Hyderabad: Bharat Biotech’s COVID-19 vaccine is being fast-tracked by reducing the size of Phase 2 trials by half.
Developed in collaboration with Indian Council of Medical Research (ICMR), Covaxin will now be tested on 380 healthy volunteers in Phase 2, instead of 750 as decided earlier, according to a report in Moneycontrol.
Safety and immunogenicity (vaccine’s ability to induce immune response) data will be submitted to the Drug Controller General of India (DCGI) in the next few weeks to seek approval for starting Phase 3 trials. The subject expert committee (SEC) of the central government had also asked for the same and in a meeting on October 5, had found Covaxin’s design of Phase 3 study “in principle satisfactory”, and suggested to conduct large trials.
The Phase 3 trial will be carried out on about 28,500 volunteers aged 18 years and above from 19 cities including Delhi, Mumbai, Patna and Lucknow.
In Phase 3 clinical trial, a dose of 0.5 ml each will be given on day 0 and 28.
Currently, the Phase 2 trial is going on and the second dose is yet to be given to volunteers at some sites.
Apart from Bharat Biotech, a vaccine by Zydus Cadila Ltd is also in Phase 2 trials. Serum Institute of India is also conducting Phase 2 and Phase 3 trials of the Oxford-AstraZeneca vaccine.
Also Read: COVID-19 Antibodies Last For 5-7 Months, Provide Enduring Immunity: Study
