Dr. Reddy’s Laboratories has announced a collaboration with Biotechnology Industry Research Assistance Council (BIRAC) to receive advisory support for the clinical trials of Russia’s Sputnik V vaccine that the company plans to start soon in the country.
Under the partnership, it will get to identify and use some of BIRAC’s clinical trial centres for the vaccine, which are funded under the National Biopharma Mission, implemented by Project Management Unit-NBM at BIRAC.
Further, it will have access to Good Clinical Laboratory Practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine, the pharma major said in a statement on Thursday.
An industry-academia interface, BIRAC was set up by the Central government’s Department of Biotechnology.
DBT Secretary and BIRAC Chairperson Renu Swarup said the government is committed to fast track clinical development of COVID vaccine candidates and provide facilitation to accelerate market readiness of a suitable vaccine.
“We at DBT look forward to this partnership with Dr. Reddy’s for this Indo-Russian collaboration for vaccine development," she said.
Dr. Reddy’s Chairman Satish Reddy said the company looked forward to working with BIRAC to “accelerate our efforts in bringing the vaccine to India.”
The company and Russia’s sovereign wealth fund RDIF, which is supporting development of the vaccine by the Moscow-based Gamaleya National Research Institute of Epidemiology and Microbiology, had in September announced a collaboration for clinical trials and distribution of the vaccine in India.
Sputnik V vaccine, registered by the Ministry of Health of Russia in August, is the world’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.
Earlier this month, Dr. Reddy’s and RDIF had received approval from the Drugs Controller General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for the vaccine. The Hyderabad-headquartered company’s CEO Erez Israeli, during a media interaction on Wednesday, had said the phase II trials were expected to begin soon. It will have about 100 participants soon and get over by December, while the Phase III trials, with 1,500 participants, could be completed as early as March.
Since the completion is subject to compilation of data and regulatory approvals, it could stretch into April or May, he had said.