Pharmaceutical company Bharat Biotech announced it had concluded the final analysis of its Phase 3 clinical trials, which it called the largest Covid-19 vaccine trial in India.
The trial involved 25,800 participants aged 18 to 98. Of those, 2,433 people were over 60 years old, and 4,500 had comorbidities.
Bharat Biotech’s chairman and managing director Dr. Krishna Ella said the result “establishes the ability of India and developing world countries to focus towards innovation.”
“Covaxin will not only benefit the Indian citizens but would also immensely contribute to protect the global community against the deadly (Covid-19),” said Balram Bhargava, the director general of Indian Council of Medical Research (ICMR), which co-developed the vaccine.
Hyderabad-based Bharat Biotech is holding talks with the World Health Organization (WHO) to receive emergency use authorization for its shot. If it does, Covaxin would be the first Indian-developed vaccine to receive WHO authorization.
Bharat Biotech, ICMR, and People’s Hospital in Bhopal, which ran the trial, have denied wrongdoing.