New Delhi: Medicinal Indian Controller General (DCGI) on Friday gave permission to Mukesh Ambani – belonging to the reliance life sciences to conduct a phase-i clinical trial of the Indigenous Covid-19 vaccine with certain conditions, said source.
Phase-i clinical trials will be carried out to evaluate safety, tolerability, and immunogenicity of the SARS-COV-2 recombinant protein subunit vaccine in healthy volunteers in accordance with the protocol, they said.
The company is required to submit a revised clinical trial protocol for immunogenicity to be assessed on day 42, instead of day 14, as recommended by the Subject Experts Committee (SEC) from the Central Medicine Standard Control Organization, said the source, citing conditions set for trials .
DCGI gives permission based on the recommendations provided by the SEC that negotiates on the company’s application on August 26.
The trial will be carried out at eight sites in Maharashtra.
Indian drug regulators have so far issued an emergency use authorization to six Covid-19 vaccines – Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s Zycov-D, Sputnik V and both made by US companies Moderna and Johnson & Johnson.