By: IPP Bureau
Last updated : September 04, 2021 6:07 pm
The trial will be conducted across eight sites in Maharashtra
The Drugs Controller General of India (DCGI) has granted permission to Reliance Life Sciences to conduct Phase I clinical trial of its two-shot Covid-19 vaccine with certain conditions.
The Phase I clinical trial will be conducted to evaluate the safety, tolerability and immunogenicity of the SARS-CoV-2 recombinant protein subunit vaccine in healthy volunteers according to protocol.
The firm is required to submit the revised clinical trial protocol for immunogenicity to be assessed on Day 42, instead of Day 14, as recommended by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation, citing the conditions set for the trial.
The DCGI gave the permission based on the recommendation given by the SEC which deliberated on the company's application on August 26th.
The trials will be conducted at eight sites in Maharashtra
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.