and as communicated earlier, the Covaxin Phase 3 study results generated from full study data. “To the public in July,” said Bharat Biotech.
Bharat Biotech is aiming for an Emergency Department (EUL) for its Covaxin vaccine against Covid-19 and the Phase 3 study data will be used for the World Health Organization prequalification.
Criticizing the first Indian study of the Covaxin and Covishield vaccine, the company said the study was not a peer-reviewed publication and the design and conduct of the study reflected ad hoc analysis.
Bharat Biotech said, “A recent comparative report evaluating immunogenicity responses to spike protein after first and second dose of an India-made vaccine study had many shortcomings. The magazine, which cited a comparative report, said Covishield produces more antibodies than Covaxin. “
The company further pointed out: “This is neither a peer-reviewed publication nor a statistically and scientifically designed study, the study design and implementation reflect an ad hoc analysis rather than a predetermined hypothesis. In addition, the study was neither registered on the CTRI website nor approved by CDSCO & SEC. “
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