Hyderabad: Dr Reddy’s Laboratories, which has applied for emergency use authorisation (EUA) for Russian C-19 vaccine Sputnik V, has submitted data from the Indian Phase II/III trials as directed by the expert committee that advises the Indian drug regulator.
The Indian trials data sought by the Drug Controller General of India (DCGI) was submitted last week and the company is now waiting to present vaccine data before the expert committee that is slated to meet this week, sources said.
Dr Reddy’s had, in the third week of February, initiated the process for seeking EUA approval for the Russian vaccine by submitting safety and immunogenicity data from the Phase II Indian study along with the interim safety, efficacy and immunogenicity data from the overseas Phase III trials.
The subject expert committee (SEC) had, during its meeting on February 24, asked the company to submit the Phase II and III data from the Indian trials.
Dr Reddy’s has conducted Phase II trials on 100 volunteers and a Phase III study on 1,500 volunteers in India as part of a bridging study to a larger global Phase III study.
It had tied up in September 2020 with Russian sovereign wealth fund, Russian Direct Investment Fund (RDIF), for conducting clinical trials and distributing over 100 million doses of the vaccine in the Indian market.