Dr. Reddy’s Laboratories, has submitted the emergency use authorization for the Russian covid-19 vaccine known as Sputnik V of Indian data phase II/III trials after the direction of the expert committee that advises the Indian drug regulator. This was submitted last month also but the subject matter committee has rejected the application because of the lack of data.
Dr. Reddy’s had applied for the Russian vaccine approval on February 19 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.
The company had phase 2 trials with approximately 1500 people and the phase 3 trials are still going on.
The Indian trials data sought by the Drug Controller General of India was submitted last week and the company is now waiting to present it before the expert committee that is slated to meet this week, sources said.
India is already running a vaccination campaign for people over 60 years and 45 years of age. The vaccination has been covering senior citizens, healthcare workers and frontline workers but now people from 45 or above age will be getting vaccinated from April 1st and India’s vaccination will get a boom from the availability of Sputnik V from Russia which has an efficacy rate of 91.6 percent.
Dr. Reddy’s had tied up in September 2020 with the 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.