The first batch of Russia’s Sputnik V vaccine for COVID-19 is likely to reach Kanpur’s Ganesh Shankar Vidyarthi Medical College by next week wherein the vaccine’s Phase 2 and Phase 3 human clinical trials will be conducted.
The decision to conduct the human clinical trials of the vaccine was taken after Dr Reddy’s Laboratories got approval from the Drugs Controller General of India (DCGI) in this regard, an official said.
Speaking to PTI , college principal R.B. Kamal said the human clinical trials of the vaccine will start from next week.
“As many as 180 volunteers have registered for the trials. Head of the research Saurabh Agarwal will determine the dosage of the vaccine to be administered. One dose will be administered and the condition of volunteers will be monitored to determine whether they need further doses or not,” he said.
Mr. Kamal said the volunteers’ vitals and condition will be checked periodically and the data will be analysed to determine whether the vaccine is a success or not.
He said the effect of the vaccine on the volunteers will be studied for seven months after the same is administered once, twice or thrice within an interval of 21 days.
After observing the effects of the vaccine for a month, authorities will be apprised of the results of the trial and they will then make a decision accordingly.
The Ethics Committee of the college has also given permission for the trails, he said.
The vaccine has to be kept at a temperature of -20 to -70 degrees Celsius.
In September, Dr Reddy’s and the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India.
As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.
On August 11, the Sputnik V vaccine 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.