SEC recommends Phase I clinical trials for Reliance’s Covid-19 vaccine candidate
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SEC recommends Phase I clinical trials for Reliance’s Covid-19 vaccine candidate

The company has to approach the DCGI for approval to commence the trials

  • By IPP Bureau | August 27, 2021

The Subject Expert Committee (SEC) has recommended Phase 1 clinical trials of Reliance's recombinant COVID-19 vaccine candidate. Reliance Life Sciences had sought approval for the Phase I trial of its proposed two-dose COVID-19 vaccine. The SEC gave its approval at its meeting held today.

The next step for the company is to approach the Drug Controller General of India (DCGI), for approval following which the company can start Phase I trials.

A total of 10 sites have been selected for the trails namely Tamil Nadu, Maharashtra, Andhra Pradesh and New Delhi.

The Phase I trail lasts for a maximum of 58 days to find out the tolerability of the vaccine.

On August 24th, the DCGI approved Phase II and Phase III clinical trials of India’s first mRNA Covid 19 vaccine HGCO19 developed by Gennova Biopharmaceuticals.

India has granted Emergency Use Authorisation (EUA) to six vaccines. However, only three have been rolled out so far Covishield, Covaxin, and Sputnik V.

COVID-19 vaccines produced by Moderna, Johnson & Johnson, and Zydus Cadila have been granted EUA but are not yet available in the Indian market.

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