Covaxin phase-3 data to be made public in July, says Bharat Biotech

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 it,” Bharat Biotech told a news agency.

Regarding the efficacy of the vaccine, Bharat Biotech said that, “Vaccine efficacy refers to the ability of a vaccine to bring about the intended beneficial effects on vaccinated individuals in a defined population under ideal conditions of use. 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 company said, “Whole virus Inactivated vaccines have demonstrated one of the best safety records globally.”
There are already several approved inactivated vaccines against Polio, Japanese Encephalitis, Rabies, Hepatitis A, and several vaccines under development such as Chikungunya, Zika, Dengue and Polio.

In a recent preliminary pre- peer-reviewed study about vaccine efficacy report, Bharat Biotech has clarified that it has undergone and will continue to undergo the most intensive safety and efficacy monitoring in Indian vaccines history.