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).
The maufacturer said that the efficacy data of Covaxin have been reported an overall efficacy as 78 per cent and efficacy against hospitalisations is 100 per cent.
Bharat Biotech, the Indian biotechnology company, which is manufacturing the COVID19 vaccine ‘Covaxin’, has stated that it will release the entire phase 3 trial data in July, following which it would begin to conduct the phase 4 trial and simultaneously apply for a full licence.
The Hyderabad-based company will submit a its trial data to Central Drugs Standard Control Organisation (CDSCO), which is national regulatory body for pharmaceutical drugs and medical devices.
Explained: What is the ‘delta’ variant of COVID19? Why is it dangerous? Can Covishield, Covaxin offer protection?
“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.
Explained: What is the third wave of COVID19? Will it hit India? Are kids at greater risk?
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%.”
Explained: What is ‘long COVID’ — how is vaccination expected to affect such patients?
“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.