Hyderabad-based vaccine manufacturer Bharat Biotech to release Covaxin phase 3 trial data in July, following that the company will be applying for the full licensure of COVAXIN.
Bharat Biotech, the Indian biotechnology company, which is manufacturing the COVID19 vaccine ‘Covaxin’, has stated that Bharat Biotech to release Covaxin phase 3 trial data in July following which it would begin to conduct the phase 4 trial and simultaneously apply for a full license.
Bharat Biotech to release Covaxin phase 3 trial
The Hyderabad-based company will submit its trial data to Central Drugs Standard Control Organisation (CDSCO), which is the national regulatory body for pharmaceutical drugs and medical devices.
“It is critical to understand, and further emphasise the Phase-3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier Covaxin phase 3 results full trial data will be made public during July,” the drug firm said.
Bharat Biotech’s release of its phase-3 trial data holds significance as it is a compulsory requirement to get the World Health Organization’s (WHO) Emergency Use Listing (EUL).
Regarding the efficacy of the coronavirus vaccine, Bharat Biotech was quoted as saying, “When it comes to efficacy and safety, the efficacy data of Covaxin have been reported at overall efficacy is 78% and efficacy against hospitalizations is 100%.”
“Bharat Biotech is also doing phase 4 trials to check on the real-world effectiveness of the vaccines, and to ensure its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” the vaccine manufacturer added.
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