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According to officials, the Hyderabad-based vaccine manufacturer applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission to run phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate.
The firm in its program said that the study would cover 28,500 subjects aged 18 years and above and would be run in 19 sites — such as Delhi, Mumbai, Patna and Lucknow — around 10 states.
According to sources, the phase-2 trial of the Covaxin is happening and the next dose is yet to be given to volunteers at some websites.
“The company presented phase-3 clinical trial protocol along with interim data of stage 1 and 2 clinical trials,” an official said.
The subject expert committee (SEC) at the Central Drugs Standard Control Organisation(CDSCO) deliberated on the application on October 5.
“After a comprehensive deliberation, the committee opined that the design of this phase-3 study is in principle satisfactory except for clarification on definition of asymptomatic, etc..
“But, the analysis should be initiated with appropriate dose identified from the phase-2 safety and immunogenicity data.
The SEC through its discussion also observed that the vaccine was well-tolerated in all dose groups and no severe adverse events have been reported so far, a source said.
The most frequent adverse event was pain at the injection site, which resolved transiently, the source said.
The phase-3 clinical trial application suggested a dose of 0.5 ml on day 0 and 28, sources said.
In any case, Bharat Biotech, indigenously developed vaccine candidate by Zydus Cadila Ltd is in the phase 2 of the human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for fabricating the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of this offender in India.
