New Delhi: Hyderabad-based drug maker Dr Reddy’s Laboratories Monday announced that no safety concerns were identified during the mid-stage trial of the Russian Covid vaccine, Sputnik V, in India.
In September, Dr Reddy’s and the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, had entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for its distribution in India.
The vaccine, which was developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology along with RDIF, became the world’s first registered vaccine against Covid-19.
In a joint press statement with the RDIF, Dr Reddy’s said the safety data has been submitted to the Drugs Controller General of India (DCGI) for a review and “approval to continue phase 3 clinical trials”.
However, it added that “the independent Data and Safety Monitoring Board (DSMB) has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continue the clinical trial without any modifications”.
The company had conducted the phase 2 study on 100 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India. “The DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety,” it said.
According to G.V. Prasad, co-chairman and managing director, Dr Reddy’s, “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.”
Prasad said in the statement his company is “working closely towards fast-tracking the launch of the Sputnik V vaccine in India”.
The Indian drug regulator, DCGI, has approved Covishield, the Oxford-AstraZeneca Covid-19 vaccine manufactured by the Serum Institute of India, and Bharat Biotech’s Covaxin for restricted emergency use in the country to kickstart the immunisation drive.
Also read: First Covishield batch to be shipped tonight or tomorrow as India gears up for vaccine drive
Sputnik showing safety & efficacy in international trials: RDIF
Based on human adenoviral vector platform, the RDIF has claimed that the vaccine has been showing safety and efficacy both.
“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,” Kirill Dmitriev, the chief executive officer of RDIF, said in the joint statement.
The vaccine’s clinical trials are currently under way in the UAE, Egypt, Venezuela and Belarus, while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.
The vaccine has been claimed to be 91.4 per cent effective in providing protection against Covid-19 and has demonstrated 100 per cent efficacy against severe coronavirus cases.
“The vaccine’s efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia,” it said.
Also read: In a pandemic, vaccine approval considerations have to change — top ICMR scientist on Covaxin