Reliance Life Sciences has obtained approval from the Drugs Controller General of India (DCGI) to carry out a Phase I clinical trial of its Covid-19 vaccine with some conditions.
This trial will assess the safety, tolerability and immunogenicity of the two-dose vaccine against Covid-19 infection in healthy subjects, PTI reported. The maximum tolerated dose of the vaccine will also be analysed in the Phase I trial that usually lasts for 58 days.
The latest development comes after the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) recommended initiation of Phase I trials of the SARS-CoV-2 recombinant Covid vaccine candidate, CNBC-TV18 had reported.
As per the DCGI conditions, Reliance needs to submit the updated clinical trial protocol for immunogenicity to be evaluated on day 42, rather than 14, as recommended by the SEC.
The trial will be carried out at eight centres in the Indian state of Maharashtra. The development of Reliance’s recombinant protein-based vaccine reportedly began in 2020.
So far, the DCGI granted emergency use authorisation to six Covid-19 vaccines, namely Covishield of Serum Institute of India (SII), Covaxin of Bharat Biotech, ZyCoV-D of Zydus Cadila, Russia’s Sputnik V and the vaccines of Moderna as well as Johnson & Johnson.
Zydus Cadila’s plasmid deoxyribonucleic acid (DNA) vaccine, ZyCoV-D, for Covid-19 is developed under the country’s ‘Mission COVID Suraksha’ in collaboration with the Department of Biotechnology, Government of India and executed by Biotechnology Industry Research Assistance Council (BIRAC).
ZyCoV-D is the first-ever plasmid DNA vaccine for Covid-19 in the world, the company noted. In June, the DCGI granted approval to the SII to produce Russia’s Covid-19 vaccine, Sputnik V, in the country.