Government sources on Monday said that Bharat Biotech has submitted Phase 3 clinical trials data of COVAXIN to Drugs Controller General of India (DCGI) over the weekend.
This comes ahead of Bharat Biotech's pre-submission meeting which has been scheduled on June 23 for evaluation of the World Health Organisation (WHO)'s Emergency Use Listing (EUL) of its indigenous COVID-19 vaccine Covaxin.
Earlier, last month, Bharat Biotech had informed that it had submitted 90 per cent of the documentation needed for WHO's EUL. The rest of the documents are to be submitted this month
The External Affairs Ministry is coordinating with Bharat Biotech to secure WHO recognition for the COVID-19 vaccine.
Covaxin is among three vaccines currently being administered in India against the COVID-19 pandemic.
India started the world's largest vaccination drive on January 16 this year in a phased manner with healthcare workers (HCWs) getting inoculated first. The vaccination of frontline workers (FLWs) started on February 2.
The next phase of COVID-19 vaccination commenced from March 1 for those over 60 years of age and for people aged 45 and above with specified co-morbid conditions. India launched vaccination for all people aged more than 45 from April 1. Phase 3 of the vaccination drive was started on May 1 for the beneficiaries belonging to the age group 18-44.