Reliance Life Sciences has reportedly approached India’s drug regulator, seeking permission for trials of its vaccine.- The subject expert committee (SEC) is said to have reviewed its application yesterday and gave its approval.
- Phase-1 of the trial usually lasts for 58 days to determine the highest dose that most patients can tolerate.
The company — run by India’s richest man
The subject expert committee (SEC) is said to have reviewed its application on Thursday and has given its approval.
Reliance Life Sciences aims to obtain reliable information on safety, tolerability, how it reacts with living organisms (pharmacokinetics or PK) and mechanism of action of the drug. The company aims to determine the maximum tolerated dose (MTD) with these trials.
Business Insider has reached out to Reliance Life Sciences seeking more details about their vaccine and Phase-1 trials.
A person aware of the development told the publication that Phase-1 of the trial usually lasts for 58 days to determine the highest dose that most patients can tolerate. The company will be able to conduct phase two or three of the vaccine only after phase one is completed, the person told ET.
The vaccine by Reliance Life Sciences will be a recombinant protein vaccine, similar to the Corbevax vaccine developed by Hyderabad-based Biological E. Biological E is expected to $4 for an emergency use authorisation (EUA), which allows temporary use of a medicine under specific conditions.
So far, six vaccines have received EUA in India. This includes Zydus Cadila’s vaccine, Serum Institute of India’s
Drugs Controller General of India (DCGI) had approved $4COVID-19 vaccine for emergency use, earlier this week. ZyCoV-D vaccine is also suitable for the younger population above 12 years of age. Adding to it, the vaccine is needle-free unlike other vaccines.
The company plans to manufacture 10-12 crore doses of ZyCoV-D annually and is expected to be made available in September in India.
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