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SEC recommends phase 1 clinical trials of Reliance's 2-dose Covid-19 vaccine
The company now needs approval from the DCGI to begin phase 1 trials of its vaccine candidate.
The Subject Expert Committee (SEC) has recommended phase 1 clinical trials of Reliance Life Sciences’ vaccine candidate against the coronavirus disease (Covid-19), news agency ANI reported on Friday. The proposed vaccine candidate comprises two doses, and is based on recombinant protein platform, as per reports.
Now that the SEC has recommended phase 1 trials, the next step for Reliance Life Sciences is to receive approval from the Drugs Controller General India (DCGI). Once the country’s top drugs regulator grants permission, the company can begin the first phase of clinical trials for its vaccine candidate.
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While Reliance Sciences itself is a testing centre for Covid-19, the exercise will be conducted at 10 sites, including those in in Delhi, Maharashtra, Tamil Nadu and Andhra Pradesh. Phase 1 lasts for nearly two months, or 58 days, and is conducted to detect the highest number of doses that most patients can tolerate.
The DCGI has thus far granted Emergency Use Authorisation (EUA) to six vaccines, of which two are indigenous while the rest are foreign-made. Covaxin and Covishield were the first two shots to receive EUA, followed by Sputnik V, Moderna, Johnson & Johnson and ZyCoV-D respectively. Among these, Covaxin and ZyCoV-D are made in India vaccines.
The nationwide vaccination drive against Covid-19 began on January 16 and every citizen above the age of 18 is eligible to be inoculated. Till now, 612,208,542 doses have been administered across the country, including 7,948,349 in the last 24 hours, as per the Union health ministry’s dashboard.
Also Read | India has administered at least 610 million Covid vaccine doses till now
Reliance Life Sciences describes itself as a research-driven organisation developing business opportunities in bio-therapeutics, pharmaceuticals, clinical research, molecular medicine etc. As the name suggests, it comes under the Promoter Group of Mukesh Ambani’s Reliance Industries Limited (RIL).
