Clinical trials of Russia's Sputnik-V coronavirus vaccine are set to begin at the Ganesh Shankar Vidyarthi Medical College in Kanpur, Uttar Pradesh. Preparations are underway at the alma mater of India's Union Health Minister Harsh Vardhan to receive the first batch of Russia's experimental Covid-19 vaccine.
According to GSVM Medical College officials, the second and third stages of clinical trials for Russia's Sputnik-V coronavirus vaccine will be conducted at the COVID special centre laboratory on the premises. The second and third stage of the clinical trials will be conducted only after official intimation is made in this regard by the Drug Controller General of India (DCGI) to Dr Reddy's Laboratory.
Research site selected, waiting for intimation
More than 180 volunteers have signed up for these clinical trials. After they are administered the Russian Sputnik-V coronavirus vaccine, the volunteers will be monitored for over a month. Use of the vaccine on these volunteers and their periodic assessment will determine the progress of the Sputnik-V in keeping Covid-19 at bay.
Speaking to India Today, GSVM Medical College's Principal Dr RB Kamal said the college has been selected as the research site and is waiting for the official intimation of the trial. The site selection has been done and the ethical committee of the college has also approved the same.
Dr Saurabh Agarwal from GSVM Medical College's Medicine department will be heading the clinical trials along with his team. Two separate wards have been set up for the clinical trials, equipped with a dedicated research laboratory on the premises. Dr Agarwal will determine the dosage to be given to each volunteer as part of the clinical trials.
21-day period for assessment
Once a single dose of Russia's Sputnik-V coronavirus vaccine is administered to a volunteer, a waiting period of 21 days will follow to determine whether a second dosage is to be given or not. The effect of the vaccine will be studied for over seven months for any long-term effects.
Upon completion of one month since the administration of the first dose of the Covid-19 vaccine to volunteers, officials will be made aware of its effects and a decision will be taken with respect to the continuation of the clinical trials.
Russia's Sputnik-V coronavirus vaccine will be kept at temperatures ranging from minus 20 degrees Celsius to below zero degrees Celsius to 70 degrees Celsius.
Data collected as a result of tests conducted on the volunteers will determine the overall assessment regarding the success of this Covid-19 vaccine candidate.
Dr Reddy's-RDIF agreement
In September 2020, Dr Reddy's and Russian Direct Investment Fund (RDIF) entered into an agreement for clinical trials of the Sputnik-V coronavirus vaccine and its delivery in India. Russia will deliver 100 million doses of the vaccine to India, as per the agreement.
On 11 August of this year, Russia's Sputnik-V vaccine became the world's first registered coronavirus vaccine based on the human adenoviral vectors platform.
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