New Delhi: Billionaire Mukesh Ambani-owned pharma firm Reliance Life Sciences has reportedly received regulatory approval to conduct clinical trials of its Covid-19 vaccine.
The Subject Expert Committee (SEC), which advises the drug regulator on vaccines and new drugs, is said to have reviewed its application on Thursday and given its approval.
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Reliance Life Sciences, as per reports, aims to determine the maximum tolerated dose (MTD) with these trials.
A person aware of the development said that Phase-1 of the trial usually lasts for 58 days to determine the highest dose that most patients can tolerate, adding the company will be able to conduct phase two or three of the vaccine only after phase one is completed, Economic Times reported.
The vaccine, which is being developed at the company’s Navi Mumbai facility, is a recombinant protein-based Covid-19 vaccine that is similar to the Corbevax vaccine developed by Hyderabad-based Biological E.
Likely to be launched by the first quarter 2022, the vaccine is expected to be “competitively priced”.
The company started the development process last year with the vaccine entering the pre-clinical stage in October.
Meanwhile, Biological E is expected to apply for an Emergency Use Authorisation (EUA), which allows the temporary use of a medicine under specific conditions.
Six vaccines, including Russia’s Sputnik V, Serum Institute of India’s Covishield, Moderna, Johnson & Johnson, Bharat Biotech’s Covaxin and Zydus Cadila’s vaccine, have so far received EUA in India.
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The Drugs Controller General of India (DCGI) had earlier this week approved Cadila Healthcare’s ZyCoV-D Covid-19 vaccine for emergency use.