India’s protein-based COVID-19 vaccine gets approval for human trial
India's drugs regulator has given its approval to Reliance Life Sciences Pvt Ltd to con-duct phase I clinical trial for its recombinant protein-based COVID-19 vaccine candidate, a local media report said on Friday.
"On Thursday the drug regulator approved Reliance Life Sciences' application to conduct clinical trials of its recom-binant protein-based COVID-19 vaccine candidate. The approval was given after the Subject Expert Committee (SEC) re-viewed its application during a meeting," New Delhi-based TV news channel News18 said.
The company had sought the Drugs Controller General of India (DCGI)'s approval to conduct phase I trial of its proposed two-dose vaccine.
"Through Phase I, Reliance wants to obtain information on safety, tolerability, pharmaco-kinetics and mechanism of action of drugs," the TV channel reported.
Earlier this week, DCGI gr-anted approval for phase II and III clinical trials of the country's first mRNA COVID-19 vaccine HGCO19 that is being developed by Genova Biopharmaceuticals.