Bharat Biotech has submitted Phase 3 trial data for Covaxin to the Drug Controller General (DGCI) of India over the weekend. VK Paul, member, health, Niti Aayog, told CNBC TV18 news channel on Monday that Bharat Biotech had made progress and submitted Phase 3 data to the DCGI.
Bharat Biotech is also slated to hold its pre-submission meeting with the World Health Organization (WHO) on Wednesday, which is part of the process for WHO emergency use listing and approval of its Covid vaccine. The company would be submitting a summary of its report at the WHO meeting. For it to supply the Covid vaccine to other countries, the approval from WHO is necessary.
Bharat Biotech has demonstrated clinical efficacy of 78% to 100% against severe Covid-19 disease in the interim results from Phase 3 trials. The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10% over the age of 60, with analysis conducted 14 days post-second dose.
Covaxin was developed with seed strains received from the National Institute of Virology and the Phase 3 clinical trials have been co-funded by the Indian Council of Medical Research. The country has till date administered 3.38 crore doses of the Covaxin vaccine.
Bharat Biotech is scaling scale up of manufacturing capacity and adding production lines across multiple facilities in Hyderabad and Bengaluru to make 700 million doses of Covaxin annually.