It will take some time for Sputnik V, the Russia-developed Coronavirus disease vaccine (Covid-19), to be approved for use in India. Dr. Reddy's Laboratories, which conducts clinical trials on it locally, was asked by the subject expert committee (SEC) of the national drug regulator to come back with more details.
Based in Hyderabad- On February 19, Dr. Reddy applied to the Central Drugs Quality Control Organization (CDSCO) for an emergency use authorization (EUA) for a human adenoviral vector-based vaccine candidate.
On Wednesday, the subject-matter expert committee accepted the application but did not recommend that the vaccine be approved for use in India with the current data set developed before its members.
More details, such as the company's immunogenicity data, were sought by the subject expert committee. The application has not been dismissed, after getting all the necessary documentation, they will be given an opportunity to present their case again,' said a senior government official with knowledge of the matter, requesting not to be named. The safety profile of Phase 2 clinical trials and interim results from Phase 3 trials have been provided by the organization.
Dr. Reddy collaborated with the Russian Direct Investment Fund (RDIF) in September 2020 to carry out the Sputnik V clinical trials and their distribution rights in India.
In India, the vaccine is currently undergoing Phase 3 clinical tests. In the interim review of Phase 3 clinical trials, which included data on 19,866 participants in Russia who received both the first and second doses of the vaccine, Sputnik V demonstrated an efficacy rate of 91.6 percent.