Hyderabad-based Bharat Biotech is all set to conduct phase II clinical trials of coronavirus vaccine Covaxin from Monday. Bharat Biotech received the approval from Central Drugs Standard Control Organisation under the Directorate General of Health Services to conduct the phase II trials of Covaxin.
According to a report by Indian Express, Joint Drugs Controller Dr S. Eswara Reddy wrote a letter to Bharat Biotech International, conveying the organisation's nod for conducting the phase II trials. The trials of Covaxin will be conducted on 380 participants, who will have to be screened for four days after they receive the vaccine shots.
The letter mentions that Bharat Biotech's request for approval to initiate phase II clinical trials was examined in consultation with Subject Expert Committee (COVID-19) experts held through virtual meeting on September 3.
"This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on 03-09-2020, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised to 4 days," reads the letter dated September 3.
Phase I clinical trials of the vaccine began on July 15 at 12 centres across the country where healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. These trials on 375 volunteers are still continuing.
Bharat Biotech had announced on June 29 that it had successfully developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The 'indigenous, inactivated vaccine candidate' has been developed and manufactured in Bharat Biotech's high containment facility located in Genome Valley, Hyderabad.