As part of its effort to fast-track COVID-19 vaccine development, Hyderabad-based Bharat Biotech has cut the size of Phase 2 clinical trials of its indigenous coronavirus vaccine Covaxin by half. The vaccine, which Bharat Biotech is developing in collaboration with the country’s apex medical research body – Indian Council of Medical Research (ICMR), will now be tested on 380 healthy volunteers in phase 2 as against 750 healthy volunteers decided earlier, Moneycontrol reported.
As a result, the number of sites conducting the clinical trials of its COVID-19 vaccine has also been reduced accordingly.
The company is set to submit safety and immunogenicity data to the apex drug regulator, the Drug Controller General of India (DCGI), in the coming weeks to seek approval to start Phase 3 as early as possible. Immunogenicity data indicates the vaccine’s ability to provoke an immune response in an individual.
As per the report, the company is ready to start Covaxin’s Phase 3 trial to test the vaccine on about 28,500 volunteers.
On October 2, the company had applied to the DCGI for conducting Phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate. The firm in its application said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites — including Delhi, Mumbai, Patna and Lucknow — across 10 states, reported news agency PTI.
The Phase 3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, as per the report.
According to report, the Phase 2 trial of the Covaxin is going on and the second dose is yet to be given to volunteers at some sites. “The company presented Phase 3 clinical trial protocol along with interim data of Phase 1 and 2 clinical trials,” it quoted an official as saying.
The central government’s subject expert committee (SEC) had asked Bharat Biotech to submit complete safety and immunogenicity data of the ongoing Phase 2 trials, besides providing some clarifications, before proceeding to the next stage. The SEC, in a meeting on October 5, found Bharat Biotech’s design of Phase 3 study “in principle satisfactory”, and suggested to conduct large trials using its indigenous COVID-19 vaccine.
Besides, Bharat Biotech, indigenously developed vaccine candidate by Zydus Cadila Ltd is in Phase 2 of human clinical trials. The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of its candidate in India.
By Chitranjan Kumar