COVAXIN PHASE 3 TRIAL RESULTS TO BE OUT IN JULY: BHARAT BIOTECH

Hyderabad-based vaccine maker Bharat Biotech said on Wednesday it will release the results of phase 3 clinical trials of its coronavirus shot only in July, a month later than the previously announced timeline of June.

The Bharat Biotech shot, Covaxin, is one of the three vaccines currently approved in India for emergency use owing to the pandemic. It was given a go-ahead in January without having carried out phase 3 trials at the time. The company released interim data in April that showed the vaccine was very effective.

The firm told news agency ANI on Wednesday it will release its data to the public in July, submit it to the Central Drugs Standard Control Organisation (CDSCO) for a full license application, and give the results for a peer-review.

The interim analysis of the trials has shown an efficacy of 78% against symptomatic disease, and 100% protection from serious illness, according to the company.

“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 told the news agency on Wednesday.