Covaxin, India's first indigenously-developed coronavirus disease (COVID-19) vaccine, has been cleared by the Drugs Controller General of India (DCGI) for conducting the Phase-3 clinical trials. The vaccine is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Earlier, the pharmaceutical firm was asked to submit complete safety and immunogenicity data of the ongoing phase-2 trial, besides providing some clarifications, before proceeding for the next stage. In the preliminary trials, the vaccine candidate had shown positive results.
According to reports, the Subject Expert Committee (SEC) at the Central Drugs Standard Control Organisation (CDSCO) met on Tuesday and recommended granting permission for the Phase-III clinical trials of Covaxin, after assessing data from Phase I and Phase II trials, as well as the animal challenge study.
Bharat Biotech had been seeking the DCGI permission to conduct phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate, Covaxin.
The firm has said that the next phase of this 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.
According to sources, 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 drug regulatory panel had earlier observed that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported so far, a source said.
The most common adverse event was pain at the injection site, which resolved transiently, the source said.
The phase-3 clinical trial application proposes a dose of 0.5 ml on day 0 and 28, sources said.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is in phase 2 of the 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 the candidate in India.