Trials to be conducted by Dr Reddy’s Laboratories from 15 November on volunteers.

 

Hyderabad: Amid the surge in Covid-19 cases in India, the Russian Sputnik V vaccine for Covid-19 has landed in India. It has arrived at the Hyderabad-based Dr Reddy’s Laboratories, as per an agreement. Earlier, it was said that Dr Reddy’s is the sole distributor of the Sputnik vaccine since an agreement has already been signed between the two, after Dr Reddy’s got approval from the Drugs Controller General of India (DCGI) to conduct phases II and III human clinical trials of the vaccine.

As far as the arrival of the Sputnik vaccine in India is concerned, Dr Reddy’s has been silent and maintaining utmost secrecy in this regard. Previously, it had announced its partnership with the Russian agency, but now it is silent. As per the agreement, 10 crore doses of the Sputnik vaccine should be supplied to Dr Reddy’s. The trials will be conducted from 15 November by Dr Reddy’s Laboratories on 2,000 volunteers. The vaccine is to be administered on volunteers in certain laboratories to test the rate of success.

Dr Reddy’s Laboratories has announced its partnership with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), Government of India, for advisory support on clinical trials of Sputnik V vaccine in India. The partnership will allow Dr Reddy’s to identify and use some of BIRAC’s clinical trial centres for the vaccine, which are funded under the National Biopharma Mission (NBM), implemented by Project Management Unit-NBM at BIRAC. Further, the company will have access to Good Clinical Laboratory Practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine. Satish Reddy, Chairman, Dr Reddy’s Laboratories, said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India.”

Commenting on the collaboration with Dr Reddy’s, Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC, said, “The government is committed to fast tracking the 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.”

The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against Covid-19 based on the human adenoviral vector platform.

It is said that this vaccine gives 92% correct and desired results; in the remaining members it may show adverse effects. Only after all kinds of trials, the vaccine is going to be released in India. It may take a longer time too. Already, the vaccine has been  tested on 40,000 volunteers. The final phase of trials is yet to be done in India; if the trials are successful, the vaccine will be released in the market. It is the world’s first vaccine for Covid-19.