Covaxin, the first indigenous coronavirus vaccine developed by Bharat Biotech, is expected to be at least 60% effective, report Hindustan Times quoting a senior official of the firm.
Bharat Biotech received the regulatory approval from the Drugs Controller General of India (DCGI) for conducting Phase 3 clinical trial of the vaccine candidate late on October 22, the report said, the results of which are expected in another six or seven months.
“The benchmark for the efficacy of our anti-Covid-19 vaccine is 60%. We will be conducting the largest Phase 3 trial for Covaxin, and the efficacy results should be available by early April-May, 2021,” Sai Prasad, executive director, Bharat Biotech was quoted as saying.
At least 50% efficacy is mandated for the vaccine, according to World Health Organization (WHO) guidelines. Prasad said Bharat Biotech aims at achieving at least 60% for Covaxin, and that it could be more than that. He said chances are less for it being less than 50%.
The Phase 3 trial of the vaccine will begin mid-November involving 26,000 study subjects across 25-30 sites spread over 13-14 states, the report said, adding that 375 and 2,400 subjects had participated in the Phase 1 and 2 trials. The interim data for Phase 2 trial will be out in November, Prasad was quoted as saying.
The vaccine developed by Bharat Biotech in collaboration with ICMR and National Institute of Virology was developed by isolating the SARS-CoV-2 strain in NIV and transferring it to Bharat Biotech.
The firm is yet to decide on the pricing of the vaccines. Prasad said the firm is eyeing an expenditure of about ₹150 crore over the next six months and looking at producing 150 million doses annually, according to the report.