Indian biotechnology company Bharat Biotech announced on Monday the start of Phase 3 trials of the COVAXIN vaccine against COVID-19.
"Bharat Biotech has announced commencement of Phase III trials of COVAXIN today. The Phase III trials will involve 26,000 volunteers across 25 centres in India, being conducted in partnership with ICMR [Indian Council of Medical Research]. It is the largest clinical trial conducted for a COVID-19 vaccine in India," the company said in a press release.
The trial has been approved by India's chief agency for drugs control.
According to Bharat Biotech, the volunteers taking part in the Phase III trials will be monitored during a year. The volunteers (all of them should be aged over 18) will receive two injections of the vaccine "approximately 28 days apart."
Suchitra Ella, the joint managing director at Bharat Biotech, said that the start of Phase 3 trials were a significant milestone for India.
"The development and clinical evaluation of COVAXIN™ marks a significant milestone for vaccinology in India, for a novel vaccine. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic. COVAXIN™ has garnered interest from several countries worldwide for supplies and introduction," Ella said in the press release.
Bharat Biotech has previously developed vaccines against illnesses such as Zika, Chikungunya, and H1N1 swine flu.
Indian manufacturers have also signed licensing agreements with international firms for the production of candidate vaccines against COVID-19.
The Serum Institute of India announced this past Thursday that it had already produced 40 million doses of Covishield, which is based on AstraZeneca's candidate vaccine, after an agreement for the production of 1 billion doses was signed back in June.