Reliance Life Sciences gets DCGI’s nod for phase-1 clinical trial of its Covid-19 vaccine

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Mukesh Ambani-owned Reliance Life Sciences on September 3 got the approval of the Drugs Controller General of India (DCGI) to conduct the phase-I clinical trial of its indigenously developed Covid-19 vaccine subject to certain conditions, according to a PTI report. The nod from DCGI was based on the recommendations put forth by the Subject Expert Committee (SEC) which looked into the application on August 26, PTI reported quoting sources.

The phase-I clinical trial will be done on healthy volunteers as per the existing protocol to assess factors such as tolerability and safety along with immunogenicity of Covid-19 recombinant protein subunit vaccine, the report added.

Reliance Life Sciences is supposed to submit the revised clinical trial protocol for immunogenicity to be assessed on Day 42, in place of Day 14, as per the recommendations put forth by the SEC of the Central Drugs Standard Control Organisation, a source told the news agency. The trials are to be conducted across eight sites in Maharashtra.

Other vaccines under trial

So far, the DCGI has granted the Emergency Use Authorisation (EUA) to six Covid-19 vaccines in India. They are Covishield (Serum Institute), Covaxin (Bharat Biotech), ZyCoV-D (Zydus Cadila), Russian Sputnik V along with vaccines made by US-based drug makers Moderna and Johnson & Johnson.

The Hindustan Times earlier reported that Bharat Biotech received DCGI’s regulatory approval to conduct the Phase 2 and phase 3 trials for its intranasal vaccine in August and it will be the first of its kind to undergo human trials in the country. The Ministry of Science and Technology said that the Phase 1 trial conducted on healthy volunteers in the age group of 18-60 years was well tolerated.

As per an Indian Express report, Phase 2 and phase 3 clinical trials for Covovax for children will kick start on September 6. The trials will be conducted in KEM Hospital and Research Centre in Maharashtra’s Vadu. On September 1, DCGI granted permission to Biological E to go ahead with Phase 2 and Phase 3 of the clinical trials for its Covid-19 vaccine for children within the age group of 5-18 years, PTI reported citing sources.