According to the India-based pharma company, the Sputnik V vaccine has been recommended by an independent data and safety monitoring board (DSMB) to advance to a phase 3 clinical trial without any modifications.
The DSMB also found no safety concerns with the vaccine, that was developed by the Gamaleya National Research Institute of Epidemiology and Microbiology.
The vaccine’s phase 2 trial in India was carried out on 100 people as part of a randomised, double-blind, parallel-group, placebo-controlled study.
Dr. Reddy’s Laboratories said that it has submitted the safety data to the Drugs Controller General of India (DCGI) for review and also for seeking its approval to undertake phase 3 clinical trials.
Dr. Reddy’s Laboratories forged a partnership with Russian Direct Investment Fund (RDIF) in September 2020 for undertaking the clinical trials of the Covid-19 vaccine. The company also holds the rights for the distribution of the first 100 million doses of the Sputnik V vaccine in India.
Dr. Reddy’s Laboratories co-chairman and managing director G V Prasad said: “The Indian clinical trial being conducted by Dr. Reddy’s and RDIF is an adaptive design phase 2/3 trial. It is a bridging study to the larger global phase 3 study on 31,000 subjects.
“The phase 2 study in India showed a very good safety profile. This further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than 1 million people in Russia and more than 300,000 people in Argentina.”
In Russia, the vaccine was confirmed to have shown the efficacy of 91.4% based on data analysis of the final control point of clinical trials. Clinical trials for the Sputnik V vaccine are also in progress in the UAE, Egypt, Venezuela, and Belarus.
Apart from Russia and Argentina, the Sputnik V vaccine has been registered in Algeria, Belarus, Bolivia, and Serbia.
Russian Direct Investment Fund CEO Kirill Dmitriev said: “The safety data from the phase 2 clinical trial from India is very positive, and confirms the safety profile of Sputnik V in the international markets.
“The Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on safe human adenoviral vector platform.”