COVAXIN PHASE 3 TRIAL DATA TO BE OUT IN JULY, SAYS BHARAT BIOTECH

NEW DELHI: Hyderabad-based vaccine manufacturer Bharat Biotech, which is carrying out its phase 3 trial will publish the data in July following that the company will be applying for the full licensure of COVAXIN.

“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. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN®,” Bharat Biotech said.

Regarding the efficacy of the vaccine, Bharat Biotech said that, “When it comes to efficacy and safety, the efficacy data of Covaxin have been reported at overall efficacy is 78 per cent and efficacy against hospitalizations is 100 per cent.”

The research found out that Covaxin creates 2.7 times less neutralising titre against the delta variant and three times less neutralising titre against the beta variant of the virus first reported from South Africa. The neutralising titre refers to the level of antibodies created.

But the vaccine remained effective against both strains.

“Our study demonstrated that despite a reduction in neutralisation