The Subject Expert Committee (SEC) from the national drug regulator is likely to meet on Monday to consider the application authorization of emergency emergency use (EUA) Dr. Reddy for Russian anti-coronavirus disease (Covid-19) Sputnik V vaccine, the conscious official of the problem has been confirmed.
“The subject expert committee meeting is being held regularly to accelerate the analysis of Covid-19-related approval requests, and can meet today to consider the Sputnik V case, after the company proposes additional data sought by experts,” said an official from the center in knowing things -Hal, who doesn’t want to be identified.
On February 19, Dr. Reddy was applied to authorize emergency use in India for the Russian Covid-19 vaccine.
In the 144th meeting held on February 24 – to examine the proposal related to Covid-19 under the accelerated approval process, the subject expert committee asked the company that presented the emergency use authorization grant, to return with more India – certain immunogenicity data.
“The company presented a proposal for giving permission to import (marketing authorization) for the emergency use of a combined vector GAM Covid Vaccine (component one and component two) along with the safety & immunogenicity data from phase II phase II / III clinical trials in India and temporary safety, efficiently & immunogenicity data from phase III clinical trials abroad, “said the subject expert committee in a previous meeting to consider sputnik applications.
“After the detailed deliberation,
the committee recommends that the company must submit immunogenicity data and the safety of phase II and III trials according to the protocol approved for further consideration of the committee. Furthermore, the company was asked to present the data more clearly,” recommended the committee.
On September 2020, Direct Reddy and Russian investment funds (RDIF) signed partnerships to conduct clinical trials of Sputnik V vaccines, and the right to distribution in India.
Sputnik V developed by Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Ministry of Health and became the first registered vaccine in the world against Covid-19 based on an established human adenoviral vector platform.
The efficacy of the vaccine was confirmed at 91.4% based on data analysis from the final control point of clinical trials in Russia.