Bharat Biotech International Limited has reportedly submitted the data from Covaxin’s Phase 3 clinical trial to the Drugs Controller General of India (DCGI). If the Indian regulator approves the data, the Bangalore-based biotechnology firm will then be able to apply for WHO approval.
For those unaware, Covaxin is the COVID-19 vaccine developed by Bharat Biotech in collaboration with ICMR (Indian Council of Medical Research). The vaccine has already been administered among millions of Indians.
The biotechnology firm had previously stated that it will submit the compiled data to the DCGI in March 2021. Moreover, this data was supposed to be published in renowned journals for peer review by July this year.
It is also worth mentioning that a successful review of the Phase 3 trials of any vaccine by a local drug regulator is required to apply for Emergency Use Authorization (EUA) in the World Health Organization. This submission of data will clear Bharat Biotech’s path of getting Covaxin listed as a globally recognized vaccine.
Earlier in March, Bharat Biotech claimed that Covaxin showed 81% interim efficiency in preventing COVID-19 contraction in people without prior infection after administering two doses. However, according to the data released after the Phase-3 clinical trials, the shot was found to be 77.8% effective against COVID-19.
Around 25,800 people had participated during the Phase-3 trial, out of which 4,500 suffered from comorbities while 2,400 were above the age of 60 years. The jab showed 60% efficacy against asymptomatic cases of COVID-19 and 93% efficiency against severe disease.
Bharat Biotech is also planning to increase the supply of its COVID-19 vaccine to the private sector. The current price at which Covaxin is sold to the Indian government is also likely to be readjusted.